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INSIGHTS+

New Drug Designations - October 2023
New Drug Designations – October 2023
Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA and the EMA. This month’s report includes 2 biological drugs, 12 small molecules, 10 cell and gene therapies, 2 vaccines, 1 peptide, 1 exosome-based therapy and 3 devices  HuidaGene Therapeutics’ HG204 CRISPR RNA-editing therapy, focused on the treatment of MECP2 duplication…
November 20, 2023
Insights+: The US FDA New Drug Approvals in October 2023
Insights+: The US FDA New Drug Approvals in October 2023 
Shots:  The US FDA approved 5 NDAs & 9 BLAs in October 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023  In October 2023, the major highlights drugs were Velsipity (Etrasimod) approved for Ulcerative Colitis, and Bimzelx (bimekizumab) for the Treatment of Adults…
November 15, 2023
Know Your Investor: OrbiMed Advisors
Know Your Investor: OrbiMed Advisors
Shots:  Know Your Investor’s October Edition focuses on a renowned healthcare investment firm, OrbiMed Advisors, known for making considerable investments in healthcare companies   In 1989, Viren Mehta and Samuel Isaly founded a money management and research organization, an antecedent to OrbiMed. The company made its first investment in 1993   In 2022, OrbiMed Advisors made 31…
November 2, 2023
Insights+ Key Biosimilars Events of October 2023
Insights+ Key Biosimilars Events of October 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 October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple…
November 1, 2023
Insights+: EMA Marketing Authorization of New Drugs in September 2023
Insights+: EMA Marketing Authorization of New Drugs in September 2023
Shots:  The EMA approved 11 New Chemical Entity (NCE) and 8 Biologic Drugs in September 2023, leading to treatments for patients and advances in the healthcare industry  In September 2023, the major highlight drugs were Litfulo (ritlecitinib) for adolescents and adults with s9ere alopecia areata & Orserdu (elacestrant) for ER+, HER2- locally advanced or metastatic…
October 26, 2023
Top Performing Drug – Tagrisso (October 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 Tagrisso and prepared a curated analysis report for our readers Tagrisso is indicated for the treatment of non-small-cell lung carcinomas with specific mutations. It is a 3rd generation drug that belongs to the…
October 25, 2023
Insights+: The US FDA New Drug Approvals in September 2023
Insights+: The US FDA New Drug Approvals in September 2023
Shots: The US FDA approved 7 NDAs and 2 BLAs in September 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023 In September 2023, the major highlights drugs were Ojjaara (momelotinib) approval for myelofibrosis patients with anemia, and Entyvio (vedolizumab) for subcutaneous…
October 18, 2023
New Drug Designations - September 2023
New Drug Designations – September 2023
Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, and China. This month’s report includes 10 biological drugs, 15 small molecules, 5 cell and gene therapies, 4 devices, 1 vaccine and 1 microbiota  MicuRx’ Contezolid and Contezolid acefosamil, focused on the treatment of Diabetic…
October 16, 2023
Disease of the Month- Osteoporosis
Disease of the Month- Osteoporosis
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 Osteoporosis, a bone and tissue disorder  October 20th is observed as…
October 12, 2023
Insights+ Key Biosimilars Events of September 2023
Insights+ Key Biosimilars Events of September 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 September, Sandoz entered into a development and commercialization agreement…
October 4, 2023
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