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With the late-stage win, Bayer announced Monday that it plans to talk to regulators about seeking approval in an indication that is central to its $3 billion-plus peak sales forecast.
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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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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Two analyses of the final U.S. data from the EMPagliflozin compaRative effectIveness and SafEty real-world study show that Jardiance® was associated with a reduction in risk of hospitalization for heart failure compared with two other classes of glucose-lowering therapies in adults with type 2 diabetes in routine care.
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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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Following the J.P. Morgan Healthcare Conference and other parallel meetings in San Francisco, it’s time to reflect on some of the significant deals secured last week.
After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.
The agency nevertheless said that it could not definitively rule out a small risk of suicidal ideation associated with GLP-1 receptor agonists, and that it will continue evaluating the evidence.
Dropping the potential Cytokinetics buy runs contrary to Novartis’ recent dealmaking frenzy, which included the acquisition of Calypso and three research collaborations.
Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.
Speaking to BioSpace in San Francisco, Elena Koundourakis, the head of the orexin franchise at Takeda Pharmaceuticals, gave a preview of what is ahead for its aims to treat narcolepsy.
If it feels like there has never been a tougher time to look for work, you’re not alone—and you’re likely not wrong.
Carina Clingman answers questions about forging professional connections in-person and on LinkedIn.
Biologics have a major advantage over small molecule drugs under the Inflation Reduction Act’s provisions, according to stakeholders attending this week’s J.P. Morgan conference.
The German biotech is dropping $20 million upfront on two preclinical monoclonal antibodies for undisclosed targets developed by WuXi Biologics.