EMA Marketing Authorization of New Drugs in April 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 4 Biologics and 4 New Chemical Entites in April 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Amgen’s Tepezza to Treat Thyroid Eye Disease PharmaShots has compiled a list of 8 drugs that have been granted positive opinions…

ByDipanshu DixitMay 20, 2025

NEWS

Rznomics Partners with Eli Lilly for RNA Editing Therapeutics

Shots: Rznomics has signed a strategic global license agreement with Eli Lillyto develop & commercialize RNA-editing therapies for inherited hearing loss using Rznomics' trans-splicing ribozyme platform As per the deal, if Lilly avail all its options then total deal value could surpass $1.3B with undisclosed upfront payment, in addition to separate royalties from product sales The…

ByDipanshu DixitMay 16, 2025

NEWS

AbbVie Partners with ADARx Pharmaceuticals to Develop siRNA Therapies Across Multiple Disease Areas

Shots: AbbVie has entered into collaboration & license option agreement with ADARx to develop siRNA therapeutics across multiple disease areas, incl. neuroscience, immunology & oncology, leveraging ADARx's RNA tech As per the deal, ADARx will receive $335M upfront & will be eligible to receive several billion in additional contingent payments incl. option fees, milestones, plus tiered royalties…

ByDipanshu DixitMay 15, 2025

INSIGHTS+

The US FDA New Drug Approvals in April 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2025 The US FDA has approved a total of 3 new drug including 1 new molecular entity and 2 Biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Johnson & Johnson’s…

ByDipanshu DixitMay 13, 2025

NEWS

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Shots: This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advance to the planned PDUFA of Jun 30, 2025, which will be available in the US within a week as a co-pack Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200 mg,…

ByDipanshu DixitMay 9, 2025

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Key Biosimilars Events of April 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…

ByDipanshu DixitMay 6, 2025

NEWS

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Shots: The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing Trial showed superior disease control per MG-ADL…

ByDipanshu DixitMay 1, 2025

INSIGHTS+

Disease of the Month – Myocardial infarction (MI)

Shots: Myocardial infarction (MI), colloquially known as a heart attack, occurs when blood flow to the heart is severely reduced or blocked, causing tissue damage or mortality due to lack of oxygen PharmaShots' Disease of the Month report aims to familiarize the general population with conditions impacting communities worldwide. The report outlines disease characteristics, types,…

ByDipanshu DixitApril 30, 2025

NEWS

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

Shots: The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2'25 Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…

ByDipanshu DixitApril 29, 2025

NEWS

CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin)

Shots: CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states The opinion…

ByDipanshu DixitApril 26, 2025

Dipanshu Dixit

EMA Marketing Authorization of New Drugs in April 2025

Rznomics Partners with Eli Lilly for RNA Editing Therapeutics

AbbVie Partners with ADARx Pharmaceuticals to Develop siRNA Therapies Across Multiple Disease Areas

The US FDA New Drug Approvals in April 2025

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Key Biosimilars Events of April 2025

Johnson & Johnson Reports the US FDA’s Approval of Imaavy (Nipocalimab-aahu) for Generalized Myasthenia Gravis (gMG)

Disease of the Month – Myocardial infarction (MI)

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

CuraTeQ Biologics Receives CHMP’s Positive Opinion for Dazublys (Biosimilar, Herceptin)

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