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INSIGHTS+

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…
November 3, 2022
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…
October 27, 2022
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…
October 26, 2022
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…
October 20, 2022
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…
October 18, 2022
Insights+ Key Biosimilars Events of September 2022
Insights+ Key Biosimilars Events of September 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 September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the…
October 6, 2022
PharmaShots' Key Highlights of Third Quarter 2022
PharmaShots’ Key Highlights of Third Quarter 2022
The third quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include CVS Health acquired Signify Health for ~$8B, Amgen acquired Chemocentryx for ~$4B The third quarter of the year also showcases multiple approvals of the therapies which include Incyte's Opzelura US FDA's approval for Vitiligo,…
September 29, 2022
Disease of the Month: Duchenne Muscular Dystrophy (DMD)
Disease of the Month: Duchenne Muscular Dystrophy (DMD)
INTRODUCTION Duchenne Muscular Dystrophy (DMD) is a rare and the most frequent genetic neuromuscular disorder affecting all races and ethnicities (affecting approximately 1 in 3,500 population). It is characterized by progressive muscle weakness and some specific abnormalities like changes in muscle fiber size, scar tissue formation, muscle fiber necrosis, and inflammation evidenced from muscle biopsy…
September 29, 2022
Insights+ EMA Marketing Authorization of New Drugs in August 2022
Insights+: EMA Marketing Authorization of New Drugs in August 2022
The EMA approved 5 New Chemical Entity (NCE) and 4 Biologic Drugs in August 2022, leading to treatments for patients and advances in the healthcare industry In August 2022, the major highlights drugs were Lynparza’s approval for breast cancer, Imbruvica (ibrutinib) for chronic lymphocytic leukaemia, Sunlenca (lenacapavir) for HIV Infection PharmaShots has compiled a list…
September 28, 2022
Top Performing Drug of 2021 – Eylea (September Edition)
Top Performing Drug of 2021 – Eylea (September Edition)
Active Ingredient: Aflibercept Strength: 2 mg (0.05 mL) Dosage Form: Injection (intravitreal) Mechanism of Action: VEGF-A and PlGF inhibitors First Approval: US (18 Nov 2011), EU (27 Nov 2012) Revenue1 EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in…
September 22, 2022
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