Spotlight On... Big-time drugmakers hold the cards in FDA voucher program; Biodel cuts staff; and much more...

The FDA's controversial priority review vouchers, which grant companies coupons for quick approval, are all in hands of major drugmakers, according to PricewaterhouseCoopers. The FDA's program, established in 2007, was designed to incentivize the development of treatments for tropical and rare pediatric diseases, giving companies that win such approvals a one-time voucher that shortens the review time from any medicine from 10 months to 6 months. And, to sweeten the deal, such vouchers can be sold to the highest bidder. Since the beginning of the program, 9 vouchers have been handed out and 5 have been sold, with the most recent going for $350 million. And, as PwC notes, all of the vouchers now rest in the hands of companies with market caps over $35 billion. More

@FierceBiotech: ICYMI: Merck gets FDA OK to go toe-to-toe with Gilead's hep C market goliath. Article | Follow @FierceBiotech

@JohnCFierce: Gee, so Allergan does R&D? How surprising. (droll overtone here.) rapastinel/GLYX-13 BTD $AGN. Release | Follow @JohnCFierce

@DamianFierce: this man missed a huge opportunity in orthopedics. More from STAT | Follow @DamianFierce

> Biodel ($BIOD), struggling after a series of clinical setbacks, cut 15 of its employees in an effort to conserve cash. News

> Wave Life Sciences ($WVE), fresh off a $112 million IPO, is planning to get 6 of its programs into the clinic by 2018. Item

Medical Device News

@FierceMedDev: ICYMI: Investor urges J&J to spin out poor-performing device, consumer businesses. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Sony, Carlyle Group, KKR among bidders for Toshiba's imaging unit, expected to fetch $3B+. Article | Follow @VarunSaxena2

@EmilyWFierce: ICYMI: J&J to fork over $120M to settle thousands of vaginal mesh suits. Article | Follow @EmilyWFierce

> Vascular Flow Technologies raises $14M+ for its prosthetic vascular graft. Story

> Walgreens severs some ties to Theranos amid CMS lab inspection fallout. Report

Pharma News

@FiercePharma: Gilead's John Martin replacing Milligan as CEO. Release | Follow @FiercePharma

@EricPFierce: ICYMI from FiercePharmaManufacturing: Novartis is revamping its manufacturing after having disposed of 25 plants. Story | Follow @EricPFierce

@CarlyHFierce: Riding Q4 diabetes growth, Lilly aims for even more with Jardiance. Report | Follow @CarlyHFierce

> Gilead Sciences' John Martin stepping out of CEO role after two decades, is replaced by John Milligan. News

> Strong Q4 showings for AbbVie abroad offset Humira, Viekira stumbles at home. Article

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