A year and a half gone, two HIV vaccine studies shut down. That’s the case with the Janssen Pharmaceutical Cos. of Johnson & Johnson as the phase III Mosaico study of its HIV vaccine regimen was not effective in preventing infection compared to placebo. Based on a data and safety monitoring board’s report saying the study was not expected to hit its primary endpoint, Janssen discontinued the clinical trial more than a year ahead of its estimated March 2024 completion date. Read More
Upcoming catalysts from Annexon Biosciences Inc. put some joy into shares as the firm talked up its prospects during the recent J.P. Morgan Healthcare Conference, where attendees heard Jan. 8 about the news ahead with C1q protein complex inhibitor ANX-005 in Huntington’s disease (HD) as well as progress in Guillain-Barre syndrome (GBS), and more. The stock (NASDAQ:ANNX) enjoyed a 43% stock boost in the days after JPM, rising from $4.79 on Jan 8 to $6.84 on Jan. 13. Read More
Iaso Biotherapeutics Inc. raised ¥500 million (US$75 million) in a series C1 round as looks for its first drug approval by China after its NDA was accepted for what is claimed to be the first B-cell maturation antigen-targeting CAR T-cell therapy in China. Read More
The U.S. Department of Health and Human Services received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens, but legislative fixes might be necessary to ensure that all the gaps are closed. Read More
Pulmobiotics Ltd., which was founded in 2019, is developing cell therapy for lung diseases, including lung cancer. But unlike other cell therapies for cancer, this one is based not on harnessing T cells but on engineering bacteria. The team has engineered Mycoplasma pneumoniae to deliver various therapeutic proteins to the lung, depending on the therapeutic indication. Read More
In the absence of a European framework, industry is stepping up with an initiative to help EU patients cross borders to participate in clinical trials. Read More
Just as the U.S. mpox public health emergency declaration is about to end, the FDA is releasing a draft guidance on developing drugs and biologics to treat infections caused by the virus. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2seventy, Advaxis, Alphazyme, Ayala, Boehringer Ingelheim, Concert, Dyadic, Editas, Foundation Medicine, JW, Medigene, Neurosense, Ono, Repare, Shoreline and Sun. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Atyr, Avidity, Briacell, Cyrano, Exegenesis, Hutchmed, Junshi, Krystal, Novavax, Orphagen, Paratek, Pharmather, Sanofi, Scisparc, Takeda. Read More
