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Astrazeneca
AstraZeneca’s Truqap Plus Faslodex Receives the CHMP’s Positive Opinion for Treating Breast Cancer 
Shots:  The CHMP's positive opinion was based on the P-III (CAPItello-291) study assessing Truqap + Faslodex vs PBO + Faslodex to treat ER+, HER2‑ locally advanced or metastatic breast cancer patients (n=708) having ≥1 PIK3CA, AKT1 or PTEN-alterations after recurrence or progression on or after an endocrine-based regimen  The study demonstrated reduction in the disease…
April 29, 2024
Pfizer
Pfizer’s BEQVEZ (fidanacogene elaparvovec-dzkt) Receives US FDA Approval for Adults with Hemophilia B 
Shots:  US FDA granted approval to Pfizer’s Beqvez, based on BENEGENE-2 (P-III) study (n=45) to treat of Haemophilia B adult patient using factor IX (FIX) prophylaxis therapy, with life-threatening hemorrhage, spontaneous bleeding episodes, no FDA-approved test detected neutralizing antibodies to AAVRh74var capsid; met 1EP of non-inferiority in the ABR of total bleeds  Based on durability…
April 26, 2024
Takeda
Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 
Shots:  The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights  The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…
April 26, 2024
Samsung Bioepis
Samsung Bioepis Receives EC’s Marketing Authorization for Pyzchiva (Biosimilar, Stelara) to treat Autoimmune disorders
Shots:  The EC has granted marketing authorization for Pyzchiva (Biosimilar, Stelara) to treat autoimmune disorders in gastroenterology, dermatology, and rheumatology  The approval was based on P-I & P-III studies of Pyzchiva vs Stelara. P-I trial assessing the PK, safety, tolerability & immunogenicity in healthy volunteers, and  P-III trial assessing the efficacy, safety & PK profile…
April 22, 2024
Immunity Bio
ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC) 
Shots:  ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024  The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate…
April 22, 2024
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