Oyster Point’s New Drug Application (NDA) for the dry eye disease therapy OC-01 was accepted for FDA regulatory review on the back of positive Phase III data.
In a new draft guidance, the U.S. FDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary.
Forty Seven Inc., a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable a patient’s immune system to defeat their cancer, announced an agreement with Merck KGaA to conduct a Phase 1b clinical trial combining Hu5F9-G4 with avelumab in patients with ovarian cancer.
Promacta received breakthrough therapy designation from the FDA for first-line treatment of SAA.
A groundbreaking deal between Allergan Plc and a Native American tribe to shield the company’s patents in administrative proceedings could also be used be to protect them from challenges in federal court, legal experts said, potentially dealing a blow to generic competition.
BASEL, Switzerland – Novartis AG (NVS) will pay $390 million to settle a civil lawsuit related to the kickback payments to specialty pharmacy companies that distributed the drugs Exjade and Myfortic, Novartis announced Friday. The settlement, which is between Novartis Pharmaceutical Corporation (NVS), a U.S. subsidiary of Novartis AG, will be paid to both the […]