FDA's priority-review vouchers come under fire; Naia raises $5.3M for metabolic R&D;

@FierceBiotech: FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval. Story | Follow @FierceBiotech

@JohnCFierce: Anthony Philippakis at The Broad will be on my JP Morgan Big Data panel. Any other recommendations for Drug Development and Big Data: 2025? | Follow @JohnCFierce

> Congress decided to let the FDA hand out priority review vouchers as a reward for innovation in rare pediatric diseases. But some critics tell the Wall Street Journal that while these vouchers may be worth a lot, the program hasn't had the intended effect. Story

> Biotech backer Naia Limited raised $5.3 million to fund subsidiaries working on treatments for metabolic diseases. More

> The FDA has requested more information about Zogenix's ($ZGNX) proposed Phase III trial for an epilepsy treatment, but the company still plans to launch the study in the fourth quarter of this year. Item

Medical Device News

@FierceMedDev: Check out this year's Fierce 15: The new strategic med tech mania sets the stage for 2015's Fierce 15. Feature | Follow @FierceMedDev

@VarunSaxena2: Fierce 15 co. Shockwave Medical aims to deploy energy-delivering balloons in the peripheral and coronary arteries. More | Follow @VarunSaxena2

@EmilyWFierce: ICYMI yesterday: Lightpoint Medical nabs EU approval for cancer molecular imaging device. Article | Follow @EmilyWFierce

> Stryker scores point in patent battle with Zimmer. More

> Philips spins Axsun back out of Volcano, sells it to venture firm. Story

Pharma News

@FiercePharma: Japanese drugmakers Eisai, Ajinomoto team up on gastrointestinal diseases. FiercePharmaAsia story | Follow @FiercePharma

@EricPFierce: Regeneron more than doubles investment in plant in Ireland, adding 200 more workers. Report | Follow @EricPFierce

@CarlyHFierce: ICYMI: Merck KGaA exits 'sea of sameness' with futuristic rebrand. More | Follow @CarlyHFierce

> Cipla runs into FDA concerns for plant in India, as well as one it will buy in U.S. News

> Vocal pricing critic Clinton rakes in big campaign dollars from Big Pharma. Article

Drug Delivery News

> Computer models demonstrate stronger liposomal shells for drug delivery. More

> Researchers deploy malarial protein as targeting agent for anticancer drugs. Report

> Ear drug delivery to get a boost from launch of hearing loss therapeutics company Decibel. Item

> Alnylam reveals molecule to reverse effect of its RNAi therapies. Story

> Novo to expand use of Emisphere's oral delivery platform in deal potentially worth $80M+. Article

Pharma Manufacturing News

> FDA cites Cipla India plant after U.S. recall of asthma drug. News

> Recipharm shelling out $105M for Indian sterile injectables CMO. Report

> Hovione adding a formulation plant in Portugal. More

> TxCell, whose plant was closed for mold issues, intends to use CMOs exclusively. Story

> Regeneron doubles down on plant project in Ireland. Article

Pharma Asia News

> Indian drug manufacturers face higher costs with bar-code requirement. Report

> NY-based Athenex has big China manufacturing plans with name change to boot. Story

> Japan's Daiichi Sankyo to cut as many as 1,200 U.S. jobs in reorganization. Item

> Vietnam's Vinamilk on the block--will Abbott bite? More

> HK-based Chi-Med looks to tap funds in Nasdaq listing with China focus. Article

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