Biden presses for capping insulin costs and nursing home reforms in first State of the Union BMS, Novartis, Akebia and more face FDA approval decisions soon, with big sales on the line Facing omicron 'curveball,' Inovio seeks endpoint switch amid fear it will strike out against original goal Russia-Ukraine war: Siemens vows to continue serving all patients while Conformis freezes Russian sales SAB's shares drop 45% after NIH ditches COVID-19 trial due to waning hospitalizations FDA approves J&J’s allergy-fighting contact lens infused with an antihistamine Pfizer revs up to leave GSK in the dust as maternal RSV vax granted FDA breakthrough tag Black patients wait longer for diagnosis, treatment of colorectal cancer, new study finds Palm-sized PCR testmaker Visby ropes in $100M for tenfold production boost FDA slaps hold on Finch's C. diff med to get info on COVID-19 screening for donor-derived therapy COVID-19 tracker: J&J shot less effective than Pfizer's against hospitalization, study says FDA warns against using unauthorized COVID tests from ACON, SD Biosensor, Celltrion Tenet Healthcare is no longer spinning off Conifer, its revenue cycle subsidiary FDA says no, thank you to Xpovio’s cancer expansion bid, prompting Karyopharm to run new study Featured Story | By Robert King President Biden called for a $35 monthly cap on insulin costs and a series of reforms to nursing homes such as staffing requirements during his first State of the Union speech. read more |
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Top Stories By Kevin Dunleavy An interesting and varied group of drugs—ranging from two first-in-class cancer therapies to a treatment that removes frown lines—face target dates for approval this month. Many of the decisions bear watching as their status could have far-reaching implications in the industry and for patients. read more By Nick Paul Taylor The long wait for phase 3 data on Inovio’s COVID-19 vaccine just got longer. With DNA vaccine INO-4800 generating significantly lower antibodies against omicron than original SARS-CoV-2, Inovio has paused enrollment and asked regulators to change the primary endpoint to prevention of severe disease. read more By Andrea Park According to a report from the U.S. commerce department’s International Trade Administration, the market for medical equipment in Russia totals more than $5 billion. read more By Max Bayer SAB Biotherpeutics' COVID-19 antibody treatment SAB-185 is no longer following in the footsteps of AstraZeneca’s Evusheld as the National Institutes of Health has axed a sponsored phase 3 trial citing low COVID-19 hospitalizations. read more By Conor Hale Johnson & Johnson’s Acuvue Theravision lenses are laden with ketotifen, the same drug used in a variety of eye drops for taming reactions to pollen, grass, pet dander or dust. read more By Annalee Armstrong Pfizer already got a major boost for its maternal RSV vaccine this week, when trials for GlaxoSmithKline’s rival shot were halted. And now the FDA has granted Pfizer a breakthrough therapy tag, which could allow the New York pharma to put the pedal to the metal and leave its U.K. peer in the dust. read more By Anastassia Gliadkovskaya Black patients were more likely to be diagnosed at a more severe stage of the disease and waited an average of eight days longer than white patients for treatment. read more By Andrea Park COVID-19 case numbers may be plummeting, but the demand for fast-acting and easily accessible PCR-quality diagnostics—for the coronavirus and beyond—shows no sign of slowing down. read more By Kyle LaHucik Finch Therapeutics' phase 3 trial for a C. difficile med has been placed on clinical hold by the FDA as the agency requests more information on how the biotech screens the donor-derived microbiome therapy for the virus that causes COVID-19. read more By Angus Liu,Eric Sagonowsky,Kevin Dunleavy,Fraiser Kansteiner,Sophia Sorensen A study from France shows that Johnson & Johnson vaccine recipients were five times more likely to be hospitalized from COVID-19 than those who received the Pfizer-BioNTech jab. Pfizer will supply the U.S. with 1 million courses of its antiviral pill this month and double that supply in April. Brazil has produced its first batch of COVID-19 vaccines made entirely in the country. And more. read more By Andrea Park Nearly two full years into the COVID-19 pandemic, the FDA is still rooting out sales of unauthorized tests and so-called treatments for the coronavirus. read more By Dave Muoio After years of restructures and underwhelming offers, Tenet's board has decided to stick with Conifer for the long haul. read more By Angus Liu That was fast. Just three weeks after touting a late-stage clinical trial win, a defeated Karyopharm Therapeutics now says the FDA doesn’t think the data support a label expansion for cancer drug Xpovio. read more |
