AstraZeneca said on Aug. 26 a late-stage trial showed the company’s medicine for a rare disease that causes accumulation of copper in the body was three times more successful in helping remove deposits from tissues compared with standard care.
The U.S. drug regulator declined to approve Sesen Bio Inc.’s lead therapy candidate for a type of bladder cancer, the company said on Aug. 13, sending its shares down more than 80 percent.
Three new conditions reported by a small number of people after vaccination with Covid-19 shots from Pfizer and Moderna are being studied to assess if they may be possible side effects, Europe’s drugs regulator said on Aug. 11.
Albireo Pharma, a spinout of AstraZeneca, won regulatory approval for the first drug aimed at pruritus in patients with all subtypes of progressive familial intrahepatic cholestasis (PFIC).
The head of the EU drug regulator’s Covid-19 task force said on June 13 that AstraZeneca’s coronavirus vaccine had a favorable risk-benefit profile for all age groups and particularly for those aged over 60.
Europe’s drug regulator on June 11 identified another rare blood condition as a potential side effect of AstraZeneca’s Covid-19 vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots.
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 medicines regulator on May 28 backed the use of Pfizer’s Covid-19 vaccine for children as young as 12, paving way for a broader roll-out in the region after similar clearances in the United States and Canada.
Europe’s medicines regulator is reviewing reports of a rare nerve-degenerating disorder in people who received AstraZeneca’s Covid-19 shots, raising fresh questions about potential side effects of the vaccine.
The European Medicines Agency will conduct an accelerated review of Eli Lilly and Co.’s rheumatoid arthritis drug Olumiant for hospitalized Covid-19 patients getting oxygen, the EU agency said on April 29, as the search for treatment options continues.