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US FDA pauses new enrollment in Biohaven’s epilepsy drug trials
3+ day, 23+ 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
5+ day, 16+ 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…...
Bristol Myers’ blood cancer cell therapy succeeds in mid-stage trial
6+ day, 1+ hour ago (257+ words) Sept 8 (Reuters) – Bristol Myers Squibb said on Tuesday its experimental cell therapy showed a high overall response rate in a mid-stage trial, in patients with a hard-to-treat form of blood cancer. The study evaluated the therapy, called arlocabtagene autoleucel, or…...
Novo scraps two more heart drug trials, further dimming growth beyond obesity
1+ week, 34+ min 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, 2+ 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…...
Novartis MS pill beats older drug in trials, boosts pipeline hopes
1+ week, 6+ day ago (461+ words) LONDON, Sept 1 (Reuters) – Swiss drugmaker Novartis said on Tuesday its oral drug remibrutinib outperformed an older treatment in reducing relapses in patients with a form of multiple sclerosis, boosting hopes the medicine could become a blockbuster product. The trial results…...
AstraZeneca-Hutchmed drug combination shows promise in advanced lung cancer study
1+ week, 6+ day ago (207+ words) Sept 1 (Reuters) – AstraZeneca and China’s Hutchmed said on Tuesday that a late-stage trial of a combination of their cancer drugs Tagrisso and Orpathys significantly improved progression-free survival when given early for a type of lung cancer. Cancer therapies make up…...
Novartis pauses trials of experimental cell therapy after three deaths
1+ week, 6+ 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…...
US FDA approves Takeda, Protagonist’s drug for rare blood cancer
2+ week, 2+ day ago (313+ words) By Kamal Choudhury and Mariam Sunny Aug 28 (Reuters) – The U.S. Food and Drug Administration has approved a first-of-its-kind drug from Takeda Pharmaceutical and Protagonist Therapeutics to treat a rare blood cancer, the health regulator said on Friday. The approval of…...
US FDA expands approval for J&J’s drug for rare blood disorder
2+ week, 6+ day ago (328+ words) By Kunal Das and Padmanabhan Ananthan Aug 24 (Reuters) – The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson’s drug to treat a rare blood disorder, the company said on Monday. The approval makes Imaavy the first…...