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Key Biosimilars Events of December 2024

Shots: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 patients A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…

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Key Biosimilars Events of December 2024

Key Biosimilars Events of December 2024

Shots:      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 patients       A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…

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EMA Marketing Authorization of New Drugs in October 2024

EMA Marketing Authorization of New Drugs in October 2024

Shots:   The EMA’s CHMP has granted positive opinions to 5 Biologics and 1 New Chemical Entity in October 2024, leading to treatments for patients and advances in the healthcare industry  The major highlighted drugs were Novo Nordisk’s Alhemo to treat Haemophilia A or B with inhibitors and AstraZeneca & Ionis’ Wainzua for Hereditary Transthyretin-Mediated Amyloidosis PharmaShots has…

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Key Biosimilars Events of October 2024

Key Biosimilars Events of October 2024

Shots:      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 patients       The major highlights were the US FDA’s approval of Dong-A ST’s Imuldosa…

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The US FDA New Drug Approvals in September 2024

The US FDA New Drug Approvals in September 2024

Shots:     PharmaShots has compiled a list of US FDA-approved drugs in the month of September 2024     The US FDA has approved a total of 7 new drugs including 4 new molecular entities and 3 biologics leading to the treatment of patients and advances in the healthcare industry       The major highlighted drugs were Roche’s Tecentriq Hybreza & Ocrevus Zunovo for…

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New Drug Designations - August 2024

New Drug Designations – August 2024 

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices  In August 2024, Invenra’s INV724 received the…

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Insights+: EMA Marketing Authorization of New Drugs in August 2024

Insights+: EMA Marketing Authorization of New Drugs in August 2024

Shots:   The EC has approved to 5 Biologics and 3 New Chemical Entities in August 2024, leading to treatments for patients and advances in the healthcare industry  The major highlighted drugs were Johnson & Johnson’s Balversa to treat Metastatic Urothelial Carcinoma (mUC) and Takeda’s Adzynma for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) PharmaShots has compiled a list…

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