| Affordable, Expert IRB Solutions Our service-first IRB solutions, customer focused fee schedules and nationally recognized IRB committees with expertise in recombinant DNA, gene therapy, stem cell, rare diseases, oncology, digital health (and more) give you the assurance that the biggest IRB isn’t always your best option. Request a consultation. | Play-by-play: How Sanofi jacked up its offer twice to seal the $1.9B deal for Kadmon Facing backlash from scientific community, Cassava drops interim Alzheimer's data with plenty of caveats Walgreens Boots Alliance makes $970M investment in Shields Health Solutions An Epic success: FDA approves Abbott's upgraded, longer-lasting replacement mitral valve Reckitt's Mucinex ushers in cold and flu season with tribute to Latinos making a difference OIG: Most states not doing enough to monitor Medicaid telehealth fraud for behavioral health services Lonza's march of manufacturing expansion continues with more backyard plans Striking deals with Blueprint COO Haviland Kaufman Hall: Hospitals could lose $54B this year due to more expenses, sicker patients SAB Biotherapeutics banks $60M more in funding from U.S. officials for COVID-19 antibody FDA clears Paige's AI as first program to spot prostate cancer in tissue slides COVID-19 tracker: J&J teams up with HealthVerity; Amnesty International blasts vaccine makers Featured Story By Angus Liu With an existing transplant portfolio, Sanofi is naturally fit to be the new owner of Kadmon, developer of graft-versus-host disease drug Rezurock. And the French pharma spent less than three months to successfully convince the biotech of that and at the right price. read more |
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| | Webinar: Building a robust FIH biologics regulatory CMC package Thursday, October 7, 2021 | 2pm ET / 11am PT Join us to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan: progressively developing knowledge of the molecule’s critical quality attributes to justify the manufacturing and control strategy, planning for continuing development, and identifying opportunities to enhance with scientific advice. Register Now. | Top Stories By Annalee Armstrong As the scientific community continues to debate the validity of Cassava Sciences’ clinical data for the Alzheimer’s disease candidate simufilam, the biotech is hoping some interim results will soothe worried investors. read more By Paige Minemyer The Walgreens Boots Alliance is making a $970M investment in Shields Health Solutions, a prominent company in health system-owned specialty pharmacy. read more By Andrea Park With a green light from the FDA, Abbott is scaling up its replacement mitral and aortic valve portfolio to epic proportions—or, more specifically, to Epic Plus proportions. read more By Beth Snyder Bulik Reckitt's Mucinex brand is spotlighting Latino front-line workers with a campaign that celebrates their contributions—and their need to stay healthy. A nurse, a boxing coach and an esthetician in southern California star in the "Our Community Needs You" effort. read more By Robert King States aren't doing enough to monitor for fraud and determine the impact of telehealth services for treating behavioral health for Medicaid enrollees, a new report from a federal watchdog finds. read more By Joseph Keenan Swiss CDMO giant Lonza, which has been on a growth spurt around the world, is now planning more improvements to expand production capabilities in its own backyard. read more By Amirah Al Idrus Blueprint Medicines’ portfolio of molecularly targeted treatments is the “sweet spot” for a small company, but sometimes a deal is the best way to move forward. Fierce Biotech caught up with the biotech's Chief Operating Officer Kate Haviland to talk about her approach to dealmaking. read more By Robert King Hospitals could lose an estimated $54 billion this year as higher acuity cases and greater expenses could offset recovery in volumes, a new analysis finds. read more By Annalee Armstrong SAB Biotherapeutics has snared another $60.5 million from the U.S. Department of Defense (DOD) to fund an antibody program to treat COVID-19. This brings the total funding SAB's received from the Biomedical Advanced Research Development Authority and the DOD to $200 million. read more By Conor Hale Tech companies have been questing for years to develop artificial intelligence able to help diagnose cancer—and now one has an FDA clearance to do just that. The software highlights areas of a standard prostate biopsy image most likely to contain cancer and flags them for further review by a trained professional. read more By Noah Higgins-Dunn,Kevin Dunleavy,Fraiser Kansteiner,Emmy Lucas Biopharmas such as Clover and SAB are seeing progress with their COVID-related programs. Plus more. read more |