Pfizer wins $107.5M from AZ in US cancer drug patent trial
Wyeth Pharma`s Biologic Besponsa (inotuzumab ozogamicin) Receives Approval in the U.S.
Wyeth’s Mylotarg (Gemtuzumab Ozogamicin) Receives Supplemental Approval In US
On June 16, 2020, the Food and Drug Administration extended the indication of gemtuzumab ozogamicin (MYLOTARG, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.
Wyeth’s Mylotarg (Gemtuzumab Ozogamicin) Receives Supplemental Approval In US
Wyeth Pharm’s Mylotarg (Gemtuzumab Ozogamicin) Receives Supplemental Approval In US
Wyeth Pharm’s Inotuzumab Ozogamicin Receives Supplemental Approval In US
Pristiq itself was a drug launched to protect Pfizer sales from the patent loss on a preceding antidepressant, Effexor. Pristiq was first developed by Wyeth before it merged into Pfizer in 2009 to create the drug giant it is today.
Pfizer has resubmitted its antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) for regulatory review almost seven years after withdrawing it from the market.
There is no doubt that the number of FDA approvals for new chemical entities (NCEs) in 2016 will be lower than in the past two years. That isn’t a surprise. The 86 NCEs approved by the FDA over 2014/2015 is the second-highest total in FDA history, surpassed only by the 92 approved in 1996/1997. In fact, one could argue that, given the much higher hurdles that now exist for getting drugs not just approved but also reimbursed, the 2014/2015 productivity is the best ever achieved by the industry.