Tag:
Arzerra
Latest Headlines
Latest Headlines
U.K. earmarks £200M for NICE-rejected drugs
The U.K.'s National Health Service will indeed get the money it was promised to help pay for pricey cancer drugs not approved by the cost-effectiveness watchdog NICE. The government has set up an
NICE rejects new use of Novartis, GSK meds
Britain's cost-effectiveness watchdog has rejected two cancer-treatment approaches: GlaxoSmithKline's Arzerra for resistant leukemia, and Novartis' Glivec in high doses for gastrointestinal tumors.
EMEA approves GSK, Genmab's Arzerra
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arzerra, a treatment for chronic lymphocytic leukemia, which is a cancer of the
Genmab wins $23M on blockbuster cancer approval
Genmab has won a $23 million milestone payment from GlaxoSmithKline on the FDA's approval of Arzerra ( ofatumumab ) for chronic lymphocytic leukemia. The FDA provided an accelerated approval of the
Genmab tanks on disappointing cancer data
Shares of Denmark's Genmab slid 27 percent as investors reacted to the news that its lead cancer drug delivered disappointing data in a late-stage trial for non-Hodgkin's lymphoma. Arzerra gained the
GSK, Genmab touts Phase III RA drug data
GlaxoSmithKline and Genmab's rheumatoid arthritis drug Arzerra (ofatumumab) performed well in a Phase III trial in patients who had not responded to the common RA drug methotrexate. After 24 weeks,
Genmab shares slide on FDA delay
Asking for more time to review chemistry and manufacturing data, the FDA pushed back its deadline to make a decision on the leukemia drug Arzerra by three months. The news cost Genmab about seven
Blockbusters face a final decision from FDA
The FDA is facing a pair of big PDUFA dates, and the agency's conclusions will make or break two would-be blockbusters. The analysts are closely focused on the fate of Xarelto, an anticoagulant that
