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Aquestive
NEWS

Aquestive Therapeutics’ Libervan Buccal Film Receives the US FDA’s Approval to Treat Seizure Activity  

Shots:   Aquestive’s Libervant buccal film (oral, 5mg, 7.5mg, 10mg, 12.5mg & 15mg) received the US FDA’s approval as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures), distinct from the usual pattern in epilepsy patients (2-5yrs.)  The company further provided an update on Anaphylm (epinephrine) sublingual film,…
April 29, 2024

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NEWS

Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval

Shots:  Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US  The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing…
April 29, 2024

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Astrazeneca
NEWS

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

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Johnson& Johnson
NEWS

Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis 

Shots:  The CHMP has granted positive opinion to the company’s Sirturo (bedaquiline) and recommended approving its Type II variation plus transitioning its conditional marketing authorization into a standard marketing authorization  The opinion was based on the data from P-III (STREAM) stage 2 trial assessing the safety & efficacy of bedaquiline-containing regimen to treat MDR-TB, depicting…
April 29, 2024

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Pfizer
NEWS

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

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BMS
NEWS

BMS Receives the CHMP’s Positive Opinion for Opdivo (Nivolumab) as a 1L Treatment of Urothelial Carcinoma 

Shots:  The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024   The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed…
April 26, 2024

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Johnson& Johnson
NEWS

Johnson & Johnson Gains the CHMP’s Positive Opinion for Rybrevant (Amivantamab) as a 1L Treatment of NSCLC  

Shots:  The company's Rybrevant + CT (carboplatin & pemetrexed) has gained the CHMP’s positive opinion as a 1L therapy for NSCLC associated with activating EGFR exon 20 insertion mutations   The opinion was based on the P-III (PAPILLON) trial assessing the safety & efficacy of Rybrevant + CT vs CT in NSCLC patients (n=308) with EGFR…
April 26, 2024

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Takeda
NEWS

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

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