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Insights+: EMA Marketing Authorization of New Drugs in February 2023

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots: The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome PharmaShots has compiled…

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Disease of the Month: AIDS

Disease of the Month: AIDS

“Putting Ourselves to the Test: Achieving Equity to End HIV”  -Theme of the year 2022  Introduction: HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system. HIV, a type of retrovirus that isn't…

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Viewpoints_Dr. Susana Banerjee

Dr. Susana Banerjee, Medical Oncologist at The Royal Marsden Shares Insights from the SOLO-1 P-III Trial of Lynparza in Patients with BRCA Mutated Ovarian Cancer

Shots: Dr. Susan talked about the results from the SOLO-1 P-III trial of Lynparza in patients with BRCA mutated (BRCAm) newly diagnosed advanced ovarian cancer presented at ESMO’22 Dr. Susan also spoke about the overall survival of this 7-year follow-up study.The 7-year follow-up of SOLO-1 showed that olaparib provided a clinically meaningful improvement in OS…

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ThoughtSpot_Senior Editor

ILAP and its nuance vs PRIME since BREXIT

Introduction PRIME (PRIority MEdicines) EMA launched PRIME on March 07, 2016, to support the development of medicines targeting unmet medical needs. The scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients faster. PRIME builds on the…

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LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE) 

  Shots:    The CHMP has granted positive opinion to Anzupgo cream (topical pan-JAK inhibitor) for treating moderate to severe chronic hand eczema (CHE), inadequately managed by topical corticosteroids  Opinion was based on P-III (DELTA 1 & DELTA 2) trials assessing the safety & efficacy of Anzupgo (BID) vs vehicle for moderate to severe CHE. Those…

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Insights+ Key Biosimilars Events of July 2020

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar) Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020 1. Samsung…

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