AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma

Shots:AstraZeneca has reported P-III (LOGOS & KALOS) trial results evaluating Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts (n=~4400) with uncontrolled asthmaTrial met its 1EP, with BGF 320/28.8/9.6μg showing significant improvement in forced expiratory volume in 1 second (FEV1) AUC 0 to 3hrs. at…

ByRidhi RastogiMay 2, 2025

News

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots:The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNPAlvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech &…

ByRidhi RastogiMarch 26, 2025

News

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Shots:The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU) Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in…

ByDipanshu DixitMarch 10, 2025

News

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Shots:The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

BySenior EditorJanuary 28, 2025

THOUGHTSPOT

Health Equity: A Pressing Need

Shots: With half of the World's population devoid of primary healthcare facilities, health equity is indeed an indispensable need of the present. With health equity instated, potentially everyone can attain the highest level of health. It means no more deaths from vaccine-preventable diseases, and a healthy equilibrium in the physical, mental, and social aspects of…

BySaurabh ChaubeyOctober 10, 2023

INSIGHTS+

Top Performing Drug – Dupixent (April 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 Dupixent and prepared a curated analysis report for our readersDupixent is an interleukin-4 receptor alpha antagonist used for the treatment of multiple indications including atopic dermatitis, asthma, eosinophilic esophagitis, etc.PharmaShots…

BySenior EditorApril 26, 2023

VIEWPOINTS

Zack Usilton, Chief Development Officer at Senta Partners Shares Insights from their Partnership with Reston ENT to Expand its Network of ENT Practices

Shots: Zack Usilton spoke about their partnerships with Reston ENT. He also elaborated on their past collaborations with some of the allergy groupsHe also spoke on how these alliances will help Senta Partners to expand its footprint across 57 locations in 5 states in the Mid-Atlantic region The interview gives an understanding of Senta…

BySenior EditorMarch 2, 2023

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Top Performing Drug – Dupixent (April Edition)

Zack Usilton, Chief Development Officer at Senta Partners Shares Insights from their Partnership with Reston ENT to Expand its Network of ENT Practices

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AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP

Health Equity: A Pressing Need

Top Performing Drug – Dupixent (April Edition)

Zack Usilton, Chief Development Officer at Senta Partners Shares Insights from their Partnership with Reston ENT to Expand its Network of ENT Practices

FOLLW US

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