The FDA has issued a complete response letter to Braeburn Pharmaceuticals, denying its application for an investigational weekly and monthly buprenorphine depot injection designed to treat adults with opioid use disorder. The company reported that the dreaded CRL does not request additional clinical studies, but Braeburn did not elaborate as to what sort of additional […]
NeuroMetrix, GSK ink development deal for Quell wearable pain-relief tech
Shares in NeuroMetrix (NSDQ:NURO) soared this morning after the company announced it would partner with GlaxoSmithKline (NYSE:GSK) to expand development of NeuroMetrix’s Quell wearable pain-relief device. According to the terms of the deal, GSK’s consumer healthcare business will have exclusive rights to the Quell system for markets outside of the U.S., while NeuroMetrix will retain ownership […]
Braeburn raises $110m for opioid use disorder depot injection
Braeburn Pharmaceuticals has raised $110 million in a mezzanine round of financing led by Wellington Capital. Other investors included Avista Capital Partners, RA Capital Management, Deerfield Management and Apple Tree Partners. The Princeton, N.J.-based company said it plans to use the new funds to support the FDA approval process and commercialization of CAM2038, a weekly […]
Egalet teams up with Valeant division to promote pain-relief nasal spray
Egalet (NSDQ:EGLT) has partnered with a division of Valeant Pharmaceuticals (NYSE:VRX), OraPharma, to co-promote its pain-relief nasal spray to dentists and oral surgeons in the U.S. Sprix nasal spray is a nonsteroidal anti-inflammatory drug designed for the short-term management of moderate to moderately-severe pain. Financial terms of the two-year deal were not disclosed. “Given the need for […]
Medtech stories we missed this week: Dec. 22, 2017
From Hepa Wash’s new collaboration to Stimwave’s FDA clearance, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Hepa Wash collaborates with GALS program Hepa Wash announced in a Dec. 7 press release that it has collaborated with the German Accelerator Life Sciences (GALS) program to expand its […]
Histogenics inks deal to develop Neocart for the Japanese market
Histogenics (NSDQ:HSGX) has inked a deal with Medinet to develop and commercialize its Neocart implant for the Japanese market. The Waltham, Mass.-based company’s Neocart implant is designed to repair knee cartilage damage. The product is made using a patient’s own cells, harvested from the surface of the patient’s femur. “This transformative collaboration for Histogenics is […]
7 medical devices combating the opioid crisis
Opioid-related deaths have become an epidemic in the U.S., garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause more […]
Egalet wins tentative FDA nod for intranasal abuse-deterrent pain-killer
Egalet (NSDQ:EGLT) said today that the FDA tentatively approved an expanded label for its Arymo extended-release pain-relief tablets. The new label includes data from a intranasal human abuse potential study and an intranasal abuse-deterrent claim. The FDA previously excluded this data from Arymo ER’s label due to exclusivity given to another company, Egalet reported. The FDA […]
pSivida touts pilot osteoarthritis trial for Durasert implant
pSivida (NSDQ:PSDV) touted results today from a Phase I safety and efficacy pilot trial of its sustained-release Durasert implant in patients with osteoarthritis of the knee. The company’s Durasert tech, combined with an implantable device from the Hospital for Special Surgery, was designed to continuously deliver a low dose of dexamethasone into the knee joint. Six patients […]
Medherant raises $5m to move transdermal ibuprofen patch to clinical trials
Transdermal drug-delivery company Medherant said yesterday it raised $5.1 million (GBP £3.8 million) in a funding round as it looks to move its drug-delivering ibuprofen Tepi Patch into clinical development early next year. The funding round was led by majority shareholder Mercia Technologies and joined by existing shareholders and new private investors, the Coventry, U.K.-based […]
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