By January 2022, 12 billion COVID-19 vaccine doses had been manufactured and, to date, roughly 20 vaccines have received either full approval or emergency use authorization in countries around the world. In places such as Europe and the U.S., most of the people who want vaccinations have gotten their jabs. And the vaccines continue to show efficacy, with the latest CDC data showing consistently less risk for testing positive for COVID-19 or dying from the infection for those who are vaccinated and boostered. Yet the development of new COVID-19 vaccines remains surprisingly robust, with BioWorld tracking 258, the majority of which are in preclinical development. Read More
Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all. Read More
After August 2021 news from the U.S. FDA of deficiencies in the NDA that Axsome Therapeutics Inc. submitted for AXS-05 in major depressive disorder (MDD), word was especially welcome April 19 that the firm has come to an agreement with the agency with regard to post-marketing requirements. Meanwhile, another player in MDD, Relmada Therapeutics Inc., is due to report phase III data with REL-1017 (esmethadone) around the middle of this year. Read More
Isofol Medical AB’s slow reveal of data from its phase III registration trial of arfolitixorin in first-line metastatic colorectal cancer (mCRC) will not reach a conclusion until the fourth quarter of this year. The news follows a December 2021 warning to investors that an unexplained level of therapy switches occurring in the absence of disease progression would impair its analysis of a key secondary endpoint, the rate of progression-free survival. Read More
Bridge Biotherapeutics Inc. inked an exclusive in-license agreement for Shaperon Inc.’s G protein-coupled receptor 19 (GPCR19) agonist, BBT-209, a potential treatment for idiopathic pulmonary fibrosis. Bridge will pay Shaperon ₩2 billion (US$1.63 million) up front. The potential deal value, which includes up-front, milestone, and royalty payments, is ₩30 billion. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adiso, Astrazeneca, Epicentrix, Maat, Novavax, Orasis, Servier. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alzecure, Arev, Celsion, Codiak, Gilead, ICER, Immune-Onc, Janssen, Legend, Pfizer, Sanofi, Terran, Vallon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Dragon Boat, Hansa, Moleculin, Nrx, Otsuka, Tvardi, Vertex, Zambon. Read More
