NMPA Grants First Approval to CAR T-Cell Therapy
The National Medical Products Administration (NMPA) has approved the first CAR T-cell therapy called Yescarta for China, which has been found to be successful in treating certain kinds of late-stage blood cancer. Fosun Pharma Kite Biotechnology will market Yescarta in...
FDA Accepts Fennec Pharmaceutical’s NDA Resubmission for PEDMARK™
Following up on their NDA resubmission, Fennec Pharmaceuticals has been granted U.S. Food and Drug Administration (FDA) approval for its unique formulation of sodium thiosulfate called PEDMARK™. PEDMARK™ is meant to prevent ototoxicity in patients between one month...
Parkinson’s Phase II Clinical Trial Authorized by FDA
The U.S. Food and Drug Administration (FDA) has authorized the Hope Biosciences Stem Cell Research Foundation (HBSCRF) to conduct Phase II clinical trial for simultaneous allogeneic adipose-derived mesenchymal stem cells administered intravenously to treat Parkinson's...
Roche COVID-19 Molecular Test Granted EUA for PCR Testing
The U.S. Food and Drug Administration (FDA) has granted Roche Emergency Use Authorization (EUA) for its PCR cobas® SARS-CoV-2 Nucleic acid test. The EUA was granted for use on the cobas® Liat® System, and is the first RT-PCR (reverse transcriptase polymerase chain...
FDA Grants Breakthrough Therapy Designation to Novartis’ Prostate Cancer Drug Therapy
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis' prostate cancer drug therapy that is currently in Phase III development. The experimental treatment, called Lu-PSMA-617, has illustrated substantial improvements over...
“Significant Milestones” Reached on Various Regulatory Guidelines Reports ICH
The International Council for Harmonisation (ICH) has reported that "significant milestones" have been reached over the past year. From the adoption of guidances regarding carcinogenicity testing, residual solvent testing, and specifications for electronic Common...
EU Adds Another Blood Condition Side Effect to AstraZeneca’s COVID-19 Vaccine
The European Medicines Agency (EMA) has added another blood condition side effect to the growing list for AstraZeneca's COVID-19 vaccine. The rare blood condition known as capillary leak syndrome causes blood to spill from blood vessels to nearby muscles and body...
FDA Grants Pre-Approval for IND for Potential HIV Cure
The U.S. Food and Drug Administration (FDA) has granted pre-approval for Enochian BioSciences' Investigational New Drug (IND) application for a potential functional treatment or cure for HIV (human immunodeficiency disorder). The submission is based off of an...
Delta Variant: Likely More Than 6% of US COVID Cases
Initially detected in India in December last year, the CDC has declared that the Delta variant (B.1.617.2.) can now be found in over 60 countries. The Delta variant appears to have a relatively higher transmissible rate and continues to delay progress combatting the...
EMA Launches Draft for EU Electronic Product Information (ePI)
Following the European Medicines Agency (EMA) and the European Commission and Heads of Medicines Agencies’ (HMA) release of principles outlining a standardized approach to electronic product information (ePI) last year, the EMA is holding a stakeholder consultation to...
Extensive Clinicom Interview: ‘Stigma-Eraser’ and Saving Lives
CSOFT Health Sciences sat down with Dr. Nelson M. Handal, President and Chairman of Clinicom, in our newest podcast episode of Coffee & Conversations to discuss the value of Clinicom’s digital assessment tool in enhancing patient care and eliminating misdiagnoses....
FDA Approves New Pfizer Pneumococcal Vaccine for Adults
A new pneumococcal 20-valent conjugate vaccine by Pfizer, PREVNAR 20™, has been approved for adults by the FDA in efforts to strengthen the prevention of disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. The authorized vaccine not...
Effective Cardiovascular Results from Lipoprotein Apheresis
A study conducted by the Centre of Nephrology, Apheresis and Dialysis in Germany concluded that Lipoprotein apheresis (LA) is a safe and effective treatment for high-risk dyslipidemia and lowers Cardiovascular rates. The study concluded that LA decreases levels of...
First Alzheimer’s Treatment by Biogen Approved by FDA
The U.S Food and Drug Administration (FDA) has approved Biogen’s aducanumab treatment for Alzheimer's which aims to eliminate the sticky deposits of amyloid beta found in the brains of patients in the initial stages of the disease. In spite of controversy and...
Regeneron COVID-19 Antibody Therapy Approved for Injection
In a move to combat treatment delay, as well as to meet the demand for antibody drugs, the U.S has approved Regeneron Pharmaceutical’s lower dose COVID-19 antibody cocktail that can be administered through injection. The therapy, REGEN-COV, is now permitted to...
FDA Authorizes Cognoa Pediatric Autism (ASD) Diagnosis Device
The U.S Food and Drug Administration (FDA) authorized the marketing of unique autism diagnostic device developed by Cognoa to help diagnose autism spectrum disorder (ASD) in young children between 18 months and 5 years of age. Using a machine learning- based software...
Possible Link Between Myocarditis in Young Males and Pfizer Vaccine
Israel’s Ministry of Health has found a possible link between myocarditis (heart inflammation) in males aged 16-30 and the second Pfizer vaccine. In examining the matter, the Ministry has disclosed the findings of its commissioned study stating that among the total 5...
FDA Approves Amgen’s Lumakras for Lung Cancer Mutation
The U.S. Food and Drug Administration (FDA) has given Amgen’s Lumakras (sotorasib) accelerated approval as a treatment for patients diagnosed with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) - the first FDA approved treatment...
Fennec Pharmaceuticals Resubmits NDA for PEDMARK™
Fennec Pharmaceuticals has resubmitted their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™, a unique sodium thiosulfate formulation. PEDMARK is designed to prevent ototoxicity caused by cisplatin chemotherapy in patients under...
FDA Places Restrictions for Obeticholic Acid (Ocaliva)
The U.S. Food and Drug Administration (FDA) has placed restrictions on the use of obeticholic acid (Ocaliva of Intercept Pharmaceuticals) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis due to risk for serious liver injury. The restriction...