Outsourcing-Pharma’s Post

By August 4, the FDA is set to release its verdict on Adaptimmune Therapeutics’ Biological License Application (BLA) for afami-cel, an investigational engineered T cell therapy the biotech is proposing for the treatment of advanced synovial sarcoma. The regulator has granted afami-cel Priority Review, which cuts down the review process from the standard 10 months to six months.... #celltherapy #cellandgenetherapy #advancedtherapies #regenerativemedicine #biotech #biotechnology #BLA #tcelltherapy #lifescience #lifesciences #synovialsarcoma #priorityreview #commercialization #pharma #pharmaceuticals #raredisease #rarediseases #Therapeutics #therapies #FDAAction

Thoughts on this? >> Kezar drops solid tumor drug that has yet to prove worth in phase 1 >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #competitivemarketing #biotech #pharmaceutical #healthcare #pharma

Thoughts on this? >> Kezar drops solid tumor drug that has yet to prove worth in phase 1 >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #competitivemarketing #pharma #biotech #pharmaceutical

Novartis, PTC Therapeutics, Inc. Ink Up-to-$2.9B Huntington’s Disease Collaboration The pharma giant to assume development, manufacturing, and commercialization rights to oral small molecule PTC518.

Top 20 Radiopharma Companies based on Market Cap Unveiling one of the PharmaShots' most-anticipated reports on the Top 20 Radiopharma Companies based on Market Cap This year, POINT Biopharma with a market cap of $726.88B ranks first on the list, followed by Novartis & RayzeBio with a market cap of $235.92B and $102.14B respectively For a curated report, reach out to us at connect@pharmashots.com Sign up for an early access to PDF versions of our reports: https://lnkd.in/gyTYU9ix Happy Reading! Stay Tuned! #diagnostics #theranostics #therapy #radiopharmaceuticals #marketsize #Pointbiopharma #novartis #rayzebio #pharmashots #report #top20

Bronchopulmonary Dysplasia Pipeline Therapeutics, Assessment, Companies, Products, Unmet Needs, Market Drivers and Barriers: DelveInsight’s, “Bronchopulmonary Dysplasia Pipeline Insight 2024” report provides comprehensive insights about 12+ companies and 12+ pipeline drugs in Bronchopulmonary Dysplasia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, … Continue reading → #PharmaceuticalsBiotech

BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, presented positive initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart Association (AHA) Scientific Sessions. ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational, near-complete, orally-administered, small molecule stabilizer of TTR. The preliminary results from this ongoing OLE study were also simultaneously published in Circulation. The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.

Heart Failure Pipeline Therapeutics, Assessment, Companies, Products, Unmet Needs, Market Drivers and Barriers: DelveInsight’s, “Heart Failure Pipeline Insight 2024” report provides comprehensive insights about 75+ companies and 90+ pipeline drugs in the Heart Failure pipeline landscape. It covers the pipeline drug profiles, including Heart Failure clinical trials and nonclinical stage products. It also … Continue reading → #PharmaceuticalsBiotech

🔹 According to GlobalData’s Pharmaceutical Intelligence Centre, there were 22,338 clinical trials initiated in #2023. The main indication of trials initiated in 2023 was oncology, followed by central nervous system. Of the trials initiated in 2023, the majority (36%) were Phase II trials. Also in 2023, 7,183 clinical trials ended, with 6,234 completing and 777 terminated. 🔹 #Oncology had the highest number of clinical trials in Phase I and II in 2023 while the central nervous system had the most Phase III and IV trials, the same as it was in 2022. 🔹 Although oncology had the highest number of trials within Phase I, #metabolic disorders had the largest proportion of Phase I trials with 36.5%, followed by cardiovascular (34.9%) and immunology (33.4%). #clinicaltrials #pharma #biotech #onlinecourses #SymmetricTraining

Sanofi 𝗵𝗮𝘀 𝗺𝗮𝗱𝗲 𝗮 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 $𝟴𝟬 𝗺𝗶𝗹𝗹𝗶𝗼𝗻 𝘂𝗽𝗳𝗿𝗼𝗻𝘁 𝗶𝗻𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁 𝗶𝗻 𝗮 𝗽𝗿𝗼𝗺𝗶𝘀𝗶𝗻𝗴 𝗿𝗮𝗿𝗲 𝗱𝗶𝘀𝗲𝗮𝘀𝗲 𝗱𝗿𝘂𝗴 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗲𝗱 𝗯𝘆 Fulcrum Therapeutics, 𝘀𝗲𝗰𝘂𝗿𝗶𝗻𝗴 𝘁𝗵𝗲 𝗲𝘅-𝗨.𝗦. 𝗿𝗶𝗴𝗵𝘁𝘀 𝘁𝗼 𝘁𝗵𝗲 𝗽𝟯𝟴 𝗶𝗻𝗵𝗶𝗯𝗶𝘁𝗼𝗿 𝗹𝗼𝘀𝗺𝗮𝗽𝗶𝗺𝗼𝗱. This strategic move places Sanofi in a leading position in the race to market, with plans to seek approval in multiple global markets while Fulcrum retains U.S. rights. The phase 3 trial for losmapimod, targeting facioscapulohumeral muscular dystrophy (FSHD), could potentially pave the way for the first approved therapy for this condition, affecting 𝗮𝗽𝗽𝗿𝗼𝘅𝗶𝗺𝗮𝘁𝗲𝗹𝘆 𝟯𝟬,𝟬𝟬𝟬 𝗶𝗻𝗱𝗶𝘃𝗶𝗱𝘂𝗮𝗹𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗨.𝗦. alone. With a strong commitment to advancing rare disease treatments, this collaboration underscores Sanofi's dedication to addressing unmet medical needs. https://lnkd.in/gw2i--Y6 #RareDisease #PharmaInnovation #DrugDevelopment #BiotechNews #MedicalBreakthrough