Pfizer and Moderna's updated COVID boosters win FDA nods, with swift rollouts to follow Guardant, Merck KGaA expand precision therapeutics collab, focusing on hard-to-treat cancer NIH-funded study to test if Apple Watch can prevent strokes, limit blood thinners Guess what’s SPAC? Ocean Biomedical resuscitates Wall Street play all but dead in 2022 AstraZeneca scores injunction to temporarily halt former exec's start at crosstown rival GSK Jounce gets trounced as phase 2 data disappoint once again, prompting pipeline rethink Investment losses and massive growth in expenses push Cleveland Clinic to $787M loss Medtronic picks up BioIntelliSense's round-the-clock vital sign monitor in distribution deal FDA sparks hope for Curis, lets biotech resume enrollment for part of phase 1/2 leukemia study Oscar Health loses major tech customer amid integration challenges Six years after initial pledge, Califf launches another FDA program to study the opioid crisis Sanofi's rare disease drug Xenpozyme scores FDA approval after nods in Japan and Europe Featured Story | By Fraiser Kansteiner The public wait for another round of COVID-19 vaccine boosters is finally coming to an end. Wednesday morning, the FDA gave the all-clear to Omicron-targeted COVID-19 shots from Moderna and Pfizer-BioNTech. read more |
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Top Stories By Andrea Park Developing an entirely new cancer drug from scratch is a notoriously complex and time-consuming process, with drugmakers taking years to produce a single candidate that may or may not ever make its way to approval. Luckily for Merck KGaA, the German pharma is getting a head start in that department through a partnership with blood-testing company Guardant Health. read more By Heather Landi The seven-year study, expected to launch next spring, will recruit 5,400 patients who will receive standard AFib care of blood thinners or Apple Watch-directed treatment. read more By Max Bayer After being left for dead in 2022, Ocean Biomedical is trying to revive the once-booming SPAC play that hit Wall Street. The new company, equipped with a preclinical assets plucked from research institutions, expects to be valued at nearly $350 million. read more By Fraiser Kansteiner Just hours before outgoing AstraZeneca executive Chris Sheldon was set to take up his post at crosstown rival GSK, a judge has ordered a temporary injunction. read more By Max Bayer Jounce can't seem to find success atop its pipeline, reporting another phase 2 failure. As a result, the company says it's reevaluating one of its top monoclonal antibody programs in an attempt to gain some traction. read more By Dave Muoio The 20-hospital nonprofit reported a -5.9% operating margin in the second quarter, a turnaround from the 10.5% margin it recorded a year ago, and only made worse by $603.5 million in accompanying non-operating losses. read more By Andrea Park Situating the BioButton under Medtronic’s umbrella will be especially beneficial in helping hospitals navigate the growing shortage of healthcare workers and rising healthcare costs, per BioIntelliSense CEO James Mault, M.D. read more By Gabrielle Masson Curis has received another spark of hope as the FDA lets the biotech resume enrollment for a part of its phase 1/2 study assessing emavusertib in patients with leukemia. read more By Heather Landi Health First Health Plans, an early adopter of Oscar Health's tech stack, is pulling the plug on the project amid implementation challenges. read more By Kevin Dunleavy In a blog post, FDA Commissioner Robert Califf said the agency has launched an Overdose Prevention Framework to combat the opioid crisis. The strategy targets unnecessary prescriptions, prolonged prescribing and counterfeit drugs, while promoting the development of treatments for substance use disorders and education programs for doctors. read more By Kevin Dunleavy Sanofi's Xenpozyme is the first drug approved by the FDA for the non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD). Earlier this year, regulators in Japan and Europe sanctioned the drug. read more Resources Sponsored by: Ferma.AI, a Product of ZoomRx Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Catalent Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Bio-Techne Advanced research requires advanced tools. Our next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume. 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