The U.S. Food and Drug Administration (FDA) approved Eisai’s Dayvigo (lemborexant) for adults with sleep onset and/or sleep maintenance in adults—insomnia, in other words. Before it can hit the market in the U.S., the U.S. Drug Enforcement Agency (DEA) will…
UK hospital introduces TytoCare remote medical exam device
A UK hospital has introduced a modular device allowing for remote examinations for patients with acute and worsening chronic conditions. Bradford Teaching Hospitals NHS Foundation Trust is poised to become the first provider in the UK to partner with TytoCare,…
Intra-Cellular ends year with OK for schizophrenia drug lumateperone
US biotech Intra-Cellular Therapies’ has claimed an FDA approval for schizophrenia therapy lumateperone setting up the launch of the drug as its first commercial product next year. The green light for the drug – which will be sold under the…
FDA approves Allergan’s migraine tablet ahead of AbbVie merger
Allergan’s migraine tablet Ubrelvy (ubrogepant) has been approved in the US for the acute treatment of patients with or without aura. Approval of Ubrelvy follows an FDA okay for Eli Lilly’s Reyvow (lasmiditan), which is also used to treat symptoms…
Merck claims first-ever FDA approval for an Ebola vaccine
Merck & Co’s Ebola vaccine Ervebo has been cleared for marketing in the US, just weeks after getting a world-first regulatory approval in Europe. Originally developed by NewLink Genetics, Ervebo – which was previously known as V920 or rVSVΔG-ZEBOV-GP –…
VERO Biotech Receives US FDA Approval of GENOSYL® for the Delivery of Inhaled Nitric Oxide
ATLANTA, Dec. 20, 2019 /PRNewswire/ — VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering and improving the health economics of care, today announced it has received US Food and Drug Administration (FDA) approval of GENOSYL®…
Johnson & Johnson Acquires TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer
NEW BRUNSWICK, N.J., Dec. 20, 2019 /PRNewswire/ — Johnson & Johnson announced today the acquisition of TARIS Biomedical LLC (TARIS), a privately-owned biotechnology company specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including…
Clinical Innovations to be acquired by LABORIE Medical Technologies
SALT LAKE CITY–(BUSINESS WIRE)– Clinical Innovations, one of the largest medical device companies dedicated to labor and delivery and neonatal intensive care, has signed a definitive agreement to be acquired by LABORIE Medical Technologies for an enterprise value of $525M.…
AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod
Dive Brief: Digital health company Eko said Wednesday it received FDA’s breakthrough device designation for priority review of the company’s algorithm to detect heart failure with a specialized stethoscope during a routine physical exam. The algorithm helps identify reduced left…
Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software
Dive Brief: FDA on Friday authorized the third and final type of diabetes management technology necessary for a fully interoperable, automated insulin dosing system. The De Novo clearance went to Tandem Diabetes’ Control-IQ glycemic control algorithm, which is designed to in…
