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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back.
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Topline results for its Daiichi Sankyo-partnered antibody-drug conjugate showed statistically significant improvement. However, AstraZeneca shares dropped around 6% in early Monday trading.
Pharmas, advocacy groups and regulatory bodies have made moves to put each other in legal crosshairs in 2023. Follow along with BioSpace’s Lawsuit Tracker to see what’s piling up on the docket.
The verdict, rendered by a California jury on Friday, found that the companies did not engage in an anticompetitive conspiracy to delay generic versions of HIV PreEP medicines.
The revised guidance comes amid lawsuits filed by drug manufacturers and industry groups, which claim the Inflation Reduction Act is unconstitutional. Prices negotiated will be effective as of 2026.
The companies Friday reported positive late-stage results for elafibranor as a second-line treatment for primary biliary cholangitis, a rare liver disease.
More than a month after failing its Friedrich’s ataxia trial, PTC Therapeutics’ vatiquinone has again missed its primary endpoint, this time in a mitochondrial disease-associated seizures study.
In its third acquisition this month, Eli Lilly is buying antibody-drug conjugates startup Emergence Therapeutics to bolster its cancer business.
After an initial rejection, BioMarin has finally secured the FDA’s approval for Roctavian, the first gene therapy in the U.S. for the most common form of the bleeding disorder.
The company Thursday reported positive topline results for a Phase III trial of its Alzheimer’s-related agitation treatment, while also disclosing improprieties by a principal investigator.
The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.