LONDON – The U.K. Recovery trial has added a fourth drug to the list of therapies it has shown are effective in treating hospitalized COVID-19 patients, demonstrating the JAK inhibitor Olumiant (baricitinib) reduces the risk of death by 13% in seriously ill patients. That effect is in addition to treatment with dexamethasone, which became standard of care after the Recovery trial showed it reduced mortality by one-third in patients on ventilators. Read More
PERTH, Australia – The independent data safety monitoring board of the global REMAP-CAP COVID-19 study has uncovered a concerning safety signal in treatment arms that include an angiotensin converting enzyme inhibitor and an angiotensin receptor blocker in patients with severe COVID-19, and it has recommended that recruitment be suspended for those treatment arms. Read More
Amgen Inc.’s pioneering lung cancer drug, Lumykras (sotorasib), is set to become available to NHS patients in England, after cost-effectiveness body NICE recommended financing from the Cancer Drugs Fund (CDF) in final draft guidance. Read More
There’s nothing like beginning-of-the-year price increases to turn up the heat on the prescription drug pricing debate in the U.S. This year is no exception. Citing a mean price increase of 5.1% on brand drugs in the first 25 days of 2022, 13 Democratic lawmakers, led by Sen. Elizabeth Warren (D-Mass.), wrote this week to Steven Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, demanding an explanation for those hikes. Read More
To counter the worldwide growth of antimicrobial resistance, a subject of worldwide concern but little actual progress, Arrepath Inc. has raised a $20 million seed financing to advance its machine learning-based platform for discovering new classes of anti-infectives. Read More
A Purdue Pharma LP bankruptcy settlement is back on track now that the Sackler family has agreed to pay at least $5.5 billion, and up to $6 billion, for the role they played in the nationwide opioid epidemic. Read More
The U.S. FDA does not have legal authority to impose recalls on most regulated products, making the March 3 final guidance for voluntary recalls a key policy declaration for industry. The guidance recommends that recalling firms make extensive use of electronic communication to announce a recall, but the referenced FDA guidance for electronic communications was finalized in 2006 and makes no reference to social media as an electronic conduit for recall information. Read More
New hires and promotions in the biopharma industry, including: Adrestia, Aim Immunotech, Clearside Biomedical, Dyne, Entos, Hutchmed, Janux, Merck, Outlook, Pardes, Synlogic, Tevogen. Read More
Biopharmas raising money in public or private financings, including: Aikido, Atlas Venture, Aytu, First Wave, Innoviva, Mediwound, Modulus Discovery, Oxurion. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: A2, Aquestive, Athira, Autolus, Avenge, Haisco, Inspirevax, Oragenics, Sorrento, Spexis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Carsgen, Cidara, I-Mab, Inhibrx, Priothera, Sorrento, TG, Tonix. Read More
