Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.## Intellia reported an adverse event in its gene therapy trial, causing its stock to drop, adding to existing safety concerns in gene therapy. Analysts downplayed the event, but patient deaths in other trials have raised red flags.## Moderna lost a $760 million bird flu vaccine contract amid uncertainties surrounding its COVID-19 vaccine. ## Other news includes Iteos closing down after a failed trial, Merck and Daiichi Sankyo pulling a lung cancer filing, and Novo opposing pharma tariffs.## AGC Biologics will be at Bio International to discuss their capabilities in drug production. ## Additional stories cover Rocket's gene therapy hold, Biogen's strategy shift, and AbbVie's staff cuts.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Former Chinook board member, Rouzbeh Haghighat, has been indicted for insider trading related to Novartis' $3.2 billion acquisition of the company. Despite this scandal, pharma R&D spending increased in 2024, climbing 1.5% across the global pharmaceutical sector. The acquisition of SiteOne by Lilly follows Vertex into the non-opioid pain space, providing diversification for Lilly, which has been focusing on obesity and diabetes treatments. Meanwhile, AbbVie's Allergan cuts over 200 staff after a botched marketing campaign, and Inflarx axes a rare skin disease study due to disappointing late-stage data.AGC Biologics will be at Bio International in Boston to showcase their global capabilities in drug production. Vaccine overhaul, rocket grounding, and drug price transparency are also highlighted in the latest news. Biogen's strategy for Zurzuvae shifts as obstetricians/gynecologists rise to the front lines. Drug price transparency in the US is discussed as being easier said than done. Additionally, Rocket's gene therapy for Danon disease is on hold after a patient death, and four biotechs are facing uncertainty in the COVID-19 vaccine landscape.Global pharmaceutical companies are increasing their research and development spending despite political and economic challenges. Biogen is shifting its strategy for the drug Zurzuvae as obstetricians and gynecologists become more involved. Drug price transparency in the US is still a challenge, despite efforts to increase transparency. Trilink has introduced a new poly(A) tail modification to enhance protein expression.In other news, a former Chinook board member has been indicted for insider trading, Trump has appointed Dr. Oz to lead drug pricing negotiations, and Lilly is following Vertex into non-opioid pain treatment with a SiteOne acquisition. Sanofi has purchased Vigil for $470 million to reignite an Alzheimer's target.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.A patient death has led to the halt of Rocket's gene therapy trial for Danon disease, due to complications from an acute systemic infection. This incident highlights the unpredictable nature of gene therapies and may pose challenges for investment in the field. On the other hand, mRNA technology has been both helped and hindered by the COVID-19 pandemic. While the pandemic has increased interest and funding in mRNA research, vocal skeptics of COVID-19 vaccinations have negatively impacted the reputation of mRNA technology. Despite this, some see promise in mRNA for therapeutics in cancer and rare diseases.In other news, Prothena is considering business options after a failed phase III trial, and a new biotech company has been launched to focus on neuro diseases. Additionally, AGC Biologics will be at Bio International to showcase their capabilities in protein biologics and advanced therapies.mRNA technology played a significant role in combating COVID-19, but is now facing scrutiny due to vaccine skeptics and cuts in government funding for research. Despite this, the pandemic accelerated advancements in mRNA therapeutics for cancer and rare diseases. The lack of FDA-approved treatments for rare diseases, particularly in children, highlights a critical need for innovation in this area. The American Association for Cancer Research's annual conference will unveil data that could impact cancer treatment, while the future of vaccine development faces challenges amidst regulatory changes and funding issues. Additionally, advancements in cell and gene therapy are on the horizon. Suggestions for coverage topics in the biopharma industry are welcomed.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The biopharma industry is currently facing challenges such as tariff threats and regulatory upheaval. The market has been described as 'moribund' with the need for companies to survive in these tough times. Recent top stories include biotech's struggle with investor pullback due to new tariffs, HHS vaccine requirements sparking controversy, and layoffs in major biopharma companies. AGC Biologics will be at Bio International to showcase their global capabilities in drug production. FDA and NIH are shifting away from animal research, China remains a key source for new drugs despite tariffs, and the top highest-paid pharma CEOs are highlighted. The importance of understanding Trump's MFN executive order and the most active corporate VCs in pharma are also discussed.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.A court has halted the Trump administration's plans to reduce and lay off employees in government agencies, citing a lack of authority. Meanwhile, a report called "Make American Healthy Again" criticizes pharmaceutical lobbying, GLP-1s, and vaccines. The report also addresses rising autism rates and over-medication of children. Bio-Rad is redefining antibody discovery with their Pioneer Antibody Discovery Platform.In other news, Merus' bispecific shows promise in head-and-neck cancer, while Congress narrowly passes a tax bill with changes to IRA penalties and negotiation exemptions for orphan drugs. The FDA vaccine advisors agree on a COVID-19 vaccine as a new framework looms, and GSK wins expansion for Nucala after an FDA delay. Lilly expresses concern as CMS leaves obesity drugs out of Medicare coverage, and Sanofi acquires Vigil for $470 million upfront. And that's all for today's updates in the pharmaceutical and biotech world. Stay tuned for more essential news in our next episode.