FDA granted Teva’s Plan B One-Step exclusive marketing rights for the next three years. The regulator’s ruling made Teva the only company able to sell the drug, in OTC fashion, to all ages. Manufacturers can apply to have their contraceptive sold in drug aisles, but Teva maintains exclusivity to sell their products to those under 17 for three more years.
AbbVie rheumatoid arthritis (RA) drug Humira was shot down by an FDA advisory committee for a potential new indication, treating inflammatory disease of the spine. The committee suggested the drug maker conduct additional trials to prove the drug’s efficacy in treating early stages of spondyloarthritis. AbbVie was angling to see Humira approved in spondyloarthritis patients who have been resistant to other treatments.
The Joint Committee on Vaccination and Immunisation (JCVI), a government advisory committee in the UK, rejected Novartis meningitis B vaccine Bexsero, citing a lack of evidence the shot protects children well enough to justify routine use. Prof. David Salisbury, director of immunisation at UK’s Department of Health, noted: “This is a very difficult situation, we have a new vaccine against meningitis B but we lack important evidence.” The committee said it plans to give the vaccine to people at high risk of contracting meninigitis B as well as lab workers.
Indian drugmaker Wockhardt was hit with a warning letter from FDA July 18 for concerns about its Waluj plant, in the western part of the country. The generics maker found deficiencies at the plant, which included a lack of drainage from employee urinals. In addition, FDA cited the company for using stall tactics to delay inspection by throwing out paperwork from studies, batch records and stability protocol records.
