OPDP slams Kowa for Lipofen-touting email; Pharma responds to FDA's social media rules; Novo nabs EU approval for Xultophy;

> The FDA's Office of Prescription Drug Promotion jumped on Kowa Pharmaceuticals and Cipher Pharmaceuticals ($CPHMF) for "unsubstantiated claims" in an email promoting its cholesterol treatment Lipofen. Report

> Drugmakers aren't happy about the FDA's new social media rules, and they've filed their grievances with the agency as part of the rulemaking process. Report

> Novo Nordisk's ($NVO) new combination diabetes treatment Xultophy, comprising Tresiba and Victoza, won approval in Europe; the company plans to launch early next year. Release

> AstraZeneca ($AZN) posted new trial data on Bydureon, its long-acting version of exanatide, showing that it matched or beat the twice-daily version, Byetta, at helping people with diabetes control their blood sugar. Report

> Spectrum Pharmaceuticals ($SPPI) licensed two of its cancer drugs, Zevalin and Marqibo, and a Phase III candidate to CASI Pharmaceuticals ($CASI) to develop and sell in China. Report

And Finally... Merck ($MRK) and Bristol-Myers Squibb ($BMY) may be wrapping up their Sustiva patent fight with Cipla, according to newly filed court documents. Report

Suggested Articles

Last year at ESMO, AZ and Merck showed Lynparza topped its rivals at fending off prostate cancer. Now, Lynparza has helped patients live longer, too.

The Tecentriq-Avastin-chemo cocktail did slightly better in PD-L1-positive patients but still failed to cross the statistical significance bar.

Trodelvy's bladder cancer data look weaker compared with what Seattle Genetics' rival drug Padcev achieved in its own trial.