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Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U.S. in February 2025.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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.
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Sarepta Therapeutics, Inc. today announced topline results from Part 2 of Study SRP-9001-102 (Study 102), an ongoing, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, efficacy and tolerability of a single dose of SRP-9001.
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Read our takes on the biggest stories happening in the industry.
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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Recent changes in the board of directors at Biogen has garnered attention due to potential conflicts of interest. Such conflicts vary widely, but one thing is clear: perception matters.
The acquisition of the privately-held company will bring its novel, investigational beta-lactamase inhibitors and other antimicrobials into the Japanese pharma’s pipeline.
FibroGen takes another hit as its antibody hopeful fails in a second indication. The biopharma says that it is cutting costs to extend its cash runway.
A year after treatment, Vertex’s VX-880 has eliminated the need for insulin injections in two Type 1 diabetes patients in a Phase I/II clinical trial of its investigational stem cell-based therapy.
New Phase II data, published in the New England Journal of Medicine, showed Lilly’s oral GLP-1 receptor agonist orforglipron induced nearly 15% weight loss in obese and overweight adults.
CMS has stated that it will cover new Alzheimer’s drugs if the therapies are fully approved. But significant financial questions remain.
Results of a Phase IIb trial of the company’s anti-TL1A antibody showed more than a third of ulcerative colitis patients entered remission while receiving the experimental treatment.
Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.
A day after the FDA denied Intercept’s application for its non-alcoholic steatohepatitis treatment, the pharma announced it has axed all NASH investments and one-third of its staff.
Citing anti-trust issues, six states—California, Illinois, Minnesota, New York, Washington and Wisconsin—are joining the FTC’s legal challenge to Amgen’s nearly $27.8 billion buyout of Horizon.