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NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Shots:  The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO)  The approval was based on analytical, pre-clinical, clinical and manufacturing data…
June 28, 2024

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Johnson& Johnson
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Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC) 

Shots:  The CHMP has granted a positive opinion to Balversa monotx. (QD, oral) to treat inoperable mUC adults with susceptible FGFR3 mutations & previously treated with at least 1L of therapy with PD-1/PD-L1 inhibitor  The opinion was based on the arm 1 of P-III (THOR) trial assessing the safety & efficacy of erdafitinib (n=136) vs…
June 28, 2024

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Regeneron
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Regeneron’s Ordspono Gains the CHMP’s Positive Opinion to Treat r/r Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) 

Shots:  The CHMP has granted a positive opinion for conditional marketing authorization of odronextamab (CD20xCD3 bispecific Ab) to treat r/r FL or r/r DLBCL post ≥2L of therapies, with the EC’s decision anticipated in the upcoming mos.  The opinion was based on the P-I (ELM-1) & pivotal P-II (ELM-2) studies, showing strong durable response rates…
June 28, 2024

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MERCK
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Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH) 

Shots:  The CHMP has granted positive opinion to Winrevair combined with other therapies to treat PAH. EC’s decision is anticipated in Q3’24, applicable across EU, Iceland, Liechtenstein & Norway  The opinion was based on the P-III (STELLAR) study evaluating the safety & efficacy of Winrevair (target dose 0.7mg/kg; n=163) or PBO (n=160) + stable background…
June 28, 2024

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NEWS

Moderna’s mResvia (mRNA-1345) Gains the CHMP’s Positive Opinion to Prevent Lower Respiratory Tract Disease (LTRD) 

Shots:  The CHMP’s positive opinion of mRESVIA to prevent lower respiratory tract disease (LTRD) due to RSV infection based on the P-III (ConquerRSV) study in adults (n=37,000; ≥60yrs.)  Primary analysis (3.7mos. median follow-up) showed vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis (8.6mos. median follow-up) showed sustained VE of 63.3% against RSV-LRTD…
June 28, 2024

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NEWS

Coherus Reports the Divestment of Yusimry (Biosimilar, Humira) to Hong Kong King-Friend Industry

Shots:  Coherus has divested Yusimry under an asset purchase agreement to Hong Kong King-Friend Industry (HKF) granting it global rights & all relevant assets of Yusimry such as its development & regulatory outcomes for $40M upfront  HKF has further granted the US commercial rights of the asset to Meitheal Pharmaceuticals (its subsidiary) under an exclusive…
June 27, 2024

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NEWS

The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC) 

Shots:  The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC)  The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3%…
June 26, 2024

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Verona Pharma
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Verona Pharma’s Ohtuvayre (Ensifentrine) Receives the US FDA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD) 

Shots:  The US FDA has approved Ohtuvayre as a maintenance therapy to treat COPD patients, with its launch anticipated in Q3’24  The approval was based on the P-III (ENHANCE-1 & ENHANCE-2) studies analyzing Ohtuvayre monotx. or in addition with other maintenance therapies. Trials reached their 1EPs showing improved lung function; results were published in the…
June 26, 2024

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NEWS

The EC Approves Biogen’s Tofidence (Biosimilar, Roactemra) for Treating Arthritis and COVID-19 

   Shots:  The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19  The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III…
June 24, 2024

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