Skip to content Skip to footer
Subscribe Now
GRIN Therapeutic
NEWS

GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder

Shots: The US FDA has granted BTD to radiprodil for the treatment of seizures in GRIN-related neurodevelopmental disorder harboring GoF mutations Designation was supported by P-Ib (Honeycomb) trial data of radiprodil in pediatric pts, showing 86% decrease in CMS frequency. 71% had >50% CMS reduction, & 6–7 were seizure-free for ≥80% of the 8wk.…
February 27, 2025

Read more

Telix Pharmaceuticals
NEWS

Telix Pharmaceuticals Reports the US FDA’s BLA Acceptance with Priority Review of Zircaix (89Zr-DFO-girentuximab) for Kidney Cancer Imaging

Shots: The US FDA has accepted BLA & granted Priority Review to Zircaix (TLX250-CDx) for the detection of clear cell renal cell cancer (ccRCC) in pts (PDUFA: 27 Aug 2025). Expected to launch in 2025 BLA was based on P-III (ZIRCON) study assessing sensitivity & specificity of 89Zr-TLX250 in adult pts (n=300), where 284 evaluable…
February 26, 2025

Read more

Merck
NEWS

Merck Reports the US FDA’s sBLA Acceptance of Neoadjuvant Keytruda with Priority Review for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The US FDA has accepted sBLA & granted priority review to neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy ± cisplatin & then as a single agent to treat operable LA-HNSCC (PDUFA: Jun 23, 2025) sBLA was based on P-III (KEYNOTE-689) trial data assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by…
February 26, 2025

Read more

Gilead
NEWS

Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots: The EMA has accepted MAA & EU-M4all as well as granted priority review to lenacapavir (HIV-1 capsid inhibitor) for PrEP in humans at risk of HIV; MAA will be applicable in 30 EEA states (incl. Norway, Iceland & Liechtenstein) MAA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC;…
February 25, 2025

Read more

Takeda
NEWS

Takeda Reports EMA Approval for Additional SC Administration Option of Takhzyro (lanadelumab) for Patients aged ≥12 with Recurrent HAE

Shots: Takeda reported the EMA's approval of an additional 2 mL pre-filled pen option for Takhzyro (lanadelumab) for patients aged ≥12 with Recurrent hereditary angioedema (HAE) Currently Takhzyro is approved in 150 mg and 300 mg pre-filled syringes and 300 mg vial. The new approval is for a 300 mg pre-filled pen (2 mL…
February 25, 2025

Read more

Mirum Pharmaceuticals
NEWS

Mirum Pharmaceuticals Receives the US FDA Approval for Ctexli to Treat Cerebrotendinous Xanthomatosis

Shots: The US FDA has approved Ctexli (chenodiol) to treat cerebrotendinous xanthomatosis (CTX) in adults Efficacy was established in crossover withdrawal P-III (RESTORE) trial assessing Ctexli (250mg, PO, TID) vs PBO in pts for 24wks. Study showed reduced levels of plasma cholestanol & urine 23S-pentol in pts compared to PBO Ref: Prnewswire | Image: Mirum Related…
February 24, 2025

Read more

NEWS

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…
February 24, 2025

Read more

Celltrion
NEWS

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…
February 24, 2025

Read more

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 17th, 2025 – February 21th, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, COVID 19 & Biosimilars. Check out our full report below:      AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025  Read More: AstraZeneca  Exelixis Presents 5-year…
February 21, 2025

Read more

Load more