Athenex Inc.’s launch of Klisyri (tirbanibulin) likely whetted investor appetite for another prospect coming down the pike: Oraxol, an oral form of paclitaxel for which the Buffalo, N.Y.-based firm has been assigned a PDUFA date of Feb. 28.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Avacta, CNS, Seagen, WPD.
In a Feb. 17 update to its guidance on managing clinical trials during the COVID-19 pandemic, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) said all sponsors of ongoing clinical trials for indications other than treatment or prevention of COVID-19 are required to evaluate the impact a COVID-19 vaccine may have on the trial.
Investing in biopharma has never been for the faint of heart. So headline figures unveiled from a clinical development success report during the BIO CEO & Investor Conference Feb. 17, putting the average likelihood of a drug entering phase I development ultimately achieving approval at 7.9% and the average drug development timeline at 10.5 years, appear largely unsurprising. But the addition of machine learning capabilities to the mix helped identify those factors that have the greatest impact on predictive outcome.
PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altimmune, Amgen, Beigene, Coherus, JCR, Johnson & Johnson, Novartis, RDIF, Ultragenyx, Verrica.
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.
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.
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