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Sen. Bernie Sanders (I-Vt.) sent a letter to the HHS Inspector General seeking investigation into an NIH proposal granting an exclusive patent license to an “obscure company linked to a former employee” for a treatment for cervical cancer. Read More
The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and mitigating the FDA’s interest in prohibiting use of a product for an unapproved indication. Read More
The European Commission (EC) has unconditionally approved Pfizer’s $43 billion acquisition of Seagen, concluding that the transaction would not raise competition concerns in the EU, Iceland, Liechtenstein and Norway. Read More
Novo Nordisk will pay KBP Biosciences up to $1.3 billion to acquire ocedurenone, a drug for uncontrolled hypertension with potential applications in cardiovascular and kidney disease, the companies announced on Monday. Read More
Last month, the DOJ and the manufacturer of Mifeprex asked the Supreme Court to review the Fifth Circuit court’s decision to limit access to the abortion drug. Read More
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