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INSIGHTS+

Insights+ Key Biosimilars Events of September 2021
Insights+ Key Biosimilars Events of September 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 September, Sandoz entered into a commercialization and license…
October 7, 2021
PharmaShots' Key Highlights of Third Quarter 2021
PharmaShots’ Key Highlights of Third Quarter 2021
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B,…
September 30, 2021
Insights+: The US FDA New Drug Approvals in August 2021
Insights+: The US FDA New Drug Approvals in August 2021
The US FDA has approved 6 NDAs and 1 BLAs in 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 68 novel products in 2021 Additionally, last year in 2020, the US FDA…
September 16, 2021
Insights+ Key Biosimilars Events of August 2021
Insights+ Key Biosimilars Events of August 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 August, Samsung Bioepis Byooviz (biosimilar, ranibizumab) received EC's…
September 2, 2021
Insights+: The US FDA New Drug Approvals in July 2021
Insights+: The US FDA New Drug Approvals in July 2021
The US FDA has approved 6 NDAs in 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 43 novel products in 2021 Additionally, last year in 2020, the US FDA has approved 121…
August 19, 2021
Insights+ Key Biosimilars Events of July 2021
Insights+ Key Biosimilars Events of July 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 Jul, Viatris & Biocon's Semglee got the US…
August 5, 2021
Insights+: The US FDA New Drug Approvals in June 2021
Insights+: The US FDA New Drug Approvals in June 2021
The US FDA has approved 6 NDAs and 2 BLAs in 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 37 novel products in 2021 Additionally, last year in 2020, the US FDA…
July 15, 2021
PharmaShots' Key Highlights of Second Quarter 2021
PharmaShots’ Key Highlights of Second Quarter 2021
The US FDA has approved 6 NDAs and 2 BLAs in 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 37 novel products in 2021 Additionally, last year in 2020, the US FDA…
July 7, 2021
Insights+ Key Biosimilars Events of June 2021
Insights+ Key Biosimilars Events of June 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 Jun, Celltrion launched Remsima SC (biosimilar, infliximab) for…
June 30, 2021
Insights+: The US FDA New Drug Approvals in May 2021
Insights+: The US FDA New Drug Approvals in May 2021
The US FDA has approved 4 NDAs and 1 BLAs in  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 29 novel products in 2021. Additionally, last year in 2020, the US FDA…
June 17, 2021
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