FDA Encourages Telemedicine For Gaps in Gene Therapy Trials
The U.S. Food and Drug Administration (FDA) is encouraging sponsors involved in gene therapy trials to fill data gaps with remote visits and telemedicine. The encouragement comes from Wilson Bryan, the FDA’s OTAT (Office of Tissues and Advanced Therapies) during the...
FDA Authorizes Roche for Testing COVID-19 Asymptomatic Individuals
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Roche for its cobas® SARS-CoV-2 Test. The cobas® SARS-CoV-2 Test is designed to test asymptomatic individuals suspected to have COVID-19. The Center for Disease Control (CDC)...
ImmunityBio Receives FDA Authorization for Clinical Study of Memory Cytokine-Enriched NK Cell (m-ceNK) Platform in Solid Tumors
The U.S. Food and Drug Administration (FDA) authorized ImmunityBio Phase I clinical study for patients with metastatic or locally advanced solid tumors. The study will assess the safety and efficacy of ImmunityBio's IL-15 superagonist Anktiva (N-803) in combination...
Industry-First At-Home HPV Screening Has Been CE Marked
BD (Becton, Dickinson, and Company) announced today the first self-collection, at-home HPV screening has been CE marked to the IVD directive 98/79/EC. With this new claim, diagnostic labs will now be able to process the self-collected vaginal samples using the BD...
FDA Grants IDE to ZOLL Medical for ISO Shock Study
The U.S. Food and Drug Administration (FDA) has granted ZOLL Medical investigational device exemption (IDE) for a randomized study to evaluate TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients with cardiogenic shock and ST Elevation Myocardial Infarction...
New Contact Lenses for Children to Slow Myopia Progression
Eyepic Eye Care announced a revolutionary service using the only FDA-approved MiSight multifocal contact lenses meant to slow myopia progression in children. Myopia, which is a refractive eye condition causing nearsightedness, affects approximately 40% of Americans...
Pfizer & BioNTech COVID-19 Vaccine Receives EUA for Young Teens
The U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer and BioNTech COVID-19 vaccine to now include young teens between 12 and 15 years of age. Previously, the EUA was approved for patients 16 years of age and older,...
FDA Clears ConforMIS, Inc.’s Knee Replacement System
The U.S. Food and Drug Administration (FDA) has granted ConforMIS Inc. 510(k) clearance for its Identity Imprint™ Knee Replacement System. Available in both posterior stabilized (PS) and cruciate retaining (CR) versions, the system expands the range of options for...
NMPA Approves PARP Inhibitor Pamiparib of BeiGene
China's regulatory body, the National Medical Products Administration (NMPA), has granted conditional approval to BeiGene's PARP inhibitor pamiparib for treatment of patients advanced ovarian cancer. The approval marks the first for pamiparib and the third for...
FDA Approves Viome’s mRNA Technology and AI Platform for Detecting Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the early detection of oral and throat cancer through their proprietary mRNA technology in combination with Viome's next-gen AI platform. The first-of-its-kind tool screens...
Pfizer & BioNTech COVID-19 Vaccine Expected Approval From FDA for Younger Teens
Pfizer & BioNTech's COVID-19 vaccine is expected to receive FDA approval for adolescents ages 12 and older sometime this week. The expected approval comes from a Phase III trial in adolescents between the ages of 12 and 15 with 2,260 participants that demonstrated...
U.S. Patent Granted to Kemin Industries for Treatment of Human Immune Function
Kemin Industries has announced that the U.S. Patent and Trademark Office has granted the US 10,912,794 patent on the beta 1, 3 glucan for treating inflammation in the intestine and modulating human immune function. The patent approval comes after the US 9,574,217...
FDA Approves Chiesi Global Rare Diseases’ Ferriprox for Sickle Cell Disease
The U.S. Food and Drug Administration (FDA) approved Chiesi Global Rare Diseases' Ferriprox for treating transfusional iron overload which is caused by sickle cell disease (SCD). The treatment is approved in patients three years old and older, and expands the drug use...
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746: Five key questions answered for MedTech Companies
It has been almost four years since the European Commission passed the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 on May 26, 2017. With the new regulation set to be implemented in 2022, medical device manufacturers looking to market their products...
Alzheimer’s Drug Shows Language Improvement for Fragile X Syndrome
A new study published in the Nature Medicine journal has shown that Tetra Therapeutics' Alzheimer's investigational disease drug improves language and learning ability in adults diagnosed with Fragile X Syndrome. Fragile X Syndrome is a genetic condition that causes...
Moderna Working on Improving COVID-19 Vaccine
Moderna, currently one of three companies granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, is continuing its efforts in improving the vaccine. Currently, the vaccine must be stored in cold temperatures;...
Parkinson’s Clinical Trial Approved by FDA
The U.S. Food and Drug Administration (FDA) announced its approval of Hope Biosciences Stem Cell Research Foundation's (HBSCRF) Phase II double blind placebo controlled Parkinson's clinical trial. The clinical trial will test the efficacy and safety of multiple...
Health Canada Grants Marketing Approval to Rockwell Medical for Triferic® AVNU™
Health Canada granted marketing approval today (April 27) to Rockwell Medical for its Triferic AVNU, a ferric pyrophosphate citrate injection designed to replace iron for hemoglobin maintenance in adults with hemodialysis-dependent chronic kidney disease. The drug is...
FDA & CDC Lift Restrictions on J&J Vaccination
The U.S. Food and Drug Administration (FDA) and the Center for Disease Control (CDC) lifted restrictions on the single-shot Johnson & Johnson vaccination for COVID-19 this past Friday (April 23) after the FDA's Advisory Committee on Immunization Practices (ACIP)...
TGA Approves Global Sarcoma Therapy
The Therapeutic Goods Administration (TGA) has approved the use of Global Sarcoma Therapy called YONDELISÒ, marketed by Specialised Therapeutics, for Australian patients afflicted with "unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior...