Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
FDA Approves HDT Bio COVID-19 Vaccine Phase 1 Clinical Trial
The FDA (Food and Drug Administration) has evaluated HDT Bio Corp’s Investigational New Drug (IND) Application and given the company the green light for a Phase 1 clinical trial of its HDT-301 COVID-19 RNA vaccine. HDT Bio, a developer of immunotherapies for oncology...
NuVasive Pulse Receives CE Mark, Begins Clinical Evaluations
With an aim to transform disruptive spine surgery, NuVasive (NASDAQ: NUVA), a leader in spine technology innovation, announced that clinical evaluations have started for its Pulse® platform which recently received CE Mark (Conformitè Europëenne) approval. The Pulse...
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...
FDA Grants Fast Track Designation to Syndax Pharmaceuticals
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Syndax Pharmaceuticals for the treatment of relapsed/refractory acute leukemia with either MLLr or NPM1 mutations called SNDX-5613. Previously, SNDX-5613 was granted Orphan Drug...
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...
LATAM Series: Argentina’s Medical Device Regulatory Pathway
In our last Latin American series blog post, we introduced the diversity and complexity of the life science market in the region, with specific focus on Brazil’s regulatory body and track for medical devices. This week, continuing with our Latin American series, we...
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...
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