A newly-approved law in Ukraine will give the public access to clinical trial results for drugs marketed in the country.

The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.

The Medicines Company's inclisirin CV trial is 100-fold cheaper with digitized records, while Lilly is still hunting for a good HBA1C dataset, and Merck worries about "idiosyncratic" data.

The Medicines Company's inclisirin CV trial is 100-fold cheaper with digitized records, while Lilly is still hunting for a good HBA1C dataset, and Merck worries about "idiosyncratic" data.

Bayer convinces federal court to affirm USPTO appeal board decision to cancel competitor Belmora’s Flanax US naproxen product trademark because the firm used packaging that resembled a Bayer product with the same name sold in Mexico. The ruling could provide standing for owners of foreign marks to assert priority rights over similar US marks, according to a patent attorney.

Details on anticipated changes to rebate practices are in demand. HHS Secretary Azar talked about changes that would still allow negotiated discounts at the point of sale during a presentation at the FT Pharma Pricing and Value Summit.

Bayer reported consumer health sales globally fell 1.4% to $1.64bn after a late start to the allergy season drove down Claritin sales. Aleve analgesics sales grew 3.3% to $112.5m on US line extensions while Alka Seltzer line sales were flat at $47.5m.

The constant battle of assuring the sterility of purportedly sterile products is underscored by recent warning letters, consumer alerts and other notices from US FDA. It’s clear at least that some firms are serious about microbial contamination risks – others, not so much.

Zhejiang Huahai has detected a second probable carcinogen in valsartan API it manufactured. Meanwhile risk analysis suggests cancer risk from the first probable carcinogen is low, at least so far.

Bayer convinces federal court to affirm USPTO appeal board decision to cancel competitor Belmora’s Flanax US naproxen product trademark because the firm used packaging that resembled a Bayer product with the same name sold in Mexico. The ruling could provide standing for owners of foreign marks to assert priority rights over similar US marks, according to a patent attorney.

Excedrin Extra Strength US sales for the 12 months ending Aug. 12 were up 4.07% to $77.2m, but those figures don't include the 12,000 free packages of Excedrin gel tablets consumers ordered during GSK's the Limited Edition promotion. The firm offered Excedrin in packages marked with causes consumers commonly link with headaches: commuting, bad dating and "adulting."

US FDA proposes to repeal regulation that, since 1955, has required an NDA or ANDA for any drug product sterilized by irradiation, including drugs that otherwise would be marketed under an OTC monograph. It notes the Trump administration's order that federal agencies identify and potentially eliminate any unnecessary rules and regulations.