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Neurotech Pharma

Neurotech Pharmaceuticals Reports the US FDA Approval for Encelto to treat Macular Telangiectasia Type 2

Shots: The US FDA has approved Encelto (revakinagene taroretcel-lwey) to treat macular telangiectasia type 2 (MacTel); commercially available in the US by Jun 2025 Approval was based on P-III trial data demonstrating reduced macular photoreceptor loss for ~24mos. post-implantation Encelto (intravitreal implant) utilizes an encapsulated cell therapy tech to continuously deliver ciliary neurotrophic…

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Tris Pharma

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots: Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025 ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its…

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Viewpoints_Sofie Berg

Unlocking Approval: Sofie Berg from AbbVie in an Illuminating Dialogue Exchange with PharmaShots

Shots:  Recently, the European Commission approved AbbVie’s Skyrizi for the treatment of adults with moderate to severe active Ulcerative Colitis  The approval was based on positive data from the P-III INSPIRE induction trial and COMMAND maintenance study   Today, at PharmaShots we have Sofie Berg, the therapeutic area head of international immunology, International Medical Affairs, at…

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VIEWPOINTS_Andrew Menzies-Gow1_Michael Wechsler2_2024

EGPA Remission with Fasenra: Michael Wechsler and Andrew Menzies Gow in Conversation with PharmaShots

Shots:  An already established biologic treatment for SEA in the US, EU5 & Japan. Fasenra is now showing exemplary remission for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA)  Today, at PharmaShots, we have a distinguished panel of speakers shedding light on advancements under the P-III MANDARA study and the recent publication of the study…

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VIEWPOINTS_Susan Pandya_2024

Servier at SNO 2023: Dr. Susan Pandya Sheds Light on IDH-Mutant Diffuse Glioma Management

Shots:  In a stimulating conversation with PharmaShots, Dr. Susan Pandya shares insights from their presentation at SNO 2023 to strengthen Servier’s Neuro-Oncology Profile  While highlighting the details of vorasidenib, Susan articulately explains the study design of the P-III Indigo trial evaluating vorasidenib in patients with IDH-mutant diffuse glioma  With a fast-track designation and breakthrough therapy…

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

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…

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VIEWPOINTS_Jennifer Davidson_2023

Jennifer Davidson Highlights the Data from the Phase 3 QUASAR Induction Study 1

Shots:  Jennifer Davidson, VP, of Medical Affairs Immunology, Johnson & Johnson Innovative Medicine shares insights from the data of the Phase III QUASAR induction study presented at the DDW'23  P-III QUASAR induction study 1 demonstrated positive results in patients who received TREMFYA 200 mg vs Placebo, with most of the patients achieving remission at week…

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Leonard Glass, Vice President, Global Medical Affairs at Eli Lilly & Co. Shares Insights from Lilly’s Vision on New Stage of Metabolic Science

Leonard Glass, Vice President, Global Medical Affairs at Eli Lilly & Co. Shares Insights from Lilly’s Vision on New Stage of Metabolic Science

Shots: Leonard spoke about how Lilly is advancing in the field of metabolic disease research (esp. diabetes) He also talked about its lead candidate in type 2 diabetes and also discussed its clinical results in detail The interview summarizes Lilly’s objective to advance new discoveries and redefine diabetes care Smriti: Tell us how Lilly is leading…

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