68 documents

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22:58 , Dec 20, 2018 |  BC Extra  |  Politics & Policy

FDA releases next guidance in patient-focused drug development series

FDA released draft guidance on Thursday to encourage industry and other stakeholders to submit proposed draft guidances for incorporating patient experience data into product development and regulatory decisions. The agency said stakeholders could submit their...
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22:42 , Sep 21, 2018 |  BioCentury  |  Product Development

Arrowhead refills its quiver

Arrowhead Pharmaceuticals Inc.’s tox blowup in 2016 set back its clinical timelines, but it also prompted the company to bring a more versatile platform online faster than originally planned. Early data from replacement candidates suggest...
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01:29 , Dec 23, 2017 |  BioCentury  |  Regulation

Prioritizing preferences

The realization that patients have distinct preferences about the trade-offs and risks inherent in medical decisions -- and that their choices are frequently different from those physicians or regulators would make -- has mobilized FDA,...
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22:21 , Oct 12, 2017 |  BC Innovations  |  Targets & Mechanisms

Mining the negatives

By investigating why its discontinued siRNA candidate against hepatitis B caused only weak responses in certain patients, Arrowhead Pharmaceuticals Inc. has upended a dogma about the virus’ genetics that has been clouding drug design and...
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16:22 , Aug 31, 2017 |  BC Innovations  |  Translation in Brief

Extinguishing aversion

Last month in the Journal of Neuroscience , a team from the Chinese Academy of Sciences showed activating RAC1 could help treat opioid addiction by extinguishing the aversive memories of withdrawal that cause relapse in...
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20:57 , Feb 9, 2017 |  BC Innovations  |  Finance

PPP decline

BioCentury’s sixth annual analysis of public-private partnerships (PPPs) shows the lowest number of new alliances in 2016 since tracking began. The decline is a stark contrast to the enthusiasm of 2012, suggesting partners are becoming...
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21:55 , Jan 20, 2017 |  BC Week In Review  |  Company News

Heat, Shattuck deal

Heat granted newco Shattuck an exclusive license to Heat technology, which Shattuck will use to develop its agonist redirected checkpoint (ARC) platform technology. The technology blocks checkpoint molecules and stimulates tumor necrosis factor (TNF) superfamily...
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22:20 , Jan 6, 2017 |  BioCentury  |  Finance

Tiers of disappointment

A bad year for biotech was closed with an even worse 4Q16 as volatility ahead of the U.S. elections and continued concerns around drug pricing held every market cap band in the red despite a...
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00:06 , Dec 8, 2016 |  BC Extra  |  Politics & Policy

ARC submits amyloidosis draft guidance to FDA

The Amyloidosis Research Consortium said it submitted draft guidance to FDA addressing drug development and clinical trial design for amyloid light chain (AL) amyloidosis. The patient group met with FDA, industry stakeholders and disease experts...
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00:35 , Nov 30, 2016 |  BC Extra  |  Company News

Arrowhead prunes pipeline over toxicity concerns

Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) sank $2.63 (60%) to $1.76 in early after-hours trading after it said will discontinue development of all programs using its EX1 liver-targeted, IV delivery vehicle for its RNA therapies. The cuts...
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