FDA grants priority review to Zejula
Niraparib (Zejula) received a priority review by the U.S. FDA, in response to a supplemental New Drug Application (sNDA) submitted by Tesaro. The drug, acquired by GlaxoSmithKline along with the drugmaker Tesaro for USD 5.1 Million, has an action date of October 24, 2019. The sNDA submitted supports new treatments for the advanced ovarian, fallopian tube, or primary peritoneal cancer patients treated with 3 or more prior chemotherapy regimens and whose cancer is associated with either BRCA mutation or homologous recombination deficiency (HRD) and who have progressed more than 6 months after the last platinum-based chemotherapy. The current Ovarian cancer therapies include Targeted Therapy and Chemotherapy. Ovarian cancer is the 8th most common cancer among women affecting 21,000 females in the U.S.
Erytech Pharma opens up a new manufacturing facility
Erytech Pharma– a clinical-stage biopharmaceutical company – announced the opening of its new Princeton, NJ GMP manufacturing facility. The new facility will be fully equipped to support production capacity needs for its lead candidate Graspa (eryaspase). Eryaspase is in Phase III testing for the treatment of second-line metastatic pancreatic cancer at approximately 120 clinical sites in Europe and the United States. Pancreatic cancer is the fourth-leading cause of cancer death in both men and women, with an estimated 43,090 deaths in 2017. Some of the FDA-approved drugs
in the pancreatic cancer treatment market are Genentech’s Tarceva (erlotinib), Ipsen’s Onivyde (irinotecan liposome injection), Eli Lilly’s Gemzar (gemcitabine HCL) and many more.
Krystal Biotech shares soar after gene therapy berakthrough
Shares of Krystal Biotech experienced a huge boost of up to 27% after the drugmaker received an expedited review designation from the FDA for its lead drug candidate to treat a skin condition called dystrophic epidermolysis bullosa (DEB). Krystal announced positive results for its drug, called KB102, which is a viral vector responsible for delivering collagen directly into cells. Dystrophic epidermolysis bullosa is a genetic condition that makes the skin very fragile and gets blistered easily. There is currently no cure for all types of Dystrophic Epidermolysis Bullosa. The treatment generally focuses on managing signs and symptoms.