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Annexon’s late-stage Guillain-Barré syndrome trial has hit its primary endpoint and laid the foundation for a filing for approval next year, the company said Tuesday.
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Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
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Huma Therapeutics Limited today announced a new partnership with AstraZeneca to scale innovation for digital health.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.
The company’s olezarsen cleared a late-stage study, eliciting a sharp reduction in triglyceride levels in patients with familial chylomicronemia syndrome. Ionis plans to submit a New Drug Application to the FDA.
The FDA on Monday approved the Canadian biopharma’s liquid antibiotic metronidazole, an alternative for patients who are unable to use pills or injections.
The Japanese multinational pharma is pledging up to $580 million in a development and commercialization deal with AcuraStem for the latter’s PIKFYVE program for amyotrophic lateral sclerosis.
The Swiss pharma is one step closer to bringing Lutathera into the front-line setting, with data from the Phase III NETTER-2 study showing that the radiotherapy met its primary endpoint.
The company’s experimental drug for amyotrophic lateral sclerosis reduced the risk of death by 49% compared to the largest U.S. database of previous ALS therapy trials.
The FDA’s briefing documents found that BrainStorm’s BLA submission for its investigational cell therapy for ALS did not demonstrate evidence of effectiveness and that the manufacturing data was “grossly deficient.”
After dropping an early-stage study more than a year ago, AbbVie has finally terminated its CD47 collaboration with I-Mab, leaving up to $1.3 billion in potential milestone payments on the table.
The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.
Despite meeting the primary endpoint and eliciting endoscopic improvements in ulcerative colitis, Morphic Therapeutic’s investigational pill underwhelmed investors with its stock plummeting.