pharmaphorum
JANUARY 31, 2024
Reverba offers innovative patient engagement solutions and strategies that utilise the power of authentic patient influencers. Discover the secret to successful patient influencer marketing and how it can benefit your healthcare organisation.
Bio Pharma Dive
JANUARY 31, 2024
The agency is planning a pilot program across states to help sickle cell patients access treatments like the newly approved Casgevy and Lyfgenia.
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Pharmaceutical Technology
JANUARY 31, 2024
CMS’ CGT Access Model will see allow the agency to negotiate negotiate pricing and build a framework that expands access to treatments.
Bio Pharma Dive
JANUARY 31, 2024
The decision to discontinue the controversial drug closes a tumultuous three-year saga that brought significant upheaval to the company.
Rethinking Clinical Trials
JANUARY 31, 2024
In this Friday's PCT Grand Rounds, Susan Winckler of the Reagan-Udall Foundation for the FDA will present "Strategies for Improving Public Understanding of FDA and the Products It Regulates: Why Should We Care, and What Might We Do?" The Grand Rounds session will be held on Friday, February 2, 2024, at 1:00 pm eastern. Winckler is the chief executive officer of the Reagan-Udall Foundation for the FDA, a nonprofit organization created by Congress “to advance the mission of the FDA to modernize me
Bio Pharma Dive
JANUARY 31, 2024
The British drugmaker reported Arexvy sales of about $1.5 billion for 2023, higher than the range it had previously predicted for the year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JANUARY 31, 2024
The gene therapy developer’s demise has given Tectonic Therapeutic, a GPCR-focused startup founded by the prolific biotech entrepreneur, an alternate path to the public markets.
Pharmaceutical Technology
JANUARY 31, 2024
Germany’s Federal Ministry of Health has published its evaluation report on the impact of the GKV Financial Stabilization Act on access to medicines.
Bio Pharma Dive
JANUARY 31, 2024
The announcement ends a nine-month delay related to manufacturing snags that slowed Novo’s ability to meet demand for the fast-selling medicine.
Pharmaceutical Technology
JANUARY 31, 2024
In late 2023, Vertex Pharmaceuticals and CRISPR Therapeutics made history by gaining the first FDA approval for a CRISPR-based drug, Casgevy.
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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
Rethinking Clinical Trials
JANUARY 31, 2024
Speakers Mark Sendak, MD, MPP Population Health & Data Science lead Duke Institute for Health Innovation (DIHI) Suresh Balu, MD, MBA Director, Duke Institute for Health Innovation (DIHI) Associate Dean, Innovation and Partnership Duke School of Medicine Slides Keywords AI, ML, health equity Key Points The Duke Institute for Health Innovation’s (DIHI) mission is to catalyze transformative innovation in health and healthcare through high-impact research, leadership develo
Pharmaceutical Technology
JANUARY 31, 2024
Ferrer has announced that its FAB122 failed to achieve its primary efficacy and key secondary endpoints in the Phase III ADORE trial for ALS.
Fierce Pharma
JANUARY 31, 2024
More than two years after Aduhelm's controversial and ill-fated FDA accelerated approval, Bi | Biogen is discontinuing its first Alzheimer's disease therapy, Aduhelm, after walking a rocky path. The company is taking a $60 million charge, halting sales and terminating a confirmatory trial.
Pharmaceutical Technology
JANUARY 31, 2024
The NASA and US Navy-propelled company remains confident, with Defender CEO Barry Feinberg saying a meeting with the FDA has been requested.
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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
Fierce Pharma
JANUARY 31, 2024
Beaten to the punch by Pfizer in developing a vaccine for COVID, GSK has regained some of its lost luster as a vaccine powerhouse with its advancement of respiratory syncytial virus (RSV) shot Arex | GSK's RSV vaccine Arexvy generated $1.5 billion in sales in 2023 compared to $890 million for Pfizer's Abrysvo. But the British pharma major says that the successful launch represents just one round of a boxing match, and much is still to be decided, especially with Moderna expected to joi
Pharmaceutical Technology
JANUARY 31, 2024
Regeneron Pharmaceuticals has formed Regeneron Cell Medicines, a new research & development (R&D) unit in oncology and immunology.
pharmaphorum
JANUARY 31, 2024
In this exclusive interview, Gene Kinney, CEO of Prothena, discusses the latest developments in the field of neurodegenerative diseases such as Alzheimer's and Parkinson's. Gain insights and advancements being made in the treatment of these conditions.
Pharmaceutical Technology
JANUARY 31, 2024
Astellas has submitted an sNDA in Japan seeking approval for PADCEV with KEYTRUDA as a first-line treatment for advanced bladder cancer.
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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.
XTalks
JANUARY 31, 2024
This episode features an interview with Punit Dhillon, Chairman & CEO of Skye Bioscience , a pharmaceutical company developing proprietary molecules to treat diseases involving inflammatory, fibrotic and metabolic conditions. Skye Bioscience is at the forefront of exploring the endocannabinoid system for drug development. Punit Dhillon, Chairman & CEO Skye Bioscience Punit brings two decades of experience as a leader and investor within the life sciences sector.
Pharmaceutical Technology
JANUARY 31, 2024
The shelving of Biogen’s troubled Alzheimer’s drug caps a turbulent journey, with Leqembi now receiving the company’s full attention.
Outsourcing Pharma
JANUARY 31, 2024
GSK plcâs small molecule Omjjara (momelotinib), was granted marketing authorization (MA) yesterday (January 31) by the Medicines and Healthcare products Regulatory Agency (MHRA).
Pharmaceutical Technology
JANUARY 31, 2024
Pfizer reported its full-year 2023 financial results - a decline in revenues of $58.5bn and a decrease of 42% from $100.33bn in 2022.
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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.
pharmaphorum
JANUARY 31, 2024
Novartis ends development of Tim3 antibody sabatolimab in myelodysplastic syndromes after failed phase 3 trial.
Pharmaceutical Technology
JANUARY 31, 2024
As the UK pharmaceutical sector adopts the VPAG scheme, the question of how this will impact biosimilars comes to the forefront.
pharmaphorum
JANUARY 31, 2024
A surge in 2023 sales and profits fuelled by diabetes and obesity drugs has driven Novo Nordisk's valuation toward $500bn
Pharmaceutical Technology
JANUARY 31, 2024
Dr. Nicholas Finer, former senior principal clinical scientist at Novo Nordisk discusses the changing obesity drug landscape.
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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.
pharmaphorum
JANUARY 31, 2024
AbbVie’s CD20xCD3 bispecific antibody Tepkinly has been recommended by NICE for NHS use as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive and fast-growing form of non-Hodgkin lymphoma. Tepkinly (epcoritamab) – the first medicine to emerge from AbbVie’s $3.9 billion alliance with Genmab signed in 2020 – can be used to treat adults with DLBCL whose cancer has returned or has not responded to at least two previous systemic treatments.
Pharmaceutical Technology
JANUARY 31, 2024
Musk announced Neuralink's first sucessful human BCI implant on Sunday, but can the company live up to the hype?
Cloudbyz
JANUARY 31, 2024
The growing complexity of clinical trials, fueled by globalization and the digital revolution, demands innovative approaches to streamline drug development. CROs, with their specialized expertise in protocol design, patient recruitment, and regulatory compliance, offer invaluable support. eClinical companies, armed with advanced data management solutions and cutting-edge technologies, provide the tools and insights needed for efficient trial execution.
Pharmaceutical Technology
JANUARY 31, 2024
The FDA has granted an orphan drug designation to Revolo’s ‘1104, with plans for a Phase IIb study later this year.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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