Pharmaceutical Commerce
NOVEMBER 4, 2024
In the second part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Delphine Perridy, chief commercial officer, Envirotainer, explains why ultra-precise temperature control and customized logistics solutions are critical when it comes to biologics and personalized medicine.
Pharmaceutical Technology
NOVEMBER 4, 2024
Researchers from Northwestern and Case Western Reserve universities have developed a polymer therapeutic to treat Huntington's disease.
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Bio Pharma Dive
NOVEMBER 4, 2024
Wall Street analysts were impressed by data showing competitive rates of weight loss for Viking’s therapy, but shares in the company still slipped.
Pharmaceutical Technology
NOVEMBER 4, 2024
The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP).
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 4, 2024
Per terms, Novo could pay up to $285 million in upfront and milestone fees to Ascendis, which specializes in a kind of drug-enhancing technology.
Rethinking Clinical Trials
NOVEMBER 4, 2024
The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH. The updated chapter now includes information about how to develop a grant application for PCORI.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 4, 2024
Increasingly, injectable manufacturers recognise that to achieve maximum profitability, they need to focus on the value they provide.
Bio Pharma Dive
NOVEMBER 4, 2024
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.
Pharmaceutical Technology
NOVEMBER 4, 2024
UK-based biopharmaceutical company Prokarium has received two Notices of Allowance from the US Patent and Trademark Office.
Bio Pharma Dive
NOVEMBER 4, 2024
Bio-Rad’s extensive ddPCR assay offerings help researchers leverage the full power of digital PCR.
Pharmaceutical Technology
NOVEMBER 4, 2024
In an end-of-Phase II meeting, the FDA indicated support for accelerated approval based on existing clinical data.
Fierce Pharma
NOVEMBER 4, 2024
BioNTech reported surprisingly strong sales of its COVID-1 | BioNTech reported surprisingly strong sales of its COVID-19 vaccine in the third quarter. Despite the performance, the company expects to be at the lower end of its revenue guidance window for the year of between €2.5 billion to €3.1 billion.
pharmaphorum
NOVEMBER 4, 2024
Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD
Fierce Pharma
NOVEMBER 4, 2024
Despite winning an alopecia areata approval for its drug Leqselvi in July, Sun Pharma will have to wait a while longer to launch its JAK inhibitor competitor to Eli Lilly and Incyte’s Olumiant and | Sun Pharma, which had been plotting a mid-October launch for its JAK inhibitor Leqselvi, has been slapped with in an injunction blocking the rollout of the alopecia areata drug.
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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
pharmaphorum
NOVEMBER 4, 2024
Accord Healthcare unveils £50m investment, backed by the UK government, that will see a new manufacturing facility built in Newcastle
Outsourcing Pharma
NOVEMBER 4, 2024
Thermo Fisher Scientific has joined forces with Labguru to integrate Labguruâs Electronic Lab Notebook (ELN) into Thermo Fisherâs Laboratory Information Management System (LIMS) and lab operations software.
pharmaphorum
NOVEMBER 4, 2024
NHS England starts pilot trial of an iPhone app and device that could be used by nurses to speed up reviews of suspected throat cancer cases.
XTalks
NOVEMBER 4, 2024
As we approach World Diabetes Day on November 14, this year’s theme , “Diabetes and Well-being,” underscores the need to support both physical and mental health in diabetes care. With over 537 million people affected globally, diabetes complications like cardiovascular disease, kidney failure and neuropathy are on the rise. Early diagnosis and proactive management are essential to reducing these risks.
pharmaphorum
NOVEMBER 4, 2024
US district court grants an injunction sought by Incyte on the launch of Sun Pharma's recently approved Leqselvi for alopecia areata
XTalks
NOVEMBER 4, 2024
ESSA Pharma announced the discontinuation of its Phase II study on masofaniten, which it was evaluating for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The decision came after a futility analysis of data from the study indicated there was a low probability of achieving the prespecified primary endpoint. ESSA was evaluating the drug in a head-to-head study against Pfizer and Astellas’ blockbuster prostate cancer drug Xtandi (enzalutamide).
pharmaphorum
NOVEMBER 4, 2024
Novo Nordisk puts $285m into a once-monthly GLP-1 agonist for obesity using technology developed by fellow Danish pharma Ascendis
Fierce Pharma
NOVEMBER 4, 2024
As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against its competitors. | As Novartis builds an empire of radiopharmaceuticals, the Swiss pharma has ramped up legal actions against competitors.
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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.
FDA Law Blog
NOVEMBER 4, 2024
By Sara W. Koblitz & Charles D. Snow & Karla L. Palmer & John W.M. Claud — As we reported back in January, Phibro Animal Health Corporation challenged FDA’s decision to remove a drug called carbadox—used as an antimicrobial drug to treat gastrointestinal disease in food-producing pigs—from the market. More specifically, FDA rescinded approval of a “regulatory method” that Phibro used to establish that carbadox is safe and effective.
Fierce Pharma
NOVEMBER 4, 2024
After a protracted rough patch—which has included layoffs, partnership terminations and lawsuits—San Francisco’s Nektar Therapeutics is extending its cash runway with the sale of one of its two mai | Nektar is selling its Huntsville, Alabama, manufacturing plant and reagent supply business to private equity firm Ampersand for a total value of $90 million.
Drug Patent Watch
NOVEMBER 4, 2024
The development and use of generic drugs have significant implications for healthcare systems and economies worldwide.
XTalks
NOVEMBER 4, 2024
On Familial Chylomicronemia Syndrome (FCS) Awareness Day, which falls on November 1 every year, Arrowhead Pharmaceuticals launched a new campaign called ‘We’ll Get There Soon’ to shed light on the rare disease. The initiative aims to raise awareness about the disease and the challenges faced by patients living with the rare genetic disorder. The campaign includes a website, [link] , along with Instagram and Facebook pages, providing a platform for those affected by FCS to share their experiences
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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
Drug Channels
NOVEMBER 4, 2024
Here on Drug Channels , we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall. Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid ho
Fierce Pharma
NOVEMBER 4, 2024
Dermatology drugmaker Journey Medical has trekked its Dr. Reddy’s Laboratories-partnered rosacea med across the FDA finish line as Emrosi. | The drug proved superiority in clearing lesions over Galderma's standard-of-care Oracea capsules in phase 3 studies, leaving Journey to deploy its dermatology sales force to establish Emrosi as a dominant treatment.
Drug Discovery World podcast
NOVEMBER 4, 2024
The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. In a week that saw a second monoclonal antibody rejected by UK regulator NICE, antibodies have been high on the news agenda. More positively, a new indication for Fasenra was approved in the EU, researchers found an antibody platform could overcome the challenges of treating mutating viru
Pharmaceutical Commerce
NOVEMBER 4, 2024
With a 26% decline in prescription drug plans from 2024 to 2025, navigating potential gaps and accessing care remains vital for low income patients.
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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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