Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs. The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter […]
Drug-Device Combinations
Amgen wins recommendation for single injection Repatha device
Amgen (NSDQ:AMGN) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for its Repatha single monthly injection device. The device is already cleared in Europe for dosing every 2 weeks. The hands-free device, with prefilled cartridges, delivers 420 milligrams of Repatha (evolocumab) in a single injection. […]
GSK launches phase III trial for inhaled triple combination therapy
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that they launched a phase III trial evaluating the triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with asthma. The companies’ triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s […]
Japan approves Novocure’s Optune brain cancer treatment
Novocure (NSDQ:NVCR) said today that the Japanese Ministry of Health, Labor and Welfare has approved its tumor treating fields delivery system, Optune, for adult patients with supra-tentorial glioblastoma following surgery and radiation therapy. The St. Helier, N.J.-based company is expected to submit an application for public reimbursement of the device in Japan for newly diagnosed […]
Fresenius expands prefilled syringe portfolio
Fresenius (NYSE:FMS) business group Fresenius Kabi said today that it added its heparin sodium injection to the company’s Simplist prefilled syringe portfolio. The prefilled syringe for subcutaneous and intravenous bolus injections expands Fresenius Kabi’s available Heparin formulations. The Lake Zurich-Ill. company’s Simplist syringes have a 2-year shelf life and do not require any assembly or point-of […]
SMC acquires UK auto-injector developer Oval Medical Technologies
SMC Ltd., said today that it acquired auto-injector developer Oval Medical Technologies for an undisclosed amount. Cambridge, UK-based Oval Medical Technologies develops auto-injectors for a 2-step administration of non-viscous and viscous drugs using cyclic olefin plastic and glass primary drug containers. Somerset, Wisconsin-based SMC is a global contract manufacturer of single-use devices for pharmaceutical, medical […]
ClearLine wins CE Mark for intravenous line device
ClearLine MD said today that it won CE Mark approval for its ClearLine IV product line that prevents air from being introduced into intravenous lines. During IV infusion, ClearLine’s device detects air in the IV line using ultrasound and then removes the air to allow the fluid to flow continuously. Air embolisms can cause long-term clinical […]
BD launches high volume syringe for biologics
Becton Dickinson (NYSE:BDX) said today that it launched its BD Neopak 2.25 milliliter prefillable glass syringe designed for high-volume injection of biologics. The Franklin Lakes, N.J.-based company said that its prefillable glass syringe was developed to reduce drug degradation and aggregation between the container and therapeutic. The high volume syringe is commercially available in the […]
National cancer group recommends Sirtex’s microspheres for metastatic colorectal cancer
Sirtex Medical (ASX:SRX) said yesterday that the National Comprehensive Cancer Network has recommended the company’s radioactive microspheres in its Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer. The NCCN panel uniformly agreed that selective internal radiation therapy with yttrium-90 microspheres is an option for patients with metastatic, chemotherapy resistant colorectal cancer. The recommendation was […]
Novocure touts positive TTFields data for pancreatic, ovarian cancer
Novocure (NSDQ:NVCR) shares were up 6% after hours yesterday after the company released positive data for its “tumor treating fields” combined with chemotherapy for pancreatic and ovarian cancer. The St. Helier, N.J.-based company’s TTFields are low-intensity, alternating electric fields meant to inhibit cancer cell replication and cause cell death. Novocure presented data from its phase II […]