News
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
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Speaking to BioSpace at the J.P. Morgan Healthcare Conference, Novartis’ chief dealmaker Ronny Gal explains why the Swiss pharma hasn’t acquired a GLP-1, and why it probably won’t.
There hasn’t been a headline-stealing deal at J.P. Morgan yet. Nevertheless, the mood is positive amid green shoots and a flurry of dealmaking to end 2025.
Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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A day after Pfizer closed its hotly contested Metsera deal, Lundbeck has made an unsolicited offer to steal Avadel Pharmaceuticals away from Alkermes.
At $9.2 billion, the Cidara acquisition lands among the top 5 largest deals of the year.
Gilead’s investigational drug combo bic/len could help lower the pill burden in patients with virologically suppressed HIV who are on complex treatment regimens, according to BMO Capital Markets.
A BioNTech spokesperson downplayed the news, insisting that the two companies remain “close” and have a “strong collaboration.”
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Speaking at a conference this morning, Pfizer CEO Albert Bourla suggested that Metsera’s therapies could begin hitting the market in 2028.
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.
Korro Bio is moving back to square one as a preclinical biotech after the failure of KRRO-110 in alpha-1 antitrypsin deficiency. The company’s stock is down 80% on all the news.
The decision to pause dapiglutide will help Zealand focus investment into assets that have “the greatest potential for clinical differentiation” in obesity.
In January, AbbVie and Calico’s fosigotifator failed to show significant signs of efficacy in the HEALEY ALS platform trial for amyotrophic lateral sclerosis.