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INSIGHTS+

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…
September 15, 2022
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…
September 1, 2022
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…
August 31, 2022
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…
August 25, 2022
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)…
August 18, 2022
Insights+ Key Biosimilars Events of July 2022
Insights+ Key Biosimilars Events of July 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 July, Polpharma Biologics reported EMA's acceptance of MAA…
August 4, 2022
Disease of the Month: Hepatitis - D Disease
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…
July 28, 2022
Top Performing Drug of 2021 - Eliquis (July Edition)
Top Performing Drug of 2021 – Eliquis (July Edition)
Active Ingredients: Apixaban Strength: 2.5 mg and 5 mg Dosage Form: Tablet Mechanism of Action: Factor Xa inhibitors First Approval: US (Dec 28, 2012), EU (May 18, 2011) Revenue1 Eliquis is a leading novel oral anticoagulant of BMS. The revenue for BMS continued to grow due to Eliquis and other recently launched new products. BMS and Pfizer jointly develop and…
July 28, 2022
Insights+ The US FDA New Drug Approvals in June 2022
Insights+: The US FDA New Drug Approvals in June 2022
The US FDA approved 2 NDAs and 2 BLA in June 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 37 novel products in 2022 In June 2022, the major highlights drugs were Amvuttra's approval for polyneuropathy of hereditary transthyretin-mediated amyloidosis, Skyrizi for active Crohn's disease, Olumiant…
July 21, 2022
Insights+ Key Biosimilars Events of June 2022
Insights+ Key Biosimilars Events of June 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 June, Organon entered into an agreement with Henlius…
July 7, 2022
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