Archive for September 2023
Meeting Planner — Week of Sept. 25, 2023
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities, medical device counterfeiting and what to expect…
Read MorePhRMA Asks FDA to Deny Florida Proposal to Import Canadian Drugs
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. Source: Drug Industry Daily
Read MorePharma Companies Rake in $185B on Just Four Drugs Via Patent Thickets, Says Report
Drugmakers have netted a whopping $185 billion from just four mega-blockbusters by leveraging patent thickets — the filing of overlapping patents to artificially extend a drug’s intellectual property protections to block generic competition — says a new report from the Initiative for Medicines, Access and Knowledge (I-MAK). Source: Drug Industry Daily
Read MoreBMS, Other Drugmakers Sign Drug Price Negotiation Agreements With CMS
Bristol Myers Squibb (BMS) has struck an agreement with CMS to negotiate the price of its blood thinner medication Eliquis (apixaban) ahead of the Oct. 1 deadline, the drugmaker confirmed to FDAnews Wednesday. Source: Drug Industry Daily
Read MoreEuropean Parliament and EMA Agree on New Application Fee Structure
The European Parliament and the European Medicines Agency (EMA) have agreed upon a regulation — updating a newly 20-year-old model — to modernize and simplify application fees the EMA collects. Source: Drug Industry Daily
Read MoreICER, Peterson Health Technology Institute Devise Assessment Framework for DHTs
The Institute for Clinical and Economic Review (ICER) and the Peterson Health Technology Institute (PHTI) have partnered to assess digital health technologies (DHTs) against the standards that devicemakers should meet when generating early studies for their products. Source: Drug Industry Daily
Read MoreCoherus Slapped With CRL for Neulasta Biosimilar BLA Due to Third-Party Filler
The FDA issued a complete response letter (CRL) to Coherus Biosciences on its BLA for a biosimilar of Neulasta (pegfilgrastim) solely due to an ongoing review of inspection findings at a third-party filler, the company said. Source: Drug Industry Daily
Read MoreBiosimilars Spell the End of Humira’s Blockbuster Empire … Or Do They?
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. Source: Drug Industry…
Read MorePharm Tech Survey Shows Nearly All Face Drug Shortages, Pfizer Plant Shortages Continue Until 2024
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. Source: Drug Industry Daily
Read MoreCybersecurity Final Guidance Details System Considerations for Premarket Submissions
The frequent electronic exchange of health data through wireless, internet and networks along with the cybersecurity threats and vulnerabilities is driver for an FDA final guidance making recommendations for cybersecurity information to be submitted with premarket applications to CDRH and CBER. Source: Drug Industry Daily
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