AstraZeneca Pharmaceuticals LP
NEWS
The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
Weeks after AstraZeneca and Daiichi Sankyo were able to move the bar in the treatment of metastatic breast cancer with Enhertu, Gilead is answering that challenge with Trodelvy.
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC.
BMS, 2seventy bio, HUTCHMED and AstraZeneca celebrate cancer trial wins, while mutated zebrafish eyes reveal potentially important insights into cell death.
Biogen expects to lay off a potential 1,000 staffers in an effort to cut about $1 billion in costs, according to The Boston Globe, while 10x Genomics and Talis Biomedical also cut staff.
The week started off with a clinical bang for Verona Pharma, Kodiak, AstraZeneca and Daiichi Sankyo with wins in COPD, lung cancer and macular edema respectively.
Innate Pharma announced that a planned futility interim analysis of the INTERLINK-1 Phase III trial sponsored by AstraZeneca failed to hit a pre-defined threshold for efficacy.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted
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