BMS-Nektar's Opdivo combo fails phase 3 in upset to once-largest licensing deal in biotech history Long wait for pivotal data on Sanofi's oral SERD ends in failure Top 10 pharma R&D budgets in 2021 BridgeBio plots path to market for muscular dystrophy drug after posting phase 2 data Ascendis scores in phase 3 trial as it looks to expand endocrine-focused portfolio Nutcracker snags $167M series C to develop 'push-button' RNA manufacturing, signs on former Gilead CFO Drugmakers unite to set digital standards for Alzheimer's disease studies AstraZeneca, Merck's Lynparza snags first-in-class FDA nod for early breast cancer Stevanato's growth spree rolls on with China plant purchase, plans for 270 jobs KFF study: Why addressing affordability needs to go beyond plan premiums Novartis' Sandoz bulks up in respiratory as strategic review of the generics outfit rolls on FDA upgrades Baxter infusion pump safety issue to Class I recall Yale scientists energize CAR-T cancer immunotherapy by hitting the gas on metabolism Potential Alzheimer's biomarker may also be weaponized by melanoma cells, research finds Featured Story | 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 |
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Top Stories By Nick Paul Taylor Sanofi’s oral selective estrogen receptor degrader amcenestrant has flunked a pivotal trial. The failure of amcenestrant as a second-line or later treatment of ER+/HER2- advanced or metastatic breast cancer leaves Sanofi looking to studies in earlier-stage patients to rescue the potential blockbuster. read more By Annalee Armstrong Roche will not be beaten when it comes to pharma R&D. The company lands at No. 1 on our Pharma R&D budget list once again, but who else made it? read more By Nick Paul Taylor BridgeBio Pharma has posted an upbeat update on its limb-girdle muscular dystrophy type 2i program. With a phase 2 trial linking BBP-418 to positive biomarker changes, BridgeBio is preparing to talk to regulators about paths to market for the treatment of muscle wasting in the arms and legs. 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 Kyle LaHucik Nutcracker Therapeutics snagged $167 million to bankroll development of messenger RNA therapies for cancer. The California biotech will also build out its manufacturing platform across discovery, clinical and commercialization stages. 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 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 Kevin Dunleavy A week after Italian vials manufacturer Stevanato announced a $95 million deal with the U.S. government to expand operations at its facility under construction in Fishers, Indiana, the company says it has acquired a plant in Zhangjiagang, China, which it will expand to 32,000 square feet. read more By Anastassia Gliadkovskaya Many households did not have enough assets to pay the typical deductibles and most can’t afford to meet high deductibles. read more By Fraiser Kansteiner Sandoz is beefing up in respiratory medicine even as parent company Novartis weighs the generics outfit's future. The company on Monday said it acquired British medical and drug delivery device developer Coalesce Product Development. Meanwhile, Novartis' strategic review of Sandoz, launched last October, rolls on. 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 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 Max Bayer The long-debated Alzheimer's biomarker amyloid beta may play an active role in the spread of melanoma cells in the brain, according to new research from NYU Langone. The researchers found that the peptides were in higher numbers in the brain than elsewhere in the body and that they shielded the cancer cells from the body's immune response. read more Resources Sponsored by: Medidata, a Dassault Systèmes company The landscape of clinical trials has been permanently changed. Today's trials require sponsors to modernize their use of technology and data to adapt. This eBook provides an overview of how sponsors can empower trials with real-time performance data to improve study integrity, reduce risks, optimize patient safety, and increase trial success rates. Sponsored by: Thermo Fisher Scientific Learn how to navigate the top manufacturing challenges and achieve a seamless transition from discovery to clinical manufacturing across the CAR T-cell therapy workflow. 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