BioCentury | Jul 10, 2020
Product Development

Evive meets in Phase III for chemotherapy-induced neutropenia; plus regulatory updates for Biogen, Eisai, Merck, AZ

Evive planning BLA, MAA for neutropenia therapy following pivotal trial readout  Evive Biotech Inc. said efbemalenograstim alfa met the primary and secondary endpoints in a Phase III study to prevent chemotherapy-induced neutropenia in breast cancer...
BioCentury | May 21, 2020
Product Development

May 20 Quick Takes: Filgotinib meets in ulcerative colitis; broader labels for Lynparza, Tecentriq, plus updates from Eiger, eGenesis and more

High dose filgotinib meets ulcerative colitis endpoints  A 200 mg dose of filgotinib from Gilead Sciences Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) met the primary endpoints in the placebo-controlled Phase IIb/III SELECTION trial to...
BioCentury | May 12, 2020
Product Development

May 11 Quick Takes: Genfit’s elafibranor misses in NASH Phase III; plus AstraZeneca, Merck, Protalix and TolerogenixX

Genfit’s PPAR agonist fails to resolve NASH  Genfit S.A. (Euronext:GNFT; NASDAQ:GNFT) fell $10.88 (49%) to $11.22 in after-hours trading Monday after reporting that dual PPARα/δ agonist elafibranor missed the primary endpoint of the Phase III...
BioCentury | Apr 29, 2020

Zejula’s label expansion reaches an untapped ovarian cancer population

The label expansion for GlaxoSmithKline’s Zejula niraparib will allow the company to tap into a broad ovarian cancer patient population that hasn’t been touched by other PARP inhibitors. It also sends another signal to drugmakers...
BioCentury | Apr 25, 2020
Product Development

AACR Primer: first virtual AACR meeting of year will include data from over 40 trials

Data from an allogeneic CAR T therapy, bispecific mAbs and new immuno-oncology combinations are some of the highlights expected at the first virtual meeting of the year for the American Association for Cancer Research. Due...
BioCentury | Mar 13, 2020
Product Development

March 12 Quick Takes: WuXi AppTec’s Wuhan site back online; plus SOX relief, AZ, BMS, Nicox-Ocumesion, Tyligand-Context

All WuXi AppTec Chinese sites operating  WuXi AppTec Co. Ltd. (Shanghai:603259; HKEX:2359) said it has resumed operations at its Wuhan facility, which provides discovery chemistry services. The company has now restarted operations at all its...
BioCentury | Feb 15, 2020

As sales soar in China, AZ warns of hit from COVID-19 epidemic

Just as China jumped to become AstraZeneca’s second-largest region by revenue, the U.K. pharma warned in its 2020 guidance that the COVID-19 outbreak may have a negative impact on revenues for at least the next...
BioCentury | Feb 6, 2020

Beyond Keytruda: How Merck envisions innovation and growth after a spinout

As Merck becomes the latest large pharma to split in two, separating its key growth drivers and innovative programs from its slower-growing businesses, the slimmed-down innovative company will rely on the fruits of recent and...
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 Extra | Jan 13, 2020
Company News

Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer

AstraZeneca ends CV outcomes trial of Epanova  AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...
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