Insights+: EMA Marketing Authorization of New Drugs in May 2024

Shots: The EMA approved or granted Positive Opinions to 5 Biologics and 7 New Chemical Entities in May 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were BMS’ Opdivo + cisplatin & gemcitabine to treat Urothelial Carcinoma and Takeda’s ADAMTS13 for the treatment cTTP PharmaShots has compiled…

ByDipanshu DixitJune 20, 2024

News

Takeda’s ADAMTS13 Receives the CHMP’s Positive Opinion for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Shots: The CHMP has granted a positive opinion to ADAMTS13 (rADAMTS13) for treating ADAMTS13 deficiency in cTTP children and adults The positive opinion was based on the P-III study assessing the efficacy, PK, safety, and tolerability for the same. Data was published in The New England Journal of Medicine in May 2024 rADAMTS13 is a…

ByRidhi RastogiMay 31, 2024

VIEWPOINTS

Takeda at AAAAI 2024: Salomé Juethner highlights P-IV Results from ENABLE and EMPOWER Studies

Shots: At the American Academy of Allergy, Asthma, & Immunology (AAAAI), Takeda presented 9 abstracts focusing on health equity and real-world data from P-IV (ENABLE) & (EMPOWER) studies evaluating HAE patients Salomé Juethner, Senior Medical Director-Head of Rare Genetics at Takeda, in a stimulating conversation with PharmaShots, talks about shares insights from the real-world P-IV…

BySaurabh ChaubeyMay 6, 2024

INSIGHTS+

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

Shots: Witness the journey of the biopharma companies over 20 years with this informative and engaging report. The report highlights the development of the biopharma industry and the key factors influencing them In 2023, JNJ reclaims the topmost position in the list from Pfizer with a revenue of $85.16B, showcasing a sharp 10.30 percent vs…

BySaurabh ChaubeyMay 1, 2024

News

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer

Shots: The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…

ByDipanshu DixitApril 26, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of February 2024 The US FDA approved a total of 7 drugs including 6 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Takeda’s Eohilia (budesonide oral suspension) for treating eosinophilic…

BySenior EditorMarch 13, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in January 2024

Shots:The EMA approved 2 BLA and 6 New Chemical Entities in January 2024, leading to treatments for patients and advances in the healthcare industryIn January 2024, the major highlighted drugs were Padcev to treat Bladder Cancer and Eylea for the treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)PharmaShots has…

BySenior EditorFebruary 21, 2024

News

The US FDA Approves Takeda’s Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis (EoE)

Shots: The approval was based on the results from 2 trials (Study 1) & (Study 2) evaluating the safety & efficacy of Eohilia (2mg, BID) vs PBO in patients (aged 11-56yrs. & 11-42yrs.) with EoE. The efficacy endpoints of the trials were histologic remission & change from baseline in patient reported DSQ post 12wks of…

ByDipanshu DixitFebruary 12, 2024

News

Takeda Reports EC’s Approval of Hyqvia as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

ShotsTakeda’s Hyqvia has been approved as maintenance therapy for treating chronic inflammatory demyelinating polyneuropathy (CIDP) on stable IVIG therapy valid throughout the EU plus Iceland, Liechtenstein, Norway & Northern IrelandThe approval is based on the results from the P-III (ADVANCE-CIDP 1) study assessing Hyqvia’s safety and efficacy as a maintenance therapy to…

ByDipanshu DixitJanuary 29, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in November 2023

Shots: The US FDA approved 5 NDAs & 4 BLAs in November 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 109 novel products in 2023 In November 2023, the major highlights drugs were Wezlana (ustekinumab) approved for Multiple Inflammatory Diseases, and Cosentyx (secukinumab) for the Treatment…

BySenior EditorDecember 20, 2023

Insights+: EMA Marketing Authorization of New Drugs in May 2024

Takeda’s ADAMTS13 Receives the CHMP’s Positive Opinion for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Takeda at AAAAI 2024: Salomé Juethner highlights P-IV Results from ENABLE and EMPOWER Studies

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2004-2023)

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer

Insights+: The US FDA New Drug Approvals in February 2024

Insights+: EMA Marketing Authorization of New Drugs in January 2024

The US FDA Approves Takeda’s Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis (EoE)

Takeda Reports EC’s Approval of Hyqvia as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Insights+: The US FDA New Drug Approvals in November 2023

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