Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG). Read More
Jiangsu Recbio Technology Co. Ltd. released phase II data showing its recombinant two-component COVID-19 vaccine Recov appeared more effective than Comirnaty (tozinameran), the mRNA vaccine developed by Biontech SE and Pfizer Inc., as a booster for users of inactivated vaccines. Read More
The Australian government delivered an early Christmas present to the biopharma industry in the form of a new National Medicines Policy giving voice to major industry goals – among them a clear vision to “achieve the world’s best health, social and economic outcomes for all Australians through a highly supportive medicines policy environment.” Read More
Facing a 26.5% rebate on 2023 sales of branded prescription drugs in the U.K., the Association of the British Pharmaceutical Industry (ABPI) is seeking talks with the government early in the new year to develop a new biopharma settlement for the future that will reflect the potential of the life sciences sector to drive improvements in the health and economy of the U.K. Read More
It was a year of turmoil in Europe as Russia’s invasion of Ukraine and the fall-out from the COVID-19 pandemic shaped the fortunes of the life sciences industry in 2022. After years of tension, Russia’s attempt to annex Ukraine on Feb. 24 caused outrage and disruption and was unanimously opposed on humanitarian grounds by the life sciences and pharma industry. Read More
Over the past few years, the pandemic clearly has put a spotlight on vaccines and the infectious disease space. But the struggle to adjust in COVID-19’s wake also brought into stark relief another high unmet need. “Coming out of COVID, there was a mental health focus coming into play,” said Andrew Levin, partner and managing director at investment firm RA Capital Management who is also serving as interim CEO at Lusaris Therapeutics Inc., a 2021 startup targeting neuropsychiatric and neurological conditions, with an initial focus on treatment-resistant depression. Read More
Although the war is still raging in Ukraine, Russia is marching forward with asserting its regulatory framework on health care in the parts of Ukraine it’s claiming as the spoils of the war it started 11 months ago. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acasti, Bioxytran, Can-Fite, Clene, PDS. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzamend Neuro, Biomind Labs, Gilead, Iveric Bio, Jounce, Opus Genetics. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genentech, Intercept, Ipsen, Janux, Kaken, Leo, Mediwound, Mindrank AI, Neuren, Neurocrine, Nova Mentis, Regeneron, Revive, Springworks, Valneva, Zielbio. Read More
