Civica Rx’s Post

Budget 2024: Relief for Cancer Patients and Increased PLI Allocation for Pharma The Union Budget 2024 brings some positive changes for the pharma and healthcare sectors: 🎗️ Cancer Patient Relief: Custom duties fully exempted on three AstraZeneca drugs - Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. Medical Devices: Reduced basic custom duty on x-ray tubes and flat panel detectors, aiding domestic capacity addition. 📈 PLI Scheme: Increased allocation from ₹1,200 crore to ₹2,143 crore, boosting the pharma industry.

Despite criticisms of the Accelerated Approval pathway - commercial payers defer to FDA. New Center for the Evaluation of Value and Risk in Health (CEVR) blog using SPEC data by my colleagues Fariel LaMountain and James Chambers shows: ✔️ payers often defer to the FDA label in coverage decisions for Accelerated Approval drugs ✔️ when plans do impose coverage limits, non-oncology and/or orphan drugs tend to face additional restrictions ✔️non-coverage of oncology drugs was <1% compared to 20% non-oncology drugs ✔️coverage policies for Amondys 45, Exondys 51, Viltepso, and Vyondys 53 were most likely to include restrictions https://lnkd.in/em3je_SD

Here's your TL;DR of #lifesciences updates from #JPM24 Day 1, courtesy of Fierce Pharma: 💊 Regeneron's high-dose Eylea has achieved $123 million in sales in its first full quarter, surpassing Roche's Vabysmo in a comparable period, with CEO Len Schleifer expressing satisfaction at the achievement and anticipating better #patientaccess once a permanent J-code is established. 💊 Biogen CEO Chris Viehbacher highlights the successful launch of Friedreich's ataxia therapy Skyclarys, outperforming other #raredisease launches, and emphasizes the need for a pediatric study due to patients' early diagnoses. 💊 Johnson & Johnson aims for growth with new launches, expecting significant revenue from Tecvayli, Talvey, Carvkyti, and Spravato, aiming for a potential annual sales target of $25 billion in its #multiplemyeloma franchise by 2027. 💊 Gilead Sciences anticipates a catalyst-rich 2024 with a focus on #oncology, aiming to derive a third of its overall revenues from the oncology field by 2030 and exploring expansion into earlier therapy lines and different tumor types. 💊 Amgen emphasizes a busy 2024, integrating Horizon Therapeutics and concentrating on its #obesity program, led by phase 2 asset MariTide, while also working on #biosimilars targeting Stelara, Eylea, and Soliris.

The the US FDA has just released a new draft guidance on multi-regional clinical trials and how to ensure their representativeness to the US population.   Key takeaways: ✅ Single-country or single-region data no longer sufficient to support a marketing application ✅ Increased focus on U.S. population representation ✅ Emphasis on diverse study sites ✅ Comprehensive evaluation of regional differences Want to know how this affects your oncology clinical trials? Read the below Parexel Regulatory Navigator Blog post from my colleagues Mwango Kashoki MD MPH and Sinan B. Sarac (MD, MSc, PhD) for a deep dive into the new guidance and its implications for oncology drug development. #ClinicalTrials #Oncology #FDA #WithHeart

The landscape of NSCLC treatment is evolving rapidly, and personalized medicine is at the forefront. Our latest blog post dives into a massive dataset of 80,000+ ALK, 35,000+ ROS1, 11,000+ EGFR, and more FISH results, shedding light on the prevalence of key mutations and the potential for more precise treatment plans. For pharmaceutical companies seeking to target clinicians and patients effectively, this data is a game-changer. Learn how these insights can revolutionize NSCLC care: https://bit.ly/3SkGEGT #NSCLC #PersonalizedMedicine #RealWorldData #PrognosHealth

The FDA’s Project Optimus is revolutionizing early oncology trials, aiming to improve patient quality of life through increased drug effectiveness and safety. The increased data requirements have displayed benefits for both the patient and sponsor; however, they incur additional costs and time. In 2022 and 2023, increased dose-optimization requirements, inflation, and high interest rates posed significant challenges to the biotechs that play a critical role in precision oncology. From 2010 to 2020, such companies originated 46% of first-in-class cancer drug approvals. Parexel experts have identified three strategies to help sponsors overcome regulatory challenges in achieving dose-optimization requirements within their business constraints: Here’s what we know works:  1️⃣ Design an integrated first-in-human study  2️⃣ Reach agreement with FDA at each step  3️⃣ Challenge guidelines with a compelling rationale Read the full article and explore more #NovelInsights from our latest report on advancing precision oncology: https://lnkd.in/gm_wX_5y #ParexelBiotech #PrecisionOncology #Regulatory

