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

Nearly 96 percent of pharmacy technicians recently surveyed said they are facing drug shortages, primarily for chemotherapy drugs, medicines for ADHD, GLP-1 agonists for weight loss and diabetes, and local anesthetics such as lidocaine, while Pfizer reopens its NC plant — but only partially. Read More

Eli Lilly has filed 10 patent lawsuits against wellness clinics, med spas and compounders and pharmacies for marketing and selling unapproved versions of the company’s blockbuster Type 2 diabetes drug, the glucagon-like peptide-1 (GLP-1) receptor agonist Mounjaro (tirzepatide). Read More

Pandemics. War. Political upheaval. Severe weather. Availability of energy supplies. Any of these can kink up the supply chain, making it difficult (and sometimes impossible) to get drugs to the patients who need them, said Dionne Dosa, executive director of CMC Procurement for Moderna. Read More

Celgene and Bristol Myers Squibb (BMS) have used a pattern of unlawful patents to extend a monopoly in the market for Pomalyst (pomalidomide), a blockbuster drug used in the treatment of multiple myeloma, according to a lawsuit filed by Blue Cross and Blue Shield of Louisiana (BCBS). Read More

Focusing on fostering a culture of quality in a drug manufacturing company seems obvious today — a given. But that wasn't always the case, explained industry veteran Sue Schniepp, a distinguished fellow at the consulting firm Regulatory Compliance Associates. Read More

The FDA’s work with cancer drug manufacturers has brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels, the White House said in an announcement on Tuesday. Read More

Our coverage spans relief from third party funded mass tort litigation sought by the medical device industry to Apple prevailing in Masimo patent appeal and two class I device recalls. Read More

Jazz Pharmaceuticals has become the 25th drugmaker to reduce its participation in the controversial 340B Discount Drug Program. Read More