Biogen, Eisai strike back against CMS' stifling Aduhelm coverage proposal FDA denies Ardelyx’s appeal against kidney drug rejection, hammering another nail in tenapanor’s coffin Ada Health hits $120M in series B top-up for symptom assessment AI app Provider groups push court to press pause on controversial surprise billing rule FDA nominee Califf pledges to enforce accelerated approval mandates as he jockeys for Senate support Curevo will go head-to-head against GSK's Shingrix thanks to new $60M financing AstraZeneca's COVID vaccine sales reached $4B last year, but don't expect that much in 2022 Cadence teams up with Community Health Systems to bring RPM platform for chronic care to thousands AstraZeneca dumps late-phase, next-gen COVID-19 vaccine, calling time on a beta player in an omicron world Philips rolls out blood flow measuring software to its Lumify handheld ultrasound Press Ganey acquiring Forsta to beef up its tech suite, expand international reach BD joins Day Zero’s $21M fundraising for sequencing-based infectious disease diagnostics Hologic goes big with Mary J. Blige at the Super Bowl Featured Story | By Fraiser Kansteiner After The Centers for Medicare and Medicaid Services (CMS) proposed to limit coverage of Biogen’s Alzheimer’s disease drug Aduhelm to patients in approved clinical trials, the company and its partner Eisai have made their dissent official. read more |
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Top Stories By Nick Paul Taylor The FDA has deflated Ardelyx's attempt to recover quickly from a complete response letter. With Ardelyx looking to sidestep a request for another trial, the FDA held its ground and denied the appeal—leaving the biotech looking to a Hail Mary pass to overturn the decision. read more By Andrea Park It doesn’t take an artificial intelligence-powered symptom checker to diagnose Ada Health with what is clearly a serious case of fundraising fever. read more By Robert King Provider groups' latest legal filing in a lawsuit over the Biden administration surprise billing rule charges agencies are making it more difficult for them to prevail in arbitration disputes. read more By Fraiser Kansteiner Robert Califf, President Joe Biden’s pick for the top spot at the FDA, has snared the support of the Senate Finance Committee chairman, thanks to a vague pledge to reform the agency’s accelerated approval pathway if he’s confirmed. read more By Max Bayer Curevo Vaccine is hoping $60 million in financing will help the small biotech literally go head-to-head against GlaxoSmithKline's market-dominating shingles vaccine Shingrix. read more By Kevin Dunleavy AstraZeneca's COVID-19 vaccine sales reached $4 billion in 2021. But the company said not to expect a similar performance this year, projecting a revenue percentage drop in the low-to-mid 20s. In all, AZ reported $37.4 billion in revenue in 2021, a 38% increase from last year. read more By Rebecca Torrence Digital health unicorn Cadence inked a partnership with Community Health Systems to provide its remote patient monitoring and virtual care platform across the health system's national footprint in 16 states. read more By Nick Paul Taylor AstraZeneca has scrapped its beta-specific COVID-19 vaccine. The removal of AZD2816 from the pipeline follows the conclusion of a phase 2/3 clinical trial that persuaded AstraZeneca to stick with Vaxzevria, its first-generation vaccine, rather than push ahead with plans to seek authorization for its beta-specific sibling. read more By Conor Hale Philips has upgraded its smartphone-controlled handheld ultrasound system, adding pulse wave doppler support to help clinicians examine real-time blood flow across a range of diagnostic applications. read more By Dave Muoio Forsta's “comprehensive” tech platform will allow Press Ganey to offer its healthcare clients a greater range of experience intelligence tools, the company said in this week's acquisition announcement. read more By Andrea Park Amid the “hidden pandemic" of antibiotic-resistant infections, Day Zero Diagnostics is doubling down on its mission of developing tools to identify and profile those bacterial diseases as early as possible. read more By Sharon Klahr Coey For Hologic’s first DTC commercial spot, the medical tech company which is primarily focused on women’s health, decided to go big—big star, big game, big message—Mary J. Blige, during the Super Bowl, encouraging women to get their screenings. read more |
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