Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Shots: The US FDA has approved Dupixent to treat adults with bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.; regulatory review is ongoing in the EU, Japan, & China Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks.…

ByRidhi Rastogi1 day ago

News

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Shots : Regeneron highlighted the data at RAD’25 from the P-IV (DISCOVER) study evaluating Dupixent in pts (N=120) with atopic dermatitis with skin of color that received Dupixent as monotx. Q2W based on weight after loading dose: 200mg for 30-60kg pts & 300mg for ≥60kg pts Dupixent achieved a ≥75% improvement in overall disease severity…

ByPrince GiriJune 10, 2025

TOP 20

Top 20 Biopharma Companies of 2025

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…

ByPrince GiriApril 24, 2025

News

Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria

Shots: The US FDA has approved Dupixent to treat CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program; regulatory review ongoing in EU & other regions Study A & C assessed Dupixent (loading dose then 300mg Q2W; pts weighing <60kg received 200mg)…

ByRidhi RastogiApril 21, 2025

News

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…

ByRidhi RastogiMarch 28, 2025

News

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Shots: The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025) sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…

ByRidhi RastogiFebruary 18, 2025

TOP 20

Top 20 Monoclonal Antibodies of 2024

Shots: Transforming care with advanced mechanisms of action, monoclonal antibody therapies hold a strong foothold in the healthcare market In 2021, the monoclonal antibody therapy market size was valued at $178.5B and is envisioned to reach $451.89B by 2028, displaying a CAGR of 14.1%. Keytruda with $25.01B revenue ranks first in our list followed by…

ByPrince GiriSeptember 12, 2024

News

Sanofi & Regeneron’s Dupixent Receives the CHMP’s Positive Opinion for Treating Chronic Obstructive Pulmonary Disease (COPD)

Shots: The CHMP’s positive opinion of Dupixent as an add-on maintenance therapy for uncontrolled COPD patients with type 2 inflammation was based on P-II (BOREAS & NOTUS) studies assessing its safety & efficacy for the same Studies met the 1EP depicting a 34% reduction in annualized moderate or severe acute COPD exacerbations, sustained lung function…

ByDipanshu DixitMay 31, 2024

INSIGHTS+

Most Viewed Articles of 2023

2023, remained a busy year for PharmaShots. To keep our readers up to date on the developments in the healthcare sector, PharmaShots worked steadfastly to deliver real-time and real-world updates. Here’s a synopsis of our key reports and most-read news of the year. Top 20 Radiopharma Companies Based on Market Cap Shots: Integrating scintigraphy with…

BySaurabh ChaubeyJanuary 2, 2024

TOP 20

Top 20 Prescription Drugs Based on 2022 Total Revenue

Shots: Prescription drugs have an instrumental role in effectively controlling chronic diseases like heart-related conditions, diabetes, arthritis, hypertension, and cancer, among others. Unlike over-the-counter drugs, prescription drugs are advised not to be taken without the authorization of a doctor In 2022, the global market size of prescription drugs was worth $1035.5B and is envisioned to…

ByPrince GiriNovember 21, 2023

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Top 20 Biopharma Companies of 2025

Regeneron and Sanofi Report the US FDA’s Approval of Dupixent for Chronic Spontaneous Urticaria

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Top 20 Monoclonal Antibodies of 2024

Sanofi & Regeneron’s Dupixent Receives the CHMP’s Positive Opinion for Treating Chronic Obstructive Pulmonary Disease (COPD)

Most Viewed Articles of 2023

Top 20 Prescription Drugs Based on 2022 Total Revenue

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