Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval of Probuphine, First 6-Month Implant to Treat Opioid Addiction

SOUTH SAN FRANCISCO, Calif. and PRINCETON, N.J., Jan. 12, 2016 -- Titan Pharmaceuticals, Inc. (TTNP) and partner Braeburn Pharmaceuticals today announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. The Committee's vote followed presentation and discussion of data regarding Probuphine's efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016.

Published: 13 January 2016

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BioLineRx Announces Collaboration with MSD to Investigate the Combination of KEYTRUDA (pembrolizumab) and BL-8040 in Pancreatic Cancer

BioLineRx management to hold conference call this morning at 10:00 am EST to further discuss this immunotherapy collaboration

TEL AVIV, Israel, January 12, 2016 -- BioLineRx Ltd. (NASDAQ/TASE: BLRX) today announced a collaboration with MSD, known as Merck in the US and Canada, to support a Phase 2 study investigating BioLineRx's BL-8040 in combination with KEYTRUDA^® (pembrolizumab), MSD's anti-PD-1 therapy, in patients with metastatic pancreatic cancer. The study is an open-label, multicenter, single-arm trial designed to evaluate the safety and efficacy of this combination in patients with metastatic pancreatic adenocarcinoma.

Published: 12 January 2016

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Nasdaq Up on News Project Update

Acasti & Neptune Enter Into Transactional Arrangement & Sign Operational Agreements

Supports Neptune in financing transaction by granting limited recourse pledge in the amount of $2.0M CDN
Entered into positive operational arrangements with Neptune, including a licensing agreement to market Onemia®

LAVAL, Québec, Jan. 07, 2016 -- Acasti Pharma Inc. (“Acasti” or the “Corporation”) (ACST) (APO.V), an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment of hypertriglyceridemia, announces that it has entered into a transactional arrangement and signed operational agreements with its parent company, Neptune Technologies and Bioressources Inc. (“Neptune”). All amounts in Canadian dollars.

Published: 08 January 2016

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Healios and Athersys Enter Into Regenerative Medicine Partnership for Treatment of Stroke Using MultiStem® Therapy

Alliance to Focus on Development and Commercialization of Regenerative Medicine Products for Stroke and Other Potential Indications Using New Regulatory Framework in Japan

CLEVELAND and TOKYO, Jan. 08, 2016 -- Healios K.K. (“Healios”) (Tokyo Stock Exchange: 4593) and Athersys, Inc. (“Athersys”) (ATHX) have announced a partnership and license agreement that will focus on the development and commercialization of novel cell therapy treatments, including MultiStem^® for the treatment of ischemic stroke and potentially other indications, in Japan. The partnership involves MultiStem, a proprietary, patented off-the-shelf stem cell therapy being developed by Athersys, with an initial focus on treating ischemic stroke.

Under the terms of the agreement, Healios will gain exclusive rights for the development of MultiStem for treating ischemic stroke in Japan. Healios will develop and commercialize the product in Japan, and Athersys will provide the manufactured product and support to Healios, while retaining all rights outside of Japan.

Published: 08 January 2016

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Chimerix Announces Top-Line Results From Phase 3 SUPPRESS Trial of Brincidofovir

- SUPPRESS Did Not Achieve Primary Endpoint for Prevention of Clinically Significant CMV Infection After HCT -

DURHAM, N.C., Dec. 28, 2015 -- Chimerix (CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its Phase 3 SUPPRESS trial of brincidofovir in patients undergoing hematopoietic cell transplantation (HCT) did not achieve its primary endpoint for the prevention of clinically significant cytomegalovirus (CMV) infection through Week 24 after transplant.

During the on-treatment period through Week 14 after HCT, fewer patients in the brincidofovir arm had a CMV infection, consistent with the positive antiviral effect of the compound seen in the Phase 2 study. However, during the 10 weeks off treatment from Week 14 to Week 24, there was an increase in CMV infections in the brincidofovir arm compared to the control arm. There was also a non-statistically significant increase in mortality in the brincidofovir arm compared to the control arm.

Published: 29 December 2015

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Nasdaq Up on News Project Update

Titan Pharmaceuticals Inc ( TTNP )

Titan Pharmaceuticals and Braeburn Pharmaceuticals Announce FDA Advisory Committee Recommends Approval of Probuphine, First 6-Month Implant to Treat Opioid Addiction

BioLineRx Ltd ( BLRX )

BioLineRx Announces Collaboration with MSD to Investigate the Combination of KEYTRUDA (pembrolizumab) and BL-8040 in Pancreatic Cancer

Neptune Technologies & Bioressources ( NTB )

Acasti & Neptune Enter Into Transactional Arrangement & Sign Operational Agreements

Athersys Inc ( ATHX )

Healios and Athersys Enter Into Regenerative Medicine Partnership for Treatment of Stroke Using MultiStem® Therapy

Chimerix ( CMRX )

Chimerix Announces Top-Line Results From Phase 3 SUPPRESS Trial of Brincidofovir