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PhRMA has asked the U.S. Supreme Court to grant petitions from the Department of Justice (DOJ) and Danco Laboratories and reverse the U.S. Court of Appeals for the Fifth Circuit judgment on Mileprex (mifepristone) because it “sets a precedent that — if left undisturbed — could significantly disrupt industry and stifle innovation in drug development.” Read More
In a move to strengthen its KRAS-targeting oncology portfolio, Bristol Myers Squibb is buying Mirati, the company that developed and launched Krazati (adagrasib), a best-in-class molecule that, when combined with a PD-1 inhibitor, targets non-small cell lung cancers harboring the common mutation. Read More
Cancer centers in the U.S. are still grappling with shortages of critical drugs, according to a new survey by the National Comprehensive Cancer Network. Read More
Thirty-one organizations from across life sciences came together to oppose the FTC’s new approach to antitrust enforcement and launched the Partnership for the U.S. Life Science Ecosystem (PULSE), a new coalition to raise awareness of the fundamental role of “pro-innovation M&A” in advancing the next generation of treatments and cures for patients. Read More
Sanofi and Teva Pharmaceuticals announced today a collaboration to co-develop TEV’574 to treat two types of irritable bowel disease (IBD) — ulcerative colitis and Crohn’s Disease. Read More
Humira’s biosimilar competitors have overcome the approval and patent fight process, only to run straight into what may be an even bigger challenge: getting the drugs past pharmacy benefits manager (PBM) gatekeepers and earning the trust of clinicians and patients. Read More
Eli Lilly and Point Biopharma Global have announced that Lilly will pay $1.4 billion to acquire Point, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer. Read More
Our coverage includes EMA’s revocation of conditional marketing authorization for Blenrep, FDA approvals for Pfizer’s Bosulif and Viatris/Ocuphire Pharma Ryzumvi, and the FY 2024 priority review voucher fee rate. Read More
PhRMA, the Partnership for Safe Medicines (PSM), and the Council for Affordable Health Coverage (CAHC) have sent a 10-page letter to the FDA requesting that the agency deny Florida’s Section 804 importation program (SIP) proposal to import cheaper drugs from Canada. Read More
With the approval of seven adalimumab biosimilars since January, AbbVie may have lost the keys to its Humira kingdom, and with it, up to $8 billion in sales this year alone, but for generics makers, surpassing AbbVie will require an uphill battle fought on several fronts — patents, pricing, patients and prescribers. Read More