New hires and promotions in the biopharma industry, including: Affinia, Antios, Avadel, Biocardia, Cue, Eli Lilly, Intercept, Maxwell, Scpharmaceuticals.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Astrazeneca Pty Ltd. for its COVID-19 vaccine, a recombinant adenovirus vaccine, making it the second COVID-19 vaccine to receive regulatory approval in Australia, following the Jan. 26 provisional approval for Pfizer Australia Pty Ltd.’s COVID-19 vaccine, branded Comirnaty.
HONG KONG – A Japanese phase III study of Chugai Pharmaceutical Co. Ltd.’s interleukin-6 inhibitor Actemra (tocilizumab) in patients hospitalized with severe COVID-19 pneumonia has read out, expanding what’s known about the drug’s use in the pandemic, which had been inconclusive until recently, though is now known to reduce mortality in the vulnerable population.
As expected, G1 Therapeutics Inc.’s Cosela (trilaciclib) won FDA approval for use in extensive-stage small-cell lung cancer patients undergoing chemotherapy, becoming the first proactively administered myelopreservation therapy to hit the market.
January is historically the weakest month of the year for FDA approvals and 2021 is following that trend. With only nine approvals tracked by BioWorld during the month, it falls short of the 12 approvals during the same month in 2020, and it is the lowest amount in a single month since January of 2019, which also recorded nine.
The FDA placed a partial clinical hold on atuzaginstat (COR-388) from Cortexyme Inc., of South San Francisco, stating that no new participants should be enrolled in the open-label extension portion of the phase II/III GAIN trial in mild to moderate Alzheimer’s disease.
Shares of Bluebird Bio Inc. (NASDAQ:BLUE) fell 37.8% to $28.44 on Feb. 16 as the company temporarily suspended two trials of its experimental gene therapy for sickle cell disease, Lentiglobin (BB-1111), while investigating one unexpected case of acute myeloid leukemia (AML) and another of myelodysplastic syndrome among participants in a phase I/II study of the candidate, called HGB-206. A second patient experienced MDS in 2018.
DUBLIN – Cellectis SA is picking up $15 million worth of equity in Cytovia Therapeutics Inc. and could earn as much as $760 million in development, regulatory and sales milestones from a deal involving up to five gene-edited allogeneic natural killer (NK) cell or chimeric antigen receptor (CAR-NK) cell therapies employing its Talen (transcription activator-like effector nuclease) gene editing technology.
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