BioSpace News Archive

Business

Sumitovant Biopharma Created and Launched as Sumitomo Dainippon Pharma and Roivant Sciences Close Transaction for Strategic Alliance

Sumitomo Dainippon Pharma and Roivant Sciences complete strategic alliance and formation of new company, Sumitovant Biopharma, a wholly owned subsidiary of Sumitomo Dainippon Pharma

December 30, 2019
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6 min read
Pharm Country

Dr. Reddy’s Laboratories Announces the Launch of Sodium Nitroprusside Injection, 50 mg/2 mL (25 mg/mL) Single-dose Vial in the U.S. Market

Dr. Reddy’s Laboratories Ltd. announced the launch of Sodium Nitroprusside Injection, 50 mg/2 mL Single-dose Vial, the therapeutic generic equivalent of Nitropress® Injection, 50 mg/2mL vial, approved by the U.S. Food and Drug Administration.

December 30, 2019
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3 min read
Drug Development

Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response

Demonstrated statistical significance on regulatory co-primary endpoints of pain freedom (p<0.001) and freedom from most bothersome symptom (p=0.002) at 2 hours, compared to placebo

December 30, 2019
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18 min read
Check-Cap Announces Positive Results from U.S. Pilot Study of C-Scan® System

Advancing towards IDE submission to the FDA, targeting initiation of U.S. pivotal study in late 2020

December 30, 2019
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5 min read
Business

TherapeuticsMD Announces Amendment to Term Loan Financing Facility with TPG Sixth Street Partners

Amendment revises draw trigger for $50 million loan tranche previously tied to ANNOVERATM designation

December 30, 2019
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5 min read
FDA

LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA

December 30, 2019
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19 min read
Drug Development

Sol-Gel Announces Positive Top-Line Phase 3 Trial Results of Twyneo® for the Treatment of Acne Vulgaris

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) today announced top-line results from two pivotal Phase 3 clinical trials for Twyneo®, an investigational, combination of microencapsulated tretinoin 0.1% and microencapsulated benzoyl peroxide 3% cream,

December 30, 2019
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9 min read
Drug Development

BioXcel Therapeutics Announces Initiation of Pivotal Phase 3 Studies of BXCL501 for Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar DisorderTopline results expected in mid-2020

Topline data from both Phase 3 trials are expected in mid-2020.

December 30, 2019
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7 min read
Genetown

Bruker Corporation to Present at the 38th Annual J.P. Morgan Healthcare Conference

A live audio webcast of the presentation will be available on the Investor Relations section of the Company’s website at https://ir.bruker.com

December 30, 2019
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1 min read
Genetown

Abiomed to Present at the 38th Annual J.P. Morgan Healthcare Conference

The conference will be held at the Westin St. Francis Hotel in San Francisco, California.

December 30, 2019
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2 min read