By granting accelerated approval for Biogen Inc.’s Aduhelm (aducanumab) for Alzheimer’s disease (AD), the FDA is “essentially confirming that the beta-amyloid hypothesis has been validated,” Mizuho analyst Salim Syed said in an alert to investors. Shares of Cambridge, Mass.-based Biogen (NASDAQ:BIIB) closed $395.85, up $109.71, or 38.3%, as Wall Street hailed the first new AD therapy to reach the market since 2003. Read More
Novo Nordisk A/S will this month launch its weekly weight loss glucagon-like peptide-1 injection Wegovy (semaglutide) at the same monthly cost as its older daily shot Saxenda (liraglutide), following FDA approval in overweight and obese adults. Read More
The FDA has lifted clinical holds on four studies from Bluebird Bio Inc., following recent similar actions with other gene therapy programs. Two of the studies concern phase I/II and phase III clinical trials of the gene therapy Lentiglobin (BB-1111) in treating sickle cell disease. The remaining two studies are phase III clinical trials of betibeglogene autotemcel gene therapy, which share a vector with Lentiglobin, for treating transfusion-dependent beta-thalassemia. Read More
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.
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LONDON – Iksuda Therapeutics Ltd. sealed its transition from technology licensing company to antibody-drug conjugate (ADC) development specialist, closing a $47 million series A financing to move the lead program, IKS-03, into the clinic. Read More
The European Commission unveiled its third alternative to providing global access to COVID-19 vaccines and treatments just ahead of the June 8 meeting of the World Trade Organization’s Council for Trade Related Aspects of Intellectual Property Rights and the start of the G7 summit. Read More
The Guangzhou Sino-Israel Bio-industry Investment Fund (GIBF) has raised more than half of its proposed ¥2 billion (US$313 million) round. “The second fund, GIBF2, will focus on Israeli and European biotechnology companies, which are developing innovative drugs and are in phase II to III clinical trials,” Avner Lushi, the CEO and co-founder of the GIBF, told BioWorld. Read More
Scohia Pharma Inc. has secured an agreement with Huadong Medicine Co. Ltd., enabling the former to tap the greater China market for SCO-094, its GLP-1R and GIPR dual agonist. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acepodia, Adamis, Adhera, Argenx, Astrazeneca, C4, Cilag, Equillium, Immune, Janssen, Luye, Medicinova, Medison, Mediwound, Melior, Moderna. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion. Read More
