Biogen job cuts may undermine Cambridge expansion; EMA director lays out 5-year plan;

@FiercePharma: India's Dr. Reddy's responds to U.S. FDA warning letter. FiercePharmaAsia article | Follow @FiercePharma

@CarlyHFierce: I'm sorry, but you had 20 years to brainstorm on this, and you came up with "Dengvaxia?" | Follow @CarlyHFierce

> Biogen ($BIIB) may be backing off plans to expand in the Boston area after announcing plans to cut 11% of its workforce. Story

> Biotech Alnylam Pharmaceuticals ($ALNY) threw down a gauntlet to Alexion ($ALXN), laying out plans to bring to market a drug that would challenge Alexion's orphan drug Soliris, sometimes called the worlds' most expensive drug. Story

> EMA Executive Director Guido Rasi laid out a 5-year plan for drug oversight in Europe which includes faster drug approvals, accomplished without compromising quality. Story

> Indiana-based Eli Lilly ($LLY) has made a $30,000 grant to help fund 100 drug disposal sites at pharmacies in the state. More

Medical Device News

@FierceMedDev: ICYMI yesterday: Chemotherapy cooling cap to reduce hair loss for breast cancer patients gets FDA nod. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: Edwards grabs option to acquire transcather mitral valve replacement startup. Article | Follow @VarunSaxena2

@EmilyWFierce: Cornell scientists create first litter of puppies through in vitro fertilization. FierceAnimalHealth story | Follow @EmilyWFierce

> Edwards bets on treating degenerative regurgitation via mitral repair with Harpoon investment. More

> Bloomberg: Embattled Theranos CEO continues to beat the 'transparency' drum. Story

> MicroTransponder reels in $5.5M for stroke neurostimulation device. Article

Biotech News

@FierceBiotech: With Roche in the rearview mirror, Constellation Pharma grabs $55M round. Article | Follow @FierceBiotech

@JohnCFierce: Now we get to see if Merck KGaA can swing big and actually hit the ball. Article | Follow @JohnCFierce

> After failing a PhII/III, Raptor steers Huntington's drug into a pivotal trial. Article

> Puma's once-vaunted cancer drug dogged by side effects in Phase II results. Item

> In a win for NYC, gut-brain biotech Kallyope launches with $44M. News

> FierceBiotech Radio on the burning hole in Gilead's $25B pocket and AbbVie's future in hematology. More | Subscribe

CRO News

> Icon buys a trial site network with an eye on patient data. News

> WuXi and PRA break up their Chinese joint venture. More

> Charles River digs into Parkinson's R&D with Fox Foundation in tow. Story

> Quintiles extends its R&D hand-holding service to biopharmas large and small. Report

> Restructured AMRI cuts the ribbon on a drug discovery hub. Article

Pharma Manufacturing News

> Sucampo finalizes $278M deal of R-Tech Ueno's manufacturing plant in Japan. News

> Axxess Pharma has tapped SDC Nutrition for product manufacturing. Report

> FDA issues import alert on Pan Pharma, ramping up its pressure on the India drugmaker. Story

> Eli Lilly to manufacture human and animal drugs in separate facilities. Article

> Study: Shortfall of skilled inspectors in India hinders pharma industry. Item

Pharma Asia News

> WuXi and PRA Health amend ties in China. Item

> U.S. FDA files import alert on India's Pan Drugs. More

> China aims precision medicine plans at chronic diseases. Report

> Bangladesh again noted for dominant domestic drug manufacture. Story

> Takeda inks pact with Cour for celiac disease therapy via nanoparticles. Article

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