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Sanofi has acquired Vigil for $470 million upfront, sparking interest in the Alzheimer's target Trem2 following previous failures. The FDA is encouraging states to import drugs from Canada to alleviate drug shortages. In other news, the FDA has asked Pfizer/BioNTech and Moderna to add myocarditis risk warnings to their COVID-19 vaccine labels. Lilly is disappointed by CMS's decision to exclude obesity drugs from Medicare coverage, and Canada is taking steps to protect its drug supply. Bio-rad is advancing biotherapeutic antibody discovery with its Pioneer antibody discovery platform. Additional news includes Pfizer's Talzenna expansion not receiving FDA advisory committee support, Eikon cutting its workforce by 15%, and the Southeast's growing life sciences sector. Stay tuned for more updates in the Pharma and Biotech world.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Moderna has withdrawn its application for a combination flu and COVID-19 vaccine after discussions with the FDA. The vaccine had shown efficacy in eliciting antibodies, but the company decided to pull the application. In the biotech market, executives from NextGen companies discussed strategies for surviving in what they described as a "moribund" market during a webinar. Biospace's nextgen companies are thriving in a challenging biotech market. Executives discuss survival strategies in the webinar "Are We There Yet?" Pfizer's $6 billion China deal stands out in a competitive market, with Novartis' $4 billion partnership following closely. Biopharma companies are facing pressure to cut assets early due to rising development costs and regulatory hurdles. Lotte Biologics offers specialized end-to-end services at its ADC facility in Syracuse, NY. Other top stories include the FDA's new risk-based approach to COVID-19 vaccines, Genentech's investment in Orionis, and Bio-Rad's new center for excellence for biotherapeutic antibody discovery. Roche's Genentech recently did not win adcomm backing for an expansion. Pfizer has made a deal in China, and RFK claims ignorance about HHS research cuts during a hearing. The top 5 most active corporate VCs in pharma are also highlighted. Additionally, upcoming events and job opportunities in the biotech industry are featured.In conclusion, the biotech market is presenting challenges for companies, but there are opportunities for growth and strategic partnerships. Stay tuned for more updates on regulatory changes, investment deals, and industry trends in the world of Pharma and Biotech. Thank you for listening to Pharma and Biotech daily.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Pfizer has made a $6 billion bet on acquiring 3SBio's PD-1/VEGF antibody, despite being a late entrant to the space. This deal comes after Pfizer's partnership with Summit Therapeutics, causing some confusion about the pharma company's overall strategy. Meanwhile, the success of a CRISPR baby has highlighted the lack of FDA-approved treatments for the 15 million children with rare diseases. Most rare conditions do not even have a treatment pipeline. Bio-Rad is redefining antibody discovery through their Pioneer™ Antibody Discovery Platform, which accelerates programs and identifies clinical-quality candidates with industry-leading timelines. FDA Commissioner Marty Makary has expressed support for psychedelic therapies for neuropsychiatric conditions, noting significant benefits for patients. The most favored nation executive order issued by Trump may face legal challenges and unintended consequences for the healthcare sector and patient access. Overall, these developments in the pharmaceutical and biotech industries highlight ongoing challenges and opportunities in drug development and treatment for rare diseases.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Regeneron has acquired ownership of 23andme for $256 million, promising to comply with consumer privacy policies. Makary's proposed rare disease pathway has sparked hope but raised questions among experts. At the American Society of Gene and Cell Therapy meeting, the first personalized in vivo CRISPR therapy was reported. The FDA has cleared the first Alzheimer's blood test, potentially boosting uptake of Alzheimer's disease therapies. Bio-Rad's new Center for Excellence is redefining antibody discovery with their Pioneer Antibody Discovery Platform. FDA regulations are unlikely to save money for the industry, and Applied Therapeutics' rare disease treatment has failed in late-stage trials. The memory gap in forgotten diseases is making a dangerous comeback, and Novo CEO's sudden exit has raised concerns among analysts.FDA Commissioner Marty Makary's proposal for a 'conditional approval' pathway for rare diseases has sparked hope among biopharma companies, but experts are raising concerns about safety, access, and liability due to a lack of details. The FDA and NIH are accelerating the shift away from animal research, which has raised questions about safety and implementation. Meanwhile, FDA cuts have led to chaos in planning for upcoming advisory committee meetings. The Trump administration's efforts to slash regulations may not necessarily benefit the industry as anticipated. Sarepta is seeking to strengthen its case for Elevidys with data in older kids, while other companies such as Incyte and Lilly are making progress with their drug approvals. Overall, the biopharma industry is facing challenges and uncertainties in navigating the evolving regulatory landscape.

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 CEO Lars Fruergaard Jorgensen is set to depart as the Danish pharma company's shares have been on a decline. During Jorgensen's eight-year tenure, the company saw significant growth in sales, profits, and share price, nearly tripling in value. However, since mid-2024, the shares have dropped by half in just one year. Jorgensen's departure comes as a surprise given the company's previous success under his leadership.