Drug Updates

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.  According to IQVIATM sales data for the 12 month period ending November 2021, the Lexiscan® […]

Pandemic Pulse

The single-component Sputnik Light vaccine authorized in Philippines

The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) today announced the Russian single-component Sputnik Light vaccine against coronavirus has been approved under the emergency use authorization procedure by the Food and Drug Administration (FDA) of the Republic of the Philippines. Sputnik Light vaccine based on human adenovirus serotype 26 is the first component […]

Drug Updates

Viatris Inc. and Biocon Biologics Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes

Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee® (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway. Viatris CEO Michael Goettler commented: “We are extremely proud to achieve the industry’s first approval […]

Pandemic Pulse

LifeSignals receives FDA 510 (k) Approval for LifeSignals LX1550 Multiparameter Remote Monitoring Platform

LifeSignals Inc., today announced it has received FDA Class II 510 (k) approval for the LifeSignals LX1550 Multiparameter Remote Monitoring Platform. This follows recent CE marking and is further validation of LifeSignals’ drive to create innovative wireless platforms which can be used by clinicians for the continuous collection of patient physiological data at home and […]

Drug Updates

Ampio Pharmaceuticals Receives Approval to Expand Enrollment of its AP-019 Phase II Study to India

 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it has received regulatory approval to expand enrollment of its AP-019 Phase II study to India. The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19. “FDA approval to include […]

Mental Aid Mental Wellness

HopeQure receives HIPPA certification, expands its footprints in the US markets

HopeQure HIPPA certification HopeQure, India’s fastest growing online mental health counselling platform, achieves HIPPA (Health Insurance Portability and Accountability Act) security certification. Armed with HIPAA certification, HopeQure now plans to launch its operations in USA where the company is in advance stage of discussion to finalise its partners for growth. Bringing the global best practices and international security and confidentiality […]