Breaking News in Pharma and Biotech: Gilead's Yeztugo Approval, Biopharma Deal Premiums, BioNTech-CureVac Merger, and AI in Precision Oncology

Pharma and BioTech Daily

#News #Tech News #Pharma and BioTech News #BioTech News #Pharma #Biotech #Genomics #Artificial Intelligence

40:22

There’s only so much you can do in a week – or, according to Oliver Burkeman, in the roughly 4,000 weeks the average human lives. Oliver is a journalist and author of the books Four Thousand Weeks: Time Management for Mortals, Meditations for Mortals, and the newsletter “The Imperfectionist.” Chris and Oliver discuss the paradox of why change can only occur once we accept that we might not be able to change. Oliver also shares how life’s mishaps can become our most treasured memories and why sharing your imperfections is an act of generosity. For the full text transcript, visit go.ted.com/BHTranscripts For the full text transcript, visit go.ted.com/BHTranscripts For a chance to give your own TED Talk, fill out the Idea Search Application: ted.com/ideasearch . Interested in learning more about upcoming TED events? Follow these links: TEDNext: ted.com/futureyou Hosted on Acast. See acast.com/privacy for more information.…

about a year ago 0:46

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Gilead has received approval for a twice-yearly HIV drug, Lenacapavir, which will be marketed as Yeztugo, potentially redefining the prep market. In other news, biopharma deal premiums show intense negotiations, with Sanofi paying a high premium for Vigil Neuroscience and Novartis acquiring Regulus for $800 million upfront. BioNTech is merging with CureVac after previously criticizing its failed COVID vaccine program. AI is becoming crucial in precision oncology, with companies like AstraZeneca and Pfizer using computational power to design trials and understand challenging cancers better. Intellia Therapeutics aims to transform lives with genome editing treatments.

72 episodes

Pharma and BioTech Daily

Breaking News in Pharma and Biotech: Gilead's Yeztugo Approval, Biopharma Deal Premiums, BioNTech-CureVac Merger, and AI in Precision Oncology

Pharma and BioTech Daily

published about a year ago

MP3•Episode home

72 episodes

#News #Tech News #Pharma and BioTech News #BioTech News #Pharma #Biotech #Genomics #Artificial Intelligence

All episodes

Pharma and BioTech Daily

1
Pharma and Biotech Daily: Bayer's $1.3B Deal, Arrowhead's Stock Drop, Vaccine Study Standoff, and More 1:00

1 hour ago1:00

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ## Bayer has secured a $1.3 billion deal with Kumquat Biosciences for exclusive access to their small-molecule KRAS G12D blocker. Meanwhile, Arrowhead has navigated through the Sarepta storm and experienced a drop in stock prices, despite having no direct ties to Sarepta's issues. In other news, a medical journal stands firm in refusing to retract a vaccine study, HHS has put a freeze on Vaxart's oral COVID-19 vaccine, and GenScript is celebrating a new era of innovation.## Additionally, discussions surround obesity leaders defending their injectable GLP-1 empires, recent layoffs at Merck, and the hurdles faced by oral obesity drugs. Opinion pieces delve into the skepticism towards mRNA technology and the potential repercussions of dismissing the head maha implementor following an mRNA purge. Stay tuned for more updates on upcoming events and job opportunities in the industry.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Stay Informed on the Latest Industry Updates 1:11

1 day ago1:11

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Vinay Prasad has returned to his position as director of the Center for Biologics Evaluation and Research at the FDA after a sudden exit less than two weeks ago. The FDA has restricted the patient pool for bluebird's Skysona gene therapy due to safety concerns, and Sarepta's AAV gene therapy platform has come under scrutiny following patient deaths from liver injuries. Genscript is celebrating a new era of innovation and trust.The text discusses the scrutiny faced by AAV gene therapy technology following patient deaths related to Sarepta Therapeutics' platform. There is a push for improvement in the technology, while some are looking to move on to other options. The article also highlights the importance of mRNA technology in cancer research and the need for continued investment in this area. Additionally, it mentions the FDA's decision on Biogen and Eisai's Alzheimer's drug, as well as five oral obesity drugs that could rival Lilly's Orforglipron. Other topics covered include cancer drug developments, gene therapy news, and upcoming industry events.Stay tuned for more updates on the latest news in the pharmaceutical and biotechnology industries.…

Pharma and BioTech Daily

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The Latest in Pharma and Biotech: Updates and Insights 1:36

2 days ago1:36

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Vinay Prasad has returned to the FDA as the Chief of the Center for Biologics Evaluation and Research, just 10 days after his mysterious departure. His return comes after a short "vacation" in California, and it is believed that the regulator convinced him to come back. Some speculate that Prasad's time away may have helped him gain a better understanding of the complexities involved in decision-making at the FDA, especially when it comes to ensuring the safety of patients and meeting the needs of various stakeholders. This unexpected turn of events has generated interest and optimism among industry insiders.Gilead remains positive about the prospects of its HIV prevention drug, despite uncertainties surrounding recommendations from the U.S. Preventive Services Task Force. The FDA has launched a new program to help pharmaceutical companies lower regulatory barriers to manufacturing in the U.S. Other news includes Dewpoint Therapeutics slashing headcount, Novartis rumored to be taking over RNA specialist Avidity, and Trilink Biotechnologies offering process development services for nucleic acid therapeutic development. Lotte Biologics is expanding its global manufacturing bases, while other companies like Bicycle, Tune, and Iovance are downsizing to conserve cash. The FDA is in flux, Pfizer is discussing pricing with Trump, and Merck is cutting jobs. Vertex's next-generation pain drug failed in trials despite strong Q2 earnings. Thank you for listening to Pharma and Biotech daily: your source for quick updates on the latest news in the pharmaceutical and biotechnology industries.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Navigating Challenges and Seizing Opportunities in the Industry 1:10

