Bio Pharma Dive
JANUARY 12, 2024
Arena BioWorks, which will be led by Harvard University scientist Stuart Schreiber, seeks to blend academic and venture capital drug research models.
Pharmaceutical Technology
JANUARY 12, 2024
Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.
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Bio Pharma Dive
JANUARY 12, 2024
Showing reporters and industry veterans a demonstration of its new drug development software, Recursion said at J.P. Morgan it is now licensing its work to buyers.
Pharmaceutical Technology
JANUARY 12, 2024
The US Department of Defense procurement contract for Emergent’s BioThrax is comprised of an initial five-year base agreement.
Bio Pharma Dive
JANUARY 12, 2024
Regulators will continue to evaluate suicide ideation as the data don't "definitively rule out" an association.
Pharmaceutical Technology
JANUARY 12, 2024
The UK nod for Agamree, which comes after previous approvals in Europe and the US, provides access to a corticosteroid with less severe side effects.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 12, 2024
Contract research organisation ClinChoice has acquired CSI Medical Research, marking a significant expansion of its international operations.
Drug Discovery World
JANUARY 12, 2024
Researchers in the US have discovered that a type of immune cell in the human body known to be important for allergy and other immune responses can also attack cancer. Furthermore, these cells, called human type 2 innate lymphoid cells (ILC2s), can be expanded outside of the body and applied in larger numbers to overpower a tumour’s defenses and eliminate malignant cells in mouse models with cancer.
Pharmaceutical Technology
JANUARY 12, 2024
Ji Xing Pharmaceuticals acquired Biogen’s BIIB131 for advancing worldwide clinical developments in treating acute ischemic stroke (AIS).
Pharmaceutical Commerce
JANUARY 12, 2024
An overview of a structural approach that guides development of the analytics and related reporting that may assist brands in gaining or maintaining reimbursement positions and maximizing sales.
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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 12, 2024
Dermavant will include these findings in an upcoming supplemental new drug application (sNDA) submission, which is expected in Q1 2024.
pharmaphorum
JANUARY 12, 2024
Explore the trends and challenges in the pharmaceutical and healthcare markets, specifically focusing on phase change and the complexities of scaling up operations. Gain insights into the evolving landscape of the industry as we look ahead to 2024.
Pharmaceutical Technology
JANUARY 12, 2024
SyntheticGestalt and Enamine have announced a collaboration to develop a suite of AI models to aid in the discovery of drugs.
pharmaphorum
JANUARY 12, 2024
Discover how Veeva Systems is revolutionising closed loop marketing and connectivity in biopharma, from clinical to medical. Learn more about innovative solutions and insights from the Veeva Commercial Summit, featuring industry expert Chris Moore and the power of data-driven strategies.
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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 12, 2024
In an update, the FDA reported that it is yet to find a definitive association between GLP-1RA use and suicidal thoughts.
pharmaphorum
JANUARY 12, 2024
AI technology is revolutionising the field of clinical trials by enhancing patient identification, accelerating drug development and design, and improving monitoring processes. Discover how AI is supercharging clinical trials for better healthcare outcomes.
Pharmaceutical Technology
JANUARY 12, 2024
Obesity has only recently been recognised as a disease as opposed to a behavioural/lifestyle issue.
pharmaphorum
JANUARY 12, 2024
Lantheus has filed what it says is the first generic version of Novartis’ big-selling cancer radionuclide therapy Lutathera in the US, used to treat rare neuroendocrine tumours (NETs). The FDA has started a review of the generic and – if approved – Lantheus could be in line for 180 days of market exclusivity as the first company to bring a copycat version of Lutathera (lutetium Lu 177 dotatate) to the US market.
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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
JANUARY 12, 2024
When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm. | A group of 24,000 users of Gilead's TDF-based HIV meds argue that the company knowingly shelved a safer HIV med to increase its profits. Now, Gilead will have to prove that a manufacturer can't be held liable for its development timeline of an upgraded product.
pharmaphorum
JANUARY 12, 2024
Researchers from the Wellcome Sanger Institute and partners have carried out a comprehensive analysis of cancer cells, identifying 370 ‘priority’ targets that could be used to develop new drug therapies.
Pharma Times
JANUARY 12, 2024
If successful, the new test could see routine screening introduced in the NHS
Fierce Pharma
JANUARY 12, 2024
A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. | A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said.
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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.
pharmaphorum
JANUARY 12, 2024
Bayer’s AskBio gene therapy unit has started recruiting patients into a phase 2 trial of its AB-1002 candidate for congestive heart failure.
Pharma Times
JANUARY 12, 2024
Researchers compared 20 years of antibiotic use on E.
Drug Channels
JANUARY 12, 2024
Today’s guest post comes from Maria Kirsch, President, Patient Services, Krista Pinto, President, Deployment Solutions, and Mike Scott, Senior Vice President, Specialty Consulting at EVERSANA. Maria, Krista, and Mike discuss the key reasons why patients abandon drug therapy. They then describe EVERSANA’s approach for helping manufacturers and healthcare providers improve adherence and health outcomes.
pharmaphorum
JANUARY 12, 2024
The FDA says it can find no evidence of increased risk of suicidal thoughts and self-harm with GLP-1 drugs like Novo Nordisk's Ozempic and Wegovy
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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.
XTalks
JANUARY 12, 2024
The US Food and Drug Administration (FDA) has given the nod to Ligand Pharmaceuticals’ topical antiviral Zelsuvmi (berdazimer gel 10.3%) for the treatment of molluscum contagiosum in adult and pediatric patients one year of age and older. The topical gel is the first approved treatment that can be used outside of a medical setting. It can be applied by patients, parents, caregivers or others at home, outside of a physician’s office, to treat the highly contagious viral skin infection, according
Drug Patent Watch
JANUARY 12, 2024
Annual Drug Patent Expirations for STRIBILD Stribild is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eleven… The post New patent expiration for Gilead Sciences drug STRIBILD appeared first on DrugPatentWatch - Make Better Decisions.
XTalks
JANUARY 12, 2024
The Consumer Electronics Show (CES) 2024 has once again astonished attendees with a variety of innovative food tech. This year’s event showcased how tech is increasingly interwoven into the food and beverage world, presenting everything from AI-driven kitchen gadgets to sustainable food solutions. Let’s dive into some of the most exciting and groundbreaking new food tech revealed at CES 2024.
Drug Patent Watch
JANUARY 12, 2024
Annual Drug Patent Expirations for TRUVADA Truvada is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. There are four patents protecting… The post New patent expiration for Gilead drug TRUVADA appeared first on DrugPatentWatch - Make Better Decisions.
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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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