A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit.
In what shakes out to be the largest follow-on stock offering in biopharma history, Revolution Medicines Inc., an oncology company that was the subject of buyout rumors earlier this year, priced 10.56 million shares to raise $1.5 billion just two days after wowing investors with top-line phase III data of its RAS inhibitor daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma.
Becoming the first and only fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS), Travere Therapeutics Inc.’s Filspari (sparsentan) has gained access to a second lucrative market with a regulatory package that validates proteinuria as a surrogate endpoint.
Everest Medicines Ltd. has agreed to acquire a Singapore-based commercial unit of Hasten Biopharmaceuticals (Asia) Ltd. for $150 million up front, gaining market authorization holder rights to 14 marketed products originally developed by Takeda Pharmaceutical Co. Ltd.
More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.
Abbvie Inc. is buying exclusive rights to develop, manufacture and commercialize two Nav1.8 inhibitors for pain – HSK-55718 and HSK-51155 – from Haisco Pharmaceutical Group Co. Ltd. for $30 million up front and up to $715 million in milestone payments, plus royalties.
“Unprecedented,” “remarkable” and “transformative” were just a few of the descriptives tossed out by Wall Street analysts in response to Revolution Medicines Inc.’s phase III readout, showing RAS inhibitor daraxonrasib hit its overall survival and progression-free survival endpoints in previously treated patients with metastatic pancreatic ductal adenocarcinoma, setting up the company for potential regulatory filings this year and triggering another round of M&A speculation.
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline. At the start of the biotech industry, progress was slow. Between 1983 and 1995, the U.S. FDA approved an average of two biologics each year. Now, biologics have taken the lead by the smallest of margins, accounting for 50.1% of drugs in development at the start of 2026, according to the Pharma Annual Review 2026, published by Pharmaprojects, a firm that tracks global pharma R&D.