5 days ago1:10

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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Eli Lilly is facing significant drug pricing pressure, with issues ranging from the pricing of their weight loss pill Orfoglipron to market battles with competitors like Novo Nordisk. Despite the challenges, Lilly's executives see opportunities for their products in the real world. Jazz Pharmaceuticals received FDA approval for Dordaviprone, making it the first new treatment for an ultra-rare brain tumor. In other news, Sarepta beat Q2 estimates despite not holding an investor call, and Trilink Biotechnologies is offering process development services for nucleic acid therapeutic development. Lotte Biologics is expanding its global CDMO operations, while a big pharma-backed mRNA startup raised $153 million in funding. Novo Nordisk's new CEO is focusing on obesity and diabetes, Pfizer is in talks with Trump on most favored nation drug pricing, and Bayer expects more layoffs. These developments in the pharma and biotech world showcase the ongoing challenges and opportunities in the industry. Stay tuned for more updates on the latest news and trends in this rapidly evolving sector.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Novo Nordisk's Focus on Obesity, Chinese Biotech Partnerships, and Policy Pressures in the Industry 2:05

6 days ago2:05

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Novo Nordisk's new CEO, Maziar Mike Doustdar, is focusing on developing more drugs for obesity and diabetes while trimming the company's pipeline. The Department of Health and Human Services is terminating around $500 million in contracts for mRNA vaccine development, affecting companies like Moderna and Pfizer. Chinese biotechs are turning to big pharma for partnerships to survive, while Trilink Biotechnologies offers process development services for nucleic acid therapeutic development. Other top stories include biopharma CEOs being pulled into policy discussions, Bayer expecting more layoffs, and Trump threatening high tariffs on pharmaceuticals. The industry is also seeing investments in future technologies and strategies, such as AI for real-world research and integrated supply chain strategies for pharma manufacturing.Big pharma is providing support to struggling Chinese biotech companies by out-licensing drugs to multinational corporations. The recent increase in deals highlights the potential for partnerships with biotechs in the region. Biopharma CEOs are facing policy questions from tariffs to drug pricing, impacting their second quarter earnings calls. AI can help pharmaceutical companies adapt to policy pressures in the regulatory environment. Big pharmas are investing in incubators and venture funds to uncover scientific trends and determine future focus points. Pfizer's CEO is in contact with the President over drug pricing policies, while Moderna is focused on R&D partnerships rather than mergers and acquisitions. Novo's new CEO is emphasizing execution in obesity and diabetes research while trimming their pipeline. Biontech is committing to infectious diseases amid concerns over vaccine demand. Trump's threat of high pharma tariffs, a surge in July layoffs, and legal battles between Moderna, Pfizer, and Biontech are also making headlines. Events on AI for real-world research and integrated supply chain strategies for pharma manufacturing are upcoming, along with job opportunities in biostatistics, manufacturing, and publications.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Your Quick Update on the Latest News in the Industry 2:28

7 days ago2:28

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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.##Breaking News: Pfizer announces successful COVID-19 vaccine trialsIn a groundbreaking announcement, Pfizer revealed that their COVID-19 vaccine candidate has shown to be over 90% effective in preventing the virus. This news brings hope to the world as we continue to battle the global pandemic.##FDA approves new treatment for Alzheimer's diseaseThe FDA has approved a new treatment for Alzheimer's disease, marking a significant advancement in the fight against this debilitating condition. This approval could potentially change the lives of millions of patients and their families.##Johnson & Johnson recalls baby powder due to asbestos contaminationJohnson & Johnson has issued a voluntary recall of its baby powder products after trace amounts of asbestos were found in samples. This news has raised concerns about the safety of talc-based products and the potential risks they pose to consumers.##Novartis announces major breakthrough in cancer researchNovartis has made a significant breakthrough in cancer research with the development of a new targeted therapy that has shown promising results in clinical trials. This innovation has the potential to revolutionize cancer treatment and improve outcomes for patients.##Merck receives FDA approval for new diabetes drugMerck has received FDA approval for a new diabetes drug that offers another option for patients struggling to manage their condition. This approval expands treatment options and provides hope for those living with diabetes.##Roche acquires biotech company in multi-billion dollar dealRoche has announced the acquisition of a biotech company in a multi-billion dollar deal that will expand its portfolio and strengthen its position in the market. This strategic move demonstrates Roche's commitment to innovation and growth in the biotech sector.##Incyte collaborates with academic research center to develop new therapiesIncyte has formed a collaboration with an academic research center to develop new therapies for a range of diseases, including cancer and inflammatory conditions. This partnership brings together expertise from both sectors to accelerate the discovery and development of innovative treatments.##Overall, these recent developments in the pharmaceutical and biotech industry highlight the ongoing efforts to advance healthcare and improve patient outcomes. From groundbreaking vaccines to innovative therapies, these advancements are shaping the future of medicine and providing hope for patients worldwide.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Vaccine Rates Drop, Glioblastoma Research Soars, and FDA's Surprising Rejection 1:02

8 days ago1:02

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Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. BioNTech is focusing on infectious diseases as vaccine rates drop, with expectations that the US COVID-19 vaccination rate will decrease slightly. Glioblastoma research is seeing increased funding and interest from companies like Merck and Jazz Pharmaceuticals. The FDA's rejection of Replimmune's melanoma drug, despite staff consensus, has caused a drop in the company's stock. Sarepta and Capricor learned of regulatory decisions through media leaks, causing confusion for patients and families. Trilink Biotechnologies offers process development services for nucleic acid therapeutic development. Lotte Biologics is expanding globally, Allogene is discontinuing an immunosuppressive antibody after a patient death, and NIH funding cuts are impacting biotech. Pharmas are increasing investment in AI despite challenges in the industry. Trump urges pharma companies to address drug pricing, while Merck plans to cut 6,000 jobs to save $3 billion.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Moderna, Regeneron, and FDA Updates 1:02

