Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Shots: Merck has reported 2 P-III (MK-8591A-052 & MK-8591A-051) trial data assessing DOR/ISL (100mg/0.25mg, QD, PO) in HIV-1 infected adults; MAA submission to begin by mid-2025 MK-8591A-052 assessed it vs BIC/FTC/TAF (50mg/200mg/25mg) in adults (n=513), meeting its 1EP with 1.5% subjects on DOR/ISL having a viral load ≥50 copies/mL vs 0.6% at 48wks. It…

ByRidhi RastogiMarch 13, 2025

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Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: Following the MHRA approval (Jan 2025), the EC has granted conditional MAA to Seladelpar +/- ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or intolerants to UDCA, respectively; ongoing regulatory review in Canada and Australia MAA was based on a worldwide P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs…

ByDipanshu DixitFebruary 21, 2025

NEWS

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Shots: Japan’s MHLW received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Regulatory review is ongoing in the US, EU & China, with global filings planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n>15000)…

ByRidhi RastogiFebruary 14, 2025

NEWS

Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF)

Shots: The EMA received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits approval in US and China, with global applications planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed…

ByDipanshu DixitFebruary 4, 2025

NEWS

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

Shots: ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024 MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…

ByDipanshu DixitJanuary 31, 2025

NEWS

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK's MHRA As of the data cut-off on Jul…

ByDipanshu DixitJanuary 29, 2025

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BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM

Shots: The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025 Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing…

ByDipanshu DixitNovember 22, 2024

NEWS

Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara)

Shots: Following the MAA submission by Accord Healthcare (Intas’ subsidiary) in 2023, the EMA’s CHMP has granted positive opinion to Imuldosa, a biosimilar version of Stelara (ustekinumab) Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide…

ByDipanshu DixitOctober 21, 2024

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…

ByDipanshu DixitJune 28, 2024

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Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

Shots : Dr. Mourad talked about the positive P-III data showing results for BIIB800, a Tocilizumab biosimilar candidate presented at the Annual European Congress of Rheumatology (EULAR 2022) He also spoke about the results of the 48-week analysis of the PROPER trial evaluating adalimumab biosimilar, Imraldi, in patients with autoimmune diseases The interview highlights Biogen's…

BySenior EditorJune 27, 2023

Merck Reports P-III (MK-8591A-052 & MK-8591A-051) Trial Data of Doravirine + Islatravir (DOR/ISL) for HIV-1 Infection in Adults

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF)

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

The EMA Accepts MAA for ImmunityBio’s Anktiva to Treat BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM

Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara)

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

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