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INSIGHTS+

Insight+_Senior Editor
Insights+: The US FDA New Drug Approvals in October 2020
The US FDA has approved 4 NDAs and 1 BLA in Oct 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 90 novel products so far in 2020, including 5 in Oct 2020.…
November 19, 2020
Insight+_Senior Editor
Insights+ Key Biosimilars Events of October 2020
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency During the month of October, Henlius signed two agreements for its biosimilar products and presented results of HLX03 (biosimilar, adalimumab) whereas Samsung Bioepis and Biogen announced EMA filing acceptance of SB11 (biosimilar, ranibizumab) Our team at PharmaShots…
November 5, 2020
Insight+_Senior Editor
PharmaShots’ Key Highlights of Third Quarter 2020
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B. Apart from…
October 29, 2020
Insight+_Senior Editor
Insights+: The US FDA New Drug Approvals in September 2020
The US FDA has approved 6 NDAs in Sept 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 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year…
October 15, 2020
Insight+_Senior Editor
Insights+ Key Biosimilars Events of September 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…
October 1, 2020
Insights+: The US FDA New Drug Approvals in August 2020
Insights+: The US FDA New Drug Approvals in August 2020
The US FDA has approved multiple NDAs and BLAs in Aug 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 69 novel products so far in 2020, including 10 in Aug 2020. Additionally,…
September 17, 2020
Insights+ Key Biosimilars Events of August 2020
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 Mylan with its partner Lupin and Biocon launched Nepexto (biosimilar, etanercept) and Semglee (insulin glargine injection) in Germany & in the US, respectively. Additionally, Formycon and Bioeq planned to initiate P-III MAGELLAN-AMD Trial for its FYB203 (biosimilar,…
September 3, 2020
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