In a Complete Response Letter to Biogen, the U.S. Food and Drug Administration said the regulatory agency is unable to approve the company’s supplemental Biologic License Application for subcutaneously delivered Tysabri (natalizumab) for the treatment of relapsing multiple sclerosis, at least while the sBLA remains in its present form.
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In a new draft guidance, the U.S. FDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary.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 […]