Bristol Myers Squibb’s blockbuster cancer drug Revlimid finally has a competitor as Teva Pharmaceuticals announced the launch of a generic version of Revlimid, which could significantly cut into the global biopharmaceutical company’s earnings.
Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.
Janssen Pharmaceutical and Amgen received another regulatory win for Darzalex Faspro (daratumumab and hyaluronidase-fihj) as the U.S. Food and Drug Administration approved the drug in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
The U.S. Food and Drug Administration extended Legend Biotech Corporation’s Prescription Drug User Fee Act (PDUFA) target date for the drug cilta-cel that the company is developing with partner Janssen Biotech to treat relapsed and/or refractory multiple myeloma.
COVID-19 is many things. It is creating an economic impact like we have never seen before, it’s a lesson in basic hygiene, a test in societal patience, an enormous challenge, and a rare opportunity. It also demonstrates why many have chosen the pharmaceutical profession.
Using the Real Time Oncology Review pilot program, the U.S. Food and Drug Administration approved Janssen and Genmab’s Darzalex (daratumumab) in combination with lenalidomide and dexamethasone as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant.
The U.S. patent office rejected a filing by Alvogen Pine Brook for a review challenging patents on Celgene’s blockbuster myeloma drug Revlimid.
Shares of Karyopharm Therapeutics crashed again after an advisory panel from the U.S. Food and Drug Administration recommended delaying potential approval of the company’s experimental multiple myeloma treatment until additional data is available from an ongoing Phase III study.
GlaxoSmithKline Plc will actively look to buy early-stage assets and partner with companies, the drugmaker’s chief executive officer said.
Takeda Pharmaceutical started 2019 with a spate of cell therapy collaborations designed to advance the company’s novel immuno-oncology portfolio. The three collaborations will accelerate the discovery of next-generation cancer immunotherapies.