Eight vaccines were added to France's list of mandatory vaccines: pertussis, pneumonia, meningitis C, hepatitis B, mumps, rubella, influenza and measles. Sanofi, which produces some of the vaccines, is ready for the increased demand, according to the company.
Aimmune Therapeutics is testing an oral biologic, AR101, as a peanut protein desensitizing agent. The study, which enrolled its first patient in the UK and plans to include 160 European children and adolescents, builds on midstage trials that successfully desensitized 90% of subjects to the protein equivalent of about two peanuts.
Actelion's Uptravi, or selexipag, was rejected by the Scottish Medicines Consortium for use in adult patients with functional class III pulmonary arterial hypertension, whose condition is not sufficiently controlled with dual oral combination therapy and who are considered for inhaled iloprost treatment. The committee's decision came in part because it could not compare long-term benefits of selexipag and iloprost because of lack of long-term data, Actelion said.
A final guidance document has been issued by the National Institute for Health and Care Excellence recommending the use of Ipsen's Cabometyx, or cabozantinib, as a treatment for patients with kidney cancer, a change in the institute's previous decision to reject the drug. Ipsen addressed the institute's concerns by comparing the drug with other medicines often used in the National Health Service and lowering its cost.
Regulators from France uncovered 35 Good Manufacturing Practice problems at Biocon's fill/finish plant in Bangalore, India, during inspections related to the manufacturing of three of the company's biosimilars -- Fulphila, or pegfilgrastim; Ogivri, or trastuzumab; and Semglee, or insulin glargine -- which it is developing and commercializing in partnership with Mylan. The inspection was part of the European Medicines Agency's approval process for the drugs; French officials said the treatments should not be approved until the GMP issues have been resolved.
Researchers at Singapore's National University Hospital will conduct a study on patients with liver cirrhosis that will utilize stem cell treatments to boost liver function. The four-year trial will recruit 46 patients and is financed by the National Medical Research Council.
The FDA was set to decide Wednesday on CTL019, an experimental immunotherapy developed by Novartis as a treatment for hematologic cancers, and it could become the first chimeric antigen receptor T-cell therapy approved by the agency. The treatment has kept 57 pediatric patients with acute lymphoblastic leukemia alive for 17 months in a trial of 68 critically ill patients and has led to some patients becoming cancer free, but safety remains a concern because of the therapy's serious side effects, which vary from patient to patient.
The FDA has told Amicus it will be allowed to resubmit its Fabry disease candidate migalastat without undergoing additional tests, a move that may signal a change at the FDA. Under the previous administration, Amicus was asked to do additional safety studies that would have caused a delay of several years in potential approval.
A final list of 1,003 Class II medical device types exempted from premarket notification requirements under the 21st Century Cures Act, along with new product codes, has been released by the FDA. Companies that have pending 510(k) submissions for devices included on the list should discuss with the 510(k) lead reviewer if their device falls within the exemption's general limitations or if review needs to continue, the agency said.