Insights+: EMA Marketing Authorization of New Drugs in December 2022

Shots: The EMA approved 6 New Chemical Entity (NCE) and 6 Biologic Drugs in December 2022, leading to treatments for patients and advances in the healthcare industry In December 2022, the major highlights drugs were Pluvicto’s approval for progressive PSMA+ metastatic castration resistant prostate cancer, Dupixent for Prurigo Nodularis PharmaShots has compiled a list of…

BySenior EditorJanuary 24, 2023

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Insights+: EMA Marketing Authorization of New Drugs in November 2022

Shots: The EMA approved 4 New Chemical Entity (NCE) and 4 Biologic Drugs in November 2022, leading to treatments for patients and advances in the healthcare industry In November 2022, the major highlights drugs were Skyrizi's approval for active crohn's disease, Beyfortus for RSV lower respiratory tract disease PharmaShots has compiled a list of a…

BySenior EditorDecember 28, 2022

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Insights+: The US FDA New Drug Approvals in November 2022

The US FDA approved 1 NDAs and 6 BLA in November 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 73 novel products in 2022 In November 2022, the major highlights drugs were Imfinzi (durvalumab) + Imjudo (tremelimumab) approval for metastatic non-small cell lung cancer, Elahere for…

BySenior EditorDecember 15, 2022

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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…

BySenior EditorOctober 6, 2022

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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,…

BySenior EditorSeptember 29, 2022

INSIGHTS+

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…

BySenior EditorSeptember 22, 2022

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PharmaShots’ Key Highlights of Third Quarter 2021

The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B,…

BySenior EditorSeptember 30, 2021

VIEWPOINTS

PharmaShots Interview: Dr. Ahmet Sezer, Karl Lewis, and Regeneron’s Israel Lowy Share Insights on Libtayo (cemiplimab) for NSCLC & BCC

In an interview with PharmaShots, Dr. Ahmet Sezer, (Professor in the Department of Medical Oncology at Baskent University), Karl Lewis (Professor in the Division of Medical Oncology at the University of Colorado) and Israel Lowy (Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron) shared their views on the EC's approval of Libtayo for…

BySenior EditorSeptember 29, 2021

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US…

BySenior EditorMarch 18, 2021

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Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020.…

BySenior EditorNovember 19, 2020

Insights+: EMA Marketing Authorization of New Drugs in December 2022

Insights+: EMA Marketing Authorization of New Drugs in November 2022

Insights+: The US FDA New Drug Approvals in November 2022

Insights+ Key Biosimilars Events of September 2022

PharmaShots’ Key Highlights of Third Quarter 2022

PharmaShots’ Key Highlights of Third Quarter 2021

PharmaShots Interview: Dr. Ahmet Sezer, Karl Lewis, and Regeneron’s Israel Lowy Share Insights on Libtayo (cemiplimab) for NSCLC & BCC

Insights+: The US FDA New Drug Approvals in February 2021

Insights+: The US FDA New Drug Approvals in October 2020

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