Surging Democratic presidential candidate Sen. Bernie Sanders of Vermont said he will try to block the nomination of President Obama's nominee to be the next FDA commissioner, Dr. Robert Califf, currently the deputy commissioner for medical products and tobacco. "Dr. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies," Sanders said. Sen. Edward Markey (D-MA) also said he is placing a hold on Califf's nomination because he wants the FDA to overhaul its process for approving opioid painkillers, whose addictive nature is leading to an epidemic of overdose deaths and sparking a national conversation about drug abuse. Califf is still expected to win the Senate's approval. Although Califf's ties to Big Pharma are the chief concern of some Democrats on Capitol Hill, the cardiologist has also had a hand in the creation of pro device industry sections of the 21st Century Act that are being promoted by AdvaMed. More
@FierceMedDev: Theranos flagged by CMS for serious problems at California lab: WSJ. Report | Follow @FierceMedDev
@EmilyWFierce: Big Pharma chalks up victory in Arizona Supreme Court over Rx safety warnings. FiercePharma article | Follow @EmilyWFierce
> Micro-cap LabStyle Innovations (DRIO) is slated to launch its Dario Blood Glucose Monitoring System in the U.S. this quarter, following its December FDA clearance. More
> Royal Philips ($PHG) has expanded its partnership with global incubator and seed fund 1776 into a worldwide innovation challenge for 2016. More
> PerkinElmer has completed its acquisition of Swedish noninvasive prenatal testing company Vanadis Diagnostics. More
Biotech News
@FierceBiotech: Amgen's Humira biosimilar nears FDA nod, but legal hurdles remain. Story | Follow @FierceBiotech
@JohnCFierce: So I'll be hanging out at #BIOCEO16 in NYC for a couple of days. Should be fun. | Follow @JohnCFierce
> Codiak piles on more venture cash, amassing $92M for exosome R&D. Story
> With a Duchenne MD patient struggling for life, little Akashi suspends study. More
Pharma News
@FiercePharma:India's Biocon takes a hit from analysts, but Mazumdar-Shaw upbeat. Story | Follow @FiercePharma
@EricPFierce: #EMA suspends Hubei Hongyuan Pharmaceutical after Czech inspectors find dust-covered plant and equipment. Article | Follow @EricPFierce
@CarlyHFierce: Invokana market share has trended upward post EMPA-REG, $JNJ says. Thank you, $LLY. | Follow @CarlyHFierce
> U.K. cost watchdog nixes pricey biologics for moderate rheumatoid arthritis. Story
> Novo Nordisk rolls out long-awaited Tresiba, aiming for blockbuster U.S. market share. More
Pharma Manufacturing News
> Pfizer recalls three lots of top seller Lyrica after production issues. More
> India's Mankind Pharma says it will build a plant in New Jersey. Report
> Inspectors find big issues at API repackager in France. Story
> Teva retrieves amphetamines over impurity concerns. Article
> Sterile injectables manufacturer Sagent said to be shopping itself. More
Pharma Asia News
> Indian firms in a race to buy Nasdaq-listed Sagent, report says. Report
> India and France committed to restart trade talks stalled on GVK row. Story
> Japan's Ono Pharmaceutical gears up sales reps for Opdivo. Item
> China-based VC firm WuXi Healthcare makes coast-to-coast U.S. investments. More
> India's Biocon takes a hit from analysts, but Mazumdar-Shaw upbeat. Article
Drug Delivery News
> Startup Co-D aims to resuscitate failed BMS drug using polymeric micelle drug delivery. More
> UNC team delivers cancer drugs wrapped in exosomes to cut doses. Report
> Combining light-activated and chemical treatments, new nanoparticles are more effective against tumors. Story
> Endangered inhaled insulin player MannKind collaborates with mysterious 'entity' on R&D. Item
> Cancer-focused Ensysce Biosciences adds opioid prodrug to its pipeline via merger. Article