@FierceBiotech: ICYMI: Sanofi and Regeneron's would-be blockbuster clears FDA hurdle, but questions remain. Article | Follow @FierceBiotech
@JohnCFierce: Melinta grabs $67M in pursuit of a big PhIII antibiotics finish, NDA. News | Follow @JohnCFierce
@DamianFierce: This seems to be driving the PCSK9 panelists insane. Item | Follow @DamianFierce
> Bluebird bio ($BLUE) is pressing on with plans for a new pediatric study of its gene therapy for a rare blood disorder despite the recommendation of an NIH committee, which suggested the company wait a year or two before proceeding. More
> China's push to catch up with other nations in biotech R&D is bearing fruit, Reuters reports. Story
> Israel's Intec Pharma is looking to raise $46 million in a U.S. IPO to support its development of a novel drug delivery technology. Filing
Medical Device News
@FierceMedDev: ICYMI yesterday: HeartWare tells patients how to safely use its blood pump in attempt to overcome slew of recent recalls. Article | Follow @FierceMedDev
@VarunSaxena2: India's Cipla gets first FDA approval of oral pellet to treat HIV/AIDS in infants. FierceDrugDelivery article | Follow @VarunSaxena2
> Biotronik's vascular stent determined effective in challenging cases of peripheral artery disease. Story
> KKR-backed Panasonic Healthcare to buy Bayer diabetes device biz for almost $1.2B. Article
Pharma News
@FiercePharma: GSK, Sanofi hauled up by India's competition watchdog on vaccine tenders. FiercePharmaAsia story | Follow @FiercePharma
@EricPFierce: Mylan recalls more injected cancer drugs it made for Pfizer at its Agila plants in India. More from FiercePharmaManufacturing | Follow @EricPFierce
@CarlyHFierce: ICYMI yesterday: Does brand + generic really add up? Sandoz, Actavis execs count the ways. Article | Follow @CarlyHFierce
> Inflectra vs. Remicade study could be just what the doctor ordered for biosimilars. More
> Novartis closes in on lucrative new Cosentyx use with ankylosing spondylitis results. Story
> You're free to speak, FDA tells Amarin in bid to deflate free-speech suit. Article
Pharma Marketing News
> Merck KGaA's amped-up consumer pitch delivers much-needed sales hike. Story
> Pharma needs some 'marriage counseling' for patient relationships: report. More
> Merck's best hep C strategy is niche marketing, game theory expert figures. Story
> Want new patient relationships? Digital-savvy KOLs could be your intro. Article
> Why sue, FDA asks Amarin: You can spread the word on Vascepa already. Item
Biotech Research News
> CRISPR-Cas9 furor highlights explosive growth of gene editing in China. Report
> Do U.S. biomedical researchers really waste about $28B a year? Story
> Enzyme in mice linked to obesity, diabetes. Item
> NYU study: Blocking receptor protein CXCR4 'decimated' leukemia cells. More
> ALS researchers at Gladstone, Michigan shed new light on a key drug target. Article
Diagnostics News
> Study identifies 16 new genetic variants of Bloom syndrome. News
> U.K. researchers say earlier diagnoses of bladder cancer needed, especially among women. Report
> Health Diagnostic Laboratory rails against physician kickback claims. Story
> Roche receives FDA clearance for test to diagnose herpes using its cobas system. Article
> Exact Sciences joins forces with MD Anderson for lung cancer Dx development. More