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The FTC has filed an amicus brief amid the ongoing dispute between Viatris’ Mylan and Sanofi over the latter’s patents for Lantus insulin, assailing the use of improperly listed Orange Book patents to delay generic competition. Read More
The first systematic review using statistical methods to look at the risk of switching patients from reference biologics to a biosimilar, or the other way around, found no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar. Read More
In observance of the Thanksgiving holiday, FDAnews will not be published Thursday, Nov. 23, or Friday, Nov. 24. The next issue will be published Monday, Nov. 27. Read More
Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments. Read More
When the rare disease patient community was seeking to have the FDA pay more focused attention to orphan drugs, they asked Janet Woodcock for support. She established within CDER a new office dedicated to orphan drugs and rare diseases. Read More
While the FDA has a longstanding requirement that risk information must be included in television and radio prescription drug ads, the final rule the FDA just issued focuses on ways to help consumers notice, attend to, and understand the drug’s risks. Read More
Merck appears destined for another disappointment with its investigative cough suppressant gefapixant, after an FDA advisory committee almost universally panned the drug’s phase 3 data, citing an almost complete overlap of patient-reported outcomes, a 57 percent placebo response rate, and a 28 percent dropout rate related to taste disturbance, the drug’s biggest side effect. Read More
The UK government, England’s National Health Service (NHS) and the Association of the British Pharmaceutical Industry (ABPI) have agreed to a drug pricing deal that will save the government £14 billion ($17 billion) over five years, and support research investment. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The FDA has deemed B. Braun recall of its Space Volumetric Infusion Pump System due to a potentially faulty occlusion alarm that can stop the delivery of medications as class I, the most serious type of recall as use of the device can cause serious injury or death. Read More
This edition of Quick Notes highlights a permanent injunction against a manufacturer of dietary supplements, request for improved post-market evidence standards, a study on lessening cyber threats to legacy devices, drug distribution partners going all-electronic and seeking input on pulse oximeter discrepancies. Read More
Companies that make pharmaceutical, biologic and medical devices are caught hiding relevant information or purposefully delaying applying for patents at the U.S. Patent & Trademark Office (USPTO) in gamesmanship moves that occur in the medical field far more than in other industries, according to recent reports. Read More