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

News

Arcturus and Meiji Seika Pharma Report the EMA’s Positive Opinion of Kostaive for COVID-19

Shots: The EMA’s CHMP has granted positive opinion to Kostaive (zepomeran) for active immunization to prevent COVID-19 in subjects of age ≥18yrs. The EC’s decision on marketing authorization will follow subsequently Kostaive is a self-amplifying mRNA vaccine that codes for the SARS-CoV-2 spike protein to provide active immunization against COVID-19 Ref: Arcturus Therapeutics and Meiji…

ByDipanshu DixitDecember 16, 2024

News

BridgeBio & Bayer Report the CHMP’s Positive Opinion of Beyonttra (Acoramidis) to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: The CHMP has recommended Beyonttra to treat wild-type or variant transthyretin amyloidosis cardiomyopathy (ATTR-CM) in adults, expected to launch in H1’25 Opinion was based on a P-III (ATTRibute-CM) study of Beyonttra (BID, oral) vs PBO in ATTR-CM patients. It achieved its 1EP, showing a 42% reduced composite ACM & recurrent CVH events &…

ByDipanshu DixitDecember 13, 2024

News

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: The CHMP has recommended Seladelpar + ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or as monotx. in those intolerants to UDCA. The EC’s decision is expected in Q1’25 Opinion was based on a P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs PBO in PBC patients (n=193). It showed…

ByDipanshu DixitDecember 13, 2024

News

Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis

Shots: The CHMP's recommendation of Nemluvio (SC) for mod. to sev. atopic dermatitis (≥12yrs.) & prurigo nodularis in eligible ones for systemic therapy was based on P-III ARCADIA & OLYMPIA studies, respectively. Reviews are ongoing in Australia, Singapore, Switzerland, Canada, Brazil & South Korea, with more filings underway ARCADIA 1 & 2 studies assessed…

ByDipanshu DixitDecember 13, 2024

News

Geron Receives Positive CHMP Opinion for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

Shots: The CHMP has recommended Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy, with the EC’s decision expected in the coming months Opinion was based on P-III (IMerge) study of Rytelo vs PBO that showed reduced need for RBC transfusions within…

ByDipanshu DixitDecember 13, 2024

News

CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Andembry as a prophylactic treatment of HAE in patients (≥12 yrs.), with the EC’s decision anticipated in Q1’25, based on P-III (VANGUARD) trial & ongoing OLE study The P-III study (full results published in The Lancet) of Andembry vs PBO met its 1EP, showing attack-free status in 62% while…

ByDipanshu DixitDecember 13, 2024

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

Arcturus and Meiji Seika Pharma Report the EMA’s Positive Opinion of Kostaive for COVID-19

BridgeBio & Bayer Report the CHMP’s Positive Opinion of Beyonttra (Acoramidis) to Treat Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis

Geron Receives Positive CHMP Opinion for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS

CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE)

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