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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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.
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.
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
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
Demis Hassabis, joint winner of the Nobel Prize in Chemistry 2024, shared insights on AI at the FT Pharma and Biotech Summit.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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
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.
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”.
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.
Pharmaceutical Technology
NOVEMBER 6, 2024
The UWWTD will require manufacturers to fund micropollutant removal, but Zentiva says the financial squeeze could mean shortages.
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
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
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.
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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
Nxera Pharma has entered a collaboration and licensing agreement with Antiverse to design antibodies for GPCRs.
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
Pharmaceutical Technology
NOVEMBER 6, 2024
Sales of the GLP-1RA hit $2.5bn in Q3, a 79% increase over the same period last year.
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.
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.
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
Drug Patent Watch
NOVEMBER 6, 2024
Developing a Risk Management Plan (RMP) for generic drugs is a crucial step in ensuring the safety and efficacy of these medications. An RMP provides detailed information on a medicine’s safety profile, measures to prevent or minimize risks, and plans for ongoing safety monitoring and evaluation.
Pharma Times
NOVEMBER 6, 2024
New therapy targets specific genetic alterations, promises extended survival
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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
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.
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
New results with Alligator's CD40 agonist mitazalimab show it nearly doubled survival in pancreatic cancer, ahead of phase 3 trial next year.
FDA Law Blog
NOVEMBER 6, 2024
By Sara W. Koblitz — The fight between Jazz, Avadel, and FDA over narcolepsy drug sodium oxybate has been a long and arduous one. Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023.
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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
Pharma Times
NOVEMBER 6, 2024
Phase 1 and 2 studies show promising results for anito-cel therapy
XTalks
NOVEMBER 6, 2024
In this episode, Ayesha spoke with Brent Lucas, CEO of Envoy Medical , a medical device company focused on providing cutting-edge technologies across the hearing loss spectrum. According to the National Institute of Deafness and Other Communication Disorders, 13 percent of people in the US 12 years of age and older have hearing loss in both ears, underscoring the importance of developing solutions to help this population.
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.
Fierce Pharma
NOVEMBER 6, 2024
As other biopharma giants have divested their generics units to focus on the development and commercialization of innovative drugs, Teva has relied on its copycat business to help trigger its rebou | Teva revealed booming third-quarter sales for its generics and biosimilars. In the U.S., revenue from the knockoffs came in at $1.1 billion, which was a 30% increase year over year.
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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.
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