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A district court has handed a preliminary injunction to EOFlow, blocking it from selling products developed using proprietary information derived from insulin pump maker Insulet — the decision arriving as Medtronic is slated to pay $738 million to acquire EOFlow. Read More
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Read More
Pfizer announced that the FDA has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab), giving pharmacists the ability to substitute it for Humira without intervention from the prescribing clinician. Read More
The FDA has revised the Manual of Policies and Procedures (MAPP) for ANDA assessment practices with changes intended to decrease the number of review cycles needed for approval. Read More
The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More
This year, those making combination products find themselves in a swirl of potentially confusing regulations and standards regarding risk management. Read More
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation has released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. 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
The issues the industry is grappling with these days dovetail perfectly with topics on tap at the GMP Quality Management Virtual Summit 2023 Oct. 11 and 12, according to Steve Lynn, this year’s new conference lead. Read More