BC Extra | Jan 22, 2020
Company News

Jan. 21 Company Quick Takes: First BCMA-targeted therapy gets Priority Review from FDA; plus Roche-Seattle Genetics, AZ-Merck, Chi-Med

Priority Review for GSK's anti-BCMA therapy in MM  GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA granted Priority Review to a BLA for belantamab mafodotin to treat fourth-line relapsed or refractory multiple myeloma in patients who have...
BC Week In Review | Mar 1, 2019
Clinical News

FDA concludes Treanda will benefit from Bendeka's exclusivity protection

FDA concluded that the scope of Orphan Drug exclusivity for cancer drug Bendeka bendamustine from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) extends to all applications containing the same active ingredient unless a sponsor shows clinical superiority to...
BC Week In Review | Nov 10, 2016
Company News

Bendeka sales and marketing update

Teva and Eagle said CMS issued a J-code, effective Jan. 1, for Bendeka bendamustine. The drug is marketed in the U.S. to treat chronic lymphocytic leukemia (CLL) and indolent B cell non-Hodgkin lymphoma (NHL) that...
BC Extra | Jun 11, 2016
Company News

Eagle soars after bendamustine patent ruling

A judge in the U.S. District Court for the District of Delaware upheld most claims of a patent from the Cephalon Inc. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) covering cancer drug Treanda bendamustine. Eagle...
BC Week In Review | Feb 15, 2016
Company News

Eagle Pharmaceuticals, Teva sales and marketing update

Teva launched Bendeka bendamustine in the U.S. to treat chronic lymphocytic leukemia (CLL) and indolent B cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing...
BioCentury | Jan 4, 2016
Finance

Big band swing

Many investors treated biotech's dismal 3Q15 as a buying opportunity, and the effects were apparent in 4Q15. All of the market cap bands showed positive gains save for the microcaps. Big biotechs led the charge...
BC Week In Review | Dec 21, 2015
Clinical News

Bendeka bendamustine regulatory update

FDA approved an NDA from Eagle for Bendeka bendamustine to treat chronic lymphocytic leukemia (CLL) and indolent B cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or...
BC Week In Review | Dec 21, 2015
Company News

Eagle Pharmaceuticals, Teva deal

Eagle received a $15 million milestone payment from Teva under a 2015 deal granting Teva exclusive, U.S. rights to commercialize Bendeka bendamustine to treat chronic lymphocytic leukemia (CLL) and indolent B cell non-Hodgkin’s lymphoma (NHL)....
BC Extra | Dec 9, 2015
Company News

FDA approves Bendeka for CLL, NHL

FDA approved Bendeka bendamustine RTD ( EP-3102 ) from Teva Pharmaceutical Industries Inc. (NYSE:TEVA) and Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) to treat chronic lymphocytic leukemia and indolent B cell non-Hodgkin's lymphoma that has progressed during or within six...
BioCentury | Oct 5, 2015
Finance

Event planner

For investors who are not inclined to sit it out until the volatility abates, the fourth quarter is bursting with late-stage catalysts. There are no fewer than 17 PDUFA dates on the calendar before year...
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