AstraZeneca's Fasenra hit with FDA rejection, falling further behind GSK's Nucala in nasal polyps BMS-Nektar's Opdivo combo fails phase 3 in upset to once-largest licensing deal in biotech history SXSW 2022: Best Buy, Samsung placing big bets on home health care as more seniors want to age in place Get ready to vote: Fierce Pharma's #FierceMadness drug name tournament is back for 2022 Dexcom’s next-gen G7 diabetes sensor scores European approval Yale scientists energize CAR-T cancer immunotherapy by hitting the gas on metabolism Cleveland Clinic teams up with PathAI to develop new pathology diagnostics Drugmakers unite to set digital standards for Alzheimer's disease studies Ascendis scores in phase 3 trial as it looks to expand endocrine-focused portfolio AstraZeneca, Merck's Lynparza snags first-in-class FDA nod for early breast cancer Executive Spotlight—Trinity Health's Mike Slubowski on community wellness, workforce pipelines and what's prolonging COVID-19 FDA upgrades Baxter infusion pump safety issue to Class I recall Incyte's Opzelura slapped with vitiligo delay amid topical JAK's eczema launch CAMP4 poaches Translate Bio medical chief, adds ex-Biogen R&D leader Al Sandrock to advisory board Featured Story | By Angus Liu AstraZeneca’s Fasenra is already late to the game in nasal polyps. Now, the drug is being pushed back even further—if it can eventually get there. read more |
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Top Stories By Kyle LaHucik Bristol Myers Squibb and Nektar Therapeutics said a phase 3 trial of the biotech's bempegaldesleukin combined with the Big Pharma's checkpoint inhibitor Opdivo in patients with untreated unresectable or metastatic melanoma failed. The drug was part of BMS' commitment of up to $3.6 billion to Nektar in 2018, which was the largest licensing deal in biotech history at the time. read more By Heather Landi AUSTIN, Texas—The baby boomer population is aging rapidly and most of them want to age at home. It's a business opportunity that isn't lost on technology company Samsung and retail giant Best Buy. read more By Ben Adams It’s March, so it’s time for some #FierceMadness. Last year, we channeled the NCAA tournament for the best pharma ad campaigns, but this year we’re looking for the best of the best in drug names. read more By Conor Hale Designed to be 60% smaller than its predecessor, Dexcom’s mainstay G6, the low-profile G7 includes a combined sensor and transmitter that connects it to smartphones and smart watches. The CE mark covers adults, pregnant women and children ages two and up. read more By Angus Liu Scientists at Yale University have found a way to enhance the cancer-killing power of CAR-T cells by reprogramming an amino acid metabolism pathway. The discovery could guide the development of cell therapies with improved tumor control, the researchers said, and potentially enable them to treat solid tumors. read more By Rebecca Torrence Cleveland Clinic is partnering with PathAI to develop new pathology diagnostics, using the company's tech platform to digitize hundreds of thousands of pathology specimen and link them with clinical and molecular data. read more By Conor Hale Some of the largest drugmakers tackling Alzheimer’s disease and its related dementias are banding together to ensure their pursuits make the best use of the truly massive amounts of digital data that can be gathered from patients as the companies look to track their progress. read more By Max Bayer Ascendis Pharma checked off its top boxes in a phase 3 hypoparathyroidism trial, improving calcium levels in nearly 80% of patients treated and lessening disease severity. The PaTHway trial's primary endpoint was a composite measure of serum calcium levels and independence from conventional therapy with no increase in the study drug, TransCon PTH, within the four weeks prior to the week 26 visit. read more By Angus Liu Lynparza is solidifying its lead in the PARP inhibitor class. The AstraZeneca and Merck drug has nabbed an FDA approval as a post-surgery adjuvant treatment for a specific type of breast cancer and posted an updated survival win. read more By Dave Muoio Trinity Health's CEO says healthcare must show, not tell, when it comes to drumming up support for strategic goals like community health and workforce development. read more By Andrea Park The recall encompasses more than 277,000 devices distributed in the U.S. between early 2015 and this year, according to the FDA. read more By Fraiser Kansteiner The FDA has delayed its decision on Incyte’s Opzelura in vitiligo by three months. The regulator now plans to deliver a verdict on the topical JAK inhibitor, also known as ruxolitinib cream, by July 18, Incyte said in a release. read more By Kyle LaHucik CAMP4 Therapeutics hired former Translate Bio Chief Medical Officer Ann Barbier, M.D., Ph.D., for the same post and also added ex-Biogen R&D leader Al Sandrock, M.D., Ph.D., to its scientific advisory board. The new CMO will help the biotech get its first molecule, for Dravet syndrome, into the clinic. read more |
