18:31 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

REMS prep pushes back Sage's Zulresso timeline

Sage Therapeutics Inc. (NASDAQ:SAGE) anticipates a June 2019 launch of postpartum depression candidate Zulresso brexanolone after FDA pushed back the PDUFA date three months to March 19. Sage has said Zulresso could become the first...
19:13 , Nov 20, 2018 |  BC Extra  |  Company News

REMS prep pushes back Sage's Zulresso timeline

Sage Therapeutics Inc. (NASDAQ:SAGE) anticipates a June 2019 launch of postpartum depression candidate Zulresso brexanolone after FDA pushed back the PDUFA date three months to March 19. Sage has said Zulresso could become the first...
17:54 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs Sage's postpartum depression candidate under REMS

A joint FDA panel voted 17-1 in favor of the benefit-risk profile for Zulresso brexanolone from Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression (PPD) when administered in certified facilities by qualified staff under a...
23:05 , Nov 2, 2018 |  BC Extra  |  Company News

FDA panel backs Sage's postpartum depression candidate under REMS

A joint FDA panel voted 17-1 in favor of the benefit-risk profile for Zulresso brexanolone from Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression (PPD) when administered in certified facilities by qualified staff under a...
19:57 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

FDA Reviewers: REMS could allay safety concerns for Sage's brexanolone

FDA reviewers proposed implementing a REMS to address loss-of-consciousness events associated with brexanolone (SAGE-547) from Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression (PPD), according to a briefing document issued ahead of a joint advisory...
22:22 , Nov 1, 2018 |  BC Innovations  |  Translation in Brief

New Therapeutic Targets and Biomarkers: October 2018

New Therapeutic Targets and Biomarkers: October 2018 Select top therapeutic targets and biomarkers covered by BioCentury or added to the BCIQ database during October. Therapeutic targets are defined as any protein, gene or other molecule...
20:56 , Oct 31, 2018 |  BC Extra  |  Company News

FDA reviewers: REMS could allay safety concerns for Sage's brexanolone

FDA reviewers proposed implementing a REMS to address loss-of-consciousness events associated with brexanolone (SAGE-547) from Sage Therapeutics Inc. (NASDAQ:SAGE) to treat postpartum depression (PPD), according to a briefing document issued ahead of a joint advisory...
21:43 , Oct 26, 2018 |  BioCentury  |  Finance

Springing into Cerevel

Bain Capital is following the blueprint for Pfizer Inc. (NYSE:PFE) spinout SpringWorks Therapeutics LLC and applying it on a larger scale to Cerevel Therapeutics LLC, which will develop Pfizer’s discontinued neuroscience pipeline with $350 million...
18:39 , Oct 18, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Seizures In silico , cell culture and mouse studies identified a GABRB2/GABRB3 positive allosteric modulator (PAM) that could help treat seizures. In silico screening of a small molecule library for structural similarity to a...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...