Vanda wins FDA nod for sleep therapy; GSK's Promacta gets FDA 'breakthrough' tag; AstraZeneca wraps up BMS diabetes buyout;

@FiercePharma: WSJ: Scientist's lawsuit accuses AstraZeneca of fudging Brilinta study. Story | Follow @FiercePharma

@TracyStaton: Biogen Idec's Tecfidera nabs EU approval for first-line MS treatment. Rollout TK. More | Follow @TracyStaton

@EricPFierce: The FDA says it will take a look at the heart risks of testosterone boosting drugs. Report | Follow @EricPFierce

@CarlyHFierce: More Humira sales gains help AbbVie meet forecasts. News | Follow @CarlyHFierce

> Vanda Pharmaceuticals ($VNDA) nabbed FDA approval for Hetlioz, its new drug for a sleep disorder affecting the blind. Report

> GlaxoSmithKline ($GSK) won the FDA's breakthrough designation for Promacta/Revolade, a treatment for thrombocytopenia, for a new use in severe aplastic anemia. Release

> AstraZeneca ($AZN) wrapped up its buyout of Bristol-Myers Squibb's ($BMY) share in their global diabetes partnership. Release

> South Africa's Bidvest once again upped its stake in Adcock Ingram--to more than 34%--as it seeks to block a rival bid for the company from Chile's CFR Pharmaceuticals. Report

> Alexion Pharmaceuticals ($ALXN) agreed to buy a site in Ireland for a new vial-filling facility that will employ 40 workers. Release

> Novartis ($NVS) tapped the French environmental services company Veolia Environement to manage water, energy and waste at 15 of its sites in Europe. Report

> Forest Laboratories ($FRX) wrapped up its $2.9 billion buyout of Aptalis. Release

> India's Glenmark Pharmaceuticals will re-merge its generics and unit with its Glenmark Access business, which split into two companies several years ago. Report

Medical Device News

@FierceMedDev: Montagu Private Equity grabs Rexam's healthcare packaging arm for $805M. Story | Follow @FierceMedDev

@MarkHFierce: ArthroCare, stained by a federal fraud scandal, gets a fresh start with Smith & Nephew's planned $1.7B acquisition. More | Follow @MarkHFierce

@MichaelGFierce: Study reports success in targeted therapy for common form of lung cancer. Report | Follow @MichaelGFierce

@EmilyWFierce: Given Imaging scores FDA seal of approval for PillCam COLON device. News | Follow @EmilyWFierce

> Neovasc makes a first-in-human implant of its transcatheter mitral valve. More

> Apple joins Google on FDA med tech regulators' meeting calendar. Story

Biotech News

@FierceBiotech: Buzz: GlaxoSmithKline prepares to unveil a new PhIII lineup. Story | Follow @FierceBiotech

@JohnCFierce: Eager biotechs (9!) crowd into Wall Street this week with $500M in IPO pitches. News | Follow @JohnCFierce

@DamianFierce: Portola takes its 'breakthrough' bleeding drug to PhIII with Bayer, J&J in tow. Read | Follow @DamianFierce

@EmilyMFierce: Merck halts drug testing on chimpanzees. Story | Follow @EmilyMFierce

> Merck turns to Ablynx to hunt cancer immunotherapies in potential $2.3B deal. News

> Pfizer's promising results for palbociclib stir talk of early approval push. More

CRO News

> Parexel rebounds from a shaky fall as sales jump 15%. Article

> Indian CRO GVK buys its way into biologics with Aragen deal. Story

> Ergomed cuts a risk-sharing deal on Ferrer's insomnia drug. News

> InVentiv looks to corner the market on mid-size biotechs. Story

> Growing Novotech makes its way into Africa. Article

> Algorithme doubles down on complex trials with latest addition. Brief

Biotech IT News

> J&J hands Yale the keys to its clinical trial data vault. Story

> Dassault makes a $750M play for Accelrys to expand into R&D software. Article

> Infosys co-founder backs an Indian brain computing center. News

> Bioinformatics skills help Stanford to a $40M genomics grant. Story

> The FDA's Mini-Sentinel healthcare surveillance database is growing quickly. Article

> Empiriko teams up to scale liver-mimicking technology. Brief

And Finally... The state of California said it has seen an unusually high number of flu deaths this season, with at least 147 young and middle-aged patients killed by the virus so far. Report

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