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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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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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As the incoming CEO of Vicore, Mousa is ready to rally for fresh investment to advance cures for respiratory conditions.
After picking up magrolimab in a $4.9 billion purchase of Forty Seven, a second Phase III study is being discontinued for the anti-CD47 antibody, this time in acute myeloid leukemia.
Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here’s a closer look.
As MSLs take on greater roles in healthcare, standardization is crucial to fostering trust.
While Astellas did not say why it withdrew its suit, it was the only company to file a legal complaint that wasn’t on the initial IRA drug price negotiations list and may not have had any grounds to sue.
Soon after cancelling its contract with I-Mab, AbbVie has now also turned its back on a partnership with Berkeley-based Caribou Biosciences that was focused on advancing allogeneic CAR-T therapeutics.
Following promising results in major depressive disorder, Alto Neuroscience on Tuesday reported positive data for its investigational drug ALTO-100 in post-traumatic stress disorder.
Despite filing respective lawsuits challenging the program, AstraZeneca and Bristol Myers Squibb have decided to participate in the first round of price negotiations under the Inflation Reduction Act.
The Italian pharma company is acquiring what was once one of the hottest stocks in the biotech sector, just months after the FDA rejected Intercept’s non-alcoholic steatohepatitis candidate.
Shares were up over 60% in premarket trading on news that the company’s anti-FcRn antibody exhibited dose-dependent reductions in IgG levels, drivers of inflammation in many autoimmune diseases.