Bio Pharma Dive
JANUARY 30, 2024
Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.
Pharmaceutical Technology
JANUARY 30, 2024
The EMA has accepted GSK’s regulatory application seeking expansion of its RSVvaccine, Arexvy, to include adults aged 50 to 59 years.
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Bio Pharma Dive
JANUARY 30, 2024
The company plans to soon ask the FDA for approval of the drug, which it has pitched as a safer alternative to addictive opioid painkillers.
Pharmaceutical Technology
JANUARY 30, 2024
Vertex is planning to submit a new drug application to the FDA following the announcement of its Phase III programme meeting its primary endpoint.
Bio Pharma Dive
JANUARY 30, 2024
Roche, Pfizer and Bristol Myers Squibb have all invested in the startup, which is using nanoparticle technology to retrain the body’s immune system.
Pharmaceutical Technology
JANUARY 30, 2024
The funds secured by France-based biotech Aqemia, which partnered with Sanofi late last year, bring its Series A funding sum to $65m.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 30, 2024
Setting up trial sites in countries with unmet clinical needs can lead to higher patient recruitment, compared to established trial hubs.
Bio Pharma Dive
JANUARY 30, 2024
The companies said the deal shows their “continued conviction in the TIGIT pathway,” an area of research that so far has not lived up to expectations.
Pharmaceutical Technology
JANUARY 30, 2024
By enabling mRNA delivery for transient protein expression, lipid nanoparticles could address key challenges facing CAR T-cell therapies.
Drug Patent Watch
JANUARY 30, 2024
The recent paper published in PLOS ONE presents a novel approach for efficiently retrieving a substantial number of patents related to specific technologies. The authors enhance an automated patent landscaping… The post Revolutionizing Patent Landscaping: A Human-Supervised AI Approach to Identify Tech Clusters appeared first on DrugPatentWatch - Make Better Decisions.
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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
JANUARY 30, 2024
The FDA has approved Takeda’s GAMMAGARD LIQUID for the treatment of adults with chronic inflammatory demyelinating polyneuropathy.
Outsourcing Pharma
JANUARY 30, 2024
With colorectal cancer (MRC) being the second biggest cancer type in Hong Kong, it is positive news that Hutchmed has received marketing approval for its Elunate (fruquintinib) small molecule treatment.
Pharmaceutical Technology
JANUARY 30, 2024
The UK MHRA has approved Napp Pharmaceuticals' new antifungal treatment for invasive candidiasis, Rezzayo (rezafungin).
pharmaphorum
JANUARY 30, 2024
From today, a new feature added to the NHS App used in the UK will allow millions of people to submit and view prescriptions, in a bid to save time for patients and doctors. The digital prescription function, which does away with the need for paper scrip, was put through its paces in a pilot trial last year involving a million users of the app, now being used by three-quarters of the UK population or around 33.5 million people.
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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
JANUARY 30, 2024
Gilead Sciences and Arcus Biosciences have expanded their oncology partnership agreement and announced an equity investment.
pharmaphorum
JANUARY 30, 2024
Legislation filed in the US is seeking to block Chinese biotech companies from federal contracts on the grounds they are a national security concern
Pharmaceutical Technology
JANUARY 30, 2024
Synthekine will receive an upfront payment of $40 million for its preclinical cytokine engineering clinical expertise.
Drug Discovery World
JANUARY 30, 2024
A UK-based start-up is developing technology to build a pharmaceuticals factory in space that will make antibody treatments more accessible and easier to administer. BioOrbit are aiming to build the first pharmaceuticals factory in microgravity and are currently developing a platform for large-scale crystallisation of protein drugs. As a result of ever-increasing demands on hospitals, there is a need to develop drugs that can be self-administered at home.
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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.
pharmaphorum
JANUARY 30, 2024
Explore the future of pharmacovigilance as we begin to shift towards AI-driven processes. Learn about the advancements in AI models, the role of GenAI, and how experts are leveraging these technologies to improve drug safety and monitoring.
Fierce Pharma
JANUARY 30, 2024
2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. | 2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. Now, the company is splitting in two once again, passing its R&D programs to Regeneron and going all-in on its Bristol Myers Squibb-partnered CAR-T Abecma.
Pharma Times
JANUARY 30, 2024
Type 2 diabetes is estimated to affect 462 million people worldwide
pharmaphorum
JANUARY 30, 2024
In a new episode of the pharmaphorum podcast, host Nicole Raleigh speaks with Stuart Cooper, CEO of Adelphi Group, about Anthropy – a yearly event that aims to spark innovation and foster fresh thinking among diverse leaders – and about creating healthier societies, about biopharma’s role in that, including implementation of preventative methods in ameliorating global health.
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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.
Fierce Pharma
JANUARY 30, 2024
A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. | A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion.
Antidote
JANUARY 30, 2024
Facilitating medical research relies on patient participation, yet research protocols often overlook the patient perspective. Improving patient centricity in clinical trials demands prioritizing the patient experience.
Fierce Pharma
JANUARY 30, 2024
After 'bad launch' remark by CEO, Pfizer's RSV vaccine gains traction in Q4. How will it fare in latest round of GSK showdown?
pharmaphorum
JANUARY 30, 2024
Elon Musk’s Neuralink company has said it has implanted its wireless brain implant device into a human being for the first time
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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.
BioPharma Reporter
JANUARY 30, 2024
Merck has signed a R&D collaboration deal with data and technology company Culmination Bio, a spinoff from Intermountain Health.
Fierce Pharma
JANUARY 30, 2024
With the Inflation Reduction Act's Medicare price negotiations moving ahead (PDF) rapidly, one party n | The price-negotiation component of the Inflation Reduction Act appears right up ICER’s alley. But the watchdog’s new president says there’s a condition that needs to be met for the organization to regularly contribute to the process.
Pharma Times
JANUARY 30, 2024
Around one million adults in the UK visit their GP every year due to chest pain
Outsourcing Pharma
JANUARY 30, 2024
Two new offerings have been unveiled by drug delivery and solutions provider, Stevanto Group S.p.A.
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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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