Astellas' gene therapy strategy faces fresh setback as FDA puts Pompe disease med on hold Bear market strikes again: 4D Pharma sinks into administration as creditor calls in loans Pfizer joins the omicron data party, linking adapted vaccine to increased immune response ahead of FDA meeting Nuvation's new solid tumor focus hits snag as FDA slaps hold on a lead asset Antios therapy could be a 'bridge' in hep B treatment, but first: an FDA hold to resolve Stealth could get even sneakier with Morningside's go-private deal pitch Clover’s COVID booster bolsters antibody levels against omicron GSK stakes out path to hepatitis B functional cure after clearing virus in phase 2b trial Unable to hit licensing deal terms, Basilea to hand cancer drug rights back to Merck The 15 highest paid biopharma CEOs of 2021 Cepheid, BioGX partner on PCR tests as monkeypox spreads Digital abortion providers, doctors brace for complex legal landscape after SCOTUS ruling Still wheeling and dealing, Ipsen acquires Epizyme and lymphoma drug Tazverik for $247M Featured Story | By James Waldron Astellas’ gene therapy ambitions have faced yet another setback. The FDA has slammed the breaks on a phase 1/2 study of the Japanese pharma’s Pompe disease med while the regulator investigates a report of nerve damage in one of the trial’s participants. read more |
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Top Stories By James Waldron Biotech’s bear market has claimed another victim. 4D Pharma has gone into administration after failing to secure a loan to help ride out the “difficult” market conditions. read more By Nick Paul Taylor The variant-adapted COVID-19 vaccine updates are now coming thick and fast. Days after Moderna and Sanofi shared data, Pfizer and BioNTech have stepped into the limelight with immune response results for their monovalent and bivalent omicron-adapted mRNA vaccines. read more By James Waldron Nuvation’s slimmed down solid tumor strategy is already facing difficulties, with the FDA slapping a partial clinical hold on the biotech’s drug NUV-422 following reports of eye inflammation. read more By Annalee Armstrong Antios Therapeutics’ hepatitis B therapy slowed the virus’s rebound and patients did not have to start back on Gilead’s Viread medicine during a phase 2a clinical trial. But casting a shadow over the results is a clinical hold placed by the FDA on a separate hepatitis B study. read more By Annalee Armstrong Stealth Biotherapeutics is considering taking its business underground in a going-private transaction with Morningside Venture (I) Investments. read more By Max Bayer Clover released a sneak peek of its COVID booster data, saying a third jab elevated antibody levels against two omicron variants. The preliminary analysis comes as the company hopes to complete a trio of regulatory filings in the second half of 2022. read more By Nick Paul Taylor GSK has taken a step toward its goal of providing a functional cure to hepatitis B patients. After 24 weeks of treatment, almost 30% of participants in a phase 2b clinical trial had undetectable levels of the virus, ramping up expectations ahead of the delivery of data on durability and the start of a pivotal study. read more By Gabrielle Masson Basilea Pharmaceutica will hand back a license for cancer drug derazantinib to Merck & Co. after determining it couldn’t hit the required terms and timelines of the agreement. read more By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Kevin Dunleavy,Zoey Becker In a year in which biopharma revenues increased dramatically, especially among companies that brought COVID-19 products to the market, many firms laid out eye-popping pay packages for their chief executives. Bookending this year's list are longtime CEOs who retired from powerhouse U.S. companies during the year—No. 1 Alex Gorsky of Johnson & Johnson and No. 15 Ken Frazier of Merck. read more By Conor Hale Though the global number of recorded monkeypox cases continues to climb—passing 4,100 last week, according to the CDC—many researchers and epidemiologists believe those figures are dramatically underestimating the size of the outbreak because of a lack of testing, including in the U.S. read more By Heather Landi Even just a few hours after the Supreme Court released its decision to overturn the legal right to an abortion in the U.S., digital abortion providers were gearing up to expand their services in anticipation of surging demand. As telehealth abortion becomes more prevalent, these services, and the practice of mailing abortion pills directly to patients, will likely be at the center of new legal battles. read more By Kevin Dunleavy After a busy year of M&A activity, Ipsen is still wheeling and dealing. Monday, the French biopharma said it had an agreement in place to acquire oncology specialist Epizyme for $247 million. The 15-year-old Massachusetts-based commercial biopharma reported revenue of $37.4 million in 2021, with $30.9 million coming from lymphoma drug Tazverik, the primary target in the pickup. read more Resources Sponsored By: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter, strategic consultants in the life sciences Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. This paper explores why, and how MA teams can stay ahead of the curve. 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