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INSIGHTS+

Insights+ Key Biosimilars Events of November 2022
Insights+ Key Biosimilars Events of November 2022
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 November, Samsung Bioepis presented two P-III studies results…
Top Performing Drug of 2021 – Xarelto (November Edition)
Top Performing Drug of 2021 – Xarelto (November Edition)
Active Ingredient: rivaroxaban  Strength: 2.5 mg, 10 mg, 15 mg, and 20 mg  Dosage Form: Tablets  Mechanism of Action: Factor Xa inhibitors  First Approval: US (1 Jul 2011), EU (30 Sep 2008)  Revenue Analysis of Xarelto1  Xarelto has been an important driver of the revenue generated from the cardiovascular portfolio of Janssen. The blood thinner showed an increase of 4%…
Insights+ EMA Marketing Authorization of New Drugs in October 2022
Insights+: EMA Marketing Authorization of New Drugs in October 2022
The EMA approved 2 Biologic Drugs in October 2022, leading to treatments for patients and advances in the healthcare industry In October 2022, the major highlights drugs were Yescarta approval for diffuse large B-cell lymphoma and high-grade B-cell lymphoma, and Adtralza for atopic dermatitis PharmaShots has compiled a list of a total of 2 new…
Insights+ The US FDA New Drug Approvals in October 2022
Insights+: The US FDA New Drug Approvals in October 2022
The US FDA approved 1 NDAs and 2 BLA in October 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 66 novel products in 2022 In October 2022, the major highlights drugs were Tecvayli’s approval for relapsed or refractory multiple myeloma, Furoscix for congestion in chronic heart…
Disease of the Month: Epilepsy
Disease of the Month: Epilepsy
INTRODUCTION Also known as seizure disorder, epilepsy is a non-communicable chronic disorder of the brain and is the fourth most common neurological disease globally. It is a central nervous system (CNS) disorder characterized by recurrent episodes of seizures that are short changes in normal brain activity which led to brief incidences of involuntary movements either…
Insights+ Key Biosimilars Events of October 2022
Insights+ Key Biosimilars Events of October 2022
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 October, Similis Bio entered into a development and…
Top Performing Drug of 2021 – Biktarvy (October Edition)
Top Performing Drug of 2021 – Biktarvy (October Edition)
Active Ingredient: bictegravir, emtricitabine, and tenofovir alafenamide Strength: 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF/ 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF Dosage Form: Tablet Mechanism of Action: HIV reverse transcriptase inhibitors First Approval: US (07 Feb 2018), EU (25 Jun 2018) Revenue1 Gilead's HIV drug, Biktarvy has…
Insights+ EMA Marketing Authorization of New Drugs in September 2022
Insights+: EMA Marketing Authorization of New Drugs in September 2022
The EMA approved 7 New Chemical Entity (NCE) and 4 Biologic Drugs in Sept 2022, leading to treatments for patients and advances in the healthcare industry In September 2022, the major highlights drugs were Imcivree approval for bardet-biedl syndrome, Opdualag for unresectable or metastatic melanoma, Ultomiris for generalised myasthenia gravis PharmaShots has compiled a list…
Insight+_Senior Editor
Insights+: The US FDA New Drug Approvals in September 2022
The US FDA approved 12 NDAs and 4 BLA in September 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 63 novel products in 2022 In September 2022, the major highlights drugs were Spevigo’s approval for generalized pustular psoriasis flares, Imfinzi for advanced biliary tract cancer, Retevmo…
Disease of the Month: Cerebral Palsy
Disease of the Month: Cerebral Palsy
INTRODUCTION Cerebral Palsy is a group of neurological disorders which affect motor and developmental skills. It causes disability in muscle tone, movement, balance, and posture. It is the most common motor disability in childhood with an estimated prevalence ranging from 1-4 per 1,000 live births. The incidence of CP is more in preterm or low…