BioCentury | Apr 21, 2020
Product Development

April 20 Quick Takes: Top-line data for BMS, Idorsia and Ascendis; plus Otsuka-Esperion, Regeneron and more

BMS combo meets in Phase III for malignant pleural mesothelioma  Bristol Myers Squibb Co. (NYSE:BMY) said top-line results from the Phase III CheckMate -743 trial showed a combination of anti-PD-1 mAb Opdivo nivolumab and anti-CTLA4...
BioCentury | Apr 7, 2020
Product Development

April 6 Quick Takes: Second anemia approval for BMS, Acceleron therapy; plus EU approves trio of metabolic disease drugs, Dicerna-Alnylam and Axsome

Reblozyl gets second approval  FDA approved Reblozyl luspatercept-aamt from Bristol Myers Squibb Co. (NYSE:BMY) and Acceleron Pharma Inc. (NASDAQ:XLRN) to treat anemia in certain patients with myelodysplastic syndromes. It is the second indication for the...
BioCentury | Feb 27, 2020
Product Development

Feb. 26 Quick Takes: Takeda acquires PvP for celiac therapy; plus Lilly, Esperion, Supernus, Moderna, Taiho-Arcus, Twist-Sophia

Takeda gains another celiac candidate via PvP takeout   After PvP Biologics Inc. finished a Phase I trial demonstrating proof of concept of its celiac disease therapy, Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) exercised its...
BioCentury | Feb 22, 2020
Product Development

Esperion enters crowded LDL-lowering market with FDA approval

FDA’s approval of Nexletol marks Esperion’s transition to a commercial-stage company. Esperion Therapeutics Inc. (NASDAQ:ESPR) plans to launch Nexletol bempedoic acid on March 30. The drug, which is orally administered once-daily, is approved as an...
BC Extra | Feb 1, 2020
Company News

Alnylam’s Givlaari, Novo’s Rybelsus among CHMP’s latest recommendations

Among a series of recommendations issued Friday, EMA’s CHMP backed approval of what would be Alnylam’s second approved RNAi drug in the EU, as well as an oral diabetes therapy that Novo Nordisk is relying...
BioCentury | Jan 11, 2020

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
BC Extra | Aug 29, 2019
Clinical News

Aug. 29 Clinical Quick Takes: Immunicum's off-the-shelf cell therapy misses in Phase II for kidney cancer; plus Acurx and Esperion

Immunicum's cell therapy misses survival endpoint in Phase II RCC trial  Immunicum AB (SSE:IMMU) lost SEK1.46 (14%) to SEK8.86 after reporting that ilixadencel plus Sutent sunitinib from Pfizer Inc. (NYSE:PFE) did not improve 18-month survival,...
BC Extra | May 6, 2019
Company News

May 6 Company Quick Takes: Esperion, BioMarin, WuXi AppTec, Axsome, Harbour BioMed/CTTQ, GW, Adynxx

FDA accepts Esperion NDAs for LDL-C-lowering indications  Esperion Therapeutics Inc. (NASDAQ:ESPR) gained $5 (12%) to $48.24 on Monday after FDA accepted for review a pair of NDAs for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe...
BC Week In Review | Mar 8, 2019
Company News

Esperion submits NDAs to FDA for LDL-C lowering products, EMA starts review

Esperion said it submitted two NDAs to FDA for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe combination tablet to treat elevated LDL-C in patients who need additional LDL-C lowering despite the use of currently accessible...
BC Week In Review | Jan 11, 2019
Company News

Daiichi to market Esperion's LDL-C lowering products in Europe

Esperion Therapeutics Inc. (NASDAQ:ESPR) will get $150 million cash up front in exchange for granting the European subsidiary of Daiichi Sankyo Co. Ltd. (Tokyo:4568) exclusive rights to commercialize bempedoic acid (ETC-1002) and bempedoic acid/ezetimibe in...
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