Bio Pharma Dive
OCTOBER 13, 2023
Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.
Pharmaceutical Technology
OCTOBER 13, 2023
The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.
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Bio Pharma Dive
OCTOBER 13, 2023
The awards, to biotechs Gritstone, Codagenix and CastleVax, are part of the program’s plan to develop vaccines with broader or longer-lasting benefits.
Pharmaceutical Technology
OCTOBER 13, 2023
The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.
Bio Pharma Dive
OCTOBER 13, 2023
Employers face a difficult decision over whether to cover the popular weight loss therapies, which cost between $900 and $1,400 for a typical month’s supply at list price.
Pharmaceutical Technology
OCTOBER 13, 2023
Amneal adds Prolia and Xgeva biosimilars to its oncology portfolio which already has three biosimilars products launched in the US.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 13, 2023
MediLink will receive $70m upfront and will be eligible for up to $1bn in additional milestone-based payments from BioNTech.
Bio Pharma Dive
OCTOBER 13, 2023
Following a re-examination, the EMA again concluded that Albrioza — known as Relyvrio in the U.S. — should not be cleared for the European market.
Pharmaceutical Technology
OCTOBER 13, 2023
AI-powered chatbots or virtual assistants are used to provide basic medical information and answer common patient healthcare queries.
Pharma Times
OCTOBER 13, 2023
Automated analysis of language could help diagnose and assess psychiatric conditions - News - PharmaTimes
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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
OCTOBER 13, 2023
The US FDA has granted approval for Pfizer’s Braftovi and Mektovi combination to treat metastatic non-small cell lung cancer (NSCLC).
Pharma Times
OCTOBER 13, 2023
The projects will support the development of new and longer-lasting vaccines - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 13, 2023
South Rampart Pharma has received the US Food and Drug Administration (FDA) fast track designation for SRP-001 to treat acute pain.
XTalks
OCTOBER 13, 2023
In the era of health-consciousness, sugar free cranberry juice is a product that consumers are eagerly looking for on the shelves. However, truly achieving this goal without compromising the nutrition and taste of the juice has been challenging. Enter NewTree Fruit Company (NTFC), which has successfully pioneered a method to give juice lovers exactly what they’ve been looking for.
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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
Pharmaceutical Technology
OCTOBER 13, 2023
Specialised Therapeutics has entered an agreement to license Korea-based CanariaBio’s oregovomab for treating ovarian cancer.
Drug Discovery World
OCTOBER 13, 2023
The UK’s University of Oxford is taking the lead on two collaborative international projects to improve the response to new Covid-19 variants and contribute to future pandemic preparedness. Researchers at Harvard Medical School (HMS) in the US and the University of Oxford have developed a new artificial intelligence (AI) tool named EVEscape that can predict new viral variants before they emerge.
Pharmaceutical Technology
OCTOBER 13, 2023
The US Food and Drug Administration (FDA) has rejected to approve Alvotech’s biologics licence application (BLA) for AVT04.
Intouch Solutions
OCTOBER 13, 2023
Social determinants of health (SDOH) are the non-medical factors that affect people’s health. They can include the conditions in which people are born, live, learn, work, play, worship, and age 1,2 — as well as factors like economic policies and systems, development agendas, social norms, social policies and political systems. 1 Why are SDOH important?
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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 Technology
OCTOBER 13, 2023
Keytruda was recommended by the EU CHMP based on results from KEYNOTE-859 study and is also under review in the US.
Fierce Pharma
OCTOBER 13, 2023
Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. | Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.
Antidote
OCTOBER 13, 2023
For more than 20 years, October has been deemed Health Literacy Month , a designation aimed at highlighting the importance of health literacy in the United States. An individual's health literacy, including their ability to understand doctors’ guidelines, follow medication instructions, and discuss their symptoms, has a major impact on how individuals interact with the healthcare system — and for medical organizations, it is important to understand how to tailor messaging, collateral, and inform
Fierce Pharma
OCTOBER 13, 2023
The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. | The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again.
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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.
Pharmaceutical Commerce
OCTOBER 13, 2023
CDMO’s Heidelberg facility will house the newly-completed manufacturing line.
Fierce Pharma
OCTOBER 13, 2023
Back in February, Leo Pharma revealed that its JAK-inhibitor cream delgocitinib met its primary and secondary endpoints in a phase 3 trial in chronic hand eczema, putting pressure on Incyte’s appro | Back in February, Leo Pharma revealed that its JAK-inhibitor cream delgocitinib met its primary and secondary endpoints in a phase 3 trial in chronic hand eczema, putting pressure on Incyte’s approved topical Opzelura.
pharmaphorum
OCTOBER 13, 2023
Growing health inequality in UK prompts call for ‘joined up strategy’ Mike.
Fierce Pharma
OCTOBER 13, 2023
Bristol Myers Squibb’s Zeposia is no longer the only S1P receptor modulator on the market for ulcerative colitis, thanks to an FDA approval for what appears to be a more effective drug from Pfizer. | Bristol Myers Squibb’s Zeposia is no longer the only S1P receptor modulator on the market for ulcerative colitis, thanks to an FDA approval for what appears to be a more effective drug from Pfizer.
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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 Patent Watch
OCTOBER 13, 2023
Annual Drug Patent Expirations for SOHONOS Sohonos is a drug marketed by Ipsen Inc and is included in one NDA. It is available from one supplier. The generic ingredient in… The post New patent for Ipsen Inc drug SOHONOS appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
OCTOBER 13, 2023
A UK-based study will investigate whether a common anti-viral medication could double up as a treatment for long Covid. The project involves teams from the University Hospitals of Derby and Burton NHS Foundation Trust and the University of Exeter, in collaboration with Gilead Sciences. Globally, estimates suggest that over 144 million people developed long Covid, with 22 million experiencing persistent symptoms at 12 months after the onset of their infection.
Drug Patent Watch
OCTOBER 13, 2023
Annual Drug Patent Expirations for PERSERIS+KIT Perseris Kit is a drug marketed by Indivior and is included in one NDA. It is available from one supplier. There are nine patents… The post New patent for Indivior drug PERSERIS KIT appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
OCTOBER 13, 2023
Lilly to file mirikizumab in Crohn’s after FDA colitis snub Phil.
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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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