Bio Pharma Dive
AUGUST 22, 2023
Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.
Rethinking Clinical Trials
AUGUST 22, 2023
In an article published this month in Clinical Trials , researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans. “There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensing
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Bio Pharma Dive
AUGUST 22, 2023
The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 22, 2023
The saying goes that money can’t buy you love. But can it buy you time? This is what US billionaire Bryan Johnson is hoping to find out. The 45-year-old reportedly spends millions each year in an attempt to reverse ageing and regain his 18-year-old body (presumably sans acne).
Bio Pharma Dive
AUGUST 22, 2023
The biotech, which aims to develop an alternative to existing medicines and emerging gene-based treatments, will focus further testing on sicker patients.
Pharmaceutical Technology
AUGUST 22, 2023
The functional service provider model can reduce overheads for biopharmaceutical companies and give them the ability to acquire talent from a flexible, adaptable talent pool.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
AUGUST 22, 2023
The funds going to Regeneron, clinical trial partners and other developers are the first major investments under a federal program announced in May.
Pharmaceutical Technology
AUGUST 22, 2023
Halia Therapeutics is planning to start two Phase II trials evaluating its lead drug HT-6184 before the end of the year, said CEO David Bearss.
Fierce Pharma
AUGUST 22, 2023
It was only a few weeks ago when Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. | A few weeks ago, Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. Now, Eli Lilly has revealed that a similar trial of its Retevmo was not only feasible but positive.
Pharmaceutical Technology
AUGUST 22, 2023
Leo Pharma has entered an agreement for the acquisition of US-based clinical-stage biopharma firm Timber Pharmaceuticals for $36m.
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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
XTalks
AUGUST 22, 2023
Three Wishes cereal , a better-for-you, grain-free cereal brand, will be launching a limited-edition fall favorite flavor. Back by popular demand, Pumpkin Spice is now available in a three-pack on Amazon as the company’s latest limited-time offering. Three Wishes cereal enthusiasts will recognize this fall flavor, as it quickly sold out during last year’s launch.
Pharmaceutical Technology
AUGUST 22, 2023
The US FDA has granted approval for Pfizer’s RSV vaccine, Abrysvo, for use in pregnant women to offer protection for their babies.
XTalks
AUGUST 22, 2023
Recruiting participants is perhaps the most challenging aspect of any clinical trial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. Yet, 41 percent of people in the US have no knowledge of the clinical research process, and 91 percent say they’ve never been given the opportunity to participate in a trial, according to SCORR Marketing.
Pharmaceutical Technology
AUGUST 22, 2023
Hongsik Jake Cho is initiating a project to accelerate progress in stem cell treatment for post-traumatic osteoarthritis (PTOA).
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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
BioPharma Reporter
AUGUST 22, 2023
Actimed Therapeutics Ltd will put some of its additional funding of Â4.75 million ($6 million) towards its attempt to provide the worldâs first cure for cancer cachexia.
Pharmaceutical Technology
AUGUST 22, 2023
Qualifyze has secured $12m to improve supply chain compliance in the pharmaceutical sector using technological and audit data.
XTalks
AUGUST 22, 2023
The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ high dose (HD) version of its best-selling eye injection Eyla (aflibercept). The FDA approved an 8 mg high-dose formulation of the anti-vascular endothelial growth factor (anti-VEGF) injection, which was previously only available in 2 mg doses by prescription.
Pharmaceutical Technology
AUGUST 22, 2023
Janssen’s bispecific antibody received conditional approval as a subcutaneous therapy based on Phase I/II trial data.
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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.
Fierce Pharma
AUGUST 22, 2023
With a new FDA approval to rival Teva's Austedo, Neurocrine Biosciences’ Ingrezza is debuting in a treatment area with hundreds of millions of dollars of revenue potential. | The FDA approved Ingrezza capsules to treat adult with chorea associated with Huntington’s disease. Ingrezza was first approved in tardive dyskinesia in 2017. With its second approval, the medication’s label now largely stacks up to Teva Pharmaceuticals’ Austedo.
Pharmaceutical Technology
AUGUST 22, 2023
The gene therapy trials in geographic atrophy and Stargardt disease are planned to start by the end of 2023.
Pharma Times
AUGUST 22, 2023
Around 670 people in England with epidermolysis bullosa will benefit from the treatment - News - PharmaTimes
Pharmaceutical Technology
AUGUST 22, 2023
The biopharma company has filed a comprehensive patent to address cystic fibrosis and other ailments.
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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
AUGUST 22, 2023
Improved vaccines, cutting-edge mRNA medicines and accelerated drug production are at the heart of a new funding project in the U.K., where 17 companies have been selected for government grants to | Improved vaccines, cutting-edge medicines and accelerated drug production are at the heart of a new funding project in the U.K.
Outsourcing Pharma
AUGUST 22, 2023
Those in the life sciences industry needing some creative input can now turn to Bios Health Group who have recently launched into the space.
Fierce Pharma
AUGUST 22, 2023
Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency (EMA) to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, f | Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, facility.
Pharma Times
AUGUST 22, 2023
This is the first time that this type of scientific method has been used to detect polio - News - PharmaTimes
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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.
Outsourcing Pharma
AUGUST 22, 2023
Hutchmed is planning to submit a New Drug Application (NDA) for treatment of primary immune thrombocytopenia (ITP) in China.
Fierce Pharma
AUGUST 22, 2023
After admitting to running a price-fixing scheme as part of a deal with the Department of Justice, not only will generic makers Teva and Glenmark Pharmaceuticals pay hefty fines, but they'll also b | Glenmark Pharmaceuticals will pay $30 million for similar charges. The two will also divest their generic pravastatin products and Teva is required to donate $50 million worth of generics of antifungal cream clotrimazole and antibiotic tobramycin to humanitarian organizations.
BioSpace
AUGUST 22, 2023
Spurred by an “inadvertent” disclosure, Roche’s Genentech on Wednesday released interim and immature overall survival findings for its anti-TIGIT antibody tiragolumab in non-small cell lung cancer.
Fierce Pharma
AUGUST 22, 2023
As litigation challenging the Inflation Reduction Act (IRA) piles up, Boehringer Ingelheim has become the latest drugmaker to take aim at the new law. | Boehringer Ingelheim's Eli Lilly-partnered diabetes blockbuster Jardiance will likely make the list of drugs eligible for pricing negotiations, raising the stakes for the company's lawsuit.
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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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