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INSIGHTS+

New Drug Designations - August 2023
New Drug Designations – August 2023
Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices  Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…
September 18, 2023
Disease of the Month- Mesothelioma
Disease of the Month- Mesothelioma
Shots:  To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research   Continuing the series for the disease of the month, PharmaShots brings a condensed report on Mesothelioma, a type of cancer that affects the lining of…
September 14, 2023
Insights+ Key Biosimilars Events of August 2023
Insights+ Key Biosimilars Events of August 2023
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 patients During the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…
September 6, 2023
Know Your Investor: RA Capital Management LLC
Shots: PharmaShots’ second dose of the Know Your Investor series focuses on RA Capital Management LLC. Know Your Investor is an earnest effort from PharmaShots to acquaint our readers with leading Investors and venture capital firms in the healthcare industry Founded in 2002, RA Capital forged ahead to become a key investor in life science…
August 31, 2023
Insights+: EMA Marketing Authorization of New Drugs in July 2023
Insights+: EMA Marketing Authorization of New Drugs in July 2023
Shots: The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industry In July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancer PharmaShots has compiled a list…
August 24, 2023
Top Performing Drug – Ibrance (August Edition)
Top Performing Drug – Ibrance (August Edition)
Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have selected Ibrance and prepared a curated analysis report for our readers Ibrance is a targeted cancer therapy developed to treat certain types of advanced breast cancer. It belongs to a class of drugs called CDK4/6…
August 23, 2023
New Drug Designations - July 2023
New Drug Designations – July 2023
Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test  MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…
August 21, 2023
Disease of the Month - Spinal Muscular Atrophy
Disease of the Month – Spinal Muscular Atrophy
Shots: To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research   Continuing the series for the disease of the month, PharmaShots brings this month a summary of Spinal Muscular Atrophy, a genetic neuromuscular disease that affects…
August 17, 2023
Insights+: The US FDA New Drug Approvals in July 2023
Insights+: The US FDA New Drug Approvals in July 2023
Shots: The US FDA approved 5 NDAs and 2 BLA in July 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 76 novel products in 2023 In July 2023, the major highlights drugs were Beyfortus (nirsevimab) approval for the prevention of RSV lower respiratory tract disease in…
August 16, 2023
Insights+ Key Biosimilars Events of July 2023
Insights+ Key Biosimilars Events of July 2023
Shots: 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, Samsung Bioepis reported P-III equivalence study…
August 4, 2023
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