DUBLIN – Sanofi SA and Glaxosmithkline plc are lending their considerable weight to the urgent global effort to develop a vaccine for COVID-19 by teaming up to develop an adjuvanted recombinant subunit vaccine that will employ technologies from each company. Paris-based Sanofi is contributing its recombinant spike protein antigen and its baculovirus expression system, which is also the basis of its U.S.-licensed influenza vaccine Flublok. London-based GSK is contributing its pandemic adjuvant technology. Read More
LONDON – Companies represented in the expert group brought together by the World Health Organization (WHO) to work on the development of COVID-19 vaccines have signed a pledge to strengthen collaboration and sharing of data. Read More
Arriving at MEI Pharma Inc.’s deal with Kyowa Kirin Co. Ltd., focused on phase II-stage ME-401 for B-cell malignancies, was a competitive process that brought large and midsized pharma bidders to the table, MEI Chief Operating Officer David Urso said, but the terms proposed by suitors tended to “look a lot the same.” Read More
Privately held Cerevance Inc., of Boston, raised $45 million in a series B designed to propel the discovery and development of therapies for treating CNS diseases such as Alzheimer’s disease. Read More
It has been more than 200 years since British doctor James Parkinson first identified the symptoms of a condition that he termed shaking palsy; unfortunately, there is still no cure to the disease that carries his name. Read More
New York-based Immunovant Inc.’s phase IIa results with neonatal Fc receptor (FcRn)-targeting IMVT-1401 in thyroid eye disease (TED), also known as Graves’ ophthalmopathy, prompted renewed speculation about the space, hot since the approval on Jan. 21 of Tepezza (teprotumumab-trbw) from Horizon Therapeutics plc, of Dublin. Read More
HONG KONG – Foster City, Calif.-based Gilead Sciences Inc., which is ramping up its COVID-19 candidate production and research and is donating 1.5 million doses for compassionate use, published results in New England Journal of Medicine from a cohort analysis of 53 severe patients hospitalized with severe complications from COVID-19, showing a cumulative incidence of clinical improvement of 84% after 28 days of follow-up, according to Kaplan-Meier analysis. Read More
When it comes to guidance on interchangeables, the Pharmaceutical Research and Manufacturers of America (PhRMA) has some guidance for the FDA: Be more definite. Read More
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aldeyra, Amgen, Astrazeneca, Beigene, Bioinvent, Calithera, Cytokinetics, Healios, Madrigal, Outlook. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Alnylam, AVM, Epirium, Grid, Kadmon, KD Pharma, Lifemax. Read More
