The FDA is out with new guidance for labeling biosimilar drugs--and it may not make some drugmakers happy. Regulators dismissed pharma's request that the label describe the clinical data copycats used for approval purposes. Instead, the FDA will rely heavily on the reference products' labels, focusing on the info physicians will need to use the product. Guidance (PDF) | More from FierceBiotech
@FiercePharma: India's local rotavirus vaccine launched to combat death linked to diarrhea. More from FiercePharmaAsia | Follow @FiercePharma
@EricPFierce: Japan's Daiichi Sankyo closing an API plant in with 150 workers. More from FiercePharmaManufacturing | Follow @EricPFierce
@CarlyHFierce: ICYMI yesterday: FTC digs deeper into Pfizer's proposed combo with Allergan. Article | Follow @CarlyHFierce
> Bristol-Myers Squibb ($BMY) said the EU's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Opdivo in combination with Yervoy for the treatment of advanced melanoma in adults. Release
> The EMA has recommended approval a biosimilar from Samsung Bioepis of Amgen's anti-inflammatory drug Enbrel. Find the release here
> China is considered the prize for future opioid drug sales because so few are currently used in the country. Story
> Teva ($TEVA) and Takeda have named Hiroshi Matsumori to be CEO for their new joint venture in Japan. Release
> The price of Gilead Sciences' ($GILD) hep C drug Sovaldi will fall 30% under a new drug pricing plan going into effect in Japan that cuts the prices of many prescription meds by 50%. Story
Medical Device News
@FierceMedDev: ICYMI yesterday: Swiss team designs robotic exoskeleton that mimics human knee stability. Article | Follow @FierceMedDev
@VarunSaxena2: ICYMI: CMS Joint Replacement Model won't cut implant prices, will reform postprocedural care. More | Follow @VarunSaxena2
> Philips enrolls 5,000+ in 3 new cardiovascular studies. Story
> Cardiovascular Systems to trim 8% of its workforce in effort to return to profit. More
Biotech News
@FierceBiotech: EuroBiotech report: Lundbeck falls on FDA setback; BI backs cancer vax player; and more. Article | Follow @FierceBiotech
@JohnCFierce: Proving once again that the Regeneron/Sanofi team do great work together. More | Follow @JohnCFierce
> That blockbuster anti-NGF pain drug fulranumab? J&J doesn't want it anymore. Story
> Step right up and place your bets on who might buy Medivation. Article
> GSK wins European regulator nod for new gene therapy. Item