Annalee Armstrong

The FDA has put a stop to U.S. initiation of PepGen's Phase II trial for its Duchene muscular dystrophy treatment. The company faced the same hurdle for an earlier neuromuscular candidiate in 2023.

The Danish Medicines Agency had been watching reports of a rare eye disease in patients who took Novo's GLP-1 drug but until now have declined to move forward with a more formal review. Two new studies have strengthened the link.

The Novo-Catalent deal now moving ahead highlights unprecedented investment in manufacturing, while also standing out as an exception to the unspoken rule of keeping M&As to less than $5 billion this year.

BioSpace Senior Editor Annalee Armstrong reflects on the year that was, and what’s to come in 2025.

Suddenly the hottest thing in biopharma isn’t a new indication, disease target or modality—it’s manufacturing, and all of pharma is going to be vying for capacity and talent.

The report comes just two days after Novartis announced its own Parkinson’s drug failure.

Novartis is closing down sites in Germany and Boston that were picked up in its $2.9 billion acquisition of MorphySys, Reuters reported Thursday . The move will result in layoffs affecting 330 jobs.

Novo Nordisk executives set a high bar for itself when it projected CagriSema could achieve 25% weight loss. When the GLP-1 combo didn't hit that mark, investors reeled.

Following a 90% drop in share price due to an FDA rejection and a warning letter over Applied Therapeutics' conduct during a clinical trial, the biotech's CEO has stepped aside.

High profile failures and long timeframes for revenue have shifted investment away from Phase I, as VCs seek to mitigate risk, Pitchbook said in its 2025 outlook.