LONDON – South Africa has decided against using the 1 million doses of Astrazeneca plc’s COVID-19 vaccine already in the country to start the rollout of its national vaccination program, in favor of opening a phase IIIb study of Johnson & Johnson’s single shot product. “Over the next few days, we expect to announce a plan to expedite vaccination using [J&J’s] investigational vaccine in health care professionals in South Africa,” said Glenda Gray, CEO of the South African Medical Research Council and chair of the country’s research committee on COVID-19. Read More
HONG KONG – Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, received conditional approval for use by the general public from China’s National Medical Productions Administration, two days after filing for conditional market authorization. Read More
CEO Mitchell Steiner said Veru Inc. at first downplayed the prospects of oncology candidate VERU-111 in COVID-19 treatment but now, with positive phase II data in hand, the company has a moral obligation to push onward to late-stage research. Read More
Avrobio Inc. said Feb. 8 that the first person dosed with AVR-RD-01, an investigational ex vivo lentiviral gene therapy from its upgraded manufacturing platform, Plato, experienced a complete clearance of the toxic substrate lyso-Gb3 in a kidney biopsy. Read More
Chinese cancer and autoimmune specialist Innocare Pharma Ltd. raised HK$3.04 billion (US$392 million) in private placements with two Hillhouse Capital subsidiaries and Vivo Opportunity Fund to advance its pipeline, especially its core asset, the BTK inhibitor orelabrutinib. Read More
CAJICA, Colombia – China’s Anticancer Bioscience, a company focused on developing precision oncology medicines, has raised ¥66 million (US$10.2 million) to expand its small-molecule and natural product screening libraries and move two programs into IND-enabling studies. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: CBO model touts savings of H.R. 3; FDA to ODAC: Are data ripe for 2nd TNBC Keytruda approval?; Fifth Circuit reiterates no liability remedy for generics; Consultant faces insider trading charges. Read More
New hires and promotions in the biopharma industry, including: Annexon, Chimeron, Dyne, Editas, Frequency, In8bio, Noxxon, Oxular, Palleon, Vedanta. Read More
Biopharmas raising money in public or private financings, including: Argenx, Artelo, Decibel, Equillium, Gemini, Neximmune, Ocugen, Pan Cancer, Tonix, Xortx. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Avrobio, Cassava, Covaxx, Cue, Dong-A, Eiger, Erytech, Freeline, Jasper, Magenta, Sinovac, Uniqure, Veru. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anpac, Astrazeneca, Catapult, Elevar, Ellodi, Ideaya, Janssen, Passage, RDIF, Sinovac, Supernus, Viiv. Read More
