Additional reports of patients with long COVID who were helped by Pfizer Inc.’s oral antiviral treatment Paxlovid offer fresh impetus for conducting clinical trials to test the medicine for the debilitating condition, U.S. researchers said on May 5.
Cerebras Systems, a pioneer in high performance artificial intelligence (AI) computing, and AbbVie, a global biopharmaceutical company, announced a landmark achievement in AbbVie’s AI work.
The U.S. Food and Drug Administration indirectly refuted Pfizer’s recommendation that it’s all right for COVID-19 patients to take another round of Paxlovid if they experience a rebound after completing the first course.
AstraZeneca and Daiichi Sankyo move into earlier treatment space with Enhertu
Approvals, AstraZeneca, Blockbusters, Breast Cancer, Daiichi Sankyo, Expanded Indication, FDA/Regulatory, HER2-positive breast cancer, HER2-positive metastatic breast cancer, Immunotherapies, Therapeutics, Unresectable or Metastatic HER2-Positive Breast CancerAstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval from the U.S. Food and Drug Administration. Enhertu was approved for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
AstraZeneca, Argenx Score Phase III Wins in Autoimmune Space
AstraZeneca, Autoimmune Diseases, Biologics, Bleeding Disorders, Central Nervous System, Chronic Immune Thrombocytopenia (ITP), Clinical Trial Endpoints, Clinical Trials, Generalized Myasthenia Gravis (gMG), Mayo Clinic, Medical Centers, Neuromyelitis Optica Spectrum Disorder (NMOSD), Primary Endpoints, R&D, Rare Disorders, Supplemental Biologics License Application, TherapeuticsTwo biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.
AstraZeneca’s proposed treatment for heart disease delivered positive high-level results from the company’s Phase III DELIVER trial.
Amphista Therapeutics forged two significant protein degradation partnerships with big pharma. On May 4, the U.K.-based company announced partnerships with both Bristol Myers Squibb and Merck KGaA that have a combined value of more than $2 billion.
Regeneron Overcomes Loss of COVID Antibody to Post Positive First Quarter
Acquisitions, Biologics License Application (BLA), Blockbusters, Business, COVID-19 Antibodies, FDA, Monoclonal Antibodies, Quarterly results, REGEN-COV (casirivimab and imdevimab), Regeneron Pharmaceuticals, Sales, Sanofi, TherapeuticsDespite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.
Compass Therapeutics and AstraZeneca have both provided updates to their respective clinical therapeutic programs targeting biliary tract cancers.
Moderna Inc. on May 4 forecast higher vaccine sales for the second half of 2022 than in the first six months of the year, as the company expects the virus that causes COVID-19 to follow a more seasonal pattern requiring booster shots in the fall.