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On its third-quarter earnings call Tuesday, Sage highlighted the launch of its Biogen-partnered postpartum depression drug Zurzuvae but said it will stop pursuing approval for major depressive disorder, which the FDA previously denied.
FEATURED STORIES
While some analysts say Donald Trump is a wild card when it comes to drug pricing, many argue his presidency would be more positive for the industry overall, as Kamala Harris has her price-cutting sights squarely on Big Pharma.
With Sarepta’s gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data.
FDA
As therapies for rare and neurological diseases earn accelerated approval, experts laud the program’s intent while remaining concerned about confirmatory trials and clinical efficacy, especially as products greenlit under this pathway are pulled from the market.
TRACKERS
Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
FROM OUR NEWS EDITOR
Every week, BioSpace’s Greg Slabodkin offers his take on the biggest stories happening in our industry.
CEO Albert Bourla, who is under attack from activist investor Starboard Value, got a much-needed victory on Tuesday as Pfizer reported that third-quarter revenue and adjusted profit beat the analysts’ consensus.
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CEO Albert Bourla, who is under attack from activist investor Starboard Value, got a much-needed victory on Tuesday as Pfizer reported that third-quarter revenue and adjusted profit beat the analysts’ consensus.
This webinar will help you discover effective strategies for launching your career in biotechnology. You will gain valuable insights from industry experts and leave with the essential tools you need to thrive in this dynamic field.
Novartis exceeded analyst expectations in the third quarter, driven primarily by the strong U.S. sales of Cosentyx, as well as the robust performances of Kesimpta and Kisqali.
As the Chinese contract manufacturer awaits the U.S. Senate’s consideration of the BIOSECURE Act, it has added 800 new customers in the first nine months of 2024, while being hit with a 2% revenue decline in the third quarter.
Eli Lilly and Johnson & Johnson are seeking label expansions for Omvoh and Tremfya, respectively, in Crohn’s disease following approvals for ulcerative colitis. GlobalData projects total sales for Tremfya to reach $7.8 billion globally by 2029.
A clinical research associate is a professional who oversees clinical trials. Here are our top tips on how to become one.
The acquisition of Aliada Therapeutics gives AbbVie access to a Phase I anti-amyloid antibody as well as the biotech’s novel platform engineered for efficient blood-brain barrier transport.
The Swiss pharma is paying $150 million upfront to gain rights to Monte Rosa’s VAV1-targeting molecular glue degraders, led by a Phase I candidate which holds therapeutic promise for immune-mediated diseases.
Jefferies analyst Kelly Shi in a Sunday note to investors said that both data drops for Revolution Medicines’ experimental RAS inhibitors are positive and could be “synergistic” in the first-line setting for pancreatic ductal adenocarcinoma.
Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders.