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...
BC Extra | Jul 3, 2019
Company News

After negative panel vote, FDA approves Karyopharm's multiple myeloma drug

FDA evidently saw enough data from an ongoing confirmatory trial to grant accelerated approval to Karyopharm's Xpovio selinexor to treat relapsed or refractory multiple myeloma. During the drug's extended review, the new data added to...
BC Extra | May 31, 2019
Company News

May 31 Company Quick Takes: NMPA accepts two BeiGene applications, approves Hengrui's PD-1 inhibitor; and more

NMPA accepts applications for BeiGene's tislelizumab, Abraxane  China's National Medical Products Administration has accepted an sNDA from BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) for tislelizumab to treat previously treated, locally advanced or metastatic urothelial carcinoma. The anti-PD-1...
BC Extra | May 29, 2019
Financial News

How cancer play Pi plans to deploy $19.7M series B

Existing investor Pontifax led a $19.7 million series B round for Pi, which is developing protein degradation modulators for drug-resistant multiple myeloma and solid tumor indications based on technology licensed from Johns Hopkins University. Founded...
BC Extra | May 17, 2019
Company News

May 17 Company Quick Takes: A trio of FDA approvals; plus Ligand/Cumulus, Revlimid

Takeda's Gattex gets pediatric approval  FDA approved Gattex teduglutide from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) to include treatment of patients age one and older with short bowel syndrome who are dependent on parenteral support,...
BC Week In Review | Mar 22, 2019
Clinical News

FDA places hold on Venclexta for multiple myeloma

FDA issued a safety warning after it placed a partial clinical hold on all trials evaluating Venclexta venetoclax to treat multiple myeloma after an interim analysis showed that the drug led to a higher proportion...
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