UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA's review, with additional regulatory filings planned Approval was backed by a P-II trial, 2 retrospective chart review studies, & an…

ByRidhi RastogiNovember 4, 2025

NEWS

UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa

Shots: UCB has reported 3yr. BE HEARD trials data where 2 P-III (BE HEARD I & II) trials assessed Bimzelx (320mg; Q2W till Wk. 16, then Q4W) vs PBO in 1,014 adults with mod. to sev. HS; 556 pts completing Wk. 48 entered the OLE (BE HEARD EXT) study Among pts with ≥1 draining tunnel…

ByRidhi RastogiNovember 3, 2025

TOP 20

Top 20 Immunology Companies of 2025

Shots: Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…

ByPrince GiriJuly 24, 2025

NEWS

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 GiriJune 30, 2025

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

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa

Top 20 Immunology Companies of 2025

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

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