@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
> Malvern, PA-based TetraLogic ($TLOG) has laid off 19 staffers, including its chief scientific officer, according to an SEC filing. The move leaves the biotech with 10 employees. TetraLogic reported just a few weeks ago that its drug birinipant had failed to hit the primary endpoint in a Phase II study for MDS. CSO G. Glenn Begley and Dr. Lesley Russell, the COO, have both been terminated in the shakeup. Filing
> Mapi Pharma has laid out the terms to an IPO, seeking $15 to $17 a share for 3.1 million shares. The offering is valued at up to $61 million. Story
> GlaxoSmithKline ($GSK) is working through feasibility studies to see whether its vaccine platform could be put to use against Zika virus, which is spreading in Latin America. More
> Animal drug developer Aratana Therapeutics ($PETX) filed for its first FDA approval, submitting a treatment for pain and inflammation among dogs with osteoarthritis. Item
Medical Device News
@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
> J&J hints at 'bold steps' in device deals in 2016, details 5 device collaborations. More
> U.K. startup reels in $45M in JJDC-backed round to boost liquid biopsy ambitions. Article
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