01:58 , Jun 29, 2019 |  BioCentury  |  Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
00:01 , Jun 26, 2019 |  BC Extra  |  Clinical News

June 25 Clinical Quick Takes: Minerva meets in insomnia; plus Aldeyra, Genkyotex and more

Minerva rises with insomnia data  Seltorexant (MIN-202) from Minerva Neurosciences Inc. (NASDAQ:NERV) met the primary endpoint of reducing Latency to Persistent Sleep (LPS) at night 1 vs. placebo (p≤0.001) in a Phase IIb trial to...
00:43 , Jun 18, 2019 |  BC Extra  |  Clinical News

June 17 Clinical Quick Takes: VBI's HBV vaccine misses secondary endpoint, plus ArQule, Verastem and more

VBI falls with HBV vaccine miss on secondary endpoint  VBI Vaccines Inc. (NASDAQ:VBIV) sank $1.24 (66%) to $0.65 Monday after reporting that two doses of Sci-B-Vac failed to show non-inferior seroprotection at day 168 vs....
21:21 , Jun 14, 2019 |  BioCentury  |  Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
03:07 , Jun 7, 2019 |  BC Innovations  |  Targets & Mechanisms

Following PARP, ATR axis next in line to expand synthetic lethal drug class

Promising ASCO readouts suggest targets in the ATR pathway are lining up behind PARP as the next drivers of “synthetic lethal” cancer killing. Biomarker and combination strategies presented at the American Society of Clinical Oncology...
22:33 , May 24, 2019 |  BC Extra  |  Company News

Novartis breast cancer drug marks first approval of PI3Kα inhibitor

Piqray alpelisib became the first FDA-approved PI3Kα inhibitor on Friday, as well as the first novel drug approved under the agency's Real-Time Oncology Review pilot program. FDA approved the breast cancer drug about three months...
21:09 , May 24, 2019 |  BC Extra  |  Company News

AveXis says label makes Zolgensma gene therapy ‘treatment of choice’ for newly diagnosed SMA

Gene therapy Zolgensma from Novartis’ AveXis unit received a label from FDA that will allow it to become the “treatment of choice” for newly diagnosed spinal muscular atrophy patients, according to the company, as well...
19:53 , May 13, 2019 |  BC Extra  |  Company News

May 13 Company Quick Takes: PeptiDream/JCR, Grail, Lilly, Onconova/HanX, Regeneron

PeptiDream, JCR deal produces drug carriers for CNS delivery  The 2016 partnership between PeptiDream Inc. (Tokyo:4587) and JCR Pharmaceuticals Co. Ltd. (Tokyo:4552) has led to the development of constrained peptides that bind TFRC and are...
20:11 , Apr 5, 2019 |  BC Week In Review  |  Clinical News

TG reports response rate of 52% for lymphoma candidate

TG has reported detailed interim data from the pivotal Phase IIb UNITY-NHL trial supporting the company's decision to seek accelerated approval from FDA by year end for umbralisib (TGR-1202) to treat marginal zone lymphoma. At...
17:22 , Mar 22, 2019 |  BC Week In Review  |  Company News

Petra gains Takeda's PI3K inhibitor pipeline

Takeda granted Petra a license to develop, manufacture and commercialize serabelisib (TAK-117) and additional PI3Kα inhibitors. Petra Pharma Corp. (New York, N.Y.) has rights to the inhibitors in all indications except for a set of...