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 […]

Asklepios BioPharmaceutical launches new portfolio company Actus Therapeutics

Published 15 December 2017 Asklepios BioPharmaceutical has formed Actus Therapeutics, a new portfolio company based on AskBio’s industry-leading gene therapy platform. Actus will benefit from AskBio’s ability to generate organ and tissue-specific single-stranded and self-complementary genome containing adeno-associated virus vectors (AAVs), the company’s manufacturing platform and managements’ experience progressing AAV gene therapy programs into the […]

FDA approves Pfizer’s Xeljanz and Xeljanz XR to treat active psoriatic arthritis

Published 15 December 2017 The US Food and Drug Administration (FDA) has approved Pfizer’s Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying […]

Drugmaker Teva to cut 14,000 jobs globally

PBR Staff Writer Published 15 December 2017 Teva Pharmaceutical Industries said it will lay off 14,000 jobs globally as part of a two-year restructuring plan, aimed at boosting its business and financial performance. The reductions in jobs, which will be carried out over the next two years, represent over 25% of the company’s total workforce. Teva’s […]

Wright Medical acquires surgery planning software dev IMASCAP SAS for $89m

Wright Medical (NSDQ:WMGI) said today it inked a deal to acquire shoulder replacement surgery preoperative planning software dev IMASCAP SAS in a deal worth $88.8 million (EU €75.1 million) Through the deal, Wright picked up 100% of IMASCAP’s outstanding equity on a fully diluted basis for a total of $88.8 million, consisting of $46.9 million (EU €39.7 […]

Feistein Institute launches bioelectronic medicine trial for treating Lupus

Researchers at the Feinstein Institute launched a clinical trial looking to explore the efficacy of bioelectronic medicine specifically designed to manage pain associated with lupus. The study is exploring the use of a proprietary device, designed based upon previous research at the Feinstein Institute, which emits electrical pulses through a patient’s ear for five minutes a day […]

Chemence Medical wins FDA nod for Exofin Fusion skin closure system

Chemence Medical said today it won FDA clearance for its Exofin Fusion skin closure system designed for medium to large wounds. The Exofin Fusion skin closure system features a self-adhering mesh strip, mesh anchors and a fast-curing 2-octyl cyanoacrylate topical adhesive to close and seal large incisions and form a microbial barrier to protect from infections, […]

Singapore vascular access dev Advent Access raises $2m in pre-Series A

Singapore-based vascular access dev Advent Access has raised $1.9 million (SGD $2.6 million) in a pre-Series A financing round to support its av-Guardian technology designed to create vascular access for dialysis patients. The funding round was led by Accuron MedTech, which the company touted as the largest medical device company in southeast Asia. The investment […]

Cardiovascular AI imaging dev Bay Labs raises $6m in Series A

Cardiovascular artificial intelligence medtech firm Bay Labs said today it raised $5.5 million in a Series A round to support clinical validation and further development of its cardiovascular imaging tech. The round was led by existing investor Khosla Ventures and joined by newly invested Data Collective, Greenbox Venture Partners, Minneapolis Heart Institute Ventures and Georges […]

Cybersecurity: Email is largest source of healthcare data breaches for 2017

Emails are the top source for data breaches so far this year according to the US Department of Health and Human Services, Modern Healthcare reports. A total of 73 breaches were reported between January 1 and November 30, affecting information related to 573,698 individuals, according to the report. The threat of email breaches is not unknown […]