FDA Grants EUA for Point-of-Care COVID-19 Antibody Test
Amidst the COVID-19 public health crisis, many companies have worked tirelessly to perfect testing technology. Assure Tech, a Chinese company based in Hangzhao, has prevailed with an antibody test with emergency use authorization. This is the first time that the FDA...
Paraxel Announces Resource for EU Clinical Trials Information System Regulation
With the incoming implementation of the EU Clinical Trial Regulation 536/2014 in December 2021, Parexel, an end-to-end innovative therapeutics solutions provider, has announced the launch of their Regulatory Submissions Hub Service for their life science and...
Resurgence of COVID-19 Cases in European Cities Causes New Restrictions
In the most recent report from the UK this past week, cases of COVID-19 have doubled to about 6,000 per day. While infections have been on a slow and steady increase in Europe over the last two months, especially in Spain and France, governmental bodies are...
Translating Lay Summaries – Driving Transparency
A study participant participates in a clinical trial, contributing invaluable data to understanding the safety and efficacy profile of a drug. Yet, patients, despite risking their lives by participating in a clinical trial, don’t usually get to know the outcome of the...
Orphazyme Receives Priority Review by FDA for Treatment of Niemann-Pick Disease Type C
Orphazyme, a biotech company based in Denmark, announced today (9/16) that the FDA has accepted its New Drug Application (NDA) for treatment of Niemann-Pick disease Type C. The genetic disease is both rare as well as fatal, with no currently approved...
NICE Reverses Disapproval of AstraZeneca’s Lung Cancer Therapy Tagrisso
The National Institute for Health and Care Excellence (NICE) originally rejected global biopharmaceutical company AstraZeneca’s lung cancer therapy Tagrisso (Osimertinib), but has since decided to reverse its initial decision. NICE initially did not recommend Tagrisso...
FDA Approves Edwards’ Sapien 3 for Cardiac Treatment
Edwards Lifesciences has developed the Sapien 3 transcatheter heart valve for cardiac treatment which was approved yesterday (9/8) by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients. Transcatheter heart valves is an option for the new...
FDA and NMPA Grant BeyondSpring Breakthrough Therapy Designations for Chemotherapy-Induced Neutropenia Indication
BeyondSpring, a global biopharmaceutical company focusing on immune-oncology therapy treatments for cancer patients, received today (9/8) breakthrough therapy designations (BTD) from the U.S. Food and Drug Administration (FDA) as well as the China National Medical...
FDA Approves Liquid Biopsy Tests
The U.S. Food and Drug Administration (FDA) has approved the usage of the Guardant360 CDx and FoundationOne Liquid CDx liquid biopsy tests for a number of solid tumors. The biopsies will be conducted via the blood, hence making them less painful, and more accessible....
Clinical Trials During COVID-19: A Glimpse into a Healthier World
While COVID-19 has caused many interruptions across industries, the drug development and supply chain has experienced some of the most severe repercussions. With potential exposure to the virus limiting number of trial participants, as well as site staff and...
NMPA Approves Adalimumab Injection SULINNO® for Arthritis Treatment
Biopharmaceutical company Innovnet Biologics, Inc. announced today (9/3) that the National Medical Products Administration (NMPA) has approved SULINNO®, an adalimumab injection, for rheumatoid arthritis, ankylosing spondylitis and psoriasis treatment in China....
California Passes Bill to Claim Ownership of Prescription Drugs
On Monday (8/31), a bill was passed in California, with 32 in favor and 7 against, to redistribute the state’s market power to make prescription drugs more affordable and accessible. The COVID-19 pandemic has been said to act as proof that improvements must be made to...
FDA Approves Expansion of Remdesivir for Hospitalized COVID-19 Patients
Gilead, a research-based biopharmaceutical company, has reported that their new antiviral treatment for COVID-19 Remdesivir, has just been granted an expansion on emergency use authorization (EUA) by the FDA for all patients hospitalized due to COVID-19. Originally...
FDA Grants Approval to Laurent Pharmaceuticals to Start COVID-19 Phase 2 Clinical Trial in the United States
Laurent Pharmaceuticals, a Montreal based clinical stage biopharmaceutical company has come up with an oral drug candidate, LAU-7b, to potentially treat COVID-19. The U.S. Food and Drug Administration (FDA) has granted Laurent Pharmaceuticals to begin enrolling U.S....
Transcreation: Marketing Translations for Life Science Industries
Marketing translations is a vital step across all industries. With so many different cultures affecting global markets, it’s important to present branding messages in a way that is culturally sensitive as well as linguistically accurate for product’s or service’s...
RenalytixAI FDA Clearence for New Kidney Treatment Technology
RenalytixAI, an in vitro diagnostics that uses artificial intelligence, has filed a submission to the FDA to clear new kidney treatment called KidneyIntelx. KidneyIntelx is designed to optimize clinical management and patient outcomes of kidney disease research as...
EPA Grants Emergency Approval for Antiviral Coating to be Used for American Airlines
American Airlines has been given approval by the U.S. Environmental Protection Agency (EPA) to use a COVID-19 disinfectant on surfaces throughout the airplanes. The virus-killing spray is effective on surfaces for up to seven days, and the EPA is studying whether this...
Lowering Prescription Drug Prices for Affordability and Accessibility for US Citizens
One of the biggest areas of concern in the pharmaceutical industry, particularly in the United States, is the high costs of new treatments or drug therapies for patients. The recent initiatives from regulatory agencies like the Food and Drug Administration (FDA) to...
Health Canada Implements ICH Pediatric Drug Development Guidance
Health Canada has adopted a nonclinical safety testing guidance to help develop medication in pediatrics. This guidance called GuidanceS11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines has been developed by the ICH and is slated to be...
FDA Rejects Gilead’s Rheumatoid Arthritis New Drug Application
Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotnib, a treatment for rheumatoid arthritis, which the FDA rejected due to safety concerns, particular in the 200mg dose. “We are disappointed in this outcome and will...