Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease

Shots: The approval of Kisunla (350mg/20mL, IV, QM) for early symptomatic Alzheimer's disease was based on P-III (TRAILBLAZER-ALZ 2) study. Coverage & reimbursement is available through National Coverage Determination with Coverage with Evidence Development The P-III (TRAILBLAZER-ALZ 2) trial assessed Kisunla vs PBO in patients (n=1,736) with early symptomatic AD (MCI or mild dementia) &…

ByDipanshu DixitJuly 2, 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

TOP 20

Top 20 Biopharma M&A of 2023 by Total Deal Value

Shots: With stringent antitrust regulation clasping the overall volume of M&A deals, the biopharma industry manages to hold up a few strong M&A while conquering the waves of unexpected economic turmoil in 2023 In 2023, the global biopharma industry witnessed an astounding transformation with M&A deals. Pfizer’s acquisition of Seagen for $43B ranks first in…

ByPrince GiriJanuary 24, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots: The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis PharmaShots has compiled a list of a…

BySaurabh ChaubeyJanuary 23, 2024

INSIGHTS+

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

Shots: The US FDA approved 11 NDAs & 2 BLAs in December 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 109 novel products in 2023 In December 2023, the major highlight drugs were Jaypirca (pirtobrutinib) approved for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, and Iwilfin…

BySenior EditorJanuary 17, 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+

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

Shots: The US FDA approved 5 NDAs & 9 BLAs in October 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023 In October 2023, the major highlights drugs were Velsipity (Etrasimod) approved for Ulcerative Colitis, and Bimzelx (bimekizumab) for the Treatment of Adults…

BySenior EditorNovember 15, 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

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2023

Shots: Third quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, Biogen acquired Reata Pharmaceuticals for ~$7.3B and Danaher acquired Abcam for ~$5.7B The third quarter of the year also showcases multiple clinical trial results which include Janssen reported P-IIb…

BySenior EditorOctober 2, 2023

INSIGHTS+

Insights+ Key Biosimilars Events of August 2023

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 During the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…

BySenior EditorSeptember 6, 2023

Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease

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

Top 20 Biopharma M&A of 2023 by Total Deal Value

Insights+: EMA Marketing Authorization of New Drugs in December 2023

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

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

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

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

PharmaShots’ Key Highlights of Third Quarter 2023

Insights+ Key Biosimilars Events of August 2023

Contact US

FOLLOW US