Europe’s medicines regulator added a rare nerve-degenerating disorder, Guillain-Barré syndrome, as a possible rare side effect from Johnson & Johnson’s Covid-19 vaccine after the European Medicines Agency reviewed 108 cases reported worldwide.
Ipsen’s New Drug Application (NDA) for palovarotene – an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP) – was accepted by the U.S. Food and Drug Administration.
Europe’s drug regulator is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s Covid-19 vaccine and expanded its probe into AstraZeneca’s shot to include reports of a bleeding condition.
Europe’s medicines regulator said on March 31 the EMA had not identified any risk factors such as age, sex or a previous history of blood clotting disorders, for clotting cases reported after inoculation with AstraZeneca’s Covid-19 vaccine.
Fewer Europeans trust the AstraZeneca Covid-19 vaccine after several countries reported side effects, such as blood clots, an opinion poll by YouGov showed on March 22, even though scientific studies have found it is safe and effective.
Multiple countries across Europe and parts of Asia suspended the use of AstraZeneca’s Covid-19 vaccine over fears the medication is leading to the development of blood clots in some patients who have received the medication.
Europe’s drug regulator said on March 11 it had initiated a rolling review of U.S.-based Eli Lilly’s antibodies to treat Covid-19, days after saying their combination could be used in patients at high risk of progressing to severe illness.
Europe’s drug regulator is evaluating South Korean drugmaker Celltrion’s Covid-19 antibody treatment, the third such drug against the disease to go under real-time review in the region.
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.
U.S. firm Johnson & Johnson is likely to apply for EU approval for the company’s Covid-19 vaccine candidate in February, a top lawmaker said.