Shares of Adaptimmune Therapeutics skyrocketed after the company announced an agreement to develop and commercialize allogeneic cell therapies for cancer with Genentech.
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.
Genentech’s Hemlibra (emicizumab-kxwh) showed no new safety signals and continued to deliver consistent bleeding control in the final analysis of a long-term, late-stage hemophilia A study.
Two former executives of Taiwan-based JHL Biotech were indicted on charges of orchestrating the theft of trade secrets from Genentech. The U.S. government also charged the former chief executive officer and chief operating officer of that company with wire fraud and money laundering.
U.S. health regulators approved Roche’s arthritis drug Actemra for emergency use to treat hospitalized Covid-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds.
FDA Committee Supports Maintaining Accelerated Approval of Tecentriq in PD-L1+ mTNBC
Accelerated Approval, Blockbusters, Checkpoint Inhibitors, FDA, Genentech, Oncologic Drugs Advisory Committee (ODAC), PD-1/PD-L1 inhibitors, Recommended For Approval, Therapeutics, Triple Negative Breast Cancer (TNBC)A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.
Covid-19 Wins and Losses: Genentech’s Actemra Flunks Trial; Vir & GSK’s Antibody Dazzles
Clinical Trials, COVID-19 Antibodies, Covid-19 Data, Covid-19 Pneumonia, Genentech, Gilead, GlaxoSmithKline, Hospitalized COVID-19 Patients, Independent Data Monitoring Committee (IDMC), Primary Endpoints, R&D, Remdesivir, Rheumatoid Arthritis, Vir BiotechnologyGenentech reported that the company’s rheumatoid arthritis drug Actemra failed to hit the primary endpoint in a Covid-19 trial, while Vir and GlaxoSmithKline’s antibody against Covid-19 demonstrated 85 percent efficacy.
FDA Approves First Biologic for SSc-ILD
Adults, Approvals, Autoimmune Diseases, Biologics, Blockbusters, Clinical Trials, FDA, Genentech, Immune System, New Indications, Pulmonary Function, R&D, Rheumatoid Arthritis, Scleroderma, Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), Therapeutics, VentilatorsThe U.S. Food and Drug Administration approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
RNAi-Focused Atalanta Therapeutics Launches
Alzheimer’s Disease, Biogen, Business, CNS Disorders, Collaborations, Company Launches, Deals, Financing, Genentech, Huntington’s disease, Neurodegenerative Diseases, Parkinson’s disease, RNA Interference (RNAi), RNAi therapeutics, Series A, Small Interfering RNA (siRNA)RNAi-focused Atalanta Therapeutics launched with $110 million in combined Series A funding and collaboration deals with Genentech and Biogen to address diseases related to the central nervous system, including Huntington’s, Alzheimer’s and Parkinson’s diseases.