BioSpace News Archive

Revive Therapeutics Provides Update on the Psilocybin Clinical Study for Methamphetamine Use Disorder and Oral Psilocybin Thin Film Strip Program

Revive Therapeutics Ltd. is pleased to provide an update on the Company’s Phase I/II clinical study of oral psilocybin in the treatment of methamphetamine use disorder and the development of its proprietary oral psilocybin thin film strip product.

September 16, 2022
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4 min read
Biotech Beach

Evofem Announces Successful Debt Restructuring

Evofem Biosciences, Inc. announced the successful restructuring of its debt, providing forbearance from its debtholders related to all existing events of default.

September 16, 2022
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4 min read
Haoma Medica Announces Late-Breaking Science Results for Naquinate, as a New Way to Support Bone Health and Healthy Aging, at the ASBMR 2022 Annual Meeting

Haoma Medica announced a presentation made at the 2022 American Society for Bone and Mineral Research.

September 16, 2022
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3 min read
Business

Avivagen Inc. Announces Results for the Third Quarter Ending July 31, 2022

Avivagen Inc. has announced its unaudited financial results for the third quarter of 2022.

September 16, 2022
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5 min read
Business

Enzolytics Inc. Announces Collaboration with Abveris to Discover Monoclonal Antibodies

Enzolytics, Inc. announces a collaboration with Abveris, a division of Twist Bioscience Corporation, to discover fully human monoclonal antibodies against multiple viruses.

September 16, 2022
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3 min read
Policy

Agios Receives Positive CHMP Opinion for PYRUKYND® (mitapivat) for the Treatment of Pyruvate Kinase (PK) Deficiency in Adult Patients

Agios Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on September 15, 2022, recommending the granting of a marketing authorization for PYRUKYND® for the treatment of pyruvate kinase deficiency in adult patients.

September 16, 2022
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10 min read
BioForest

CHMP Adopts Positive Opinion to Extend Indication of Veklury® (Remdesivir) for the Treatment of Pediatric Patients with COVID-19

Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the indication of Veklury® for the treatment of pediatric patients who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients with SARS-CoV-2 with pneumonia who require supplemental oxygen.

September 16, 2022
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11 min read
Drug Development

Intellia and Regeneron Announce Initial Data from the Cardiomyopathy Arm of Ongoing Phase 1 Study of NTLA-2001, an Investigational CRISPR Therapy for the Treatment of Transthyretin (ATTR) Amyloidosis

Intellia Therapeutics, Inc. and Regeneron Pharmaceuticals, Inc. announced positive interim results from an ongoing Phase 1 clinical trial of NTLA-2001, an investigational, in vivo CRISPR/Cas9 genome editing therapy in development as a single-dose treatment for transthyretin amyloidosis.

September 16, 2022
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17 min read
Genetown

Marengo Therapeutics Advances First-In-Class Selective T cell Activator, STAR0602, into Human Trials in Solid Tumors and Enters Cooperative Research and Development Agreement with the National Cancer Institute

Marengo Therapeutics today announced it is advancing its lead TCR activator, STAR0602, into the clinic following clearance of its investigational new drug (IND) application by the FDA.

September 16, 2022
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3 min read
Business

ADC Therapeutics and Sobi Announce ZYNLONTA® (loncastuximab tesirine) Receives Positive CHMP Opinion in Europe for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi®) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of ZYNLONTA® (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

September 16, 2022
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7 min read