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Johnson & Johnson and Addex Therapeutics’ epilepsy hopeful ADX71149 did not meet its primary endpoint of time to reach baseline seizure count in a mid-stage trial, as the partners look to determine the next steps for the program.
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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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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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BioSpace rounded up companies with products for Alzheimer’s, ALS, Parkinson’s and Huntington’s in the final stages of clinical testing.
Johnson & Johnson and Astellas are the latest companies to file suits against the Biden administration, challenging the constitutionality of the Inflation Reduction Act’s Drug Price Negotiation Program.
Late-stage study suggests Merck’s Keytruda is a promising treatment candidate in newly diagnosed patients with locally advanced cervical cancer, inducing better progression-free survival.
J&J, Merck and Pfizer are the subjects of a House Judiciary Committee investigation for their alleged participation in a government-sanctioned censorship campaign during the COVID-19 pandemic.
Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.
The company also terminated a Phase III trial of its TGFB inhibitor as a treatment for metastatic pancreatic ductal adenocarcinoma, though that drug will continue to be tested as a treatment for colorectal cancer.
Tuesday’s partnership will dig into Flagship’s deep ecosystem of companies and technologies to discover medicines in line with Pfizer’s core strategic areas.
Less than two years after launch, the startup posts positive Phase II results and heads into Phase III trials for major depressive disorder with a new CEO.
Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
The Netherlands-based immunology company said Wednesday it brought in $1.1 billion by selling more than two million shares in the U.S. and Europe.