Drug Patent Watch
SEPTEMBER 12, 2024
In the labyrinthine world of pharmaceuticals, where the cost of life-saving medications can often feel like a roll of the dice, the FDA is implementing a strategy that aims to bring some much-needed transparency and affordability to the market. This strategy, known as the ‘Rule of Three,’ is a game-changer in the battle against soaring drug prices.
Bio Pharma Dive
SEPTEMBER 12, 2024
The offerings by Bicara, Zenas and MBX give a glimpse into what industry insiders describe as a backlog of mature startups waiting for the right opportunity to test public markets.
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Pharmaceutical Technology
SEPTEMBER 12, 2024
The data from two Phase III trials demonstrated GLP-1/glucagon agonist’s efficacy in reducing blood glucose and weight.
Bio Pharma Dive
SEPTEMBER 12, 2024
Spun out of research at Nationwide Children’s Hospital, Vironexis claims it will be the first company to start a study testing a cancer drug delivered via the adeno-associated viruses commonly used in genetic medicines.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 12, 2024
In a significant move to enhance trade facilitation and streamline compliance with foreign trade regulations, the Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce & Industry, has announced amendments to the export obligation period for several import items.
Bio Pharma Dive
SEPTEMBER 12, 2024
The biotech will now suspend development of a drug prospect that Sanofi acquired partial rights to just four months ago.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
SEPTEMBER 12, 2024
The funding, from AMR Action Fund and others, will help U.K. based F2G complete late testing of a treatment that the FDA rejected one year ago.
Pharmaceutical Technology
SEPTEMBER 12, 2024
Agios Pharmaceuticals has announced that the US FDA has granted orphan drug designation to tebapivat to treat myelodysplastic syndromes.
Bio Pharma Dive
SEPTEMBER 12, 2024
As part of a broad restructuring, the company revealed plans to reduce research spending by 20% over the next few years and ax five programs in early development. It won’t cut jobs, however, a spokesperson told BioPharma Dive.
Pharmaceutical Technology
SEPTEMBER 12, 2024
India's CDSCO has suspended the license of Entod Pharmaceuticals’ PresVu eye drops due to safety concerns and unauthorised claims.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
SEPTEMBER 12, 2024
Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.
Pharmaceutical Technology
SEPTEMBER 12, 2024
The FDA has granted breakthrough therapy designation to Neuraptive Therapeutics’ NTX-001 for peripheral nerve injury requiring repair.
Drug Discovery World
SEPTEMBER 12, 2024
New research has shown that Ellorarxine, a novel drug compound developed by biotech Nevrargenics, provides a robust neuroprotective effect and reduces neuronal death in cell models of neurodegenerative disease. The peer reviewed study published in Frontiers in Neuroscience was conducted by academics at Aberdeen and Durham Universities in the UK. Based on the results, the company has secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to run a human study in the
Pharmaceutical Technology
SEPTEMBER 12, 2024
Johnson & Johnson has announced that the US FDA has approved TREMFYA for the treatment of active ulcerative colitis (UC).
pharmaphorum
SEPTEMBER 12, 2024
Join us for Day Two of LSX World Congress featuring presentations from top pharmaceutical companies like AstraZeneca, Takeda, Merck, Roche, Johnson & Johnson, Bayer and more. Get insights into the latest trends and innovations in the life sciences industry.
Pharmaceutical Technology
SEPTEMBER 12, 2024
Moderna will slash five clinical programmes but says it remains on track for ten product approvals in the next three years.
pharmaphorum
SEPTEMBER 12, 2024
Keir Starmer has promised the biggest 'reimagining' of the NHS in its history but said there will be no more funding without sweeping reforms
Pharmaceutical Technology
SEPTEMBER 12, 2024
The vaccine manufacturer said it could also supply 13 million doses by YE 2025 to meet requests by Africa CDC and UNICEF.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
pharmaphorum
SEPTEMBER 12, 2024
Explore how digital measurement technology is revolutionising sleep monitoring in clinical research and practice. Learn about the latest advancements and benefits for improving sleep quality.
Fierce Pharma
SEPTEMBER 12, 2024
Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. | Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.
pharmaphorum
SEPTEMBER 12, 2024
Explore the ins and outs of Medicare drug pricing negotiations with Alice Valder Curran on this insightful podcast. Learn more about what comes next in this crucial healthcare sector.
Pharmaceutical Commerce
SEPTEMBER 12, 2024
Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
pharmaphorum
SEPTEMBER 12, 2024
Mpox is on the rise again as the latest outbreak gathers pace. Stay informed and learn more about the vaccine space for this infectious disease.
Pharma Times
SEPTEMBER 12, 2024
New study highlights potential benefits of menopausal hormone therapy
Fierce Pharma
SEPTEMBER 12, 2024
By Dr. L. Alison McInnes and Jimmy Qian | We’re finally moving towards a causality-based nosology for psychiatry: specific symptoms with defined biological underpinnings can now be targeted by new therapies. But how do we bridge clinical development with real-world care? How do we ensure trial endpoints are synchronized with real-world measures, payer requirements, and clinical society guidelines?
Pharma Times
SEPTEMBER 12, 2024
Promising results for novel orexin agonist in sleep-deprived volunteers
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Drug Discovery World
SEPTEMBER 12, 2024
In the In Conversation With series, a part of the free DDW podcast, DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. In this episode, Megan Thomas is in conversation with Dr Friso Postma, Vice President of AI Drug Discovery at BioXcel Therapeutics. Thanks to BioXcel’s AI platform, the company was able to repurpose previous drugs to obtain FDA approval for its acute treatment for agitation associated with schizophr
ACRP blog
SEPTEMBER 12, 2024
As students and faculty began settling into the routines of a new academic year at universities across the U.S., ACRP reached out to experts from graduate programs in clinical research for a snapshot of how education in this field, especially at the master’s degree level, is holding up amidst rapidly evolving changes in the research enterprise itself.
FDA Law Blog
SEPTEMBER 12, 2024
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Anne K. Walsh — While we hope readers of the Blog, as our clients and friends, come out of any FDA inspection with a clean bill of health, we know that based on FDA FY2024 data to date, approximately 40% of inspections of medical device companies end up classified as voluntary or official action indicated (VAI or OAI).
Intouch Solutions
SEPTEMBER 12, 2024
Nicholas Capanear, Executive Creative Director, was recently featured in the Sports + Health edition of Lürzer’s Archive. In the article, Nicholas highlights the evolving versatility of health marketing, which increasingly intersects with various sectors, such as retail, entertainment, gaming and music, driving fresh and innovative creative approaches.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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