Hello, everyone, and how are you today? A warm and shiny sun is greeting us this morning on the Pharmalot campus, where our short person has successfully left for the local schoolhouse, the official mascots are snoozing once again, and we are brewing needed cups of stimulation. Please feel free to join us. Remember, no prescription is required. As always, here are some items of interest. Have a lovely day and drop us a line if you can …
Horizon Pharma disclosed that it received a subpoena last November from the US Attorney in New York for documents and other information related to its patient assistance programs, according to a filing with the Securities and Exchange Commission. These programs provide free medicines and co-pay coupons to consumers to help cover out-of-pocket drug costs. Last October, Valeant Pharmaceuticals received a subpoena for its programs.
The Food and Drug Administration recommended placing a so-called black box warning on the label of the Essure implantable contraceptive device and requiring Bayer to run a safety study, The Wall Street Journal reports. The move comes six months after an FDA advisory panel decided the device was linked to debilitating pelvic and abdominal pain. The agency has received more than 5,000 complaints from women who had the device implanted.
China plans to speed approval of some medicines, Reuters informs us. The country’s FDA released a statement saying it would focus on approving drugs with a clear clinical value, including those that use advanced technology or innovative methods. And certain categories of drugs would get priority, including those for children and the elderly, rare diseases, cancer, viral hepatitis, and AIDS.
Endo International plans to close its Astora Women’s Health division at the end of the month after failing to find a buyer, The Wall Street Journal writes. In explaining its decision, the drug maker cited a growing number of lawsuits related to its vaginal mesh products. So far, Endo has set aside about $2.3 billion to cover the cost of the litigation. Earlier this year, the FDA set it would tighten regulations for the products.
AstraZeneca has sold rights to the Moventig treatment for opioid-induced constipation to a unit of Kyowa Hakko Kirin for an upfront payment of $70 million, Reuters reports.
Mylan may have gotten a sales boost for its EpiPen allergy-reaction injector after the FDA identified “major deficiencies” in an application for a competing generic version from Teva Pharmaceutical, Bloomberg News says.
AstraZeneca disclosed that its tremelimumab cancer drug failed to improve overall survival as a monotherapy in patients with mesothelioma, Pharma Times writes.
BioMarin Pharmaceuticals is entering a crucial stretch, and it starts Wednesday when results from a clinical trial involving children with a type of Batten’s disease, a fatal neurodegenerative disorder, are released, TheStreet says.
Roche received FDA approval for a second indication for its slow-growing Gazyva leukemia drug, which can be used to follicular lymphoma, PMLive says.
Indian drug regulators met with officials from the UK’s Medicines and Healthcare Products Regulatory Agency in a move to ease exports to the UK, PharmaBiz tells us.
A new study found that type 1 diabetes is linked to a higher risk of several cancers but a reduced risk of other cancers, according to MedPage Today.