Spotlight On... China FDA releases long-awaited med tech clinical trial guidelines; Mayo Clinic laying off 100+ employees; St. Jude gets CE mark for quadripolar pacing leads; and more...

The China FDA unveiled long-awaited medical device clinical trial guidelines. They should provide some clarity to devicemakers, who wish they didn't have to conduct them at all, due to similar arguably duplicative requirements in Europe, the U.S. and Japan. Topics covered in the guidance include preparation criteria, informed consent and data management. It appears that the list of devices subject to the requirement is quite lengthy, to the chagrin of industry, but now at least companies will have a better sense of how to run their trials in the country. Innovative devices like TAVRs are not yet approved in China due to the need for clinical trials. Despite the obstacles, foreign interest in the fast-growing market remains quite high, as evidenced by Lilly Asia Ventures' recent investment in a Beijing-based Millin Enterprises, focused on devices and services to treat hemodialysis. More from FiercePharmaAsia | More about Eli Lilly's investment

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> The Mayo Clinic is closing its diagnostics lab in Andover, MA, at the cost of more than 100 jobs. It said the closure is occurring because the site isn't near a larger Mayo Clinic facility. The work will be transferred to Rochester, MN. More

> St. Jude Medical ($STJ) announced the CE-mark approval of its Quartet left ventricular leads for heart patients on pacemakers and defibrillators. More

Biotech News

@FierceBiotech: Sanofi hires research veteran to 'rejuvenate' its R&D division. Article | Follow @FierceBiotech

@JohnCFierce: This Merck/Harvard preclinical deal was my no.1 story last week. Which is cool. Report | Follow @JohnCFierce

> Baxalta, Medicxi back upstart's work on building a better T cell for immuno-oncology. News

> Alexza literally at end of days as its cash pile set to run out by May. Story

> Sanofi recruits AstraZeneca research veteran to 'rejuvenate' its R&D division. Report

Pharma News

@FiercePharma: Could J&J get an image boost from new health-oriented research? Experts say yes. FiercePharmaMarketing story | Follow @FiercePharma

@EricPFierce: Construction begins on Novo Nordisk's first US, API plant and first outside of Denmark. Report from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: ICYMI yesterday: Looking for a respiratory edge, Boehringer teams with Propeller to test 'smart inhaler' for adherence. Article | Follow @CarlyHFierce

> In surprise decision, FDA blocks crucial cognitive claim for Takeda's Brintellix. Story

> Astellas cancer med Xtandi draws fire as U.S. lawmakers demand a pricing hearing. Article

Drug Delivery News

> On top of strong efficacy data, Alder migraine med shows potential for differentiated drug delivery. Item

> FDA encourages generic abuse-deterrent opioids in latest effort to tackle prescription drug abuse. Report

> Vygon opens Portuguese plant for manufacture of oncology devices that deliver chemotherapy. Story

> Capsugel eyeing IPO or sale for $5B+; Bayer, Danaher, Thermo Fisher and others interested. More

> Antibiotics get a boost from stabilizing frog foam delivery. Article

Pharma Manufacturing News

> FDA cites Lupin Indian plants for what drugmaker calls 'minor' issues. More

> PuraCap gets Puerto Rico plant with buyout of Blu Pharmaceuticals. Report

> Natco plant closed during floods written up by FDA. Story

> Novo starts construction on $1.8B plant in U.S. Article

> Boehringer Ingelheim snags second client for its China CMO operation. Item

Pharma Asia News

> Samsung Bioepis offers a glimpse at biosimilar manufacturing prowess. More

> Biocon wins key Japan approval for Lantus biosimilar. Story

> South Korean startup biotechs gain government, banking funding lift. Article

> Prosecutors heap more woe on OBI Pharma as 'insider trader' investigation deepens. Report

> India releases guidelines on biosimilar approval, manufacturing. Item

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