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Pfizer New
NEWS

Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease

Shots: The EC has approved Abrysvo to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals (aged 18-59yrs.) across all EU states including Iceland, Liechtenstein, and Norway. Approval was based on a pivotal P-III (MONeT) study that assesses the safety, tolerability & immunogenicity of Abrysvo vs PBO in adults (aged 18-59yrs.) at risk…
April 1, 2025

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Genmab & Pfizer
NEWS

Genmab and Pfizer Secure the EC’s Approval for Tivdak (Tisotumab Vedotin) for Recurrent or Metastatic Cervical Cancer

Shots: The EC has approved Tivdak an ADC, as a monotx. for adults (n=502) with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy Approval was backed by P-III (innovaTV 301) global trial evaluating Tivdak vs CT alone (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) The trial met its 1EP of OS,…
April 1, 2025

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Celltrion
NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program 

Shots:  Celltrion announced that Steqeyma (ustekinumab-stba), a biosimilar to Stelara, has been added to the Costco Member Prescription Program. It was launched on Mar 12, 2025. Celltrion's adalimumab-aaty was added to the program in Aug 2024   Steqeyma will be available in the US from Costco Specialty Pharmacies on Apr 1, 2025, for self-funded employer plans,…
March 28, 2025

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Bio-Thera and Dr. Reddy's
NEWS

Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia 

  Shots:  Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab)  As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals &…
March 28, 2025

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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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