AstraZeneca, Lilly receive Fast Track designation for investigational treatment for early Alzheimer’s
AstraZeneca and Eli Lilly have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293 – an oral beta secretase cleaving enzyme inhibitor currently in Phase III clinical trial.
Evolva has entered into an agreement with a private US biotech venture to develop new production routes for a family of existing active pharmaceutical ingredients (API).
Health Canada has released new guidance for industry that will help improve the safe use of health products, making product labels and packages easier for consumers and health professionals to read and understand.
AstraZeneca has entered into an agreement with Pfizer to sell the commercialisation and development rights to its late-stage small molecule antibiotics business in most markets globally outside the US.
In support of the President Barack Obama’s Precision Medicine Initiative, the U.S. Food and Drug Administration has issued two draft guidances that, when finalised, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup.
Swedish Orphan Biovitrum today announced that the Swiss Agency for Therapeutic Products, Swissmedic, has approved Elocta® (rFVIIIFc) for the treatment of haemophilia A.
A new medicines and pharmaceuticals wholesaler and distributor has been launched to solve difficulties faced by millions of people in Iraq in obtaining modern medicines to treat many illnesses effectively.
Yorkshire-based medical diagnostic company Abingdon Health as entered into a multi-year, global distribution agreement with electrophoresis specialist Sebia.
The European Commission has granted marketing authorisation for Gilead Sciences’ once-daily Truvada in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk.
Portola Pharmaceuticals has announced that the marketing authorisation application (MAA) for IndexXa, a Factor Xa inhibitor antidote, has been submitted to the EMA, completed the validation period, and has been accepted for review.