Corporate News     04-Jul-24
European Medicines Agency validates submission of MAA for Nidlegy™
Philogen S.p.A. and Sun Pharmaceutical Industries announced that on June 20 the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy™ , which was finalized on 03 June 2024.

Nidlegy™ is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. Both companies jointly made the following announcements: - 23 October 2023 - Phase III PIVOTAL trial met the primary endpoint

- 31 May 2024 – Primary results of PIVOTAL presented at ASCO

- 04 June 2024 – MAA submission to EMA

The data of the Phase III Nidlegy™ trial are expected to be published in a peer-reviewed scientific journal in 2024.

Previous News
  Market extends record rally for 2nd day; VIX slides 2.65%
 ( Market Commentary - Quick Review 04-Jul-24   15:58 )
  European Medicines Agency validates submission of MAA for Nidlegy™
 ( Corporate News - 04-Jul-24   15:04 )
  Sun Pharma gains on EMA nod for Nidlegy
 ( Hot Pursuit - 04-Jul-24   14:18 )
  Sun Pharmaceuticals Industries Ltd rises for third consecutive session
 ( Hot Pursuit - 04-Jul-24   13:05 )
  Sun Pharmaceuticals Industries Ltd Slides 0.84%
 ( Hot Pursuit - 03-Jul-24   09:30 )
  Sun Pharma completes acquisition of Taro
 ( Corporate News - 24-Jun-24   18:05 )
  Nifty below 23,500; European market declines
 ( Market Commentary - Mid-Session 21-Jun-24   13:34 )
  Broader mkt rallies; IT shares in demand
 ( Market Commentary - Mid-Session 21-Jun-24   10:32 )
  Sun Pharma enters into patent licensing agreement with Takeda
 ( Corporate News - 21-Jun-24   09:30 )
  Sun Pharma inks agreement with Takeda Pharma for commercialising Vonoprazan tablets in India
 ( Hot Pursuit - 21-Jun-24   09:26 )
  Sun Pharmaceuticals Industries to convene AGM
 ( Corporate News - 20-Jun-24   17:14 )
Other Stories
  National Highways Infra Trust schedules AGM
  08-Jul-24   16:14
  Alexander Stamps And Coin AGM scheduled
  08-Jul-24   16:14
  Larsen & Toubro wins order for 3.5GW solar PV plants in Middle East
  08-Jul-24   15:54
  Tata Motors Group global wholesales rise 2% in Q1 FY25
  08-Jul-24   15:50
  MCX announces resignation of Information Security Officer and Data Protection Officer
  08-Jul-24   15:45
  Cupid opens new mother warehouse in Bhiwandi
  08-Jul-24   15:40
  Nava's Zambian step-down subsidiary receives two large scale exploration licenses
  08-Jul-24   15:36
  CG Power and Industrial Solutions appoints Amar Kaul as MD & CEO
  08-Jul-24   15:18
  John Cockerill India to declare Quarterly Result
  08-Jul-24   14:58
  Kumbhat Financial Services to conduct board meeting
  08-Jul-24   14:58
Back Top