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

10:34 AM Sep 19, 2018

argenx, G1 price follow-ons

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) and G1 Therapeutics Inc. (NASDAQ:THX) 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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4:14 PM Sep 17, 2018

Brain lymphatics carry pathogenic T cells in MS

Blocking a signal that attracts pathogenic T cells to the brain’s lymphatic vessels could help treat...

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4:03 PM Sep 17, 2018

Senate passes 'pay-for-delay' bill for biosimilars

The Senate passed a bill Monday that includes a provision to make it more difficult for branded drugmakers...

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3:45 PM Sep 17, 2018

argenx planning Phase III for thrombocytopenia therapy

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) said it plans to start Phase III testing of IV efgartigimod (ARGX-...

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3:34 PM Sep 17, 2018

Mersana gets green light to resume ADC trial, but new dosing may slow progress

Mersana Therapeutics Inc. (NASDAQ:MRSN) said it will resume a Phase I trial of antibody-drug conjugate XMT-...

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3:10 PM Sep 17, 2018

Management tracks: Ultragenyx, Epizyme

Rare and ultra-rare disease company Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) appointed Wladimir...

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3:02 PM Sep 17, 2018

United gets rights to Samumed's IPF compound

Samumed LLC (San Diego, Calif.) granted United Therapeutics Corp. (NASDAQ:UTHR) exclusive, U.S. and...

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2:36 PM Sep 17, 2018

Roivant launches respiratory vant, announces other vant news

Roivant Sciences GmbH (Basel, Switzerland) had a busy Monday announcing the launch of a new respiratory...

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2:29 PM Sep 17, 2018

CRISPR partners with ViaCyte to develop immune-evasive pancreatic cells

CRISPR Therapeutics AG (NASDAQ:CRSP) and ViaCyte Inc. (San Diego, Calif.) partnered to develop a gene...

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5:20 PM Sep 14, 2018

FDA approves Teva's Ajovy, second CGRP inhibitor to prevent migraine

FDA approved Ajovy fremanezumab-vfrm from Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA)...

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