6:59 PM Aug 17, 2018
BioCentury  |  Product Development

Agreement to differ

FDA’s approval of Alnylam’s Onpattro marks the start of a showdown in the Orphan disease hATTR amyloidosis, with Akcea’s Tegsedi likely coming to the U.S. market in less than two months....

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6:40 PM Aug 17, 2018
BioCentury  |  Regulation

Pediatric push

FDA has endorsed extrapolation of therapeutic efficacy from adults to children for new drugs to treat partial onset seizures in a draft guidance and is now discussing in public meetings whether...

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6:46 PM Aug 16, 2018
BC Innovations  |  Targets & Mechanisms

Unsaturated remyelination

Enzymes downstream in cholesterol biosynthesis could provide new ways to stimulate remyelination that avoid the baggage of previously identified multiple sclerosis targets, according to a group at...

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5:52 PM Aug 16, 2018
BC Innovations  |  Targets & Mechanisms

RNA party

A study in Cell uncovered a brain regulatory network involving a circular RNA, a long non-coding RNA and two microRNAs, and could provide some much needed insights in a field where finding links...

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10:05 AM Aug 16, 2018
BioCentury  |  Finance

Navigating the Hot Topics landscape

Investors are making aggressive bets on the ability of early stage companies to deliver on the next generation of therapeutics and technologies. But advances in biology and novel technologies come...

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Latest News

4:51 PM Aug 17, 2018

Antibacterial company Entasis proposes NASDAQ IPO

Entasis Therapeutics Inc. (Waltham, Mass.) proposed on Friday to raise $86.3 million in an IPO on NASDAQ...

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4:37 PM Aug 17, 2018

Harbin Gloria selling stake in biotech unit

Harbin Gloria Pharmaceuticals Co. Ltd. (SZSE:002437) said Friday it plans to sell a 51% stake in biotech...

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1:34 PM Aug 17, 2018

China unveils cancer drugs for medical insurance access negotiation

China's State Medical Insurance Administration announced 18 cancer drugs that will be included in 2018...

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11:17 AM Aug 17, 2018

FDA approves 12-week Eylea regimen after short delay

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing...

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8:38 AM Aug 17, 2018

Novo acquires Ziylo in quest for glucose-sensitive insulin

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) acquired Ziylo Ltd. (Bristol, U.K.), giving the pharma a platform...

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8:01 AM Aug 17, 2018

Opdivo gets accelerated approval in SCLC population

FDA granted accelerated approval to Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat...

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4:24 PM Aug 16, 2018

Innovative drugs reformer Bi out amid China vaccines scandal

Thursday’s resignation of Jingquan Bi, party secretary of the State Administration of Market...

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3:32 PM Aug 16, 2018

Management tracks: Achillion, Navidea

Rare disease company Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) hired Anthony Gibney as EVP and CBO. He...

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2:59 PM Aug 16, 2018

Trump calls for federal lawsuit against opioid companies

Upon President Donald Trump's request, Attorney General Jeff Sessions agreed during a cabinet meeting...

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2:28 PM Aug 16, 2018

NIH seeks to trim gene therapy review, turn oversight to newer tech

NIH wants to scrap Recombinant DNA Advisory Committee (RAC) review for gene therapy protocols in a move...

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2:28 PM Aug 16, 2018

U.K. offers no solace on future access to EU research funding

The U.K. government reiterated a promise that Brexit will not affect funding of current U.K. projects...

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2:24 PM Aug 16, 2018

Regeneron, Teva’s anti-NGF mAb meets 16-week endpoints in Phase III for OA pain

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:...

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1:07 PM Aug 16, 2018

FDA, NIAID to host workshop for microbiome products

FDA and NIH’s National Institute of Allergy and Infectious Diseases will hold a workshop on Sept. 17 to...

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11:38 AM Aug 16, 2018

Bach proposes CAR T payment options for CMS

In a perspectives piece in the New England Journal of Medicine, Peter Bach recommended several different...

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10:08 PM Aug 15, 2018

BioNTech, Pfizer sic mRNA on the flu

BioNTech AG (Mainz, Germany) partnered with Pfizer Inc. (NYSE:PFE) to develop mRNA-based influenza...

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3:50 PM Aug 15, 2018

Express Scripts wants blood disorder gene therapies exclusively

Express Scripts Holding Co. (NASDAQ:ESRX) said it is in discussions with gene therapy companies to become...

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3:14 PM Aug 15, 2018

Management tracks: Karuna, VBI Vaccines

Neurology company Karuna Pharmaceuticals Inc. (Boston, Mass.) named Chairman Steven Paul as CEO. He...

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2:51 PM Aug 15, 2018

Blackstone investing $400M in Chinese company HEC

YiChang HEC Changjiang Pharmaceutical Co. Ltd. (HKSE:1558) said it will sell $400 million in convertible...

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2:50 PM Aug 15, 2018

TGFBR1 inhibitors could stop senescence spread to treat acute liver injury

Researchers at Cancer Research UK and colleagues found that acute liver injury triggers a paracrine-...

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11:59 AM Aug 15, 2018

Gene transfer regenerates rod cells, restores light sensitivity in blind mice

Researchers at the Icahn School of Medicine at Mount Sinai developed a gene transfer process to generate...

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