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As biotechs faced investors at the J.P. Morgan Healthcare Conference this week, they emphasized agreement with the FDA on clinical trial design and regulatory pathways to approval. Atara, meanwhile, lamented the agency’s “complete reversal of position” after its therapy for a rare surgical complication was rejected.
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It doesn’t matter how many times you have traversed Union Square; no one knows which way is north, or where The Westin is in relation to the Ritz Carlton. A Verizon outage brought that into focus on Wednesday.
Primarily known as an immunology and neuroscience company, AbbVie wanted to put the biopharma world on notice during its J.P. Morgan presentation: its oncology portfolio is underappreciated. This week, the Illinois-based company dove into the sizzling PD-1/VEGF space with a licensing deal with China-based RemeGen.
Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration.
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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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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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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.
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.
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.