Pfizer stalls COVID-19 vaccine app as it awaits data on third dose in young kids Roche, Lilly push back against CMS painting their Alzheimer’s meds with the same brush as Biogen’s Aduhelm Illumina CEO: Here's why speeding Grail's cancer test to patients requires 'every part of our company' Report: Only 14.3% of hospitals compliant with price transparency rules one year in Ipsen telegraphs $400M deal for consumer healthcare split Ex-FDA interim chief Giroir rejoins biotech world with eyes on $50M fundraising for new infectious disease company Signify Health scoops up Caravan Health for $250M to form largest network of at-risk providers Dexcom bests its ‘best year ever’ with 27% surge to $2.5B revenue in 2021 Eli Lilly talks up ‘long-term’ game plan for tirzepatide launch, but don’t expect major sales early on AHIP presses for clarification on effect of CMS' Aduhelm decision on Medicare Advantage plans Cassava scores a win as FDA declines to intervene in petition to stop its Alzheimer's drug trials AbbVie runs first Qulipta TV ad spots as it focuses on what you ‘can control inside’ Senseonics lands long-awaited FDA approval for 6-month implanted CGM system Featured Story | By Fraiser Kansteiner Waiting for data on a third dose, Pfizer and BioNTech are extending the FDA submission for their COVID-19 vaccine in children younger than five. The FDA has likewise delayed its expert advisory panel for the pediatric vaccine, which was originally scheduled for Feb. 15. Pfizer says it expects to have data on a three-dose regimen in young kids by early April. read more |
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Top Stories By Annalee Armstrong In a rare moment of solidarity among fierce competitors, Biogen’s peers Roche and Eli Lilly are rallying behind the company’s troubled Alzheimer’s disease therapy, Aduhelm, in an effort to change the Centers for Medicare and Medicaid Services’ restrictive ruling against monoclonal antibodies for the condition. read more By Conor Hale The sequencing company’s $1.2 billion in sales marked a new quarterly high, but bigger spends on R&D and administrative expenses pushed net income down 56%. CEO Francis deSouza tells us that spending is key to innovation at Illumina—and he details the ways it will need to help Grail get its blood test to as many patients as possible. read more By Dave Muoio A new report from PatientRightsAdvocate.org found compliance increased less than 10% since its last review in July. Hospitals within large systems like CommonSpirit, Ascension and HCA were rarely up to snuff. read more By Fraiser Kansteiner With the blessing of its board of directors, Ipsen entered exclusive talks with French pharmaceutical compatriot Mayoly Spindler to divest its global consumer health franchise, the company said Friday. Ipsen is in line to receive about €350 million ($398 million) for its CHC unit. read more By Kyle LaHucik Former FDA Acting Commissioner and Admiral Brett Giroir, M.D., is back in the private sector and jumping into securing a series A for his latest biotech. Altesa BioSciences, which broke cover Thursday, builds upon the work of the Emory scientists behind Merck's COVID-19 antiviral molnupiravir and a billion-dollar HIV treatment. read more By Anastassia Gliadkovskaya The acquisition creates a large national network of providers including physicians, nurse practitioners and licensed social care workers that will reach more than 2 million homes this year. read more By Andrea Park How does a medtech company top its “best year ever”? According to Dexcom, by adding another half a billion dollars in revenue, growing the customer base by upwards of 30% and collecting a handful of regulatory clearances for new product launches. read more By Ben Adams Eli Lilly is taking the long view when it comes to the potential launch of its megablockbuster hopeful tirzepatide, and it's focusing on access programs to ensure patients can get their hands on the diabetes drug without being out-of-pocket. read more By Robert King AHIP commented it strongly supports CMS' decision to narrowly cover the Alzheimer's Disease drug Aduhelm, but it wants more clarification for how the decision will affect Medicare Advantage plans. read more By Annalee Armstrong Cassava Sciences has chalked up one win in an ongoing battle over the integrity of its clinical trials for Alzheimer’s disease. The FDA is declining to intervene in a citizen petition's plea to halt ongoing clinical trials of the company's drug, simufilam, saying the petition was not the appropriate venue for such a complaint. read more By Ben Adams AbbVie is running the first series of ads for its new preventative migraine drug, Qulipta, and going heavy on repetition. read more By Andrea Park More than a year after submitting its application to the FDA—and many months later than Senseonics expected to receive the agency’s sign-off—the diabetes technology developer has finally scored approval for its implanted continuous glucose monitor designed for long-term use. read more |
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