The companies were among several winners of positive recommendations from the EMA's Committee for Medicinal Products for Human Use (CHMP) on Friday, and their nods represent two cases where the FDA has beat its EU counterpart to the punch.
Bayer looks to secure blockbuster status for regorafenib; J&J demonstrated impressive results among pre-chemo prostate cancer patients; Aveo raises the flag for tivozanib; Seattle Genetics plans to look at new indications for Adcetris.
The past year has been one worth celebrating for developers of antibody-drug conjugates (ADCs), which are drugs that marry an anti-cancer toxin to a targeted antibody to kill tumors with fewer side effects than traditional treatments.
The companion diagnostic trend continues--and Ventana Medical Systems is involved yet again. This morning, Seattle Genetics and Takeda's Millennium unit announced that they are working with the Roche company on a companion diagnostic test for use in a study involving Adcetris.
Safety-conscious U.S. regulators have taken part of the blame for the drug industry's monumental problems, many of which center on an inability to bring enough new products to market. But the FDA can
Seattle Genetics ($SGEN) has crossed the finish line. The FDA has granted the biotech an accelerated approval for Adcetris to treat Hodgkin's lymphoma and anaplastic large cell lymphoma. While it's
Seattle Genetics' stock price fell to $19.17 in pre-market trading despite yesterday's expert panel recommendation accelerated approval of the company's drug, brentuximab vedotin (Adcetris).
Seattle Genetics ($SGEN) can claim a victory today. An FDA panel of experts voted unanimously for accelerated approval of the developer's drug brentuximab vedotin (Adcetris) for patients with