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.
U.S. renews COVID-19 public health emergency
The United States on Wednesday renewed the COVID-19 public health emergency, allowing millions of Americans to keep getting free tests, vaccines and treatments for at least three more months. The public health emergency was initially declared in January 2020, when the...
Phanes Therapeutics’ anti-CD73 antibody patent granted in the US
Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and development in immuno-oncology, announced that the company has been granted a patent (Patent No. US 11,299,550 B2) on its anti-CD73 antibodies by the United States Patent and...
It’s Full Speed Ahead for Many Alzheimer’s Players Following CMS Decision
Following the Centers for Medicare & Medicaid Services’ (CMS) decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm to individuals participating in clinical trials, the Alzheimer’s community is now waiting in anticipation for other...
Amphastar Receives FDA Approval for Ganirelix Acetate Injection
Amphastar Pharmaceuticals, Inc.,announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application ("ANDA") for Ganirelix Acetate Injection, 250mg/0.5mL in a prefilled syringe. Ganirelix acetate injection is...
How Innovative Technology is Reshaping Patient Centric-Communications and the Integrity of Self-Reported Patient Data
As more clinical trials shift toward decentralized models, utilizing methods that enable remote monitoring and self-reported patient data are allowing for a patient-centric drug development process that does not require in-person clinical visits. Nevertheless, many...
Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance...
BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients with ESCC and NSCLC
BeiGene, Ltd., a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that marketing authorization applications (MAA) for tislelizumab,...
Curium Announces FDA Approval of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S.
Curium announced that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022, by the U.S. Food and Drug Administration (FDA). Ioflupane I 123 Injection is a single-photon emission computed tomography (SPECT) brain imaging agent used...
FDA Action Alert: BioXcel, Alnylam and Merck
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals. BioXcel Therapeutics, based in New Haven, Conn., has a target action date...
Deliberate infection trial finds COVID symptoms don’t indicate viral shedding
The world's first "human challenge" trial in which volunteers were deliberately exposed to the coronavirus has found that symptoms had no effect on how likely an infected person is to pass the disease on to others. The findings underscore the difficulty in preventing...
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