9 days ago1:02

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Moderna CEO Stephane Bancel has stated that the company is not interested in pursuing mergers and acquisitions, preferring to focus on research and development partnerships instead. Former President Trump has threatened 17 big pharmaceutical companies with a deadline to lower drug prices or face government intervention. Regeneron faces regulatory issues affecting decision dates for high-dose Eylea, while Moderna has won a UK patent battle against Pfizer and BioNTech. After the removal of FDA chief Dr. Prasad, Dr. Makary is seeking better alignment between drug and biologic approvals at the agency. Alnylam's impressive sales of Amvuttra ATTR-CM have led to a surge in stock prices, while Merck is aiming to save $3 billion through job cuts. Moderna is also cutting 10% of its global workforce. Recent FDA approvals for myeloma and Alzheimer's treatments, as well as updates on layoffs and pipeline developments in the biotech industry are also making headlines.…

Pharma and BioTech Daily

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Top Highlights in Pharma and Biotech: Biogen's Leqembi Sales Surge, Moderna Cuts Workforce, AbbVie Celebrates Success 0:37

12 days ago0:37

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Biogen's sales of the partnered Alzheimer's drug Leqembi have climbed 20% in the second quarter, while CEO Chris Viehbacher dismisses rumors of disagreements with Eisai. Moderna has cut 10% of its global workforce as part of cost-cutting measures. AbbVie is celebrating the success of Skyrizi and Rinvoq, Lilly's Mounjaro shows promise in a cardiovascular trial, and there is optimism around Sarnas for therapeutic breakthroughs. Amidst industry challenges, many biopharma professionals are looking for new job opportunities.…

Pharma and BioTech Daily

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The Biotech Buzz: Latest News and Updates in Pharma and Biotech World 1:58

13 days ago1:58

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Vinay Prasad's departure from CBER has analysts anticipating a more traditional successor, while GSK streamlines its pipeline and pledges billions in US investments. Susan Monarez is now the confirmed CDC director, and the top biopharma venture capital raises of H1 2025 are summarized. Despite challenges like layoffs and market fluctuations, GSK remains committed to investing in the US despite tariffs. Other headlines include Madrigal's potential $2 billion investment, Biogen and Eisai's Alzheimer's drug update, and Novo Nordisk's new leadership. Trilink Biotechnologies is offering self-amplifying RNA constructs for potential therapeutic advancements.AI biotech companies have secured substantial funding in the first half of 2025, with continued investment pouring into startups within the industry. The top five biopharma venture capital raises of this period are highlighted. There is confusion surrounding Ira's definition of 'drug,' potentially hindering companies from pursuing approval for new formulations and indications. Vinay Prasad's departure from the FDA's Center for Biologics Evaluation and Research, following controversies related to Sarepta, has raised concerns among developers. Despite challenges, four biotech companies are successfully launching their products independently.Over 260 million people are impacted by rare diseases, emphasizing the need for faster evidence generation through global real-world data. GSK's commitment to investing in the US, Merck's cost-cutting measures to support its launch schedule, and Novo Nordisk's new leadership are also highlighted. The FDA has updated regulations regarding Sarepta's DMD gene therapy, making it available for ambulatory patients. Adaptimmune anticipates significant staff reductions following a cell therapy asset sale. Stay tuned for more updates on the latest developments in the biopharma industry.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: New Novo Nordisk CEO, FDA Reversal on Sarepta, and More 0:49

14 days ago0:49

0:49

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Novo Nordisk has announced Maziar Mike Doustdar as its new CEO, along with a 5% reduction in its 2025 sales guidance. This decision comes as a response to the slowed growth of its semaglutide franchise in the U.S. Senate Democrats are currently looking into HHS Secretary RFK Jr.'s controversial move to dismiss all 17 members of the CDC's vaccine advisory committee. Astrazeneca CEO Pascal Soriot emphasized the importance of global collaboration in pharmaceutical research and development. Merck has allocated $3 billion to support upcoming product launches. In a surprising turn of events, the FDA has reversed its decision on Sarepta, now permitting DMD gene therapy for ambulatory patients.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: The Latest in Industry Partnerships, Drug Developments, and Regulatory Updates 1:48

15 days ago1:48

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. GSK has entered a partnership with Hengrui worth up to $12 billion, focusing on the COPD candidate HRS-9821. The FDA's new voucher policy has caused confusion among experts, as it lacks clear definition and was announced without public input. The American Medical Association urges RFK Jr. to maintain the preventive task force, and Sarepta denies a patient death is linked to Elevidys as the FDA launches a probe. Biopharma companies are leaning towards holistic treatments for Alzheimer's, while Atai-partnered schizophrenia drug fails in a mid-stage trial. Boehringer partners with Irish startup Re-Vana in a $1 billion+ eye deal.As the Alzheimer's space becomes more competitive, biopharma companies are focusing on holistic treatments beyond disease-modifying drugs like Leqembi and Kisunla. Companies such as Bristol Myers Squibb, Acadia, Otsuka, and Lundbeck are renewing their search for symptomatic treatments. Five upcoming data drops could potentially lead to more effective therapies for Alzheimer's. Sarepta Therapeutics is facing challenges due to safety concerns surrounding its gene therapies, leading to a drop in stock value. The FDA's new voucher program aims to offer accelerated pathways for drugs meeting certain criteria, but experts criticize the lack of transparency and public input in the policy's announcement. Sarepta's future is uncertain as the FDA considers a new study for Elevidys, and the EU issues a negative opinion on the drug. Other news includes delays in the FDA decision on GSK's Blenrep, AstraZeneca's PIII win with nanobody treatment for myasthenia gravis, and the removal of thimerosal from influenza vaccines. George Tidmarsh has been appointed as the new chief of FDA's CDER.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Elevidys setback, Lilly's big commitment, and more! 0:53

