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 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…
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…
Shots:
The EC approved 10 New Chemical Entities in April 2024, leading to treatments for patients and advances in the healthcare industry
In April 2024, the major highlighted drugs were Takeda’s Fruzaqla to treat Adults with mCRC and Johnson & Johnson’s Rybrevant for the treatment NSCLC
PharmaShots has compiled a list of 5 drugs that have received positive…
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…
Shots:
The EC approved 1 Biologic and 11 New Chemical Entities in March 2024, leading to treatments for patients and advances in the healthcare industry
In March 2024, the major highlighted drugs were Novartis’ Fabhalta to treat PNH and UCB’s Bimzelx for the treatment of Adults with Moderate to Severe Hidradenitis Suppurativa
PharmaShots has compiled…
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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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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…
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 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…

