First Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate targeting Globo H, a glycolipid antigen found on multiple tumor types TAIPEI, Taiwan, Dec. 26, 2019 /PRNewswire/ — OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced…
Pfizer Strikes JAK Inhibitor Deal Worth Up to $250 Million With Theravance
Pfizer continues to bet on JAK inhibitors. This morning, the company entered into a licensing agreement with Theravance Biopharma for a preclinical program for skin-targeted, locally-acting pan-Janus kinase (JAK) inhibitors that can be rapidly metabolized. Pfizer handed over $10 million…
Atopic Dermatitis Space Will Heat Up in 2020, Analyst Predicts
The future of the atopic dermatitis space is going to be a competitive one. Multiple assets are in line to be submitted for regulatory approval and will, if approved, challenge the leading market share currently held by Regeneron and Sanofi’s…
FDA Gives Greenlight to Eisai’s Dayvigo for Insomnia
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…