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US FDA pauses new enrollment in Biohaven’s epilepsy drug trials
2+ day, 19+ hour ago (293+ words) Sept 10 (Reuters) – Biohaven said on Thursday the U.S. FDA had imposed a partial clinical hold, pausing new patient enrollment in trials of its experimental epilepsy drug after rodent findings, sending its shares down more than 15% in early trading. • The U....
Dyne, Sarepta shares tumble as Novartis setback weighs on muscle disease drug developers
4+ day, 14+ hour ago (317+ words) Sept 8 (Reuters) – Shares of Dyne Therapeutics and Sarepta slumped on Tuesday after Novartis’ treatment for a muscle-wasting disorder failed in a trial, fueling investor concerns about the prospects of similar therapies for the tough-to-treat rare disease. Dyne’s stock led declines…...
AstraZeneca’s cancer drug combo hits main survival goal in late-stage trial
4+ day, 18+ hour ago (66+ words) WTVB AstraZeneca’s cancer drug combo hits main survival goal in late-stage trial Sept 8 (Reuters) – AstraZeneca said on Tuesday its cancer drug Imfinzi combined with Amgen’s targeted immunotherapy Imdelltra significantly improved overall survival in first-line extensive-stage small cell lung cancer in…...
Novartis announces trial setback on del-desiran drug
5+ day, 1+ hour ago (176+ words) ZURICH, Sept 8 (Reuters) – Swiss drugmaker Novartis on Tuesday said a late-stage study assessing drug del-desiran’s impact on myotonic dystrophy, a form of muscle wasting, had not met its target on a key metric, but reaffirmed its sales guidance through 2030. Novartis…...
Explainer-Raids, shutdowns, warning labels – India’s unprecedented food safety push
5+ day, 2+ hour ago (652+ words) NEW DELHI, Sept 8 (Reuters) – India is witnessing an unprecedented food safety crackdown, with regulators forcing many local eateries and branded restaurants to suspend operations, while a push for front-of-pack warning labels has rattled the country’s more than $100 billion packaged food…...
Novo scraps two more heart drug trials, further dimming growth beyond obesity
5+ day, 19+ hour ago (191+ words) Sept 7 (Reuters) – Novo Nordisk said on Monday it had halted two additional trials of its experimental cardiovascular drug ziltivekimab, further denting the Danish drugmaker’s efforts to diversify beyond its blockbuster obesity and diabetes franchise. In July, Novo said ziltivekimab failed…...
Novartis, Ionis’ experimental heart drug misses key goal in closely watched trial
1+ week, 1+ day ago (464+ words) By Christy Santhosh and Bhanvi Satija Sept 4 (Reuters) – Novartis said on Friday its experimental drug pelacarsen did not cut the risk of major heart attacks and strokes in patients with a genetic risk factor in a late-stage trial, marking a…...
UK regulator suspends rare-disease drug Tavneos for new patients over unreliable data
1+ week, 4+ day ago (311+ words) Sept 1 (Reuters) – Britain’s medicines regulator on Tuesday suspended the use and sale of Amgen’s rare-disease drug Tavneos to new patients, saying the main study supporting its approval was unreliable. Sold as Avacopan Vifor in Britain by CSL Vifor, the drug…...
Roche signs global licensing pact for Simcere’s experimental blood cancer drug
1+ week, 4+ day ago (117+ words) Sept 1 (Reuters) – Switzerland’s Roche will pay $75 million upfront to Simcere Pharmaceutical Group for rights to an experimental blood cancer drug, the Chinese drugmaker said Tuesday. • SIM0660 targets B-cell malignancies, Simcere said in a filing to the Hong Kong stock exchange. • B…...
Novartis pauses trials of experimental cell therapy after three deaths
1+ week, 4+ day ago (320+ words) Sept 1 (Reuters) – Novartis said on Tuesday it paused eight clinical trials of an experimental cell therapy, called rap-cel, targeting autoimmune and neurological disorders in late August, after three patients died. The halt was implemented on August 24 after Novartis was notified…...