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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Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. |
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