The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning today for Carefusion‘s Alaris syringe drug pumps. The UK watchdog said that Alaris pumps with broken springs in the plunger assembly could accidentally release a single dose of medication if the pump also uses non-recommended syringes. “This problem comes about through a combination of using […]
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Actelion, J&J re-enter takeover negotations
Actelion (VTX:ATLN) and Johnson & Johnson (NYSE:JNJ) have re-entered talks to reach a takeover deal, after the US healthcare giant reportedly abandoned its efforts last week. Some suggest that this could mean the end of Sanofi‘s (NYSE:SNY) attempt to make a deal with the Swiss biotech firm, according to Reuters. J&J and Actelion had been engaged in informal talks […]
Fluor to build Novo Nordisk’s $2b manufacturing facility in North Carolina
Fluor Corporation (NYSE:FLR) said yesterday that it landed a contract to build Novo Nordisk‘s (NYSE:NVO) $2 billion diabetes active pharmaceutical ingredient manufacturing facility in Clayton, North Carolina. Since Denmark-based Novo Nordisk announced plans for the facility in August 2015, Fluor has been providing basic design services for the project. The manufacturing facility will measure 830,000 […]
Researchers’ bionic pancreas outperforms standard insulin pump therapy
Researchers from Boston University have developed a bionic pancreas system that outperformed conventional insulin pump therapy for patients with type 1 diabetes, according to a trial conducted at Massachusetts General Hospital. The team’s work was published in The Lancet. This device is the latest development in the race to make an entirely closed loop insulin pump system, […]
Artificial leaf produces drugs using solar energy
Researchers from the Eindhoven University of Technology have reportedly developed a leaf-inspired mini-factory to produce drugs using solar energy. The team’s work could allow medicine to be made in resource-deprived areas, as long as there is sunlight. “Theoretically, you could use this device to make drug compounds with solar energy anywhere you want,” lead researcher […]
Eyenovia touts phase II study data
Eyenovia Inc. touted data from its phase II study evaluating the safety and efficacy of its high-precision ophthalmic microtherapeutics compared to conventional eyedropper treatment. The trial comes on the heels of a previous phase II study published in Therapeutic Delivery in October. New York-based Eyenovia’s trial demonstrated that its microdosing achieved superior pharmacologic effects and bioavailability compared to […]
Bristol-Myers, PsiOxus land licensing agreement
Bristol-Myers Squibb (NYSE:BMY) said today that it landed an exclusive licensing agreement for PsiOxus Therapeutics‘ ‘armed’ oncolytic virus, NG-348, for the treatment of solid tumors. According to the agreement, Bristol-Myers will pay PsiOxus $50 million upfront and will assume responsibility for global clinical development and commercialization. PsiOxus will be eligible for $886 million in development, regulatory and […]
Draper, Pfizer ink ‘organ-on-a-chip’ deal
Draper said today that it inked a 3-year collaboration deal with Pfizer (NYSE:PFE) to develop Draper’s microphysiological system technology. The ‘organ-on-a-chip’ system is designed to improve preclinical safety and model diseases more effectively. The Cambridge, Mass.-based company’s miniature organ model enables researchers to measure tissue function and test potential new drug candidates. Draper and Pfizer will collaborate […]
21st Century Cures Act adds Hatch-Waxman rule to drug-device combos
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 […]
Study: Laser-activated deep-sea drug kills prostate cancer
Researchers from the Weizmann Institute of Science and Steba Biotech have reportedly developed a light-sensitive drug derived from deep-sea bacteria that has been shown to kill cancer cells in low-risk prostate cancer patients without affecting healthy tissue. The team’s work was published in Lancet Oncology. Vascular-targeted photodynamic therapy, VTP, utilizes a drug called WST11 which was […]