FDAnews Drug Daily Bulletin

PhRMA is asking the Supreme Court to take up and overturn the 3rd Circuit Court’s decision that reverse patent settlements between generics and branded drug makers violate antitrust law.

British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials.

Ben Venue subsidiary Bedford Laboratories is expanding its voluntary recall of chemotherapy drug leucovorin calcium due to crystalline particulates in a small number of vials.

Bayshore Pharmaceuticals has announced that the FDA has granted final approval for their ANDA for Methscopolamine Bromide tablets (2.5 & 5 mg tablets).

Aurobindo Pharma has received approval from the FDA to manufacture and market modafinil tablets of 100 mg and 200 mg.

A southern Taiwan-based National Cheng Kung University research team has discovered that rapamycin, a drug that acts as an autophagy activator, is a possible treatment to alleviating frontotemporal lobar degeneration, one of the main causes of dementia for which there currently is no effective treatment.

Boehringer Ingelheim Pharmaceuticals has completed clinical trial enrollment of two Phase III studies evaluating the safety and efficacy of nintedanib (BIBF 1120).

NovaBay Pharmaceuticals, a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides, today announced that it has received $2.6 million from partner Galderma S.A., a global leading pharmaceutical company exclusively focused on dermatology.

An international consortium of scientists studying chronic lymphocytic leukemia, based at the University of California, San Diego School of Medicine, has been awarded a five-year, $20 million grant by the National Cancer Institute, part of the National Institutes of Health.