UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients

Shots: UCB reported the P-III study (n=87; ages 1-35yrs.) of adjunctive fenfluramine vs. PBO in CDKL5 Deficiency Disorder (CDD) diagnosis and uncontrolled seizure pts. The P-III study met its 1EP (median % reduction in countable motor seizure frequency) and most key 2EPs. Fenfluramine was well tolerated with a consistent safety profile in prior DS/LGS studies UCB…

ByPrince Giri8 hours ago

TOP 20

Top 20 Biopharma Deal Terminations of 2024

Shots: In the Biopharma industry, navigating M&A and licensing deals is challenging due to strict antitrust laws and shifting regulations. When these pressures create significant risks, nullifying or restructuring existing agreements can be the most rational and strategic response In 2024, the termination of the $4.45B deal between Adaptimmune and Genentech became a major talking…

ByPrince GiriMay 14, 2025

News

Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M

Shots: Xbrane has signed an agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) including related IP and parts of its organization, including 40 employees & laboratory equipment at ~$27.25M (~SEK 275M). The transaction closing is subject to approval from Xbrane's shareholders at the EGM on Apr 14, 2025, and FDI approval. Xbrane will receive SEK…

ByDipanshu DixitMarch 21, 2025

TOP 20

Top 20 Immunology Companies of 2024

Shots: Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…

ByPrince GiriJuly 25, 2024

News

UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

Shots: The recommendation was supported by the P-III studies (BE HEARD I and BE HEARD II) assessing the safety and efficacy of Bimzelx 1014 patients with PsA evaluating bimekizumab vs. PBO at week 16 Both trials met their 1EPs & 2EPs measured by HiSCR50 and HiSCR75 respectively at wk. 16. Clinical responses were sustained up…

ByDipanshu DixitMarch 22, 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

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

News

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Shots: The approval was supported by the P-III (MycarinG) study evaluating the safety, efficacy & tolerability of Rystiggo (7 or 10mg/kg) vs PBO in gMG patients. The 1EP of the study includes a change in MG-ADL score at Day43 & 2EPs include a change in MG-C score, QMG, patient-reported outcomes at Day43 and AEs The…

ByDipanshu DixitJanuary 8, 2024

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

THOUGHTSPOT

Social Media Listening in Pharmaceutical Industry

Shots: When it comes to embracing new-age technologies, the pharmaceutical industry always remains on the front foot. Galvanized by novel technological advances and innovations, the pharmaceutical industry is forging ahead at a momentous pace Social media listening fosters the use of leveraging several social media platforms to gather insights, resolve queries, carry out online market…

BySaurabh ChaubeyAugust 8, 2023

UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients

Top 20 Biopharma Deal Terminations of 2024

Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M

Top 20 Immunology Companies of 2024

UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

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

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

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

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

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