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.
JW Therapeutics Announces IND Approval for the Pivotal Clinical Trial of Carteyva® in Second-line Large B-Cell Lymphoma
JW Therapeutics, an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products...
U.S. FDA Approves CABENUVA for Adolescents
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies...
FDA authorizes second booster of Pfizer/BioNTech COVID shot
U.S. regulators authorized a second booster dose of Pfizer Inc (PFE.N) and BioNTech SE's (22UAy.DE) COVID-19 vaccine for people 50 and older due to concerns about waning immunity in the age group, the drugmakers said on Tuesday. The U.S. Food and Drug Administration...
InnoCare Announces Approval of Clinical Trial of TYK2 JH2 Allosteric Inhibitor ICP-488 in China
InnoCare Pharma announced today that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its TYK2 JH2 allosteric inhibitor ICP-488, which is the Company's third innovative drug...
Google Tests Catching Heart, Eye Issues From Smartphone Sensors
Google announced on Thursday its latest plans for using smartphones to monitor health, saying it would test whether capturing heart sounds and eyeball images could help people identify issues from home. The company, a unit of Alphabet Inc, is investigating whether the...
How Innovative AI and Digital Health Data are Making Strides in Patient-Focused Care
What if AI could use digital health data to correctly identify the early signs of a serious health issue that is extremely hard to diagnose, yet widespread in hospital settings? In one recent example of healthcare innovation, a cutting-edge AI system that analyzes...
Pfizer Notches Breakthrough Status in Race to an RSV Vaccine
Pfizer has announced Thursday that it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for its vaccine candidate PF-06928316 (RSVpreF), intended to prevent infections caused by a respiratory syncytial virus (RSV). The respiratory...
With Robust Results, Moderna to Request Vaccine EUA for Kids Under 6
Moderna reported positive interim results from the Phase II/III KidCOVE trial of its mRNA COVID-19 vaccine for children six months to under two years and two to six years of age. The data showed a “robust neutralizing antibody response” in both cohorts. The doses were...
Takeda’s Parathyroid Hormone Injection Delayed Indefinitely
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara. Natpara is intended to help patients navigate low blood calcium due to hypoparathyroidism. In Sept. 2019, Takeda issued a U.S. recall of all natpara for...
A New Day in Cancer Treatment: FDA Approves BMS’s Opdualag
Bristol Myers Squibb (BMS) achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of patients 12 and older with unresctable or metastatic melanoma. The decision is based on the...
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