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Moderna and Pfizer/BioNTech are both pushing to get expanded Emergency Use Authorization (EUA) for a fourth dose/second booster of their COVID-19 vaccines, but a new study questions its effectiveness in the population at large. Read More
Merck’s mega blockbuster Keytruda (pembrolizumab) may soon have a new indication, this time in an earlier stage of disease than is typical for the anti-PD-L1 therapy. Read More
Diversity is a critical area in clinical research that desperately needs to be improved, the pharma industry agrees, but policies that would require sponsors to enroll more diverse populations will backfire, contends industry trade group PhRMA. Read More
Esai’s investigational anti-tau antibody E2841 grabbed some air time yesterday in Barcelona, Spain, with the first detailed look at a phase 2/3 study in people who are genetically predestined to develop Alzheimer’s disease. Read More
The FDA approved Evrysdi to treat patients two months and older with Type 1 spinal muscular atrophy in August 2020, making it the first oral drug approved to treat the disease. Read More
Patients treated with Aduhelm experienced decreased levels of tau — the second dysregulated protein in Alzheimer’s disease — which were associated with a slowing of cognitive decline, Biogen executive Samantha Budd Haeberlein said yesterday at the AD/PD 2022 meeting on Alzheimer’s disease and Parkinson’s disease in Barcelona, Spain, March 15-20. Read More
Four rival drugmakers have joined forces to help develop digital clinical measures to assess whether new treatments for Alzheimer’s disease and related dementias are working. Read More
Merck is stopping a phase 3 trial of its mega blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in combination with AstraZeneca’s blockbuster PARP inhibitor Lynparza (olaparib) for prostate cancer after an independent data monitoring committee recommended it do so. Read More
Nektar Therapeutics’ experimental immunotherapy bempegaldesleukin paired with Bristol Myers Squibb’s (BMS) blockbuster checkpoint inhibitor, Opdivo (nivolumab), did not shrink tumors, slow the growth of tumors or prolong survival rates for metastatic melanoma patients in a phase 3 trial in which the combo was compared to Opdivo alone. Read More