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 industry In 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)

Shots Takeda’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 Ireland The 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

VIEWPOINTS

Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

Shots: Björn Mellgård Vice President and Global Program Lead, TTP Program, Takeda, shares insights from the P-III data of TAK-755 for the treatment of cTTP Björn eloquently shares the highlights of the study design for TAK-755, safety and efficacy outcomes, and goes on to share an update from the P-IIIb continuation trial evaluating TAK-755 With…

BySaurabh ChaubeyOctober 19, 2023

INSIGHTS+

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

Shots: The US FDA approved 7 NDAs and 2 BLAs in September 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023 In September 2023, the major highlights drugs were Ojjaara (momelotinib) approval for myelofibrosis patients with anemia, and Entyvio (vedolizumab) for subcutaneous…

BySenior EditorOctober 18, 2023

TOP 20

Top 20 Companies Spending on R&D in 2022

Shots: R&D (Research and Development) in the biopharma industry lays the foundation stone of innovative drugs. A robust R&D bolstered with new-age technological advances assures long-term sustainability in the future market With a global expenditure of $238B in 2022, the figures are anticipated to reach $285B by 2028. In 2022, AbbVie ranked the top among…

ByPrince GiriAugust 22, 2023

INSIGHTS+

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

Shots: With the indispensable transformations carried out over the years, the biopharma industry witnessed miraculous changes in operations, technology, and innovation. Such as inclination towards the Pharma 4.0 model, adoption of a multimodal building approach, and dependence on contract manufacturing While major companies like Johnson & Johnson, Roche, and Pfizer dominated the biopharma industry with…

BySenior EditorApril 13, 2023

TOP 20

Top 20 BioPharma Companies based on 2022 Total Revenue

Shots: Biopharma companies have kept themselves afloat in the ocean of uncertainties by overcoming the hurdles of unmet demands, procurement, and maintaining a constant supply chain. However, the previous year was difficult for biopharma companies as the segment saw multiple insolvencies. Amidst all kinds of obstacles, many companies have sustained themselves to meet the market…

ByPrince GiriApril 12, 2023

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

Björn Mellgård shares insights from the Pivotal Phase III data of TAK-755 for congenital thrombotic thrombocytopenic purpura (cTTP)

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

Top 20 Companies Spending on R&D in 2022

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

Top 20 BioPharma Companies based on 2022 Total Revenue

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