The US FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019.However, there is a significant increase in multiple diseases while the new approvals are helping and advancing the changes to understand, diagnose, and treat the diseasesOur team…
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…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyHence, the providers are more likely to adopt biosimilars as a 'reference product to biologics' possessing similar therapeutic propertiesThe US FDA took an initiative to develop new pathways for Insulin biosimilars. Our team at PharmaShots has…
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop itThe outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where…
The first quarter of 2020 includes big news regarding global companies. The highlight of the quarter is the acquisition of QIAGEN by ThermoFisher for ~$11.5B, Danaher's acquisition of the biopharma business of GE Life Sciences in an all-cash transaction for ~$21.4B. Numerous alliances are there which include Fosun's agreement with BioNTech to develop and commercialize…
The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health careThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan…
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012.The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to high-priced branded biologics, offering significant and much-needed cost savings to both payers and patientsThe Korean firm, Celltrion's Remsima also showed some updates in fields of approval and…
After 7 series of successful conferences, we are back afresh with the 8th International Conference on Neurology and Neuroscience, curated by a panel of expert neuroscientists and neurologists on the dates April 06-07, 2020 in Dubai, UAE. With an experience of over 20 years in organizing international conferences, covering almost every field of life-science, Allied…
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named 'SARS-CoV-2'(severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named 'Coronavirus Disease 2019'(COVID-19). The outbreak of the respiratory disease was first detected in Wuhan…

