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Following Merus’ splash last month with a “best-in-disease profile” for its head and neck cancer bispecific, Bicara touted positive results for its monocolonal antibody, but analysts say Merus still has the upper hand.
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Compounding pharmacies aren’t the only makers of off-brand versions of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. The situation is causing the FDA regulatory headaches and, more seriously, posing potential risks to the public.
BioSpace Senior Editor Annalee Armstrong headed to the J.P. Morgan Healthcare Conference with a months-long story idea brewing. Unfortunately, it was one she’s written before.
Of the 102 company launches or series A financings since October 2023, just nine had a woman at the helm, according to a BioSpace analysis. This is happening in an era of biotech where new company founders are searching for CEOs with a track record.
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Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved the supplemental new drug application for Vemlidy® 25 mg tablets as a once-daily treatment for chronic hepatitis B virus infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.
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When talking to some of the most impressive women in biopharma, the conversation inevitably turned to what these women wanted other entrepreneurs to know. Here’s the best of the best of that advice.
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When it comes to vaccination, the COVID-19 pandemic divided American society. President Donald Trump and his new Health and Human Services secretary are bringing down the hammer. What happens when there is no middle ground?
Many companies have foreshadowed deals to come during earnings calls in recent days. The return of M&A would be a welcome sign for the biopharma ecosystem, which has been battered by macro headwinds such as tariffs and the possibility of new drug pricing pressures.
Learn how to extract the full value from executive coaching, starting with being open and honest with your coach.
Entrada is paring back its research staff even as it gears up to hire employees to support a planned clinical trial for a Duchenne muscular dystrophy candidate.
The American Association for Cancer Research’s annual conference featured updates from several companies on key candidates and assets, including Merck’s Keytruda and GSK’s Jemperli.
At the heart of the acquisition is Regulus’ farabursen, an miRNA-targeting oligonucleotide in early-stage development for rare autosomal dominant polycystic kidney disease.
GSK’s dealmaking will be “cautious and disciplined” under the current trade war, but the pharma will focus on looking for “opportunities created” amid these tensions, according to CEO Emma Walmsley. The company also reported a 4% earnings bump for the quarter.
It’s been a fraught road for the proposed merger between Acelyrin and Alumis, with Tang Capital’s Concentra Biosciences in February threatening to upend the deal with a proposed $3-per-share acquisition of Acelyrin.
The drug, a small molecule protein inhibitor, brought in $132 million in the first quarter, missing consensus estimates by 17%.
As Q1 2025 earnings season continues, tariffs remain top of mind for pharma CEOs and investors. Meanwhile, the American Association for Cancer Research’s annual event kicks off this year’s oncology conference season. Plus, will the FDA become politicized under HHS Secretary RFK Jr.?