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INSIGHTS+

Insights+ Key Biosimilars Events of May 2021
Insights+ Key Biosimilars Events of May 2021
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 During the month of May, Samsung initiated patient enrollment in the P-III…
June 3, 2021
Insights+: The US FDA New Drug Approvals in April 2021
Insights+: The US FDA New Drug Approvals in April 2021
The US FDA has approved 3 NDAs and 2 BLAs in April 2021, 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 24 novel products in 2021. Additionally, last year in 2020, the US…
May 13, 2021
Insights+ Key Biosimilars Events of April 2021
Insights+ Key Biosimilars Events of April 2021
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 During the month of April, Biocon and Viatris received EC's approval for…
May 6, 2021
Insights+: The US FDA New Drug Approvals in March 2021
Insights+: The US FDA New Drug Approvals in March 2021
The US FDA has approved 7 NDAs in Mar 2021, 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 19 novel products in 2021. Additionally, last year in 2020, the US FDA has approved…
April 15, 2021
PharmaShots' Key Highlights of First Quarter 2021
PharmaShots’ Key Highlights of First Quarter 2021
The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter…
April 4, 2021
Insights+ Key Biosimilars Events of March 2021
Insights+ Key Biosimilars Events of March 2021
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 During the month of March, Samsung Bioepis Initiated P-I Study of SB17…
April 1, 2021
Insights+: The US FDA New Drug Approvals in February 2021
Insights+: The US FDA New Drug Approvals in February 2021
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, 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 12 novel products in 2021. Additionally, last year in 2020, the US…
March 18, 2021
Insights+: Breakthrough Therapy Designation by the US FDA in 2020
Insights+: Breakthrough Therapy Designation by the US FDA in 2020
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…
March 11, 2021
Insights+ Key Biosimilars Events of February 2021
Insights+ Key Biosimilars Events of February 2021
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 During the month of Feb, Biocon collaborated with CHAI to expand access…
March 4, 2021
Insights+: The US FDA New Drug Approvals in January 2021
Insights+: The US FDA New Drug Approvals in January 2021
The US FDA has approved 4 NDAs in Jan 2021, 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 4 novel products in 2021. Additionally, last year in 2020, the US FDA has approved…
February 18, 2021
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