Novartis (NYSE:NVS) said today that a committee for the European Medicines Agency has recommended that the regulatory agency approve Aimovig, a self-administered drug designed to prevent migraines in adults who have at least four migraine days each month. The drug is the first of a new class of medicines, called CGRP inhibitors. It’s a monoclonal antibody […]
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Apotex recalls allergy nasal spray due to glass particles
Apotex yesterday issued a voluntary recall of one lot of fluticasone propionate allergy nasal spray devices, noting that they may contain small glass particles. The company first discovered the issue thanks to a customer complaint. The glass particles could block the device’s actuator, according to Apotex, and impact the pump’s functionality. The company’s sprays are used […]
Common Sensing, Flex partner to redesign digital insulin pen sensor
Common Sensing said today that it has enlisted design company Flex to help redesign its Gocap insulin pen device. Flex is tasked with finding materials to help extend the product’s battery life, as well as boost measurement accuracy and prepare for high volume manufacturing. Common Sensing’s Gocap device is designed to attach to existing injector pens and […]
Propeller raises $20m and prepares to extend reach beyond digital inhalers
Digital therapeutics company Propeller Health and drug-delivery device-maker Aptar Pharma are teaming up, yet again, to develop an array of connected drug-delivery devices. The pair has worked together in the past – in 2016, the companies launched the world’s first fully-integrated connected metered dose inhaler. Now, they hope to create a platform of digital therapeutics, […]
ContraVir’s drug slashes fibrosis by 46% in preclinical study
ContraVir Pharmaceuticals (NSDQ:CTRV) touted encouraging results today from a preclinical study of its cyclophilin inhibitor, CRV431. In an animal model, the drug reduced the extent of fibrosis by 46% compared to the control. The Edison, N.J.-based biopharma company is developing medicines to treat patients who are infected with the hepatitis B virus. In the treatment […]
Denali acquires F-star Gamma and its antibody tech to help drugs cross the blood-brain barrier
Privately-held biopharma F-star said today that its partner, Denali Therapeutics (NSDQ:DNLI), chose to exercise its option to buy F-Star Gamma in a deal valued at approximately $471 million. The two companies first inked a collaboration in August 2016 to develop antibody technologies that help drugs cross the blood-brain barrier. “When you give an antibody via IV […]
Novartis licenses BDD Pharma’s timed-release oral drug-delivery tech
Privately-held BDD Pharma said today that it signed a deal to license its OralogiK timed drug-delivery tech to Novartis (NYSE:NVS). Financial details of the agreement were not disclosed, but BDD noted that it included an upfront payment, milestones and future royalties. BDD’s technology can deliver multiple doses or a combination of drugs at pre-determined times, between […]
FDA launches medical device innovation challenge to combat opioid crisis
The U.S. FDA today announced that it has launched an innovation challenge to encourage the development of medical devices to help reduce the country’s opioid abuse crisis. The hope is that the challenge will result in new medtech including digital health technologies and diagnostic tests to help detect, treat and prevent addiction, according to FDA. Go […]
Titan, Braeburn end commercialization deal for Probuphine drug-delivery implant
Titan Pharmaceuticals (NSDQ:TTNP) and Braeburn Pharmaceuticals said today that they plan to end a 2012 licensing agreement that gave Braeburn exclusive rights to commercialize Probuphine in the U.S. and Canada. Probuphine, which was developed using Titan’s ProNeura continuous drug-delivery tech, is an implant that can be placed in a patient’s upper arm in an outpatient office […]
On second try, TherapeuticsMD lands FDA nod for vaginal capsule
TherapeuticsMD (NSDQ:TXMD) said today that it won FDA approval for its applicator-free estradiol vaginal capsule, TX-004HR. The soft-gel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. The Boca Raton, Fla.-based company plans to market the product under the name ‘Imvexxy’. This […]