BioCentury | May 30, 2020
Product Development

May 29 ASCO Quick Takes: Investors sour on Arvinas’ targeted degraders; plus MacroGenics, Karyopharm, Blueprint

Targeted degrader company Arvinas takes hit on updated proof of concept data  Arvinas Inc. (NASDAQ:ARVN) shed nearly $500 million in market cap Friday after updated Phase I/II data showed no new responses among 12 additional...
BioCentury | May 1, 2020
Regulation

China's proposed annual NRDL revisions could increase pricing pressure

China's proposed guidelines regarding the annual revision of its National Drug Reimbursement List could increase pricing pressure for all included drugs. Draft opinions released by China’s National Healthcare Security Administration (NHSA) Wednesday proposed extending price...
BioCentury | Mar 26, 2020
Regulation

China’s NMPA suspends Abraxane imports after U.S. inspection

China’s suspension of the importation and sale of Celgene’s Abraxane by BeiGene following an inspection at a U.S. manufacturing site demonstrates how far the country has come in its drive to ensure safety of drugs,...
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...
BC Extra | Dec 31, 2019
Company News

Dec. 31 Company Quick Takes: A first for BeiGene; plus MorphoSys, Junshi-CSPC, Acceleron-Fulcrum and Solasia-EditForce

First-ever China approval for homegrown BeiGene drug  China’s National Medical Products Administration approved anti-PD-1 mAb tislelizumab from BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) to treat classical Hodgkin lymphoma in a third-line setting. The approval is the first...
BC Innovations | Dec 18, 2019
Distillery Therapeutics

The proteasome-regulating kinase DYRK2 as a target in breast cancer and multiple myeloma

DISEASE CATEGORY: Cancer INDICATION: Breast cancer; multiple myeloma (MM) Inhibiting the proteasome-regulating kinase DYRK2 could treat breast cancer and MM. In patients with triple-negative breast cancer (TNBC) or MM, DYRK2 expression and protein levels were...
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...
BC Extra | Sep 20, 2019
Company News

Xospata poised for EU approval under accelerated assessment

EMA's CHMP recommended approval of Xospata for acute myelogenous leukemia in its September roundup. Under accelerated assessment, the agency backed Xospata gilteritinib from Astellas Pharma Inc. (Tokyo:4503) as monotherapy for relapsed or refractory AML in...
BC Innovations | Aug 16, 2019
Emerging Company Profile

Grace: seeking cures in pathological roots

Grace Science is targeting the root of a recently discovered genetic disorder for not just the ultra-rare condition but also for common diseases including cancer. Grace Science LLC’s origins stem from the diagnosis of co-founder...
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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