FDA Law Blog
NOVEMBER 6, 2024
By Jennifer D. Newberger — Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product. Sometimes this is because FDA has not opined on a specific set of facts, but more often it is because FDA seems to take different approaches to the same technology offered by different companies.
Bio Pharma Dive
NOVEMBER 6, 2024
Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.
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Rethinking Clinical Trials
NOVEMBER 6, 2024
In this Friday’s PCT Grand Rounds, Sumit Agarwal of the University of Michigan will present “The Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study of an Income Support.” The Grand Rounds session will be held on Friday, November 8, 2024, at 1:00 pm eastern. Agarwal is an assistant professor of internal medicine and health management and policy at the University of Michigan.
XTalks
NOVEMBER 6, 2024
LumiThera Inc. , a vision tech company focused on developing photobiomodulation (PBM) therapies for ocular diseases and disorders, has received US Food and Drug Administration (FDA) authorization for its Valeda Light Delivery System for patients with dry age-related macular degeneration (AMD), one of the most common causes of vision impairment in the aging population.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Pharmaceutical Technology
NOVEMBER 6, 2024
The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.
XTalks
NOVEMBER 6, 2024
Gelteq Limited, a biotechnology innovator in ingestible gel delivery solutions, recently completed its initial public offering (IPO), raising gross proceeds of $5.2 million. Priced at $4.0 per share, the offering included 1,300,000 ordinary shares, which began trading on the Nasdaq Global Market under the ticker symbol GELS on October 29, 2024. Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceutica
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 6, 2024
Stephen Hoge will now oversee vaccine sales at Moderna, per a Bloomberg report. Elsewhere, Intra-Cellular unveiled an ambitious sales target and Syndax inked a lucrative royalty deal.
Pharmaceutical Technology
NOVEMBER 6, 2024
Tevogen Bio’s AI effort Tevogen.AI has partnered with Microsoft to advance the development of an HPV specific CTL treatment.
Bio Pharma Dive
NOVEMBER 6, 2024
The selling price is an indication that the FDA’s planned sunsetting of the rare pediatric disease voucher program may be pushing values higher, according to one analyst.
Pharmaceutical Technology
NOVEMBER 6, 2024
Demis Hassabis, joint winner of the Nobel Prize in Chemistry 2024, shared insights on AI at the FT Pharma and Biotech Summit.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Bio Pharma Dive
NOVEMBER 6, 2024
Third quarter sales of Novo’s in-demand obesity drug totaled $2.5 billion, roughly 81% higher than the same period in 2023 and nearly doubling the total for Lilly’s Zepbound.
Pharma Times
NOVEMBER 6, 2024
Phase 1 and 2 studies show promising results for anito-cel therapy
Pharmaceutical Technology
NOVEMBER 6, 2024
The FDA-approved schizophrenia and bipolar disorder therapy met the primary and secondary endpoint in a Phase III “withdrawal trial”.
Pharma Times
NOVEMBER 6, 2024
New therapy targets specific genetic alterations, promises extended survival
Pharmaceutical Technology
NOVEMBER 6, 2024
Sales of the GLP-1RA hit $2.5bn in Q3, a 79% increase over the same period last year.
Fierce Pharma
NOVEMBER 6, 2024
Novavax has inked another settlement for a past COVID-19 vaccine supply deal. | Novavax has inked another settlement for a past COVID-19 vaccine supply deal. The Maryland biotech has agreed to pay $123.8 million to end a COVID vaccine supply pact with the U.K.
Pharmaceutical Technology
NOVEMBER 6, 2024
Nxera Pharma has entered a collaboration and licensing agreement with Antiverse to design antibodies for GPCRs.
pharmaphorum
NOVEMBER 6, 2024
Two players in medical extended reality (XR) – XRHealth and NeuroReality – have come together in a quest to build the biggest company in the sector.Boston, US-based XRHealth is leading the deal, acquiring NeuroReality of the Netherlands for an undisclosed sum, combining their products and expertise in the use of XR and virtual reality software for healthcare applications.
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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
Pharmaceutical Technology
NOVEMBER 6, 2024
GSK has received approval for its vaccine, AREXVY, in Canada to prevent LRTD caused by RSV in adults aged 50 to 59 years.
pharmaphorum
NOVEMBER 6, 2024
Novo Nordisk's sales of blockbuster obesity drug Wegovy grew by a massive 79% in the third quarter, in a relief to investors after disappointing results three months ago.
Fierce Pharma
NOVEMBER 6, 2024
Drugs for unmet needs and those from experienced companies had the best chance for successful launches in 2023: report kdunleavy Wed, 11/06/2024 - 09:23
pharmaphorum
NOVEMBER 6, 2024
Cassava Sciences is nearing a Phase 3 readout for its Alzheimer's drug, lecanemab, despite facing a scandal involving the SEC. Learn more about the latest updates on donanemab and the company's progress in the field of Alzheimer's research.
Outsourcing Pharma
NOVEMBER 6, 2024
As clinical trials evolve, electronic Clinical Outcome Assessments (eCOA) remain central to data quality but often lag in adoption due to complex setup and deployment challenges.
pharmaphorum
NOVEMBER 6, 2024
New results with Alligator's CD40 agonist mitazalimab show it nearly doubled survival in pancreatic cancer, ahead of phase 3 trial next year.
Fierce Pharma
NOVEMBER 6, 2024
Following a disappointing earnings showing from Eli Lilly last week, Novo Nordisk’s latest report on the performance of its GLP-1 stalwarts Ozempic and Wegovy is more of a mixed bag. | Among Novo’s semaglutide-based drugs, diabetes blockbuster Ozempic fell short of analysts' expectations during the third quarter while weight-loss med Wegovy came above a consensus estimate.
pharmaphorum
NOVEMBER 6, 2024
Get the latest updates on progress with the UK's VPAG (Voluntary scheme for branded medicines Pricing, Access and Growth), including the latest recommendations from the National Institute for Health and Care Excellence (NICE).
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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.
Pharmaceutical Commerce
NOVEMBER 6, 2024
In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Delphine Perridy, chief commercial officer, Envirotainer, forecasts the future of the pharma cold chain regarding technological advancements and changes in market dynamics.
pharmaphorum
NOVEMBER 6, 2024
HCG’s drive to transform is motivated by industry-leading perspective on the emerging trend of “impact”, and recognition that understanding that the impact of medical communications efforts is more critical than ever.
Pharmaceutical Commerce
NOVEMBER 6, 2024
The latest news for pharma industry insiders.
Trialfacts
NOVEMBER 6, 2024
Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center: Research Center: Henry Ford Health Location: This is a virtual study open to the United States Lead Researcher: Phillip Cheng PhD IRB: This study has been reviewed and approved by the Henry Ford Health Institutional Review Board About the Study Millions of shift workers across the U.S. face significant health challenges due to disrupted circadian rhythms.
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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
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