Anti-addiction developer BioCorRx said today it launched a research & development initiative as it seeks FDA approval for its naltrexone implant designed to treat opioid and alcohol addictions. The implant slowly releases naltrexone, a non-addictive opioid antagonist that can reduce physical cravings and block some of the effects of alcohol and opioids, the Los Angeles-based […]
Amgen taps West’s SmartDose for Pushtronex system
Amgen (NSDQ:AMGN) is partnering with West Pharmaceutical Services to integrate its SmartDose delivery platform into its Pushtronex system, the companies said today. The SmartDose technology is designed to adhere to a patient’s body, generally on the abdomen, and requires no patient operation during administration, the companies said. The technology includes integrated silicone-free Daikyo Crystal Zeniths’s cartridge […]
Intarcia launches Medici drug delivery platform
Intarcia Therapeutics said today it launched its subcutaneous Medici drug delivery system designed for the continuous delivery of medication. The Medici system is comprised of a matchstick-sized osmotic minipump placed just under the skin to deliver medication, a placement system for implantation and stabilization technology designed for proteins, peptides, antibody fragments and other high-potency small […]
Delcath raises $35m in private placement
Delcath (NSDQ:DCTH) said today it inked a securities purchase agreement with an investor for $35 million in senior convertible notes and stock purchase warrants, expecting to bring in $32.2 million to support operations and ongoing clinical trials. Of the $32.2 million in proceeds, Delcath said $3 million will be immediately available, with the remaining $29.2 million […]
Ocular Therapeutix shares plummet as 2nd Phase III misses primary endpoint
Ocular Therapeutix (NSDQ:OCUL) today saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint. Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear […]
Fighting opioid addiction with medical devices: FDA approves new implant
The FDA today cleared a new opioid-addiction fighting implant from Braeburn Pharmaceuticals, the 1st of its kind to win a nod from the federal watchdog. The matchstick-sized Probuphine implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies. […]
iVascular wins CE Mark for Luminor 18 DCB
Spanish vascular device company iVascular S.L.U. said today it won CE Mark approval in the European Union for its Luminor 18 drug eluting balloon designed for lower limb angioplasty. The Luminor 18 is 0.018 guidewire compatible and has an extra low profile, and joins the company’s Luminor 14 and Luminor 35 portfolio of drug-eluting balloons […]
FDA wants more from Proteus, Otsuka on 'smart pill'
Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA issued a complete response letter requesting more information from the companies for the combination of the Proteus “smart pill” and Otsuka’s Abilify anti-depressant drug. The Proteus pill is designed to signal a wearable patch after it reaches the stomach, recording and time-stamping data from […]
Patent office to review United Therapeutics, SteadyMed patent conflict
SteadyMed Therapeutics (NASDAQ:STDY) said today it that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office initiated an inter partes review against a United Therapeutics patent. The patent in question, No. 8,497,393, is related to a process to purify prostacyclin derivatives, such as treprostinil, which is used in United Therapeutics’ Remodulin and […]
Anika Therapeutics wins CE Mark for Cingal knee treatment
Anika Therapeutics said today it won CE Mark approval in the European Union for its Cingal drug-combo designed to treat osteoarthritis-related knee pain. Cingal is a combined viscosupplement formulated with the company’s cross-linked sodium hyaluronate and triamcinolone hexacetonide, a steroid used to treat inflammation, the Bedford, Mass.-based company said. “The European approval of Cingal marks an […]
