BioCentury | Apr 4, 2020
Product Development

U.K. government backs Oxford’s adaptive trial for COVID-19

The U.K. government is backing the University of Oxford’s adaptive Phase II/III RECOVERY trial evaluating at least three therapies to treat COVID-19. The Department of Health and Social Care (DHSC) said the study will be...
BioCentury | Mar 3, 2020
Product Development

Following Phase III readout, Karyopharm seeks approval of Xpovio for second-line MM

Karyopharm gained $11.38 (70%) to $27.72 on Monday, adding about $746 million in market value, after announcing that Xpovio selinexor met the primary endpoint of improving PFS in the confirmatory Phase III BOSTON trial to...
BioCentury | Mar 3, 2020
Regulation

Sanofi sees first fruit of renewed oncology commitment with Sarclisa approval

Sarclisa isatuximab will be the first oncology drug Sanofi launches in more than a decade, its approval Monday marking the pharma’s first cancer win after its re-entry into the space. The company’s next step is...
BioCentury | Feb 11, 2020
Product Development

Feb. 10 Product Development Quick Takes: Priority Review for Gilead CAR T cell therapy; plus Zai, Aquestive, Biohaven, Oculis, Blue Water, GlycoMimetics, Fluidi

Gilead’s second CAR T under Priority Review  Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted and granted Priority Review to a BLA for KTE-X19 to treat adults with relapse or refractory mantle cell lymphoma. The anti-CD19...
BioCentury | Jan 30, 2020
Distillery Therapeutics

Targeted Bcl-XL degrader identified to treat ALL, TNBC and SCLC

DISEASE CATEGORY: Cancer INDICATION: Acute lymphoblastic leukemia (ALL); breast cancer; small cell lung cancer A University of Florida team led by Dialectic Therapeutics Inc. co-founders Guangrong Zheng and Daohong Zhou showed the company’s lead candidate,...
BC Extra | Dec 13, 2019
Company News

Novartis gains CHMP support for Eylea competitor in wet AMD

EMA's CHMP issued a positive opinion for Novartis’ Beovu brolucizumab in its December roundup of opinions, none of which were negative. The agency backed an MAA from Novartis AG (NYSE:NVS; SIX:NOVN) for Beovu to treat...
BioCentury | Oct 31, 2019
Product Development

Amgen deal gives BeiGene dry powder to grow its own pipeline

In its second major -- and potentially transformational -- deal with a U.S. company, BeiGene has entered a development and commercialization deal with Amgen that adds nearly two dozen compounds to the Chinese biotech’s marketed...
BC Extra | Sep 16, 2019
Clinical News

Data for Oncopeptides' melflufen could support broader MM label

Oncopeptides remains on track to submit an NDA in 1Q20 for melflufen to treat multiple myeloma, as the latest data from a pivotal Phase II study showed an overall response rate of 23% among a...
BC Extra | Aug 27, 2019
Company News

Aug. 27 Company Quick Takes: GSK licenses Ionis HBV program; plus Adaptimmune-Noile, Purdue, Presage-BMS, Kyowa, Alexion, Viela, Kintai, OncoNano

GSK opts into Ionis' HBV program  Positive Phase II data prompted GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to exercise its option to license exclusive, worldwide rights to an antisense chronic HBV program from Ionis Pharmaceuticals Inc. (NASDAQ:IONS)....
BC Extra | Jul 10, 2019
Clinical News

July 10 Clinical Quick Takes: Darzalex quad combo raises MM complete response, plus Geneos and ViiV

Adding Darzalex improves MM complete response rate in Phase II  Genmab A/S (CSE:GEN; Pink:GMXAY) said Darzalex daratumumab in combination with Revlimid lenalidomide, Velcade bortezomib and dexamethasone met the primary endpoint in the Phase II GRIFFIN...
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