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Guggenheim Partners called Insmed’s Phase IIb readout “impressive across the board,” with an efficacy profile that positions TPIP to be best-in-class in pulmonary arterial hypertension.
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Benefiting from technological and conceptual groundwork and positive early data, gene therapies are advancing in the clinic for cardiovascular diseases including congestive heart failure, chronic refractory angina and cardiomyopathy.
Licensing deals have risen in prominence in a restrained market environment. Is it desperation, or an important part of the biotech ecosystem? Experts weigh in.
Look for renewed investment driven by lower interest rates in the new year, and a continued focus on late-stage assets, oncology and reaping the benefits of AI.
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Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
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After Emma Walmsley steps down as GSK CEO in January, Vertex Pharma’s Reshma Kewalramani will be the sole female CEO at a top-20 pharma company. Still, there are many prominent women in pharma that could someday break through again.
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With a new raise provided by Flagship Pioneering, the new company is aiming to find “the silent window” before disease symptoms set in.
The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
Proquad is rarely a newsmaker from Merck’s earnings, but this time around, the U.S. has had a series of measles outbreaks. Sales of the vaccine were $539 million for the quarter, a 5% decline from the same period in 2024.
Where thousands of former Health and Human Services employees will work next is unknown, but biopharma companies likely aren’t the main destination. Two biopharma executives discuss potential landing spots.
Companies are announcing significant investments in U.S. manufacturing in response to looming tariffs. An AstraZeneca executive and Eli Lilly and Novo Nordisk spokespeople discuss potential job and skill-building opportunities and where manufacturing might head in the future.
Roche’s exposure to the tariffs is mostly limited to four medicines, three of which it already produces in the U.S., according to CEO Thomas Schinecker, who declined to reveal what these assets are.
In this discussion, our guests explore how recent regulatory changes are shaping the future of AI in drug development in the US market. Watch now.
The deal is a blast from the not-too-distant past, when special purpose acquisition companies were an easy way for companies to list on the public market with a bundle of cash to operate on.
Roche’s Genentech is betting on the Flagship Pioneering–founded company’s discovery platform called DECODE to find new targets for an undisclosed autoimmune disorder.