March 7, 2016 Off

Pharma crusader takes India’s drug regulators to court

By Dino Mustafić

One of India’s best-known whistleblowers, who exposed dangerous practices in the generic drug industry in 2013, is taking the country’s drugs regulators to court, accusing them of failing to enforce rules on drug safety in the $15 billion (11 billion pound) industry.

February 19, 2016 Off

AstraZeneca’s Brilique OK for marketing in EU

By Dino Mustafić

The European Commission has granted to AstraZeneca marketing authorisation for Brilique (ticagrelor) at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.

February 17, 2016 Off

Durvalumab granted BTD by FDA for cancer patients

By Dino Mustafić

AstraZeneca and MedImmune, its global biologics research and development arm, on Wednesday announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1), for the treatment of patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen.