FDA expands faster drug review pilot from supplemental to full applications
The FDA on Dec. 2 will open up an expedited review pilot program that's meant to speed therapies that substantially improve upon what's currently available for serious conditions to full marketing...
View ArticleBioNTech eases 2024 revenue outlook despite hefty Covid vaccine third-quarter...
Despite strong third-quarter revenues, BioNTech has softened its 2024 sales guidance in light of changes to Covid-19 vaccine uptake, pricing and seasonal variations. The company’s €1.2 billion ($1.3...
View ArticleRare disease biopharma companies weigh in on FDA's new innovation hub
AstraZeneca's Alexion, BridgeBio, BioMarin, Ultragenyx and others, including Sen. Bob Casey (D-PA), recently weighed in on the details of a new cross-cutting FDA collaboration hub focused on rare...
View ArticleThe election is Tuesday. What’s at stake for the pharma industry?
The biopharma industry has been a bipartisan political target in recent years. But in the 2024 presidential election, details are scarce around key issues that could impact drugmakers. Drug pricing has...
View ArticleFDA cites Mark Cuban's drug compounding center in Dallas with sterility,...
The FDA is raising sterility and other quality concerns with Mark Cuban's Cost Plus Drugs compounding facility in Dallas, following a nine-day inspection of the site in August and September. A
View ArticleViking CEO on ‘shocking’ market reaction to oral obesity data, preparing for...
SAN ANTONIO — Promising data don’t always equal a stock pop. Viking Therapeutics presented what analysts thought were compelling data on an oral GLP-1/GIP dual agonist on Sunday evening, but the market...
View ArticleSana narrows focus again to zero in on diabetes and autoimmune disease
Sana Biotechnology is pruning its pipeline and headcount for the second time in around a year to stretch its cash and support key data readouts over the next 12 to 18 months. The change in ...
View ArticleNektar divests manufacturing site and reagent arm for $90M
Nektar Therapeutics is selling off its only manufacturing facility as well as its reagent business to private equity firm Ampersand Capital Partners for $90 million. In the deal, which is expected to...
View ArticleVertex makes money from sickle cell therapy Casgevy
Vertex said it made $2 million in revenue from the first patient who received its sickle cell therapy Casgevy. The commercial launches of Casgevy and bluebird bio’s Lyfgenia have been closely watched...
View ArticlePrognomiQ raises $34M for lung cancer test
PrognomiQ has raised an additional $34 million in funding as the company prepares to release its blood-based protein test for lung cancer. The company is part of the growing rush to mine ...
View Article#ASH24: Beam discloses first clinical data on base-edited sickle cell...
Beam Therapeutics gave an initial look at the first handful of patients who received its experimental gene-edited treatment for sickle cell disease. As of July 2, six people with severe sickle cell...
View ArticleSyndax inks a $350M royalty deal; FDA pushes back decision on Organon’s...
Plus, news about Merus, Supernus and Verrica: Syndax Pharmaceuticals’ $350M deal with Royalty Pharma: The agreement is based on US sales of Niktimvo, Syndax’s graft-versus-host disease treatment....
View Article#ASH24: Sanofi reveals positive Phase 3 data for BTK inhibitor from $3.7B...
Sanofi’s BTK inhibitor rilzabrutinib helped 23% of adults with a rare autoimmune blood disorder achieve target platelet counts in a Phase 3 trial, compared to zero patients in the placebo arm, the...
View Article#ASH24: Gilead and Arcellx spotlight safety of multiple myeloma cell therapy,...
Gilead and Arcellx’s early trial data on their multiple myeloma cell therapy show that patients saw no cases of certain delayed neurotoxicities, which are associated with Johnson & Johnson and...
View Article#ASH24: J&J's Darzalex hits primary endpoint in Phase 3 early-stage multiple...
Johnson & Johnson’s CD38 inhibitor Darzalex showed a benefit in delaying or preventing disease progression in patients with high-risk smoldering multiple myeloma, a precursor to active multiple...
View ArticleZealand details Phase 1 obesity data for amylin drug as it plans next steps
SAN ANTONIO — Zealand Pharma, hoping to create the next "foundational" therapy for obesity, detailed more Phase 1 data on its amylin analog that was the backbone of a $1 billion raise this summer....
View Article#ASH24: Novo Nordisk takes Forma’s sickle cell treatment into Phase 3
Novo Nordisk’s once-a-day sickle cell disease drug etavopivat cut the rate of pain crises in a yearlong mid-stage study. The Danish pharma company, known for its diabetes and obesity treatments, plans...
View ArticleCatalent touts customer confidence ahead of Novo deal, but misses revenue...
Catalent reported a slight revenue upswing during its latest quarterly results, which CEO Alessandro Maselli attributed to "customers' continued confidence” in the CDMO. Yet the manufacturer missed...
View ArticleCerebral to pay nearly $3.7M over controlled substance prescribing practices
Troubled mental health startup Cerebral has agreed to pay nearly $3.7 million in connection with its efforts to encourage unauthorized prescriptions of ADHD medications and other controlled substances...
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