Caldera wins FDA nod for vaginal mesh alternative; Boston Scientific rolls out new pacers;

@FierceMedDev: Activaero readies for hoped-for EU launch of its first drug/device treatment. Editor's corner | Follow @FierceMedDev

@DamianFierce: Delcath is axing 20% of its workforce after the FDA frowned upon its cancer-treating device. News | Follow @DamianFierce

> In a new study, 2012 Fierce 15 winner Tyrx reported that its antibacterial envelope reduced major infection rates by 100% in patients receiving cardiac implants. News

> Caldera Medical won FDA clearance for Vertessa Lite, a polypropylene mesh used in abdominal sacrocolpopexy procedures designed to treat pelvic organ prolapse. More

> Bausch + Lomb won Canadian approval for its Victus laser eye surgery system, which handles cataract and corneal procedures. Release

> Michigan's Tangent Medical has launched U.S. commercialization of NovaCath, an IV catheter equipped with stabilization, passive needle encapsulation, tubing management and blood control. Item

> Boston Scientific ($BSX) has launched a new line of pacemakers in Europe, saying the devices provide valuable monitoring capabilities to manage patients with co-morbidities. Story

> In response to the global concern over Middle East Respiratory Syndrome Coronavirus, Life Technologies ($LIFE) is touting its Applied Biosystems 7500 Fast Dx Real-Time PCR instrument as ideal for analysis of assays for the virus. News

Biotech News

@FierceBiotech: Where were the breakthrough drugs for diabetes at ADA 2013? Editor's corner | Follow @FierceBiotech

 @JohnCFierce: Have to wonder how PTC's IPO will come out as questions are raised about its lead obsession, um, program. Article | Follow @JohnCFierce

@RyanMFierce: Verastem launching a PhI for second FAK inhibitor in pipeline. | Follow @RyanMFierce

 @EmilyMFierce: And back to biotech... Genetic biomarkers could help tailor breast cancer therapies. Article | Follow @EmilyMFierce

> Roche, AstraZeneca join forces on precompetitive R&D initiative. More

> Delcath slashes U.S. staff by 20% after FDA-panel disaster. Story

Pharma News

@FiercePharma: U.K. cost agency recommends Bayer's Xarelto to prevent potentially fatal blood clots in the lungs and legs. More | Follow @FiercePharma

@EricPFierce: Ranbaxy gets some support from India's Supreme Court as company faces down concerns there. Item | Follow @EricPFierce

@CarlyHFierce: Proxy fight heating up at Vivus... First Manhattan announces search for new CEO candidates. Report | Follow @CarlyHFierce

> Spain sugarcoats pharma-purchasing medicine with payment guarantee. Story

> Sanofi, Novartis, GlaxoSmithKline reportedly circling India's Elder Pharma. More

Biomarkers News

> Arizona's TGen and Ventana Medical Systems partner to find cancer biomarkers. News

> New diagnostic IDs patients unlikely to benefit from chemoradiation. Item

> Traumatic brain injury biomarker company raises $6M for diagnostic. Item

> HPV antibodies point researchers to high risk for oral cancer. Story

> Brain scan may provide biomarker guideposts to ideal depression treatment. Article

Drug Delivery News

@MichaelGFierce: Trending right now at FierceDrugDelivery: Insulin delivery devices at ADA 2013. Roundup | Follow @MichaelGFierce

> Acorda reports positive data for epilepsy nasal spray. Item

> Alnylam posts positive preclinical RNAi delivery results for fatal conditions. Article

> Roundup: Insulin delivery devices at ADA. Story

> Microbubbles for imaging offer targeted drug-delivery approach. More

> Peptide-coated nano-gold shows cancer-fighting promise. Report