16 days ago0:53

0:53

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The European Medicines Agency's CHMP did not recommend approving Elevidys for ambulatory patients with Duchenne muscular dystrophy, dealing a blow to Sarepta. FDA is rumored to request new data for Elevidys, leading to uncertainty as FDA considers a new study for the drug. In other news, Eli Lilly commits $856 million to Gate Bioscience for a new class of medicines, while Rocket trims headcount and pipeline focus. Roche also drops an early obesity asset as layoffs continue in the biopharma industry, with companies like Adicet optimizing their pipelines. Novartis makes a billion-dollar drug discovery deal with Matchpoint, and the FDA opens a pilot run of the commissioner voucher program.Stay tuned for more updates on the latest developments in the pharmaceutical and biotech world.…

Pharma and BioTech Daily

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Pharma and Biotech Update: Roche drops obesity asset, Novartis strikes deal, AstraZeneca's Phase III win, and more! 0:56

19 days ago0:56

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Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Roche has dropped an early-stage obesity asset, CT-173, citing lack of competitiveness. Novartis has entered into a drug discovery deal with Matchpoint Therapeutics, acquiring global rights on all molecules for several inflammatory diseases. AstraZeneca claims a Phase III win with its nanobody treatment for myasthenia gravis. Second-quarter earnings season is approaching, and biotechs to watch include Sarepta and others facing challenges in the biopharma industry. Genentech downsizes as priorities shift, and GSK's comeback for Blenrep is on pause as the FDA delays its decision. The FDA's lack of transparency has tarnished Sarepta's reputation after patient deaths triggered an FDA battle. Opportunities in the industry include roles like Quality Specialist at CSL and Clinical Research Physician at Eli Lilly and Company.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: FDA Voucher Program, Sarepta's Elevidys Halts, and AstraZeneca's $50 Billion Investment 1:17

20 days ago1:17

1:17

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The FDA has initiated a voucher program to address lower drug prices and boost domestic investment, with up to five companies being selected based on national priorities. Roche has halted shipments of Sarepta's Elevidys gene therapy after reports of patient deaths. Sarepta is under FDA scrutiny following a third patient death, while the agency welcomes a new top drug regulator and rejects multiple new drugs from entering the market. Insights from women in biopharma highlight the importance of resilience. Zhen Li, an engineer, is playing a crucial role in shaping the field of siRNA. Research suggests that GLP-1s may offer protection against neurodegenerative diseases. Dispatch Bio enters the scene with a substantial $216 million investment for universal CAR T therapy. Sarepta complies with an FDA request to suspend US shipments of Elevidys, raising concerns about transparency and impacting the company's reputation. Replimune experiences a significant drop in stock value following an FDA rejection, while AstraZeneca makes a bold $50 billion investment in US manufacturing to prepare for potential tariffs. Thank you for tuning in to Pharma and Biotech daily for the latest updates in the industry.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: The Latest News and Trends in the Industry 0:50

21 days ago0:50

0:50

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Sarepta Therapeutics has halted the distribution of Elevidys in the US after the FDA request, following two deaths. The company's transparency has been called into question, affecting its stock value. Replimmune also faced setbacks after the FDA rejected its melanoma treatment, causing a significant drop in shares. On a more positive note, AstraZeneca has pledged $50 billion for US manufacturing, focusing on drugs like Baxdrostat and oral glp-1 therapies. Sanofi has made a $1.6 billion vaccine acquisition, while Biogen commits $2 billion to expand US drug production. The pharmaceutical industry is seeing various developments and challenges, with companies adapting to regulatory demands and market pressures.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Navigating the Latest Industry News 1:51

22 days ago1:51

1:51

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.George Tidmarsh, a biopharma veteran and adjunct professor at Stanford's medical school, has been appointed as the new head of the FDA's Center for Drug Evaluation and Research (CDER). His extensive industry experience will be valuable in his new government position. Data secrecy among cell and gene therapy developers is hindering progress in the field, causing fragmentation, stalling innovation, and delaying access to treatments. Meanwhile, Sarepta is facing challenges with its elevidys shipments and has lost platform designation for its technology. At the same time, Roche's phase III trial in COPD has failed, impacting the market path for astegolimab. Layoffs are happening at companies like GSK, Sail, and BioNTech. Experts are exploring new ways to overcome barriers in cell therapy production.Data secrecy among cell and gene therapy developers continues to hinder progress and access to treatments. Acadia has introduced a new team and pipeline with ambitious goals. Patients are fighting for access to Brainstorm's ALS drug after promising real-world data. Moderna's withdrawal of its flu vaccine has left combination flu/COVID-19 vaccines in limbo. In other news, Sarepta is facing challenges with its DMD gene therapy, Ultragenyx's gene therapy for Sanfilippo syndrome is rejected by the FDA, GSK's Blenrep loses an adcomm vote, and BMS' anemia drug Reblozyl fails a Phase III trial. The FDA is experiencing layoffs and employee turnover amid an overhaul. Vinay Prasad overruled reviewers on Moderna's COVID-19 shot for kids. Upcoming events include a webinar on AI for real-world research and job opportunities in the biopharma industry. Readers are encouraged to provide feedback and suggest topics for future coverage.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Sarepta's Stock Plummets, Novartis' Positive Trial, AstraZeneca's Vaccine Delivery Delay, Pfizer and BioNTech's Booster Shot Study 2:58

