FDA has granted accelerated approval to Bristol-Myers Squibb cancer treatment Opdivo (nivolumab). The PD-1 inhibitor will go up against Merck’s Keytruda (pembrolizumab), the first of the PD-1 immuno-therapies to be sanctioned in the US in September. Like Keytruda, Opdivo is initially indicated for use in patients with Yervoy-treated melanoma and in those who have been treated with a BRAF inhibitor (if their tumors express the BRAF V600 mutation). MM&M is tracking this story. In the meantime, here is a link to recent MM&M coverage on this highly touted class of oncology therapies.


India is taking steps to regulate pharma marketing, with the issuance by the country’s Department of Pharmaceuticals of a Uniform Code of Pharmaceutical Marketing practices, PharmaBiz tells us. The code bans pharma firms and wholesalers from offering gifts, payments and travel accommodations to prescribers and other healthcare professionals and their families, and to other suppliers of drugs. Free samples can be supplied only to qualified prescribers and must be handed directly to them. The guidelines will be voluntary for six months then reviewed after industry input.


Omnicare is again the focus of kickback allegations, this time involving Abbott Labs. The US Department of Justice has filed a complaint against the pharmacy services provider alleging it received millions of dollars in kickbacks from Abbott for recommending its epilepsy drug Depakote, and allegedly describing them as educational in nature, Reuters reports. Earlier this year, Omnicare paid $124 million to settle Justice Department charges that it paid kickbacks to secure drug supply contracts with nursing homes.


PTC Therapeutics has commenced a rolling NDA submission to FDA for Translarna (ataluren) as a treatment for Duchenne muscular dystrophy, as it completes a Phase-III confirmatory trial. The first to commercialize a DMD drug with Translarna’s launch in Germany this month under conditional EU approval, PTC is advancing the protein restoration therapy for a range of applications, and this month earned FDA and EU orphan status for treating mucopolysaccharidosis.


Achillion Pharma has top-lined data for an experimental hep. C drug it says shows the promise of eradicating the virus in a shorter duration of treatment than Gilead’s or AbbVie’s HCV therapies. In a mid-stage study pairing Achillion’s NS5A inhibitor ACH-3102 with Gilead’s Sovaldi, the virus disappeared within four weeks, after a six-week course of therapy, the company said, whereas Gilead’s all-oral Harvoni requires eight weeks to achieve the same response, Reuters reports. The FDA approved AbbVie’s all-oral HCV regimen last Friday.