Pharmaceutical Technology
NOVEMBER 17, 2023
The Internet of Medical Things (IoMT) technologies have transformed what is possible in healthcare. Tech has resulted in better patient outcomes due to faster diagnoses and personalised therapies.
Bio Pharma Dive
NOVEMBER 17, 2023
Following the approval of Zepbound, Lilly is adding capacity to avert shortages and restricted access.
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Pharmaceutical Technology
NOVEMBER 17, 2023
Micron Biomedical has received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.
Antidote
NOVEMBER 17, 2023
Achondroplasia, also known as achondroplastic dwarfism or ACH, is a rare disorder characterized by short stature, a large head, and short arms and legs. It is the most common type of skeletal dysplasia, the umbrella term that identifies hundreds of conditions , and occurs in about one in 15,000 to 35,000 births.
Pharmaceutical Technology
NOVEMBER 17, 2023
Daiichi Sankyo has signed an agreement with Japan's MHLW to deliver 1.4 million doses of its omicron-adapted mRNA vaccine for Covid-19.
Pharma Times
NOVEMBER 17, 2023
The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
NOVEMBER 17, 2023
Researchers from West Virginia University College of Law have conducted a study examining the frequency of drug patent invalidations based on inequitable conduct. The findings, published in JAMA, shed light… The post Navigating Legal Waters: Study Delves into Inequitable Conduct in Drug Patent Cases appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
NOVEMBER 17, 2023
The US FDA has granted approval for Merck’s Keytruda plus chemotherapy as a first-line treatment for adult gastric cancer patients.
Fierce Pharma
NOVEMBER 17, 2023
After the landmark success of Enhertu in HER2-low breast cancer, AstraZeneca has blazed another trail in the world’s most common cancer type. | After the landmark success of Enhertu in HER2-low breast cancer, AstraZeneca has blazed another trail in the world’s most common cancer type. But an unexpected restriction has cast a dark cloud over the first-in-class approval.
Pharmaceutical Technology
NOVEMBER 17, 2023
GSK has obtained approval from Health Canada for Jemperli plus carboplatin and paclitaxel to treat endometrial cancer in adults.
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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
Fierce Pharma
NOVEMBER 17, 2023
Amid a corporate review of AstraZeneca’s global manufacturing and supply network, the company’s Indian subsidiary is planning to close up shop at the “beating heart” of its India operations in Bang | AstraZeneca Pharma India will exit its production plant in Bangalore, India, “in due course,” the company said in a filing. AZ plans to find a buyer who can also serve as a contract manufacturer for the drugs produced there.
Pharmaceutical Technology
NOVEMBER 17, 2023
Gilde Healthcare now manages over $2.8bn in assets across Europe and North America, much of which is held in young companies.
Fierce Pharma
NOVEMBER 17, 2023
The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. | The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer.
Pharmaceutical Technology
NOVEMBER 17, 2023
As part of the government and NHS’s primary care access recovery plan, the service aims to enhance healthcare accessibility.
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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
Outsourcing Pharma
NOVEMBER 17, 2023
OSP was delighted to speak to Galina Nesterova, executive medical director at the Rare Disease & Pediatrics Center of Excellence, and Susan McCune, vice president of pediatrics and clinical pharmacology both within medical science and strategy at PPD, part of Thermo Fisher. They answered some pertinent questions surrounding rare diseases.
Pharmaceutical Technology
NOVEMBER 17, 2023
Apollomics’ Chinese partner, Avistone Biotechnology, received a conditional approval for velbretinib from China's NMPA.
Outsourcing Pharma
NOVEMBER 17, 2023
Definitive agreements with Fresenius Kabi have been signed by Prange Group and its affiliate Adragos Pharma for its sterile pharmaceutical production site in Halden, Norway.
Pharmaceutical Technology
NOVEMBER 17, 2023
Following the agreement, ABVC BioPharma will hold 57% of the consolidated shares of AiBtl, which plans to go IPO in 2024.
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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.
Pharma Times
NOVEMBER 17, 2023
The University of Leeds and NHS organisations will host the network in 2024 - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 17, 2023
CH-0601 is under clinical development by Caelus Health and currently in Phase I for Type 1 Diabetes (Juvenile Diabetes).
Pharmaceutical Commerce
NOVEMBER 17, 2023
With new mandates right around the corner, there is an unwavering demand for pharma operations to perform at peak efficieny.
Pharmaceutical Technology
NOVEMBER 17, 2023
The pivotal Phase II trial is designed to evaluate Vigil in platinum-sensitive recurrent ovarian cancer patients.
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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
NOVEMBER 17, 2023
As Daiichi Sankyo holds out for local approval of its omicron-adapted mRNA shot for COVID-19, the company has struck up a major supply pact in its native Japan. | Daiichi Sankyo has reached an agreement with Japan’s Ministry of Health, Labor and Welfare (MHLW) to supply its shot—coded DS-5670—for a vaccination program against COVID that kicked off this fall.
Pharmaceutical Technology
NOVEMBER 17, 2023
Truqap is approved in combination with Faslodex for HR-positive/HER2-negative breast cancer patients in the US.
Drug Channels
NOVEMBER 17, 2023
Today’s guest post comes from Maria Kirsch, President of Patient Services at EVERSANA. Maria discusses the challenges patients and healthcare providers face accessing specialty therapies. She introduces us to ACTICS ® eAccess , EVERSANA’s technology platform for electronic prior authorization and benefits verification that can be used for both the pharmacy benefit and the medical benefit.
Pharmaceutical Technology
NOVEMBER 17, 2023
(Atorvastatin + fluconazole + minocycline) is under clinical development by GlobeStar Therapeutics and currently in Phase I for Relapsing Multiple Sclerosis (RMS).
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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.
pharmaphorum
NOVEMBER 17, 2023
Frontiers Health 2023: Hakim Yadi, Closed Loop Medicine Mike.
Pharmaceutical Technology
NOVEMBER 17, 2023
HZB-0071 is under clinical development by Heilongjiang ZBD Pharmaceutical and currently in Phase I for Gastric Cancer.
pharmaphorum
NOVEMBER 17, 2023
Digital health company BehaVR hits the merger trail again Phil.
Pharmaceutical Technology
NOVEMBER 17, 2023
HZB-0071 is under clinical development by Heilongjiang ZBD Pharmaceutical and currently in Phase I for Adenocarcinoma.
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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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