23 days ago2:58

2:58

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Sarepta Therapeutics experienced a significant drop in shares as the FDA considers requesting a halt to shipments of the Duchenne muscular dystrophy therapy Elevidys. This decision comes after a third patient death linked to the underlying platform. The company's stock plummeted by 37% on Friday afternoon as reports of the potential shipment stop circulated in the media. This news adds to the already turbulent week for Sarepta, which has been facing challenges in its gene therapy and siRNA biotech developments. ## Novartis announced positive results from a phase 3 trial of its drug Cosentyx in treating axial spondyloarthritis. The study showed that patients treated with Cosentyx had significant improvements compared to those on a placebo. These results further solidify Novartis' position in the market for treatments of autoimmune diseases. The company plans to submit the data to regulatory authorities for potential approval of this indication.Novartis revealed encouraging outcomes from a phase 3 trial of its drug Cosentyx for treating axial spondyloarthritis. The study demonstrated that patients who received Cosentyx experienced notable enhancements compared to those who were given a placebo. These findings strengthen Novartis' standing in the autoimmune disease treatment market. The company intends to present the data to regulatory bodies for potential approval of this indication.## AstraZeneca faced setbacks as it announced delays in delivering its COVID-19 vaccine doses to the EU. The company cited production issues as the cause of the holdup, leading to frustration among European officials. This news comes at a time when vaccine distribution is crucial in combating the ongoing pandemic, highlighting the challenges faced by pharmaceutical companies in meeting global demand for vaccines.AstraZeneca encountered obstacles when it disclosed delays in distributing its COVID-19 vaccine doses to the EU. The company attributed production problems as the reason for the delay, causing frustration among European officials. This development occurs during a critical period in vaccine distribution to combat the current pandemic, underscoring the difficulties pharmaceutical companies encounter in meeting worldwide vaccine demands.## Pfizer and BioNTech announced plans to test a third dose of their COVID-19 vaccine to assess its effectiveness against new variants of the virus. The study will involve participants who have already received two doses of the vaccine and will evaluate the immune response generated by a booster shot. This initiative reflects ongoing efforts by pharmaceutical companies to adapt their vaccines to combat emerging strains of the virus.Pfizer and BioNTech unveiled intentions to examine a third dose of their COVID-19 vaccine to determine its efficacy against new virus variants. The research will include individuals who have already been administered two doses of the vaccine and will assess the immune response produced by an additional shot. This undertaking demonstrates continuous endeavors by pharmaceutical firms to modify their vaccines in response to evolving virus mutations.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Sarepta's Stock Soars and Novartis Reshoring Operations 1:16

26 days ago1:16

1:16

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Sarepta Therapeutics has recently experienced an 18% increase in its stock value following a significant business overhaul, which included staff layoffs and pipeline shifts. Analysts are cautiously optimistic about the company's future. At the same time, patients are advocating for access to Brainstorm Cell Therapeutics' ALS drug, Nurown, after promising results from an expanded access program. In other news, Novartis is in the process of reshoring its drug manufacturing operations in the US, a move that may take several years to complete. Additionally, a notable number of employees have departed from the FDA's Center for Drug Evaluation and Research amidst an overhaul by the Department of Health and Human Services. These developments underscore the continuous changes and challenges within the pharmaceutical industry. Sarepta Therapeutics recently announced a strategic overhaul, which involved cutting 500 staff members and shifting focus to sirna platform assets. This decision came after two patients passed away following treatment with its Duchenne muscular dystrophy gene therapy, Elevidys. The company has also added a black box warning for acute liver injury and failure to Elevidys as it pivots away from gene therapy programs.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Insights from the Industry Leaders 1:25

27 days ago1:25

1:25

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Johnson & Johnson reported second-quarter earnings of $23.7 billion, driven by cancer and neuroscience drugs, exceeding analyst expectations. CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030. Despite challenges in the industry, Johnson & Johnson remains optimistic about its oncology sales target as the biotech industry continues to navigate the evolving landscape of drug development and funding.In a difficult investing environment where IPOs are not guaranteed, AI-focused biotech unicorns are facing challenges in securing funding. GSK's Blenrep is facing setbacks as the FDA questions its efficacy in treating multiple myeloma, while AstraZeneca's amyloidosis asset failed to improve survival in a late-stage trial. The industry is also seeing the rise of women leaders like Audrey Greenberg and the team at Acadia, who are making significant contributions to the field.Biospace is launching a new weekly newsletter focused on critical manufacturing issues in the biopharma industry, covering developments and impacts on companies such as Roche, Sanofi, and Johnson & Johnson. The newsletter aims to provide deep dives, analysis, and roundups of the biggest manufacturing stories of the week every Tuesday. Stay informed with weekly analysis and updates on the changing landscape of manufacturing in the U.S.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Your Morning Dose of Industry Updates 1:06

28 days ago1:06

1:06

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The U.S. Department of Health and Human Services (HHS) has begun formally laying off thousands of employees following a Supreme Court ruling allowing the Trump administration to reorganize the agency. FDA Commissioner Marty Makary has proposed lowering industry user fees to make it easier for smaller companies and academics to participate in the regulatory process. Developments in HIV and prep treatments are being presented at the IAS 2025 conference, while a new dual glp-1/gip molecule from Hengrui and Kailera Therapeutics has shown promising weight loss results in Phase III trials. A new 96-channel pipettor from Rainin is also being promoted to streamline library preparation for next-generation sequencing. Updates on Acadia's pipeline, FDA rejections for Ultragenyx, advancements in narcolepsy treatments by Takeda, and the potential use of psychedelics in depression treatment are also discussed in this episode. Stay tuned for more updates on the latest news and developments in the pharmaceutical and healthcare industries.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Navigating the Latest in Drug Development and Innovation 2:11

29 days ago2:11

2:11

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Takeda has taken the lead in the race for a narcolepsy treatment with back-to-back phase III wins for their drug Oveporexton. Investors are eagerly awaiting breakthroughs in using psychedelics to treat depression. Ultragenyx faced a setback as the FDA rejected their gene therapy for Sanfilippo syndrome, citing manufacturing issues. The FDA is considering speeding up reviews for companies that promise to lower drug costs. Market reaction to recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression shows the challenges psychedelic therapies must overcome for commercial viability. Rainin Micropro offers a solution to streamline NGS preparation with their 96-channel pipettor. The industry is also focused on precision diagnostics to support precision therapeutics in the future. AstraZeneca's Baxdrostat showed promising results in lowering blood pressure in a phase III trial. The ADA revealed R&D priorities for potential blockbuster obesity treatments. Relmada has abandoned development of a depression drug after three failed attempts.The challenges faced by psychedelic therapies in the treatment of depression are discussed, as recent readouts from Compass Pathways and Beckley Psytech/Atai in treatment-resistant depression have left investors wanting more. The market reaction highlights the hurdles psychedelic therapies must overcome to prove their commercial viability. Additionally, the importance of precision diagnostics in the development of next-generation precision oncology therapies is emphasized, stating that only with the adoption of digital imaging and AI-powered analysis will these therapies reach their full potential. The FDA has several important decisions lined up, including applications in lymphoma, rare diseases, and hormone deficiency, while the American Diabetes Association's annual meeting reveals R&D priorities for weight loss medicines. Topics discussed include Capricor's FDA rejection of a DMD cell therapy, the ALS community petitioning the FDA to reconsider Brainstorm's Nurown, and updates on COVID-19 vaccines and Alzheimer's drugs. Upcoming webinars and job opportunities in the biopharma industry are also included.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: FDA Rejections, Vaccine Approvals, and Industry Acquisitions 1:01

