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.

FDA

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.

Celgene Corporation announced that the Phase III, randomized, open-label, international clinical study OPTIMISMM achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival for the pomalidomide arm versus the comparator arm.

Humira

AbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.

Janssen-Cilag International NV announced that the European Commission granted approval to Darzalex (daratumumab) for use in combination with lenalidomide and dexamethasone, or bortezomib – which is marketed as Velcade – and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.