LONDON – Controversy has erupted over COVID-19 vaccines dosing after the U.K. said it is to prioritize giving as many people as possible a single dose of the two currently approved products, rather than two doses three or four weeks apart, as scheduled on their labels. The move prompted a sharp rebuke from FDA Commissioner Stephen Hahn and Peter Marks, director of FDA’s Center for Biologics Evaluation, who said any such change “is not rooted in the science.” Read More
COVID-19 vaccines have taken most of the limelight lately, but therapies are making progress, too, with San Diego-based Atyr Pharma Inc. and Cerecor Inc., of Rockville, Md., separately offering favorable phase II news. Read More
HONG KONG – India’s conditional approval on Jan. 3 of a COVID-19 vaccine developed domestically by Bharat Biotech International Ltd. but still in phase III trials has sparked concerns about its safety. The Drugs Controller General of India (DCGI) gave emergency authorization to the product, Covaxin, along with the Astrazeneca plc and Oxford University vaccine Covishield. The DCGI said the conditional approval granting “restricted use in emergency situation” for Covaxin was done in “clinical trial mode” to account for the fact that the shot is still being tested. But the rush to approve it has created controversy and confusion. Read More
Relief spread across the world in December when the first two mRNA COVID-19 vaccines received emergency use approvals, although that deep sigh was short-lived as a highly-transmissible SARS-COV-2 mutation began to make its rounds, highlighting the need for continued research to strengthen the arsenal. Read More
DUBLIN – European biopharma, like the rest of the global industry, scaled new heights in 2020 from an investment perspective. European firms collectively raised $12.682 billion from the private and public equity markets, as well as substantial levels of debt and grant funding. It was a bumper year for both venture capital investment and for Europe’s growing cadre of listed companies. Read More
Iconovir Bio Inc., of San Diego, raised $77 million in a series A financing to develop differentiated oncolytic virus candidates the company said it believes could potentially be I.V.-administered, tumor-selective and could broadly infect tumor cells. Read More
Immuneering Corp., a bioinformatics specialist that has for years helped big companies like Teva Pharmaceutical Ltd. and Bristol Myers Squibb Co. better understand their own medicines, has landed $62 million in an oversubscribed series B financing that will help it leverage lessons learned in that journey to build out its own pipeline, starting with IMM-1-104, a dual inhibitor of MEK and a related target. Read More
The exceptional and speedy response in bringing safe and effective vaccines and therapeutics to combat COVID-19 has kept investors engaged and supportive. As a result, not only have companies involved in this research and development benefited, but so has the sector as a whole. Those biopharma companies have enjoyed significant jumps in their share values, with the BioWorld Drug Developers index closing up 4.6% in December and up 29% for 2020. Read More
A New Year tradition in the U.S. is the inevitable price increase for a multitude of brand drugs. 2021 isn’t breaking with that tradition, despite American families being ravaged economically by nearly a year of the COVID-19 pandemic. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Arcturus, Ascentage, Atriva, Chipscreen, Cure, Genentech, Marius, Marker, Moderna, Ovoca, Precigen, Roche, Zosano. Read More