4 weeks ago1:01

1:01

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The FDA has rejected Capricor's therapy for Duchenne Muscular Dystrophy (DMD), causing shares to plunge due to insufficient evidence of effectiveness for cardiomyopathy associated with DMD. Lilly and Sarepta also received Complete Response Letters (CRLs) for their therapies. Moderna has won full approval for its COVID-19 vaccine for higher-risk kids, while Pacira has cut staff in San Diego. The FDA has released a cache of CRLs, providing insights into the journeys to market for various drugs. AbbVie has acquired Ichnos Glenmark's lead myeloma antibody, and Ultragenyx's stock plummeted after a late-stage trial disappointment. Kennedy postponed a preventive care panel meeting after a Supreme Court win. Transitioning from one piece of news to the next, let's move on to the webinar exploring digitization strategies for drug development. Stay tuned for more updates in the pharmaceutical industry.…

Pharma and BioTech Daily

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Insights from Pharma and Biotech: CRL Transparency, Acquisition Updates, and Digitization Strategies 1:28

5 weeks ago1:28

1:28

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The FDA has recently released over 200 complete response letters (CRLs) as part of its initiative to enhance transparency regarding the reasons behind the rejection of new drug and biologics applications. This effort reflects the agency's commitment to being more open with the public about its decision-making processes.In other news, AbbVie has made a significant acquisition by purchasing Ichnos Glenmark's lead myeloma antibody for nearly $2 billion, including a substantial upfront payment of $700 million. However, Ultragenyx and Mereo Biopharma faced challenges as their stocks declined following the announcement that the phase II/III study of their osteogenesis imperfecta candidate did not yield strong results during an interim analysis.Furthermore, there is growing concern surrounding the potential dismissal of the U.S. Preventive Services Task Force, following a Supreme Court ruling that affirmed Health Secretary Robert F. Kennedy Jr.'s authority to remove its members at his discretion. This development has raised questions about the future of preventive health initiatives in the country.For drug developers, finding the right balance between speed and quality is essential for achieving success in the industry. To optimize processes and leverage technology throughout the development journey, new digitization strategies are being explored. Embracing these advancements can help streamline operations and enhance overall efficiency in drug development efforts.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Merck's Acquisition, Supreme Court Ruling, and Trump's Tariff Threats 1:04

5 weeks ago1:04

1:04

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Merck recently made a significant move in the pharmaceutical industry by acquiring Verona for $10 billion, gaining access to the commercial COPD drug Ohtuvayre. This acquisition is viewed as a strategic decision to offset potential revenue loss when the patent for Keytruda expires. In other news, the Supreme Court has suspended an injunction preventing RFK Jr.'s HHS cuts. AstraZeneca also finalized a deal with JCR worth up to $825 million for gene therapy AAVs. Additionally, Trump has threatened 200% pharma tariffs, but has provided a one-year grace period for implementation. Drug developers are being advised to digitize their outsourcing path for optimal success in the industry. Furthermore, Novo Nordisk has terminated a deal with Hims & Hers, while Lilly has received an FDA label update for an Alzheimer's drug. Various developments in the longevity biotech space have also been highlighted. Stay tuned for more updates in the pharmaceutical industry.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Legal Battles, Acquisitions, Policy Changes, and Innovation 1:11

5 weeks ago1:11

1:11

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Medical societies, including the American Academy of Pediatrics, have filed a lawsuit against RFK Jr. over changes to COVID-19 vaccine policies. They argue that his directive to remove COVID-19 from vaccination guidelines for healthy pregnant women and children puts them at risk of serious illness. Concentra has acquired struggling biotech company Cargo Therapeutics in a $200 million buyout. President Trump's tax law has restored orphan drug exemptions, cut Medicaid funding, and threatened the 340B program, while giving pharmacy benefit managers a pass. The ALS community has petitioned the FDA to reconsider Brainstorm's cell therapy Nurown, citing recent survival data. Drug developers are exploring new digitization strategies to optimize processes and embrace technology in drug development. Overall, the text discusses legal action against RFK Jr. over vaccine policy changes, recent acquisitions in the biotech industry, implications of Trump's tax law on healthcare programs, petitions regarding ALS therapies, digitization strategies in drug development.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Latest in Drug Approvals, Biopharma Milestones, and Industry Trends 1:17

5 weeks ago1:17

1:17

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Kalvista has received approval for the first on-demand hereditary angioedema pill after facing challenges with the FDA. Meanwhile, Robert F. Kennedy Jr. has made significant cuts and rehires at the Department of Health and Human Services. Upcoming biopharma milestones to watch include developments in obesity and rare genetic diseases, as well as therapies targeting the TIGIT space. Drug developers are exploring digitization strategies to optimize processes and embrace technology in the development journey amidst a busy buyout period in the pharmaceutical industry.Transitioning to the next news, the text discusses four therapies targeting TIGIT that are still holding on in a troubled space where many others have failed. It also highlights the potential of using AI and genetics to reduce adverse drug reactions and restore public trust in the pharmaceutical industry. Additionally, it mentions the FDA's decision to remove risk evaluation and mitigation strategies for certain cell and gene therapies, as well as recent developments in ultrarare therapies, cancer treatments, and regulatory changes. The text provides information on the HHS overhaul by the numbers, including rehiring hundreds of employees but still operating with reduced staff.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Keeping You Informed on the Latest Advancements 2:08

