GSK Reports the CHMP Positive Opinion of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots: CHMP recommended GSK's depemokimab as add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively; EC’s decision expected in Q1’26 SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma exacerbations by 54% over 52wks. (1EP)…

ByRidhi RastogiDecember 15, 2025

INSIGHTS+

Key Biosimilars Events of November 2025

Shots: Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…

ByDipanshu DixitDecember 2, 2025

NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…

ByRidhi RastogiSeptember 29, 2025

NEWS

Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

Shots: Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…

ByRidhi RastogiAugust 5, 2025

NEWS

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 asthma Trial 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 & CRSwNP Alvotech & 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 readers Dupixent 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

GSK Reports the CHMP Positive Opinion of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Key Biosimilars Events of November 2025

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

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)

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