Bio Pharma Dive
OCTOBER 6, 2023
The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.
Pharmaceutical Technology
OCTOBER 6, 2023
Ocular Therapeutix has confirmed the launch of a trial of an intravitreal eye implant intended to combat macular degeneration.
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Bio Pharma Dive
OCTOBER 6, 2023
Regulators’ holdup of the deal had stoked investor fears of greater scrutiny on M&A. In the end, Amgen agreed to requirements meant to guard against product “bundling.
Pharmaceutical Technology
OCTOBER 6, 2023
Biologics are poised to overtake innovative small molecules in terms of sales revenue by 2027, with forecast sales of $120bn.
Bio Pharma Dive
OCTOBER 6, 2023
The negative panel vote likely means Amgen will need more data to support a full approval for its conditionally cleared lung cancer drug Lumakras.
Pharmaceutical Technology
OCTOBER 6, 2023
The panel identified several issues with the trial including study organisation and loss of follow-up data from patients who withdrew consent.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 6, 2023
Genomics company Twist Bioscience has entered into an antibody discovery, option and licence agreement with German drug manufacturer Bayer.
Intouch Solutions
OCTOBER 6, 2023
Working at EVERSANA INTOUCH means being surrounded by forward-thinking, highly innovative and creative individuals who strive to think differently. Recently, a group of EVERSANA INTOUCHers began a new internal series called “Brainspo.” The idea for Brainspo began as an internal pilot within the EVERSANA INTOUCH Oxygen affiliate and came out of wanting to get people out of their day-to-day and spend 15 minutes of thought-provoking conversation together, once a week, to open minds and ultimately g
Pharmaceutical Technology
OCTOBER 6, 2023
TREAT California started collecting signatures for a 5 November ballot measure that aims to raise money for psychedelic therapy research.
Outsourcing Pharma
OCTOBER 6, 2023
EDETEK and Pfizer are in collaboration to speed access to clinical data, promote interoperability and enable data visualization to drive faster decision-making capabilities in clinical operations.
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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 6, 2023
Emergex and Saudi Vaccine Industrial Company (VIC) will develop T cell-priming immune set-point candidates against infectious diseases.
Fierce Pharma
OCTOBER 6, 2023
Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog. | Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog.
Pharmaceutical Technology
OCTOBER 6, 2023
AbbVie has acquired discovery-stage biotechnology company Mitokinin in a deal totalling $655m, to bolster its neuroscience pipeline.
Fierce Pharma
OCTOBER 6, 2023
People who use Novo Nordisk’s popular weight-loss drugs are taking on a small risk of developing severe stomach problems, according to research conducted by the University of British Columbia and < | People who use Novo Nordisk’s popular weight-loss drugs are taking on a small risk of developing severe stomach problems, according to research conducted by the University of British Columbia.
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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 6, 2023
The expansion at the St. Louis (Missouri) would include up to four bioreactors to accommodate the production of biologic therapies.
Pharma Times
OCTOBER 6, 2023
The study used data from 50,000 people in the UK Biobank - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 6, 2023
Serum is already India's most valuable unlisted company, and it is looking to expand its offering into wealthier nations.
Pharma Times
OCTOBER 6, 2023
NPIP will transform medical research and provide better outcomes for patients - News - PharmaTimes
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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 6, 2023
Tuttle and colleagues recognized that patients with T2D and CKD are limited in their therapeutic use because their low eGFR.
Intouch Solutions
OCTOBER 6, 2023
You’re singing the song right now, aren’t you, after reading the title of this article? Recently, John Kenny, Head of Strategic Planning for EVERSANA INTOUCH, wrote an article on the catchyjingle for Pharmalive.com and Med Ad News. John’s work has received numerous creative awards, including a 2022 Cannes Lion Grand Prix in Creative Effectiveness.
Pharmaceutical Technology
OCTOBER 6, 2023
Agomab Therapeutics FSCD therapy has received the US Food and Drug Administration (FDA)'s fast track designation
Fierce Pharma
OCTOBER 6, 2023
Aiming to hit a corporate value of around $15 billion by the end of the decade, Korean CDMO Lotte Biologics has laid out plans to stand up three new manufacturing facilities in the same time frame. | Lotte this week unveiled a land purchase agreement with the Incheon Free Economic Zone Authority in Incheon, Korea. With the new real estate, Lotte plans to build out three separate bio plants by 2030.
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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 Technology
OCTOBER 6, 2023
GSK has announced plans to divest its 2.9% stake in consumer healthcare company Haleon for £885.6m ($1.07bn).
Pharmaceutical Commerce
OCTOBER 6, 2023
Sr. Director of Community Engagement for Pharmaceuticals at GS1 US explains what the implementation guidelines are meant to accomplish.
Drug Patent Watch
OCTOBER 6, 2023
For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.com The post New tentative approval for Mylan Gmbh drug trastuzumab-dkst appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Commerce
OCTOBER 6, 2023
Conference hosts roundtable chats, with topics ranging from data-driven decision making to cold chain logistics.
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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 Channels
OCTOBER 6, 2023
Today’s guest post comes from Michael Carr, Group Vice President, CoAssist Pharmacy at AssistRx. Michael discusses the challenges that patients and healthcare providers face during the prescription intake and enrollment process. He outlines four key features of solutions that improve digital intake. To learn about AssistRx’s digital intake technologies, download their case study: Digital Intake for More Meaningful Patient and HCP Interactions.
pharmaphorum
OCTOBER 6, 2023
What AI really means for biology and the pharmaceutical industry Mike.
Drug Patent Watch
OCTOBER 6, 2023
Annual Drug Patent Expirations for TIVICAY Tivicay is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from three suppliers. There are two patents… The post New patent for Viiv Hlthcare drug TIVICAY appeared first on DrugPatentWatch - Make Better Decisions.
WCG Clinical
OCTOBER 6, 2023
Media outreach is a great tool to connect large groups of potential participants to actively enroll in clinical research studies. No matter how broad the outreach or how innovative the execution, to find enrollment success, outreach strategies must connect with the personal healthcare journey of each participant, explains Tyler Bye, Director of Site Solutions and Product Strategy at WCG.
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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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