Leqembi’s EU review drags on; Sanofi gets a new development head

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of insolvency and Novartis hired a new top lawyer.

By BioPharma Dive staff • April 2, 2025

New genetic medicine CDMO acquires Landmark Bio

Artis BioSolutions joins a host of startups trying to improve development and manufacturing capacity for cutting-edge gene and cell therapies.

By Kristin Jensen • April 2, 2025

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

RNA editing biotech Airna adds $155M in funding

Airna will use the Series B round to launch a Phase 1/2 trial of its lead program for alpha-1 antitrypsin deficiency, a disease targeted by several other firms.

By Gwendolyn Wu • April 1, 2025

Isomorphic raises $600M on big ambitions for AI drugmaking tech

The drug discovery company, which has partnerships with Eli Lilly and Novartis, is developing AI models to design drugs and predict molecular structures.

By Gwendolyn Wu • March 31, 2025

FDA official’s ouster sends shares of vaccine makers sliding

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

By Delilah Alvarado • March 31, 2025

How discoverable, comparable and explorable is your data?

Accelerate biomarker research with high-quality, expert-curated data to drive precision medicine.

By QIAGEN Digital Insights • March 31, 2025

Novo gains Lexicon obesity drug; CRISPR COO to step down

Novo is paying up to $1 billion for a “non-incretin” medicine that might boost Wegovy’s effects. Elsewhere, Arbutus laid off 57% of its workforce and Bicycle Therapeutics shook up its leadership team.

By Ben Fidler • March 28, 2025

Nkarta to lay off staff, senior leadership, in bid to advance autoimmune cell therapy

The biotech is slashing a third of its workforce and more than half of its executive team in moves it called “necessary in today’s challenging financial and competitive environment.” 

By Ben Fidler • March 27, 2025

Alcon buys majority stake in IPO-seeking cell therapy startup Aurion

The share acquisition is the latest twist in a dispute between Alcon and fellow Aurion shareholder Deerfield Management over the direction of the company, which filed to go public in January. 

By Kristin Jensen • March 27, 2025

First Prader-Willi drug to reduce hunger approved by FDA

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

By Ben Fidler • Updated March 27, 2025

Bayer gains cancer drug from China’s Puhe; Axsome gets mixed ADHD data

The German firm licensed a PRMT5 inhibitor that’s now in Phase 1 testing. Elsewhere, GSK is testing an intriguing hypothesis and Novo fine tuned its Wegovy cash-pay program.

By BioPharma Dive staff • March 26, 2025

Wave to seek approval of Duchenne drug after mid-stage study data

The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.

By Kristin Jensen • March 26, 2025

Epicrispr banks $68M to test epigenetic editing on rare muscle disease

The startup is using CRISPR tools to stop errant expression of a gene linked to facioscapulohumeral muscular dystrophy, a disorder on the radars of several drugmakers.

By Gwendolyn Wu • March 26, 2025

Character Biosciences raises $93M with an eye on vision loss drugs

The startup is bringing into Phase 1 testing an experimental treatment it says could be more effective than marketed geographic atrophy medicines.

By Gwendolyn Wu • March 25, 2025

23andMe files for bankruptcy as CEO Anne Wojcicki resigns

The DNA-testing company plans to sell its assets after the board rejected an acquisition proposal from Wojcicki.

By Elise Reuter • March 24, 2025

Biogen plots new global headquarters in Kendall Square

The big biotech signed a 15-year lease for approximately 580,000-square-feet of space in “Kendall Commons,” a development project spearheaded by MIT.

By Jacob Bell • March 24, 2025

Tempero Bio gets $70M to advance substance abuse treatment

The Series B round will help the Aditum Bio-backed startup fund two mid-stage clinical trials in people with alcohol and cocaine use disorders.

By Delilah Alvarado • March 24, 2025

AstraZeneca deepens China investment; Editas loses CFO to Dyne

The pharma is spending $2.5 billion on an R&D center in Beijing. Elsewhere, Adaptimmune warned it could run out of cash and Pfizer sold its remaining stake in Haleon.

By BioPharma Dive staff • March 21, 2025

Alnylam prices heart drug at premium to rivals

Initially, Amvuttra’s annual list price will be nearly double the yearly cost of rival medicines from Pfizer and BridgeBio. But executives argue its “compelling and highly differentiated value” justify the higher charge.

By Ben Fidler • March 21, 2025

Alnylam drug gets long-awaited FDA approval in deadly heart disease

Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a fast-changing market.

By Ben Fidler • Updated March 20, 2025

Cargo shelves cell therapy research, lays off more staff

CEO Gina Chapman is also departing the company, which plans to review options for pursuing a reverse merger or other business combination.

By Gwendolyn Wu • March 19, 2025

Stoke CEO exits; Medicare drug price talks advance

Ed Kaye, Stoke’s longtime leader, will be replaced by former Vertex executive Ian Smith. Elsewhere, all 12 drugmakers targeted for second round of Medicare price talks agreed to participate.

By BioPharma Dive staff • March 18, 2025

Sofinnova’s latest biotech fund sprouts three new startups

As part of its “pan-European” plans, Sofinnova is backing startups developing treatments for fibrosis, cancer and Alzheimer’s.

By Gwendolyn Wu • March 18, 2025

Duchenne patient dies after receiving Sarepta gene therapy

A young man treated with Elevidys died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future, some analysts wrote.

By Ben Fidler • Updated March 18, 2025

Arbor raises $74M amid genetic medicine’s funding slump

The round will fund a “one-and-done” treatment for a rare kidney condition that its CEO says can address concerns patients have with therapies from Alnylam and Novo Nordisk.

By Gwendolyn Wu • March 18, 2025