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INSIGHTS+

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…
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,…
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…
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…
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…
Insights+ The US FDA New Drug Approvals in August 2022
Insights+: The US FDA New Drug Approvals in August 2022
The US FDA approved 4 NDAs and 1 BLA in August 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 47 novel products in 2022 In August 2022, the major highlights drugs were Calquence's approval for blood cancer, Imbruvica (ibrutinib) for chronic graft versus host disease in…
Insights+ Key Biosimilars Events of August 2022
Insights+ Key Biosimilars Events of August 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 August, Formycon reported P-III (VESPUCCI) trial results of…
Disease of the Month: Gastroparesis Disease
Disease of the Month: Gastroparesis Disease
Gastroparesis is a chronic disease affecting the motility of the stomach muscles. It refers to partial paralysis of the stomach. It usually occurs due to nerve injury including vagus nerve damage. Normally the strong muscular contractions of vagus nerve move the food through the digestive tract, but in the case of gastroparesis, this spontaneous movement…
Top Performing Drug of 2021 – Stelara (August Edition)
Top Performing Drug of 2021 – Stelara (August Edition)
Active Ingredients: Ustekinumab Strength: 45 mg/0.5 mL or 90 mg/mL (SC), 130 mg/26 mL (IV) Dosage Form: Injection Mechanism of Action: Interleukin 12 & 23 inhibitor First Approval: US (25 Sep, 2009), EU (16 Jan, 2009) Revenue1 Stelara is the leading blockbuster drug of Johnson & Johnson. Stelara contributed 9.7% of the Company's total revenues for 2021. Stelara up took…
Insights+ The US FDA New Drug Approvals in July 2022
Insights+: The US FDA New Drug Approvals in July 2022
The US FDA approved 4 NDAs and 1 BLA in July 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 42 novel products in 2022 In July 2022, the major highlights drugs were Zonisade's approval for partial seizures in adults and pediatric patients with epilepsy, Opzelura (ruxolitinib)…