AstraZeneca and Daiichi Sankyo’s Enhertu received supplemental Biologics License Application (sBLA) acceptance and U.S. priority review for the treatment of HER2-positive metastatic gastric cancer.
Gilead Sciences Inc. cut the company’s 2020 revenue forecast, citing lower-than-expected demand and difficulty in predicting sales of remdesivir, the only treatment approved in the United States for patients hospitalized with Covid-19.
Amgen Inc. reported that third-quarter 2020 adjusted profit rose 17% due to stronger sales of drugs such as the osteoporosis treatment Prolia and the psoriasis medication Otezla, bucking challenges from lower drug prices and Covid-19.
The U.S. Food and Drug Administration approved Kala Pharmaceuticals’ Eysuvis for the short-term treatment of dry eye disease.
Denmark-based Genmab A/S announced positive topline data from the second part of the Phase III CASSIOPEIA trial evaluating daratumumab (marketed as Darzalex) monotherapy as maintenance treatment compared to observation for patients with newly diagnosed multiple myeloma that are eligible for autologous stem cell transplant.
Catalyst Pharmaceuticals filed new patent infringement lawsuits against Jacobus Pharmaceuticals and PANTHERx Rare LLC over a treatment for the rare autoimmune disease Lambert-Eaton Myasthenic Syndrome (LEMS).
The European medicines watchdog recommended approving AstraZeneca’s treatments for a form of heart failure and a lung disorder, the British drugmaker said.
The U.S. Food and Drug Administration granted full approval of Genentech’s Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Full-service health and wellness marketing agency Fingerpaint announced the appointment of Dr. Daniel Schroen as head of Photo 51, a consultancy launched during June 2020 that is focused solely on advanced therapeutics.
In a Phase III study, the biologic Dupixent met primary and all key secondary endpoints in children ages 6 to 11 who have uncontrolled moderate-to-severe asthma.