The FDA granted approval to Biomarin Pharmaceutical's Palynziq, or pegvaliase-pqpz, for use in reducing blood phenylalanine concentrations in adult patients with phenylketonuria, whose blood Phe concentrations is higher than 600 micromo/L and is uncontrolled. The decision was supported by data from a late-stage trial in which the drug reduced blood Phe levels of patients versus placebo use.
The FDA accepted for review AcelRx Pharmaceuticals' Dsuvia, or sufentanil sublingual tablet, 30 mcg, with a PDUFA date of Nov. 3. Dsuvia is being developed for adult patients to manage moderate-to-severe pain under medically supervised settings.
Bio Products Laboratory's supplemental biologics license application for Coagadex, which is being developed as a prophylactic treatment for patients with hereditary factor X deficiency who are younger than 12, was accepted by the FDA. The application was backed by results from a late-stage prospective study of the candidate in which investigators rated it excellent for all study subjects.
Merck announced Wednesday that recent study outcomes show that its cancer drug Keytruda increased survival times and decreased recurrence in untreated patients with squamous non-small cell lung cancer, results already seen in other forms of lung cancer. Merck plans to present expanded data at the American Society of Clinical Oncology meeting early next month.
The FDA ruled that Recro Pharma's nonopioid shot IV meloxicam did not meet expectations on pain relief despite the statistically significant outcomes it showed pertaining to its main goals in late-stage trials. The agency also cited issues on the chemistry, manufacturing and controls related to certain data provided by Recro in its application.
Novartis unit Sandoz's Zessly, or biosimilar infliximab, was approved by the European Commission for all of the same indications for which its reference medicine, Merck and Johnson & Johnson's Remicade, has been cleared -- including Crohn's disease, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.
The National Institute for Health and Care Excellence recommended against the use of Chiesi's Lamzede, or velmanase alfa, in patients with alpha-mannosidosis. The cost regulator ruled that trial evidence showed the nature and size of the clinical benefits are uncertain in the short and long term, and the drug's benefit did not meet cost-effectiveness standards.
A recall was issued by Stop & Shop for its SB Cut Broccoli because it could be contaminated with listeria monocytogenes. The recalled product bears the UPC number 068826700926 and the "best-by date of March 15, 2020, and was distributed to Stop & Shop stores in Connecticut, Massachusetts, New Jersey, New York and Rhode Island.
Student submissions wanted for FDLI's H. Thomas Austern Writing Competition! Winners receive up to $750, and top papers will be considered for publication in the Food and Drug Law Journal. Accepting entries through June 11. Submit your work.
Xin Tao of Hogan Lovells reports for FDLI's Update Magazine on recent changes to the Chinese regulatory scheme aimed at facilitating market entry for pharmaceuticals. Developments to watch include changes in the approval process, patent rights and overseas inspections. Read more.