EMA Marketing Authorization of New Drugs in January 2025

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics in January 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Capvaxive to treat Pneumococcal Disease PharmaShots has compiled a list of 4 drugs that have been granted positive opinions and approvals by the EMA’s…

ByDipanshu DixitFebruary 18, 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

INSIGHTS+

New Drug Designations – December 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, MHLW and NMPA The December 2024 report covers designations granted to 43 drugs and 3 devices, encompassing 13 small molecules, 10 biologics, 7 cell and gene therapies & 3 medical devices among others Significant…

ByPrince GiriJanuary 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

INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2024

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics and 4 New Chemical Entities in December 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Galderma’s Nemluvio to treat Prurigo Nodularis and Atopic Dermatitis PharmaShots has compiled a list of 9 drugs that have been granted positive…

ByDipanshu DixitJanuary 23, 2025

NEWS

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots: The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain Sipavibart was discovered…

ByDipanshu DixitJanuary 9, 2025

INSIGHTS+

New Drug Designations – November 2024

Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, and NMPA The November 2024 report covers designations granted to 28 drugs and 3 devices, encompassing 9 small molecules, 6 biologics, 7 cell and gene therapies as well as 3 medical devices Significant trends…

BySaurabh ChaubeyDecember 31, 2024

NEWS

Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC

Shots: The EC has approved Rybrevant + Lazcluze as a 1L treatment of advanced NSCLC harboring EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations. The EC’s decision of lazertinib for the corresponding combination regimen is pending (was granted CHMP’s recommendation last month) Approval was based on P-III (MARIPOSA) trial assessing Rybrevant +…

ByDipanshu DixitDecember 30, 2024

INSIGHTS+

EMA Marketing Authorization of New Drugs in November 2024

Shots: The EMA’s CHMP has granted positive opinions to 3 Biologics and 2 New Chemical Entities in November 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B PharmaShots has compiled a list of…

ByDipanshu DixitDecember 19, 2024

NEWS

Bio-Thera Solutions and SteinCares Add Another Biosimilar, Expanding their Alliance

Shots: Bio-Thera Solutions has expanded its collaboration with SteinCares, granting it exclusive rights to market a third biosimilar in Brazil and the LATAM region Bio-Thera will handle development, the US FDA & the EMA submissions to support LATAM regulatory filings & commercial supply of each biosimilar from its Chinese manufacturing facilities SteinCares will utilize its…

ByDipanshu DixitDecember 16, 2024

EMA Marketing Authorization of New Drugs in January 2025

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

New Drug Designations – December 2024

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

EMA Marketing Authorization of New Drugs in December 2024

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

New Drug Designations – November 2024

Johnson & Johnson Reports the EC’s Approval of Rybrevant (Amivantamab) Plus Lazcluze (Lazertinib) as a 1L Treatment of EGFRm NSCLC

EMA Marketing Authorization of New Drugs in November 2024

Bio-Thera Solutions and SteinCares Add Another Biosimilar, Expanding their Alliance

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