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3:24 PM, Jun 21, 2018  |  BC Extra | Preclinical News

Low GABA transporter levels linked to alcohol dependence

In a Science paper published Wednesday, researchers at Linkoping University and colleagues showed a link between alcohol dependence and decreased levels of solute carrier family 6 member 11 (SLC6A11; GAT3) and increased gamma-aminobutyric acid (GABA)...
3:07 PM, Jun 21, 2018  |  BC Extra | Company News

FDA restricts Keytruda, Tecentriq monotherapy

FDA restricted the labels of Keytruda pembrolizumab and Tecentriq atezolizumab as monotherapy for urothelial cancer in a first-line setting. The update applies to Keytruda or Tecentriq's use in locally advanced or metastatic urothelial carcinoma to patients...
3:07 PM, Jun 21, 2018  |  BC Extra | Politics & Policy

Stakeholders release comprehensive opioid crisis action plan

Healthcare leaders should develop value-based and evidence-based models for integrated pain management and substance use disorder treatment, according to a road map organized by the Healthcare Leadership Council. The report, from more than 70 healthcare...
3:05 PM, Jun 21, 2018  |  BC Extra | Clinical News

Nanobiotix’s NBTXR3 meets in Phase II/III for STS

Nanobiotix S.A. (Euronext:NANO) said NBTXR3 met the primary and secondary endpoints in the Phase II/III trial to treat locally advanced soft tissue sarcoma. The compound comprises crystalline nanoparticles of hafnium oxide activated in vivo...
2:06 PM, Jun 21, 2018  |  BC Extra | Politics & Policy

Beacon to develop right-to-try patient match platform

Beacon Pharmaceutical (New York, N.Y.) said it will launch a new platform to connect terminally ill patients with experimental therapies under the new right-to-try law. The firm is developing the platform as a philanthropic effort through...
2:05 PM, Jun 21, 2018  |  BC Extra | Company News

UCSD launches bacteriophage treatment center

The University of California San Diego launched the Center for Innovative Phage Applications and Therapeutics (IPATH) to develop bacteriophages to fight multidrug-resistant bacteria. The initial focus will be on treating chronic infections associated with cystic...
1:52 PM, Jun 21, 2018  |  BC Extra | Clinical News

Novo expands market cap on oral semaglutide data

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) added DKK20.4 billion ($3.2 billion) in market cap in Copenhagen on Thursday after reporting that oral diabetes candidate semaglutide was at least non-inferior to two approved therapies in reducing...
1:40 PM, Jun 21, 2018  |  BC Extra | Politics & Policy

FDA releases draft guidance for antidepressant trials

FDA published draft guidance on developing drugs for major depressive disorder, which when finalized will replace the agency's guidance on the topic issued in 1977. Double-blind, placebo-controlled trial designs are the current standard for short-term treatments...
11:57 AM, Jun 21, 2018  |  BC Extra | Clinical News

Heron flying on Phase IIb pain data ahead of NDA

Heron Therapeutics Inc. (NASDAQ:HRTX) added $9.25 (30%) to $39.95 on Thursday after reporting that HTX-011 met the primary endpoint in a pair of Phase IIb trials to treat postoperative pain. The stock move added more...
10:48 AM, Jun 21, 2018  |  BC Extra | Politics & Policy

FDA scraps biosimilars draft guidance

In an effort to reduce the cost and increase the efficiency of biosimilars development, FDA Thursday withdrew draft guidance on statistical approaches for evaluating analytical similarities between a proposed biosimilar and its reference product. The...