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Leerink Partners called the announcement a ‘positive’ given the delayed timeframe and the uncertainty that the administration will implement tariffs at all.
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Expanding volumes of data point to mechanisms beyond weight loss and blood sugar control that contribute to cardiovascular benefits in the world’s fastest-growing drug class.
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
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The Phase 3 trial investigating Sarclisa® in combination with carfilzomib, lenalidomide and dexamethasone showed a statistically significant improvement in the rate of minimal residual disease negativity, compared with KRd alone, after autologous stem cell transplant consolidation in transplant-eligible patients with newly diagnosed multiple myeloma.
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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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At the intersection of radiation and precision, Novartis, Bayer, AstraZeneca and more hope to cash in on a radiopharmaceuticals market that could top $16 billion by 2033.
To more effectively treat neurodegenerative conditions, we first need diagnostic tools that lend a more complete picture of protein aggregates in the brain.
As the Trump administration slashes funding for HIV-related research and infrastructure, Gilead, Immunocore and more are targeting the next goalpost: a cure.
In a recent BioSpace LinkedIn poll, nearly half of respondents predicted the job market won’t turn around until 2027 or later. It’s easy to see why people are skeptical, especially when you consider recent hiring activity and layoffs.
With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over.
Insitro’s layoffs affect about 65 employees as the AI-focused biotech looks to advance its pipeline in metabolic disease and neuroscience.
After losing its powerhouse partner, IGM Biosciences closed “most” of its labs and offices and initiated a strategic review of potential strategic alternatives and options for the business.
The FDA expects to fully integrate its AI approach by June 30, though its different centers have been instructed to start the rollout immediately.
The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action dates.
The company discontinued development last month of its most mature asset, RLYB212, following disappointing mid-stage pharmacokinetic findings in a rare bleeding disorder.