Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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Yiling Pharmaceutical Gains Market Access in the Ukraine

Yiling Pharmaceutical Gains Market Access in the Ukraine

Yiling Pharmaceutical has received medicine registration document from the Ministry of Health of Ukraine for its drug therapy Lianhua Qingwen Capsules. Lianhua Qingwen Capsules are designed to treat COVID-19, as well as other viruses like the flu or cold. The medicine...

PMDA Grants Regulatory Approval for Leukemia Drug Therapy

PMDA Grants Regulatory Approval for Leukemia Drug Therapy

Japan's regulatory body, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), has granted HUYABIO International, Shenzhen Chipscreen Biosciences' licensing partner, regulatory approval for leukemia drug therapy, Tucidinostat. Tucidinostat, also referred to...

NMPA Grants First Approval to CAR T-Cell Therapy

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...

Parkinson’s Phase II Clinical Trial Authorized by FDA

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

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 Pre-Approval for IND for Potential HIV Cure

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

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...

FDA Approves New Pfizer Pneumococcal Vaccine for Adults

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...

First Alzheimer’s Treatment by Biogen Approved by FDA

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...