Pfizer announced on Sept. 2 the dosing of the first patients in a Phase III trial assessing a single dose of the company’s investigational RSV bivalent prefusion F subunit vaccine candidate (RSVpreF) in adults ages 60 and older. One day earlier, Pfizer announced the initiation of a Phase II/III clinical study of 1,140 participants for an oral pill expected to be used in a broad population of Covid patients.
AstraZeneca Plc’s cancer drug Imfinzi was approved in Europe and Britain for a spaced-out regimen in a common type of lung cancer to help reduce the frequency of hospital visits while continuing treatment.
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.
Novartis’ Beovu matched Regeneron’s Eylea in vision clarity scores for a blindness-causing eye disease, the Swiss drugmaker said, after early safety stumbles for the medicine in another condition caused disappointing early sales.
The U.S. Food and Drug Administration approved the expansion of Amgen’s Kyprolis (carfilzomib) U.S. prescribing information to include the product’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens – once weekly and twice weekly – for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.
During this webinar, learn more about benefits and risks of changing primary components during product development and how a design of experiments approach can be used to address issues and risks.
Eli Lilly and AbCellera dosed the first patients in a Phase I study of a potential antibody treatment for COVID-19.
A high dose of filgotinib, the JAK1 inhibitor under long-term development by Gilead Sciences Inc. and Galapagos NV, proved effective in a Phase IIb/III study as a treatment for patients with moderately to severely active ulcerative colitis.
Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
Intent Solutions, an Atlanta-based company that provides technology to secure medications and track prescription adherence, is collaborating with AT&T to integrate LTE-M cellular technology into the new release of Intent’s tad dispensing system.