BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Extra | Jun 11, 2019
Company News

June 10 Company Quick Takes: Roche's Spark takeover delayed again; plus Insys, China audits, Novavax and more

More delays for Roche's Spark acquisition, plus U.K. investigation   After at least three previous delays, Roche (SIX:ROG; OTCQX:RHHBY) has extended its deadline to acquire Spark Therapeutics Inc. (NASDAQ:ONCE) to July 31 from June 14...
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 | Feb 22, 2019
Clinical News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review during the beginning Feb. 18, according to company announcements. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib...
BC Extra | Feb 19, 2019
Company News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review, according to company announcements early this week. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib and polatuzumab...
BC Week In Review | Nov 2, 2018
Clinical News

EC approves AbbVie's Venclexta in combination with Rituxan for CLL

The European Commission approved Venclyxto venetoclax in combination with Rituxan rituximab to treat relapsed/refractory chronic lymphocytic leukemia in patients who have received at least one prior therapy. Venclyxto is already approved for the indication as...
BC Week In Review | Jun 15, 2018
Clinical News

FDA grants regular approval to Venclexta

FDA granted regular approval to Venclexta venetoclax alone or in combination with Rituxan rituximab to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients with or without the 17p deletion who have...
BC Extra | Jun 8, 2018
Company News

FDA grants regular approval to Venclexta

FDA granted regular approval to Venclexta venetoclax alone or in combination with Rituxan rituximab to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients with or without the 17p deletion who have...
BC Week In Review | May 25, 2018
Clinical News

Genmab's Arzerra misses in Phase III for indolent NHL

Genmab A/S (CSE:GEN) said Arzerra ofatumumab plus Treanda bendamustine missed the primary endpoint of improving progression-free survival (PFS) in the Phase III COMPLEMENT A+B trial to treat indolent B cell non-Hodgkin's lymphoma (NHL). The company...
BC Extra | May 24, 2018
Clinical News

Genmab's Arzerra misses in Phase III for indolent NHL

Genmab A/S (CSE:GEN) said Arzerra ofatumumab plus Treanda bendamustine missed the primary endpoint of improving progression-free survival (PFS) in the Phase III COMPLEMENT A+B trial to treat indolent B cell non-Hodgkin's lymphoma. The company said...
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