Dr. Dean Kereiakes knows a thing or 2 about coronary stents – he’s been a principal investigator in a number of clinical trials evaluating coronary stents over the past 20 years. So it counts when Kereiakes names the Synergy stent made by Boston Scientific‘s (NYSE:BSX) “the safest stent yet.” An interventional cardiologist at the Christ Hospital, he was also a […]
Drug-Device Combinations
CMS updates on criteria for Dexcom G5 coverage
Shares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B. Patients covered by Medicare who have Type I or II diabetes and […]
Lilly details plans for $850m investment in U.S. operations
Eli Lilly (NYSE:LLY) said today that it plans to invest $850 million in its U.S. operations in 2017. The company presented details of its plans at the Lilly Technology Center in Indianapolis, joined by federal, state and local government officials. Lilly said it will invest in an $85 million expansion of its Trulicity device assembly […]
Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]
Tandem Diabetes Care prices $22.5m public offering
Tandem Diabetes Care (NSDQ:TNDM) today announced the pricing details of a $22.5 million underwritten public offering. The company priced 18 million shares of its common stock at $1.25 apiece. Tandem also gave underwriters a 30-day option to buy up to an additional 2.7 million shares of common stock at the public offering price. The offering is expected […]
Mylan recalls 81,000 EpiPens over reports of device failure
Mylan (NSDQ:MYL) recalled 81,000 EpiPen emergency allergy auto-injectors this week after receiving 2 reports that the device failed to work in emergencies. The recall affects devices in Australia, New Zealand, Europe and Japan, the company reported. Canonsburg, Penn.-based Mylan said that in both cases, patients received treatment using an alternate EpiPen. The drugmaker also said that it […]
Press Release: Nemera wins the “Editor’s choice” Exhibitor Award at Interphex with its autoinjector Safelia
(Press release) – International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical and biotechnology innovation, technology, and knowledge from development through commercialization and sponsored by the Parenteral Drug Association (PDA), has announced the winners for the INTERPHEX Exhibitor Awards for 2017. Nemera was recognized for the ‘Editor’s choice’ for Safelia. Safelia is an innovative […]
Novaliq, AFT Pharmaceuticals ink licensing deal for NovaTears dry eye therapy
Ocular therapeutics company Novaliq said today that it inked a strategic licensing agreement with AFT Pharmaceuticals for the commercialization of its dry eye therapy, NovaTears, in Australia and New Zealand. NovaTears is the Germany-based company’s 1st commercially available product indicated for the treatment of evaporative dry eye diseases. According to the agreement, AFT has an exclusive […]
These tiny jet engines could propel pharmaceuticals in the body
Researchers at the Max Planck Institute for Intelligent Systems in Stuttgart, Germany are creating nanorobot propulsion systems that could help transport pharmaceutical agents in the body. Two types of propulsion systems were created. One was powered by bubbles that are oscillated by ultrasound, while the other one was powered by an enzymatic reaction that would […]
Opthea gets positive feedback from European regulatory groups for wet AMD injection
Opthea (ASX:OPT) said today that it received positive feedback from meetings with the U.K.’s Medicines and Healthcare Products Regulatory Agency and Sweden’s Medical Products Agency over its OPT-302 therapy for the treatment of wet age-related macular degeneration. The Australia-based company’s OPT-302 therapy consists of a soluble form of vascular endothelial growth factor receptor 3 that […]