CGT Weekly WITH Spencer Knight "Cinical Update: BMCA CAR T Phase 3 Trial Kite Pharma, in partnership with Arcellx, has announced plans to initiate a Phase III clinical trial named iMMagine-3 for anitocabtagene autoleucel (anito-cel), a promising therapy for multiple myeloma. This trial aims to assess anito-cel's efficacy and safety compared to standard care in patients with relapsed and/or refractory multiple myeloma. With enrollment targets set at around 450 adults across multiple study sites globally, the trial will focus on key endpoints such as progression-free survival, complete response rate, overall survival, and safety. Beginning in H2 of 2024, this initiative represents a significant step forward in addressing the pressing unmet needs of individuals grappling with relapsed and/or refractory multiple myeloma. Moreover, with Kite's dedicated manufacturing facility in Frederick, Maryland, USA, designated for anito-cel production, and the successful transfer of manufacturing capabilities, this initiative underscores a robust commitment to ensuring quality, reliability, and speed in therapy delivery."

Partnerships can bring innovation to our space, and meaningful difference to those who need it. Ora have partnered with Kiora Pharmaceuticals, Inc. Inc. and the Choroideremia Research Foundation - Cure CHM to validate functional vision assessments for patients with profound blindness. These measurements, which are intended to correlate to improvements in everyday life, are essential to standardizing clinical trial design across the industry in order to bring about new therapies for vision impairment. Work will begin shortly. We recently received approval to initiate the related clinical work to validate the endpoints with the goal of incorporating the endpoints into our planned Phase 2 clinical trial assessing KIO-301 in an inherited retinal disease. We invite you to read more...https://hubs.la/Q02trn1g0

The Skyscraper-06 press release highlights concerns about combining anti-TIGIT ICIs with anti-PD-1/PD-L1 therapies, showing a cumulative negative effect (PD-L1 + Tirag + chemo, OS HR=1.33, PFS HR=1.27). Anti-TIGIT clinical trials show varied outcomes on primary endpoints. In mouse models, standalone anti-TIGIT mAbs are insufficient against subcutaneous tumors, necessitating combination therapies with PD-1 inhibitors. Regarding ICI combinations, I see two approaches: 1. The null model of drug independence suggests ICIs provide multiple opportunities for monotherapy response (not additive or synergistic), which hasn't been demonstrated effectively in anti-TIGIT studies. Combination outcomes range from mixed to cumulatively negative effects. 2. Alternatively, evaluating the Chemotherapy + anti-PD-L1 + anti-TIGIT combination in molecularly defined patient subsets remains crucial and unexplored. Most trials lean towards approach 1) for anti-TIGIT, despite the disappointing outcomes of SKYSCRAPER studies with tiragolumab. Do you think another anti-TIGIT could succeed where tiragolumab failed? Drug development is challenging. What are your thoughts on anti-TIGIT therapies? Press Release: https://lnkd.in/ggpgbRZA #Skyscraper06 #AntiTIGIT #PDL1 #ImmunoOncology

At Olive Ridley Advisory (ORA), At ORA, we believe that knowledge is power. Our mission is to empower businesses with actionable insights and strategic guidance. Our expertise, combined with cutting-edge technology, allows us to address critical challenges across various domains. One of the key services in our portfolio is conference coverage, specifically focusing on pharmaceutical conferences. Here are the highlights of our comprehensive conference coverage: ● Live Snapshot within 90 Minutes: We understand the urgency of real-time information. Our team swiftly summarizes abstract presentations, distilling key insights within just 90 minutes. This ensures that your clients stay informed and engaged, even during fast-paced conferences. ● Conferences Covered: We provide coverage for notable events in the pharmaceutical industry, including: §ASCO (American Society of Clinical Oncology) §ESMO (European Society for Medical Oncology) §AACR (American Association for Cancer Research) §ASH (American Society of Hematology) §EHA (European Hematology Association) These conferences serve as critical platforms for sharing groundbreaking research, clinical advancements, and industry trends. Our goal is to keep your clients up-to-date with the latest developments, enabling informed decision-making and help to shape their strategy based on these clinical updates Feel free to explore our offerings and join us in shaping the future of Pharma and healthcare! https://lnkd.in/d3hP6BNE sales@oliveridleyadvisory.com