5 weeks ago2:08

2:08

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Breakthrough in Cancer TreatmentExciting news in the world of oncology as a new breakthrough in cancer treatment has been announced. Researchers have discovered a novel therapy that targets specific mutations in cancer cells, leading to significantly improved outcomes for patients. This groundbreaking treatment is set to revolutionize the way we approach cancer care and could potentially save countless lives in the future.## FDA Approval for New DrugIn other news, the FDA has granted approval for a new drug that shows promising results in the treatment of a rare genetic disorder. This drug has undergone rigorous testing and has been shown to be both safe and effective in clinical trials. The approval of this medication represents a major milestone in the field of rare disease treatment and offers hope to patients who previously had limited options for managing their condition.## Collaboration between Pharmaceutical CompaniesA collaboration between two leading pharmaceutical companies has been announced, with the goal of developing innovative therapies for a range of diseases. This partnership brings together the unique expertise and resources of both companies, potentially leading to the discovery of new treatments that could benefit patients worldwide. This collaboration highlights the importance of working together to address unmet medical needs and advance the field of medicine.## Advancements in Gene TherapyExciting advancements have been made in the field of gene therapy, with researchers reporting promising results in early clinical trials. Gene therapy has the potential to treat a wide range of genetic disorders by replacing or modifying faulty genes. These latest developments represent a significant step forward in the field of genetic medicine and offer hope to patients who previously had limited treatment options.## ConclusionIn conclusion, these recent developments in the world of Pharma and Biotech are not only groundbreaking but also offer hope for patients facing serious medical conditions. From breakthroughs in cancer treatment to advancements in gene therapy, the future of medicine is looking brighter than ever. Stay tuned for more updates on these exciting developments as we continue to follow the latest news in Pharma and Biotech.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: RSV Vaccine Expansion, Biogen's Deal Struggle, and More! 0:51

6 weeks ago0:51

0:51

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people aged 50-59 who are at risk of severe disease, following recommendations from ACIP members he had previously fired. Biogen CEO Chris Viehbacher tried to strike a deal with Sage as the company searched for a way forward after setbacks, but Sage was not interested. In other news, late-stage stumble for Cosentyx sets Novartis back in autoimmune conditions, and Gilead eyes HIV market domination with a twice-yearly treatment. Additional stories include biotech leaders and investors urging the FDA to maintain access to Mifepristone, Regeneron scoring a nod for a bispecific drug for multiple myeloma, and the increasing demand for bioinformatics roles in the industry.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: M&A Surge and Regulatory Updates in the Industry 1:29

6 weeks ago1:29

1:29

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. A judge has suspended mass layoffs at the Department of Health and Human Services, ruling that the staff cuts are likely unlawful as the agency does not have the authority to make such changes without Congress. In other news, private equity firms have recently acquired Bluebird Bio, a gene therapy biotech company, raising questions about their motivations. Additionally, RFK Jr. is advocating for changes to the vaccine injury compensation program to include COVID-19 vaccines, while the FDA is considering regulatory action on Argenx's Vyvgart Hytrulo due to safety concerns. The article also discusses Gilead's plans for dominance in the HIV market with a new drug, and other updates in the pharmaceutical industry.Private equity firms are increasingly targeting biotech companies, with Bluebird Bio recently being acquired by two firms. The first half of the year saw a surge in M&A activity in the pharmaceutical industry, with big pharmas like Eli Lilly and Novartis making multiple deals. Deals related to Alzheimer's disease also saw a significant increase following the approval of new treatments. Gilead is expanding its presence in the HIV market with a new drug, while GSK is also vying for market dominance. Other notable deals include AbbVie's acquisition of Capstan and Novartis' partnership for cardiovascular disease targets. Overall, the industry is seeing increased activity and interest from private equity firms and big pharma companies.…

Pharma and BioTech Daily

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The Pharma and Biotech Daily: Beckley's Nasal Spray Success, M&A Activity Surge, and Job Opportunities 1:14

6 weeks ago1:14

1:14

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Beckley's psychedelic nasal spray, BPL-003, has successfully cleared Phase II trials for treatment-resistant depression, showing robust efficacy data. Analysts predict the asset could reach peak market sales of $1 billion. This paves the way for late-stage development and a proposed merger with atai life sciences. In other news, M&A activity saw a significant increase in June, with big pharmas like Eli Lilly, Sanofi, and Novartis making multiple deals. The FDA's decision to remove risk evaluation and mitigation strategies from approved CAR T cancer therapies has been well-received by the cell and gene therapy community. Additionally, Argenx has made a $1.5 billion acquisition of Unum Therapeutics' macrocyclic peptides, aimed at "undruggable" targets. Moderna, Merck, UroGen, and other companies received regulatory nods for various treatments in June. Evotec is hosting a webinar on preserving quality in the pharma industry amidst financial challenges on July 16. Job opportunities in the industry include positions at Biomarin Pharmaceutical Inc., Regeneron Pharmaceuticals, and AbbVie.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: AbbVie's Acquisition, Moderna's Flu Vaccine, and More! 1:04

6 weeks ago1:04

1:04

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.AbbVie's acquisition of Capstan Therapeutics for $2.1 billion highlights the increasing trend of mergers and acquisitions in the biopharmaceutical industry. This move gives AbbVie access to Capstan's novel in vivo CAR T therapy for autoimmune diseases. Meanwhile, Moderna's mRNA flu vaccine has shown promising results, outperforming the current standard shot in adults aged 50 and older. The FDA's deployment of an AI tool has sparked concerns regarding its readiness and legal implications.Following the approval of monoclonal antibodies for Alzheimer's disease, there has been a surge in deals related to research in this area. Wacker Biotech is now offering comprehensive biologics manufacturing services, covering everything from concept to commercialization.Additional updates cover various topics such as clinical trials progress, industry layoffs, and discussions on vaccine safety. Job opportunities within the biopharmaceutical sector are also available for those interested.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Supreme Court Ruling, Depression Drug Updates, and FDA Decisions 1:02

