PharmaShots’ Key Highlights of Third Quarter 2023

Shots: Third quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, Biogen acquired Reata Pharmaceuticals for ~$7.3B and Danaher acquired Abcam for ~$5.7B The third quarter of the year also showcases multiple clinical trial results which include Janssen reported P-IIb…

BySenior EditorOctober 2, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in August 2023

Shots: The EMA approved 5 New Chemical Entity (NCE) and 6 Biologic Drugs in August 2023, leading to treatments for patients and advances in the healthcare industry In August 2023, the major highlight drugs were Aquipta (atogepant) approved for the preventive treatment of migraine in adults & Opdivo (nivolumab) as an adjuvant treatment for completely…

BySenior EditorSeptember 28, 2023

INSIGHTS+

Know Your Investor: F-Prime Capital Partners

Shots: PharmaShots' tertiary report on the Know Your Investor Section features F-Prime Capital Partners. 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 1969, F-Prime Capital Partners is a subsidiary of Fidelity Investments and primarily invests in healthcare…

BySenior EditorSeptember 28, 2023

INSIGHTS+

Top Performing Drug – Ozempic (September Edition)

Shots: PharmaShots’ next episode on the top-performing drug of the month, based on 2021 revenue, focuses on Ozempic, a drug developed and marketed by Novo Nordisk Ozempic (semaglutide) is a human GLP-1 receptor agonist (or GLP-1 analog). It, when taken along with diet and exercise, is proven to improve blood sugar in adults with type 2…

BySenior EditorSeptember 27, 2023

VIEWPOINTS

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Shots: Ruud talked about the key findings from the new RWE data at ERA-EDTA'23 which demonstrated the staggeringly low rate of diagnosis in chronic kidney disease (CKD) He then discussed the risk factors of CKD and the urgent need to act on the growing global burden of CKD and how this disease is impacting the…

BySenior EditorSeptember 25, 2023

VIEWPOINTS

The US FDA OTC Approval of Topical Gel for Erectile Dysfunction: Insights from Ken James

Shots: Ken gave a brief overview of the OTC marketing approval of Eroxon (MED3000) by the US FDA. He also talked about Eroxon’s mechanism of action and how it helps to treat erectile dysfunction Later, he discussed the study design and results obtained from the clinical trial based on which the approval was granted. In…

BySenior EditorSeptember 21, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in August 2023

Shots: The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023 In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…

BySenior EditorSeptember 20, 2023

VIEWPOINTS

Grant Kim Shares His Views from the Data Showing the World’s First Dual-Chamber Leadless Pacemaker Study Achieving All Three Primary Endpoints

Shots: Grant started by highlighting the characteristics of the AVEIR DR leadless pacemaker and this pacemaker is an effective treatment for people with slower-than-normal heart rhythms He discussed the AVEIR™ DR i2i™ IDE study's design and outcomes, which assessed the safety and performance of the world's first dual-chamber leadless pacemaker. The study effectively met all…

BySenior EditorSeptember 19, 2023

VIEWPOINTS

Simon Portsmouth Shares Insights from P-III Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Shots: Simon spoke about the enrollment of the first participant in Japan in the P-III (SCORPIO-PEP) study to evaluate the safety and efficacy of Ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection He mentioned how this study will supplement data from the pivotal SCORPIO-SR trial's P-III segment which showed ensitrelvir's effectiveness in treating mild-to-moderate COVID-19…

BySenior EditorSeptember 18, 2023

INSIGHTS+

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…

BySenior EditorSeptember 18, 2023

Senior Editor

PharmaShots’ Key Highlights of Third Quarter 2023

Insights+: EMA Marketing Authorization of New Drugs in August 2023

Know Your Investor: F-Prime Capital Partners

Top Performing Drug – Ozempic (September Edition)

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

The US FDA OTC Approval of Topical Gel for Erectile Dysfunction: Insights from Ken James

Grant Kim Shares His Views from the Data Showing the World’s First Dual-Chamber Leadless Pacemaker Study Achieving All Three Primary Endpoints

Simon Portsmouth Shares Insights from P-III Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

New Drug Designations – August 2023

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