FDA releases guidance on animal studies; Carmat's artificial heart patient faring well;

@FierceMedDev: Intelesens gets FDA approval for its Zensor wearable vital signs device. More | Follow @FierceMedDev

@VarunSaxena2: California cutbacks: BD cuts 95 at CareFusion; Medtronic to cut 21 at distribution facility. Report | Follow @VarunSaxena2

@EmilyWFierce: Advera: AbbVie's Viekira Pak riskier than Gilead's Harvoni for hep C. FiercePharma report | Follow @EmilyWFierce

> The FDA released a draft guidance about general considerations for animal studies of medical devices. More

> A third patient implanted with Carmat's investigational permanent artificial heart is faring well 6 months after receiving the device, reassuring news after the first two patients 74 days and then 9 months post-implantation. More

Biotech News

@FierceBiotech: Zafgen finally breaks its silence, says it's probing death of a patient. Report | Follow @FierceBiotech

@JohnCFierce: Still trending -- Moderna's top scientist steps down amid a billion-dollar R&D push by @DamianFierce. Article | Follow @JohnCFierce

@DamianFierce: There is perhaps no greater tribute to Steve Jobs than obfuscating your business model and threatening your critics. WSJ story | Follow @DamianFierce

> Bristol-Myers inks a blockbuster $1.74B deal for an Opdivo combo drug. Story

> Galapagos moves third component of AbbVie-partnered CF therapy toward clinic. Report

> Hearing the call of a new quest, Third Rock answers with $52M biotech startup. Article

> FierceBiotech Radio on Lilly's latest pipeline peril, Mylan's M&A broken record, and German Merck's big rebrand. More | Subscribe

Pharma News

@FiercePharma: ICYMI: Can J&J's Invokana reap the benefits of Lilly and BI's new cardiac data? Its CFO thinks so. Article | Follow @FiercePharma

@EricPFierce: Pests, lack of data integrity thwart another Indian API maker, this time Unimark Remedies. FiercePharmaManufacturing article | Follow @EricPFierce

@CarlyHFierce: UPDATED: Mylan hopes new show-and-tell will woo Perrigo shareholders. Story | Follow @CarlyHFierce

> Valeant hit with two federal subpoenas as drug-price controversy rages on. Story

> Pfizer CEO: Drug-pricing snafu isn't pharma's fault. It's insurers and their poor coverage. More

> Advera: AbbVie's Viekira Pak riskier than Gilead's Harvoni for hep C. Article

CRO News

> INC bolsters its Phase I platform with new cardiac tech. Story

> Aesica bids to manage its clients' many contractors. More

> Cel-Sci lines up cash to fund its $50M suit against ex-partner inVentiv. Report

> CRO Frontage gets into agrochemicals with new service offering. Story

> PRA adds a biotech vet to its board amid an expansion effort. Article

Pharma Manufacturing News

> Myanmar offers incentives to lure its drug distributors into production. News

> Medline recalls 500 mg acetaminophen labeled as 325 mg. More

> Valeant's Bausch + Lomb plant getting $150M in investments, up to 200 jobs. Report

> Chinese company intends to build plant to produce Ebola vax. Article

> GSK selling its drug distribution biz in Romania. Story

Pharma Asia News

> Superbug infections drop in China with new controls on antibiotics. Article

> China's State Council urges Suzhou Industrial Park to be more innovative. Story

> Japanese drug regulator opening Indian office. Item

> Lupin inks deal with Boehringer for diabetes drugs in India. News

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