5:53 PM Sep 14, 2018
BioCentury  |  Politics, Policy & Law

Debating diagnostics

Instead of perpetuating a decades-old dispute about whether FDA can and should regulate laboratory-derived tests, the agency and test makers have moved on to conversations about how FDA should do...

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3:58 PM Sep 14, 2018
BioCentury  |  Regulation

Closing NICE’s Orphan gap

As the list of Orphan drugs rejected by NICE grows, industry and patient groups are pressuring the agency to make broader use of tools that currently apply only to selected ultra-Orphan therapies....

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7:37 PM Sep 13, 2018
BC Innovations  |  Product R&D

Academia’s manufacturing problem

With backups at academic manufacturing centers beginning to hamper translation of early stage gene therapies, pushing those who can afford it to CMOs, at least one non-profit has stepped in with a...

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6:50 PM Sep 13, 2018
BC Innovations  |  Targets & Mechanisms

Repeat offenders

Dozens of intractable DNA repeat-driven diseases could boil down to a common problem: disrupted boundaries between chromatin domains, according to a study from the University of Pennsylvania. The...

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5:00 PM Sep 07, 2018
BioCentury  |  Product Development

Data distribution

TransCelerate BioPharma Inc. is taking its data sharing initiative to the next level with a new platform that will integrate clinical and preclinical data sets in a single repository and provide...

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Latest News

4:07 PM Sep 19, 2018

Management tracks: GSK adds Corsico, Enzmann to chair CHMP

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) hired Chris Corsico, CMO of Boehringer Ingelheim GmbH (Ingelheim,...

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3:56 PM Sep 19, 2018

NICE wavers on end of life exception for DLBCL CAR Ts, says Kymriah doesn't meet criteria

Inconsistencies between appraisals by U.K.'s NICE of CAR T therapies emerged Wednesday after the committee...

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3:39 PM Sep 19, 2018

Molecular Templates gains on deal with Takeda

Building on a previous discovery collaboration, Molecular Templates Inc. (NASDAQ:MTEM) and Takeda...

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3:27 PM Sep 19, 2018

China looks to hone essential drug system

China's State Council outlined requirements on which drugs should be given priority for inclusion on the...

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3:20 PM Sep 19, 2018

HHS requests applicants for innovation and investment summit

HHS is calling for applicants to participate in the newly created Deputy Secretary’s Innovation and...

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2:11 PM Sep 19, 2018

Hillhouse closes $10.6B fund

Hillhouse Capital said it closed its oversubscribed Hillhouse Fund IV with $10.6 billion. The fund will...

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11:42 AM Sep 19, 2018

Mayo Clinic team implicates senescent cells in neurodegenerative diseases

Clearing out senescent brain cells could prevent tau-mediated neurodegeneration and cognitive loss,...

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11:24 AM Sep 19, 2018

FDA wants extra trial for Pharming's Ruconest as HAE prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa...

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11:17 AM Sep 19, 2018

Ahead of Phase III mucositis study, Galera raises $150M

Galera Therapeutics Inc. (Malvern, Pa.) raised a combined $150 million in a $70 million series C round...

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10:34 AM Sep 19, 2018

argenx, G1 price follow-ons, CRISPR proposes

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) and G1 Therapeutics Inc. (NASDAQ:GTHX) raised $300.6 million and $...

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3:35 PM Sep 18, 2018

Ono, Fate in off-the-shelf CAR T deal

Fate Therapeutics Inc. (NASDAQ:FATE) added $1.13 (10%) to $12.20 on Tuesday after partnering with Ono...

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3:24 PM Sep 18, 2018

Sosei, Allergan to delay trials of dementia candidate

Sosei Group Corp. (Tokyo:4565) and partner Allergan plc (NYSE:AGN) have suspended clinical development of...

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2:52 PM Sep 18, 2018

Management tracks: BioTime, Immune-Onc

Degenerative disease company BioTime Inc. (NYSE-A:BTX; Tel Aviv:BTX) named Brian Culley CEO, to replace co-...

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2:04 PM Sep 18, 2018

Viking gains on Phase II NAFLD data

Viking Therapeutics Inc. (NASDAQ:VKTX) added $9.07 (87%) to $19.46 on Tuesday after reporting that VK2809...

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1:53 PM Sep 18, 2018

Novo's R&D restructuring adds to innovation push

Four new R&D centers fueled by a dedicated business development unit and increased investment in...

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1:39 PM Sep 18, 2018

Azar to head U.S. biodefense strategy

HHS will serve as the lead agency for implementing the U.S.’s biodefense strategy, with HHS Secretary...

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8:48 AM Sep 18, 2018

WuXi AppTec queues up for Hong Kong listing

Less than five months after its IPO in Shanghai, WuXi AppTec Co. Ltd. (Shanghai:603259) proposed Tuesday...

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8:17 AM Sep 18, 2018

Versant seeking $500M for seventh fund

Versant Ventures is targeting $500 million for Versant Venture Capital VII, according to an SEC filing....

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4:37 PM Sep 17, 2018

AI code could speed cancer diagnosis, treatment decisions

New York University School of Medicine researchers described in Nature Medicine a machine learning-based...

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4:29 PM Sep 17, 2018

FDA to re-examine diabetes CVOT requirements

FDA is reconsidering its policy to require pre- and postmarket cardiovascular outcomes trials for diabetes...

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