One of the problems of doing business in the EU is that each member nation has its own more or less unique requirements for clinical trial registration, but the Medical Device Coordination Group may have a solution in the form of a pilot program for harmonized clinical trial registration.
Evotec SE has received a $5 million milestone payment from Bristol Myers Squibb Co. (BMS), following the acceptance of an IND application by the FDA in the companies’ strategic protein degradation partnership.
A four-way interagency initiative in South Korea, started in 2020, is working to bolster funding for the local medical device industry and grow homegrown devices for the global market.
The U.S. FDA is turning the clock back more than 20 years to advance women’s health by narrowing the boxed warning on hormone replacement therapies (HRTs) for menopause. The agency announced at a Nov. 10 news conference that it’s working with companies to update their HRT labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia.
The U.K. Medicines and Healthcare Products Regulatory Agency has laid out an approach to medical products for rare diseases, which the agency said afflict 3.5 million U.K. citizens. One of the objectives of this program is to simplify evidence requirements for these therapies with the hope of providing patients with more rapid access to much-needed therapeutic options.
On Nov. 5, the Chinese Ministry of Commerce reported it would lift the export ban on Illumina Inc., which had been in place since March 4. While the ban will be lifted starting Nov. 10, Illumina remains on the unreliable entities list, requiring government approval for instrument purchases.
Baxter International Inc. recently received clearance under the Medical Device Regulation for its Floseal Hemostatic Matrix device, a proven adjunct hemostatic agent effective in a wide range of bleeding scenarios. With bleeding control still a critical concern, the device offers health care professionals a reliable solution to enhance patient safety and improve surgical outcomes.
The U.S. Patent and Trademark Office (PTO) has resurrected a previous policy that requires parties to a proceeding at the Patent Trial and Appeals Board to disclose all the parties of interest in the proceeding. PTO said this shift is driven in part by national security considerations, but the reversal forces participants in PTAB proceedings to disclose the identity of any affiliates that may have an interest in the outcome lest the petition for an administrative hearing be denied.
Industry watchers were surprised when Eli Lilly and Co.’s oral GLP-1 candidate, orforglipron, did not appear among the first nine recipients of the U.S. FDA’s commissioner’s national priority voucher (CNPV) program aimed at shortening regulatory review times, boosting domestic manufacturing and improving affordability. But orforglipron, which recently nailed endpoints in a second phase III trial and has been hailed a potentially best-in-class compound, was among the second batch of six drugs added to the CNPV list.
Hailing it as a win-win and a historic step forward in fighting chronic disease, the Trump administration announced pricing agreements Nov. 6 with Eli Lilly and Co. and Novo Nordisk A/S that will expand the availability of the companies’ weight loss drugs by cutting prices and, for the first time, providing coverage for the drugs in obesity through Medicare and Medicaid.
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