In letter to health providers, the FDA said that it is "aware of reports of magnetic interference between breast tissue expanders with magnetic injection ports and either implantable cardioverter-defibrillators (ICDs) or pacemakers in patients, interfering with the functioning of these cardiac devices." The agency said that "at this time, the FDA believes that there is a very small population at risk, as it is generally uncommon for patients with an ICD or pacemaker to have breast reconstruction. However, we are alerting healthcare providers to this risk, so you can help prevent it." More
@FierceMedDev: ICYMI yesterday: J&J's Ethicon to buy NeuWave for soft-tissue, microwave ablation for cancer. Article | Follow @FierceMedDev
@VarunSaxena2: Toyota developing wearable device to improve mobility for the blind. Report | Follow @VarunSaxena2
@EmilyWFierce: Duke University teams with NC State for new cancer drug development project in canines. FierceAnimalHealth story | Follow @EmilyWFierce
> Smith & Nephew ($SNN) has launched the Truclear 5C Hysteroscope Set, a new version of an existing device to diagnose and remove abnormalities in the uterine cavity. More
> Life Spine has received FDA clearance for its Prolift Expandable Interbody System to treat spinal disorders. More
> Sensor-assisted total knee arthroplasty player Orthosensor has partnered with electronic components company IM-Tech for R&D and manufacturing in order commercialize the former's Verasense disposable sensor in the U.S. More
Biotech News
@FierceBiotech: Eyeing the U.S. market, TiGenix touts 52-wk data from PhIII stem cell trial. Story | Follow @FierceBiotech
@JohnCFierce: I have a gut feeling that UC and The Broad are going to settle up on CRISPR. Excellent summary from @sxbegle. STAT story | Follow @JohnCFierce
> Aprea starts recruiting a U.S. team as it preps for PhII on p53 'Holy Grail' cancer drug. Report
> Reeling from an FDA rejection, Telesta sheds 15% of its staff. Story
> Medivation's mystery cancer drug gets out from an FDA hold. Article
Pharma News
@FiercePharma: South Korea's Green Cross to supply Americas with flu vaccine in $32M deal. FierceVaccines item | Follow @FiercePharma
@EricPFierce: More biologics manufacturing capacity comes online in the U.S. FiercePharmaManufacturing article | Follow @EricPFierce
@CarlyHFierce: ICYMI yesterday: Amgen is eyeing heftier deals, but so are its biggest rivals. Story | Follow @CarlyHFierce
> Orexigen takes another body blow from ill-fated Contrave trial. More
> With FDA settlement, tiny Amarin creates opening for pharma in off-label marketing. Story
> Surprise proposal: Medicare wants to jump on the value-based pricing bandwagon. Article
Pharma Marketing News
> Allergan rolls out third round of Linzess ads, targeting patients fed up with OTC meds. Report
> Fake smiles star in Otsuka and Lundbeck's DTC push for Rexulti in depression. Story
> Ill-fated Contrave trial piles more hurt on Orexigen. Item
> AbbVie's Humira, Pfizer's Lyrica kick off 2016 with hefty TV ad spend. Article
> Blind Pfizer sales rep gets her chance to argue for a car and driver in court. More
Biotech Research News
> MIT team spotlights role of amino acids in building tumor cells. Item
> Single gene mutation linked with significantly reduced heart attack risk. Report
> Mouse, tissue tests confirm a new pathway for insulin resistance in diabetes. Story
> Karolinska: Nanoparticle tech opens up new drug, vaccine targets. More
> Mount Sinai: CDK4/ARK5 inhibitor could offer new treatment for multiple myeloma. Article
Vaccines News
> Sanofi digs into details on hastened Zika effort. Story
> Vaxart, Immunovaccine, Mayo Clinic jump onto Zika vaccine bandwagon. More
> South Korea's Green Cross to supply Americas with flu vaccine in $32M deal. Item
> Duke, NIAID track HIV evolution with eyes on creating a vaccine. Article