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Merck
NEWS

Merck Secures the EC’s Approval for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD)

Shots: The EC has approved Capvaxive for active immunization against invasive disease & pneumonia caused by S. pneumoniae in adults (≥18yrs.) in 30 EEA states Approval was backed by P-III (STRIDE-3) data, assessing Capvaxive vs PCV20 in pneumococcal vaccine-naïve adults (≥18yrs.), plus data from various P-III trials (STRIDE-4, STRIDE-5,  STRIDE-6, STRIDE-7, & STRIDE-10) assessing it in both vaccine-naïve & vaccinated adults STRIDE…
March 27, 2025

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GSK
NEWS

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Shots: The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25 Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days)…
March 26, 2025

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Disease of the Month – Lennox-Gastaut syndrome (LGS)
INSIGHTS+

Disease of the Month – Lennox-Gastaut syndrome (LGS)

Shots:  Lennox-Gastaut syndrome (LGS) is a severe childhood-onset epileptic condition characterized by repeated seizures   Our Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and patient advocacy groups involved in enhancing patient care. Additionally, we are highlighting the key industry players advancing treatments for LGS   For a detailed epilepsy…
March 26, 2025

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Alvotech and Xbrane
NEWS

Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M 

Shots:  Xbrane has signed an agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) including related IP and parts of its organization, including 40 employees & laboratory equipment at ~$27.25M (~SEK 275M). The transaction closing is subject to approval from Xbrane's shareholders at the EGM on Apr 14, 2025, and FDI approval.   Xbrane will receive SEK…
March 21, 2025

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Alvotech and Dr. Reddy's
NEWS

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva) 

Shots:  The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product  As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. …
March 18, 2025

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Biocon Biologics
NEWS

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara) 

Shots:  Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025  The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…
March 7, 2025

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A Complete Account of EMA Approvals in 2024
INSIGHTS+

A Complete Account of EMA Approvals in 2024

Shots:   In 2024, EMA approved around 53 drugs in various therapy areas, ranging from cardiology, oncology, hematology, neurology, and dermatology to infectious diseases, vaccines, diagnostic agents, pneumology, nephrology, hepatology, ophthalmology, and endocrinology   PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, &…
March 6, 2025

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