EnGeneIC said today that the FDA granted orphan drug designation to the company’s targeted EDV nanocells for the treatment of glioblastoma multiforme. The clinical stage biopharmaceutical company is developing bacterially-derived EDV nanocells as a nanoparticle, siRNA and miRNA delivery platform designed to target and kill tumor cells, while triggering the immune system’s natural anti-tumor response. […]
Wall Street Beat
Cydar lands Roche exec for 3D imaging software play
Cydar EV, a medical software start-up, said this week that it hired several new directors, including Roche’s recently-retired chairman Franz Humer. The U.K.-based company is developing cloud-based software to produce 3D images of a patient’s blood vessels in X-ray guided endovascular surgery. Cydar said Humer will bring a “wealth of commercialization” and key developmental insights […]
Glenmark, Evestra ink deal to develop generic NuvaRing
Glenmark Pharmaceuticals and Evestra said today that the companies inked a development, license and commercialization deal for a generic version of Merck’s NuvaRing. Development of the etonogestrel/ethinyl estradiol contraceptive is under way, according to the companies, and they plan to file an Abbreviated New Drug Application in fiscal 2019. Get the full story at our sister […]
Tie forces 2nd Senate Finance vote on CMS nominee Verma
A tie vote yesterday by the U.S. Senate’s Finance Committee on Seema Verma, the nominee to head the Centers for Medicare & Medicaid Services, reportedly prompted the panel to schedule another ballot today. The finance panel deadlocked at 9-9 yesterday on whether to pass Verma’s nomination on to the full Senate for a confirmation vote; […]
Study: Insurers paid double for hip and knee implants
Health insurers essentially paid double the price for hip and knee implants over a 5-year period, according to a study published this week in the Journal of the American Medical Assn. Researchers at Boston’s Childrens Hospital culled statistics on total knee arthroplasties and total hip arthroplasties from the de-identified database of some 45 million patients belonging to […]
Tandem claims 1st remote software update for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) said today that it released a software update using the company’s Tandem Device Updater tool for its t:slim insulin pumps purchased before April 2015. It marks the 1st time an insulin pump manufacturer has provided a software update that employs customers’ personal computers. The Mac and PC-compatible tool remotely overhauls Tandem’s insulin pump software, […]
Amend Surgical wins FDA nod for NanoFuse BA bone graft extender
Amend Surgical said today that it won 510(k) clearance from the FDA to market its NanoFuse BA as a bone graft extender for spine and orthopedic indications. The Alachua, Florida-based company’s NanoFuse BA is a composite of bioactive glass and a human demineralized bone matrix that Amend Surgical touts as providing optimal surgical handling performance […]
Aerie resubmits NDA for Rhopressa eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection. Aerie’s Rhopressa eye drops specifically target the eye’s trabecular network – the diseased tissue responsible for […]
Trump calls for speedier approval process, while Sanders takes aim at drug prices
In his 1st address to Congress, President Donald Trump called for speeding up drug approvals within the FDA. Earlier that day, Sen. Bernie Sanders (I-Vermont) proposed a bill to allow the importation of prescription drugs from Canada in the hopes of lowering drug prices. The new administration has been critical of drug prices, with Trump saying that […]
AtriCure gains on Q4
AtriCure (NSDQ:ATRC) shares are up today after the company beat the forecast with its 4th-quarter and full-year bottom line. The Mason, Ohio-based company pared its losses by -21.0% to -$8.6 million, or -27¢ per share, on sales of $41.2 million for the 3 months ended Dec. 31, for a top-line gain of 14.8% compared with Q4 […]
Mylan posts Street-beating Q4 earnings
Shares in Mylan (NSDQ:MYL) rose today after the EpiPen-maker met expectations on Wall Street with its 4th quarter results. The Canonsburg, Pa.-based company posted profits of $417.5 million, or $1.57 per share, on sales of $3.27 billion for the 3 months ended Dec. 31, for bottom-line growth of 114.5% on sales growth of 31.3% compared with the same […]