6 weeks ago1:02

1:02

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The Supreme Court ruled in favor of Gilead in an HIV prevention case, leaving decisions on coverage of the pre-exposure prophylaxis drug to a task force led by RFK Jr. A depression drug missed its phase II endpoint but showed positive signals in other areas. The ACIP committee is scrutinizing the safety of mRNA vaccines, while analysts are focusing on safety data presented by Novo, Lilly, and Amgen at the American Diabetes Association meeting.In other news, the FDA blocked an accelerated path for a Becker muscular dystrophy drug, Altimmune's stock dropped due to mixed mid-stage data, and Calico entered into an aging research deal with Mabwell. ACIP also voted to remove thimerosal from all flu vaccines, and former regulators expressed concerns about the integrity of the FDA approval process. These updates cover a range of developments in the pharmaceutical industry, shedding light on key advancements and challenges within the healthcare sector.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Navigating the Latest News in the Industry 0:54

7 weeks ago0:54

0:54

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Former FDA official Peter Marks criticized the agency's new risk-based COVID-19 vaccine framework, stating it contradicts the administration's transparency and science standards. The CDC's advisory committee recommended Merck's infant RSV vaccine, and Novavax's approval delay raised concerns about politicization of drug approval processes. Lilly's Verve deal revealed regulatory turmoil following Marks' resignation. Meanwhile, Trump's CDC pick supports vaccine safety, Novartis made a large bet on cardiovascular disease targets, and RFK cut US funding from vaccine alliance Gavi. The biopharma industry is hiring less international talent, and pharma companies face challenges with failed immuno-oncology projects. Evotec is hosting a webinar on preserving quality in the pharmaceutical industry.…

Pharma and BioTech Daily

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Pharma and Biotech Daily: Your Essential Dose of Industry News 2:07

7 weeks ago2:07

2:07

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.The CDC's new vaccine advisors are meeting with an unexpected agenda today, including discussions on topics such as Sanofi and Gilead's protein degrader deals, the FDA's review of Sarepta's gene therapy, and a contentious hearing with RFK Jr. over vaccines. The meeting marks the beginning of a new era for the influential vaccine committee. The FDA has named a psychedelic proponent as CDER deputy director, while Nektar has declared a Phase IIb win for eczema treatment. Experts say conflicts of interest among axed ACIP members are a "red herring," and the pharma industry is facing turmoil in failed immuno-oncology projects. Prescription drug sales are projected to hit $1.75 trillion by 2030, thanks to GLP-1s. Transitioning to the next news, a major pharmaceutical company has announced a breakthrough in cancer research, potentially changing the landscape of treatment options for patients worldwide. This development comes at a time when the industry is seeing significant advancements in personalized medicine and targeted therapies. Moving on to regulatory updates, the FDA has recently approved a new drug for a rare disease, providing hope for patients who previously had limited treatment options. This decision showcases the agency's commitment to expediting the approval process for innovative therapies that address unmet medical needs. In other news, a biotech startup has secured funding for its groundbreaking technology that aims to revolutionize drug delivery methods. This investment highlights the growing interest in novel approaches to drug development and underscores the importance of innovation in the industry.Wrapping up today's episode, we take a look at the latest trends in digital health, with companies leveraging artificial intelligence and big data analytics to improve patient outcomes and streamline healthcare delivery. These technological advancements have the potential to transform the way healthcare is delivered and pave the way for a more efficient and patient-centric system. That's all for today's episode of Pharma and Biotech daily. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology sectors.…

Pharma and BioTech Daily

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Pharma & Biotech Daily: FDA Leadership Turnover and Industry Challenges 0:59

7 weeks ago0:59

0:59

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The FDA's Center for Drug Evaluation and Research (CDER) head, Jacqueline Corrigan-Curay, is leaving the agency in July, becoming the latest in a series of FDA leaders to depart. Eli Lilly is facing concerns about gastrointestinal side effects for their weight loss pill, Orfoglipron, despite brushing off these worries. Vertex's cell therapy for diabetes shows promise, but questions remain about its market potential. HHS Secretary Robert F. Kennedy Jr. has restacked the CDC's vaccine advisory committee, claiming conflicts of interest within the previous group, which experts argue may impact the committee's apolitical nature. Prothena has downsized following a failure in an Al amyloidosis trial, and Novavax is adapting to regulatory uncertainty. Overall, the FDA is experiencing significant turnover in leadership, and challenges persist in drug development and regulation.…

Pharma and BioTech Daily

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Navigating Regulatory Uncertainty: Updates from the Pharma and Biotech World 1:10

7 weeks ago1:10

1:10

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Nicole Verdun has exited the FDA as CBER director, allowing Vinay Prasad to consolidate power within the agency. Prasad is seen as a stabilizing and trustworthy figure within the rapidly changing FDA, especially since the departure of Peter Marks in late March. Novavax is adapting to regulatory uncertainty following the delayed approval of its next-generation COVID-19 vaccine. The company is relying on agility and a diverse pipeline to navigate changing regulations. Additionally, the FDA has frozen trials shipping cells to countries like China due to new export control policies. Exemptions have allowed companies to ship biological materials overseas, but this practice is now being restricted. Zealand's GLP-1/GLP-2 drug has shown promising results in weight loss trials, with analysts believing there is potential for further improvement. Intellia Therapeutics aims to transform the lives of people with severe diseases through genome editing treatments. Overall, the biotech industry is facing various challenges and changes, requiring companies to stay adaptable and innovative.…

Pharma and BioTech Daily

9 weeks ago1:05