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Home » Topics » Drugs » Commercial Operations

Commercial Operations
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PhRMA Asks FDA to Deny Florida Proposal to Import Canadian Drugs

September 27, 2023
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

Biosimilars Spell the End of Humira’s Blockbuster Empire ... Or Do They?

September 26, 2023
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

Pharm Tech Survey Shows Nearly All Face Drug Shortages, Pfizer Plant Shortages Continue Until 2024

September 26, 2023
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

Lilly Becomes Second Maker of GLP-1 Inhibitors to File Lawsuits Against Copycats

September 21, 2023
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

BCBS of Louisiana Sues Celgene, BMS for Patent Fraud of Blockbuster Drug Pomalyst

September 21, 2023
Several generics manufacturers are also named in the lawsuit for allegedly receiving payments for delaying market entry of their drugs. Read More

Culture of Quality and Compliance Go Hand in Hand, Says Expert

September 20, 2023
The culture behind compliance metrics is important to understanding the numbers, expert says.  Read More

Crisis Response Can Build Resiliency Into Supply Chain Business Plans, Says Moderna Expert

September 19, 2023
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, BMS Sued by BCBS of Louisiana for Patent Fraud of Blockbuster Drug Pomalyst

September 19, 2023
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

Compliance and a Culture of Quality Go Hand in Hand, Says Expert

September 18, 2023
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

Cisplatin at Nearly Normal Levels, After FDA Taps Manufacturers to Reduce Cancer Drug Shortages

September 15, 2023
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

Quick Notes for Sept. 13, 2023

September 13, 2023
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 Pharma Becomes 25th Drugmaker to Restrict Participation in 340B Program

September 13, 2023
Jazz Pharmaceuticals has become the 25th drugmaker to reduce its participation in the controversial 340B Discount Drug Program. Read More
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