Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

Shots: Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanoma She also spoke on the epidemiology of melanoma and…

BySenior EditorMay 16, 2023

INSIGHTS+

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…

BySenior EditorMarch 23, 2023

INSIGHTS+

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…

BySenior EditorDecember 20, 2022

VIEWPOINTS

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…

BySenior EditorNovember 14, 2022

THOUGHTSPOT

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…

BySenior EditorSeptember 13, 2022

INSIGHTS+

Disease of the Month: Hepatitis – D Disease

Hepatitis D is a liver infection caused by the Hepatitis D virus (HDV) which causes the liver to become inflamed. It is also known by name of Hepatitis Delta virus or Delta Hepatitis1. Hepatitis D is a double infection as HDV requires the Hepatitis B virus (HBV) to replicate itself, therefore in the absence of…

BySenior EditorJuly 28, 2022

NEWS

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…

ByDipanshu DixitJuly 26, 2022

INSIGHTS+

Top Performing Drug of 2021 – Revlimid (June Edition)

Active Ingredients: Lenalidomide Strength: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg Dosage Form: Capsules Mechanism of Action: Angiogenic inhibitor First Approval: US (Dec 27, 2005), EU (14 Jun, 2007) Revenue Revlimid (lenalidomide) is one of the key products of Bristol-Myers Squibb (BMS) that represent a significant percentage of the company’s total revenue. Sales of…

BySenior EditorJune 23, 2022

INSIGHTS+

Insights+ Key Biosimilars Events of January 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. Hence, the providers are more likely to adopt biosimilars as a 'reference…

BySenior EditorFebruary 4, 2021

INSIGHTS+

Insights+: COVID-19 Healthcare News Monthly Updates – January 2020

Shots: Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019 PharmaShots is keeping a track of all of the important updates in the Lifesciences sector…

BySenior EditorDecember 31, 2020

Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

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

Disease of the Month: AIDS

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

ILAP and its nuance vs PRIME since BREXIT

Disease of the Month: Hepatitis – D Disease

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

Top Performing Drug of 2021 – Revlimid (June Edition)

Insights+ Key Biosimilars Events of January 2021

Insights+: COVID-19 Healthcare News Monthly Updates – January 2020

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