Tags : 2020

Fitbit to Launch ECG App in the US and EU

Shots: Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The ECG app will be available in Oct’2020 to the users on the Fitbit Sense smartwatch The company has launched a multi-site clinical trial across the US, to detect AFib from […]Read More

Insights+ Key Biosimilars Events of August 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally, […]Read More

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19

Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants In P-I study, BNT162b2 (@7days after the second dose […]Read More

Insights+: The US FDA New Drug Approvals in June 2020

 The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, […]Read More

Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July,

Shots: Moderna has reported the robust results of its ongoing P-I study that demonstrated mRNA-1273 at (25-, 100- & 250-mcg dose levels) induced anti–SARS-CoV-2 immune responses in all participants with no trial-limiting safety concerns. These results were published in NEJM All participants seroconverted by the 15-day mark. Post two vaccinations, @57day, geometric mean titers exceeded […]Read More

20th International Nutrition & Diagnostics Conference 2020

INDC 2020, Congress Centre Masarykova kolej, Prague, Nov 29 – Dec 02, 2020 INDC is an international forum for a scientific discussion focused on the understanding the relationship between nutrition and clinical diagnostics. TOPICS: METABOLOMICS AND MICROBIOME, PROBIOTICS, PREBIOTICS, NUTRACEUTICALS AND BOTANICALS FOR HUMAN HEALTH Probiotics and Prebiotics, Microbiota, Polyphenols, Bioactive Compounds, Prediction of Bioavailability, Chronic Diseases, Celiac […]Read More

Insights+ Key Biosimilars Events of June 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More