The U.S. Food and Drug Administration approved a shorter two-hour infusion time for Roche Group member Genentech’s Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions.
Antibodies against the novel coronavirus declined rapidly in the British population during the summer, a study found, suggesting protection after infection may not be long lasting and raising the prospect of waning immunity in the community.
ADC Therapeutics SA announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
Roche aims to defend the company’s multiple sclerosis (MS) franchise from rivals Novartis and Sanofi with new studies of the Swiss drugmaker’s $4 billion-per-year Ocrevus product and advanced trials of the experimental medicine fenebrutinib.
Novartis announced that the Phase III COMBI-I trial of the company’s experimental checkpoint inhibitor spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) failed to hit the primary endpoint in melanoma.
Several studies suggest that even mild cases of Covid-19 stimulate lasting immune responses, not only in disease-fighting antibodies, but in B-cells and T-cells.
The U.S. Food and Drug Administration approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis in adults.
Sanofi is rumored to have a $50 billion budget for mergers and acquisitions and is taking a look at U.S.-based biotech companies, including South San Francisco-based Principia Biopharma.
One day, cell and gene therapies will be as common as small molecules and antibody-based therapies are today, according to panelists at BIO 2020.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.