Shares of Berlin's ReWalk Robotics Technologies fell 13% on news of an FDA warning letter. The document was actually sent to the company in September (when it went by the name Argo Medical), but only just disclosed by the FDA, perhaps in a bid to raise the stakes. The FDA said that the maker of the ReWalk wearable exoskeleton, which provides mobility to those with a spinal cord injury, has repeatedly blown off the FDA's requests for a postmarket study plan. The agency said it issued an order for a postmarket study upon de novo approval in 2014 because "the device's failure to prevent a fall would be reasonably likely to cause serious user injury and/or death through fall related sequelae, such as traumatic brain injury (TBI), spinal cord injury (SCI), and fractures to the user." The letter lists several instances of Argo's failure to comply with the order, and accused the firm of selling a misbranded device under section 522 of the Federal Food, Drug and Cosmetic Act. The FDA once again asked for the study plan in the warning letter. Here's the letter | More
@FierceMedDev: IYCMI: FDA approves Gore's endoprosthesis for iliac artery aneurysms. Article | Follow @FierceMedDev
@EmilyWFierce: AZ stokes $45 billion sales hopes with expanded approval for breast cancer drug Faslodex. FiercePharma story | Follow @EmilyWFierce
> Royal Philips ($PHG) may have another offer from Blackstone Group and Onex for one of its lighting businesses, said to be worth €4.5 billion ($4.9 billion) and €5 billion ($5.5 billion). The conglomerate is working to divest itself of its lighting businesses in order to further invest into its HealthTech focus. More
> A court has opted to stand firm on a prior ruling against Boston Scientific ($BSX) that found $14 million in royalty payments were due to a doctor under a licensing agreement for tech used in angioplasties. More
> Roche Diabetes Care has integrated its blood glucose AccuChek Connect System with the Apple Health app; it works with the Accu-Chek Aviva Connect meter. More
Biotech News
@FierceBiotech: EuroBiotech Report: Genfit bags €50M as IPO plan simmers; British biotechs form cancer JV; Zealand drug fails PhII. More | Follow @FierceBiotech
@JohnCFierce: Tim Anderson is digging deep to find cause to believe that Merck's anacetrapib PhIII could be +; would certainly surprise the hell out of me. | Follow @JohnCFierce
> Baxalta dumps Onconova's cancer drug in the midst of Phase III. Report
> Vitae tanks after cutting its psoriasis trial short, stoking safety concerns. Story
> CRO giant inVentiv Health could be in line for a $500M IPO. Article
Pharma News
@FiercePharma: Pet obesity on the rise as owners treat animals like humans: Report. FierceAnimalHealth story | Follow @FiercePharma
@EricPFierce: ICYMI from FiercePharmaManufacturing: France finds potentially tainted heparin being made by China manufacturer. Article | Follow @EricPFierce
@CarlyHFierce: Teva's Treanda follow-up faces uphill climb as payers get tough on 'me-too' drugs. Article from FiercePharnaMarketing | Follow @CarlyHFierce
> Victoza comes up big for Novo with heart-risk lowering data. Story
> AZ stokes $45 billion sales hopes with expanded approval for breast cancer drug Faslodex. More