Spotlight On... MGH to study Philips' digital pathology tools to get diagnostic clearance; Cook Medical catheter recall deemed Class I; and more...

Royal Philips ($PHG) announced that Massachusetts General Hospital will study the reproducibility of its digital pathology whole slide imaging (WSI) IntelliSite Solution to get to clearance to use the device for primary diagnostic use. "With rising health care costs, we have a public responsibility to work effectively," said study principal investigator Dr. Jochen Lennerz. "Through the genomic revolution we have started to learn how to manage big data. Now there is a pressing need to gain access to and increase flexibility in how pathologists manage the massive amounts of imaging data we procure every day." More

@FierceMedDev: ICYMI: Theranos slammed again after new study points to testing flaws. Article | Follow @FierceMedDev

@EmilyWFierce: Forgot how much I liked the word "torrent" until I read this lead $VRX. More from the NYT | Follow @EmilyWFierce

> The recall of Cook Medical's Central Venous Catheter due to tip separation has been deemed Class 1 by the FDA, meaning there is a reasonable probability that the use of or exposure to the device "will cause serious adverse health consequences or death." More

> Two University of Minnesota students have developed a credit-card-sized epinephrine autoinjector. The ease of transport means the device is more likely to be available in the case of a potentially deadly anaphylaxis-related allergic reaction. More

Biotech News

@FierceBiotech: Jazz Pharma's much delayed rare liver disease drug finally wins FDA approval. News | Follow @FierceBiotech

@JohnCFierce: PureTech startup sets out to develop new tech for controversial 'vaginal seeding.' Article | Follow @JohnCFierce

> Lilly's new arthritis drug beats placebo in latest successful trial. Item

> Genocea shares shoot up on promising genital herpes data. Story

> Genfit moves liver disease pill into mid-stage, hints at upcoming IPO. Article

Pharma News

@FiercePharma: Keryx anemia med Auryxia trounces placebo in study aimed at big new use. More from FiercePharmaMarketing | Follow @FiercePharma

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

@CarlyHFierce: FDA falls short on safety monitoring, delaying public communications, report says. Report | Follow @CarlyHFierce

> Have the feds gone soft on pharma? Shrinking fines suggest it's yes, Public Citizen says. More

> With deal scouts knocking, Medivation hires JPMorgan to man the door. Report

> FTC digs deeper into Pfizer's proposed combo with Allergan. Article

Pharma Manufacturing News

> Anuh Pharma plant savaged in EMA report. Report

> Dr. Reddy's recalling injected drug manufactured by Gland Pharma. More

> Citing microbial growth, B. Braun issues dextrose injection recall. Story

> Catalent issues lead to CRL for OPKO. Article

> Japan's Daiichi Sankyo closing Japan plant with 150 workers. Item

CRO News

> Rho seeks 30 new hires after bumper year. More

> Snapdragon Chemistry announces extended partnership, lab space, and a new leader. News

> Alten Calsoft Labs looks to extend U.S. reach, reporting services with PVR Technologies buy. Report

> Former GSK staffers launch new Canadian CRO. Story

> Quintiles named 'best CRO in Asia' again. Article

Pharma Asia News

> AZ approval for Tagrisso in Japan a big change to NSCLC treatment options in Asia. Item

> Australian pharma firms splashed AU$43M to docs, with lunches, Vienna trips raising eyebrows. Report

> Big Pharma finds second chance for failed drugs in China. More

> GSK pumps $29M into infectious disease R&D hub in Beijing. Story

> India's local rotavirus vaccine launched to combat death linked to diarrhea. Article

Suggested Articles

Abbott launched a rapid coronavirus test able to deliver positive results in as little as five minutes, from a table-top box the size of a toaster.

The FDA will be working with government and public-private partners to distribute and evaluate 3D designs and models.

The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators amid new shortages.