The U.S. Food and Drug Administration revised the emergency use authorization (EUA) for AstraZeneca’s Evusheld to a higher dose to be effective in the prevention of COVID-19.
Shares of LogicBio Therapeutics fell more than 57 percent on February 2 after the company announced that its gene therapy for pediatric patients with methylmalonic acidemia was placed on clinical hold by the U.S. Food and Drug Administration.
In the 40 years since the HIV epidemic first came to light, treatment options for those infected have come a long way. During January 2021, the FDA approved ViiV Healthcare’s Cabenuva as the very first once-a-month injection for HIV patients. But the Research Triangle pharma is not satisfied yet.
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.