22:40 , Mar 18, 2019 |  BC Extra  |  Financial News

OrbiMed, Arix lead Imara's $63M B round

Imara will use its $63 million series B round to prepare lead compound IMR-687 for a Phase III program in adults with sickle cell disease, and to position the oral phosphodiesterase-9 (PDE-9) inhibitor for pediatric...
22:01 , Mar 15, 2019 |  BioCentury  |  Product Development

Broadening the PARP playing field

With its latest clinical win for Lynparza, AstraZeneca is leading the field in stretching the use of PARP inhibitors beyond tumors that carry BRCA mutations. The results highlight one piece of a broader strategy companies...
17:44 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

ViiV planning submissions this year for two-drug HIV regimen

ViiV said it plans to submit regulatory applications this year for a once-monthly two-drug regimen comprising cabotegravir and Johnson & Johnson's Edurant rilpivirine to treat HIV-1 infection. ViiV Healthcare Ltd. (Brentford, U.K.) disclosed its plans...
00:29 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

Syndax pauses entinostat-PD-1/PD-L1 combo program

Syndax said in its 4Q18 financial results that it will "defer advancement" of its program evaluating entinostat plus PD-1/PD-L1 inhibitors after the combinations missed the primary endpoints of improving progression-free survival (PFS) in a pair...
20:07 , Mar 13, 2019 |  BC Extra  |  Financial News

BioNTech mum on $800M IPO report

Amid a report that it will seek an $800 million IPO, BioNTech told BioCentury it is still evaluating all financial options. Citing undisclosed people familiar with the IPO, Reuters has reported that BioNTech AG (Mainz,...
12:23 , Mar 13, 2019 |  BC Innovations  |  Translation in Brief

Electrifying drug synthesis and manufacturing

Taking a page from the book on lithium ion batteries, an academic-Pfizer collaboration has developed a scalable and safe method for reducing arene carbons in drug-like molecules. In a Science paper published last month, a...
17:36 , Mar 8, 2019 |  BC Week In Review  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions on March 1, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first...
17:28 , Mar 8, 2019 |  BC Week In Review  |  Clinical News

Higher dose of tanezumab meets in latest Phase III pain readout

Pfizer and partner Eli Lilly reported on Feb. 19 that the 10 mg dose of tanezumab met the primary endpoint in the Phase III A4091059 trial to treat chronic low back pain. The data follow...
17:28 , Mar 8, 2019 |  BC Week In Review  |  Clinical News

Keytruda, Inlyta combo improves OS by 47%, PFS by 31% in first-line RCC

Merck & Co. reported detailed data from the Phase III KEYNOTE-426 trial of Keytruda pembrolizumab plus Inlyta axitinib as first-line treatment of renal cell carcinoma. New data showed that the combination significantly improved overall survival...
22:30 , Mar 5, 2019 |  BC Extra  |  Politics & Policy

PhRMA, BIO on board with NIH's HEAL committee

NIH said it partnered with PhRMA and BIO to form a committee to help guide its Helping to End Addiction Long-term Initiative to address pain and addiction. Industry, academics and patients will be represented on...