BioSpace News Archive

Empower Clinics Successfully Completes Health Canada Review To Sell Covid-19 At-Home Saliva Collection Kit

EMPOWER CLINICS INC. is pleased to announce that it is has received approval from Health Canada to proceed under the original Device Class I authorization for Kai Care COVID-19 At-Home Saliva Collection Kit (“Kai Care Kits”).

December 1, 2021
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4 min read
Policy

U.S. FDA Grants Bionomics Fast Track Designation to BNC210 for the Acute Treatment of Social Anxiety Disorder and Other Anxiety Related Disorders

Bionomics Limited, a clinical-stage biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration has granted Fast Track designation to the BNC210 development program for the acute treatment of Social Anxiety Disorder and other anxiety-related disorders.

December 1, 2021
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6 min read
Policy

Helixmith Announces 50% Enrollment in its Clinical Trial for COVID-19, involving TADIOS

Helixmith Co., Ltd. has announced that 50 subjects have been enrolled in its double-blind placebo controlled COVID-19 clinical trial involving 100 subjects.

December 1, 2021
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2 min read
Business

Biodesix Partners with Spesana to Streamline Digital Access to Molecular Diagnostics for Precision Medicine in Lung Cancer

Spesana and Biodesix Inc. announced today that they have partnered to further streamline and automate the use of molecular diagnostics in clinical workflows across the United States utilizing Spesana’s digital platform solutions for comprehensive lung cancer.

December 1, 2021
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6 min read
Business

Notable and CicloMed Initiate Phase 1B/2A Clinical Trial of Fosciclopirox in Acute Myelogenous Leukemia Under Co-Development Agreement

Notable Labs, Inc., a clinical-stage predictive precision therapeutics company and CicloMed LLC, a developmental-stage pharmaceutical company have initiated a Phase 1B/2A clinical trial of fosciclopirox in patients with refractory acute myelogenous leukemia under the terms of a co-development agreement.

December 1, 2021
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4 min read
Ortoma obtains JP certification for hip implant planning module

Ortoma has obtained certification in Japan for its module OTS Hip Plan for pre-operative planning of hip replacement surgery.

December 1, 2021
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1 min read
Genetown

Curie Therapeutics Raises $75 Million Financing to Further its Mission of Transforming Cancer Care with Precision Radiopharmaceuticals

Curie Therapeutics Inc today announced a Series A investment of $75 million by its founding syndicate to continue the development of its multimodal pipeline of precision radiopharmaceuticals to a broad range of high unmet need solid tumors.

December 1, 2021
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5 min read
Business

Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD

In the zuranolone 50 mg cohort, the majority of patients who responded to an initial 14-day course received only one two-week course of treatment during the study and nearly 80% received only one or two treatment courses in total.

December 1, 2021
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16 min read
Pharm Country

U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for VAXNEUVANCE.

December 1, 2021
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6 min read
Pharm Country

BD Issues 2021 Global Inclusion, Diversity and Equity Report

Progress Builds Strong Foundation for Bold 2030+ ESG Goals to Advance the World of Health for All.

December 1, 2021
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4 min read