Fri.Nov 17, 2023

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Navigating data consent in the era of connected healthcare

Pharmaceutical Technology

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.

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Lilly plans new $2.5B manufacturing plant as obesity drug demand ramps up

Bio Pharma Dive

Following the approval of Zepbound, Lilly is adding capacity to avert shortages and restricted access.

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Micron Biomedical receives funds to produce needle-free vaccines

Pharmaceutical Technology

Micron Biomedical has received $23.6m in funding from the Bill & Melinda Gates Foundation for the bulk manufacturing of needle-free vaccines.

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AstraZeneca plans to exit 'beating heart' of Indian operations in Bangalore

Fierce Pharma

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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Daiichi Sankyo signs agreement with Japan to supply Covid-19 vaccine

Pharmaceutical Technology

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.

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FDA signs off on new uses for Astellas and Pfizer's Xtandi, Merck's Keytruda

Fierce Pharma

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.

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What is achondroplasia?

Antidote

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.

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FDA grants approval for Merck’s Keytruda combo for gastric cancer

Pharmaceutical Technology

The US FDA has granted approval for Merck’s Keytruda plus chemotherapy as a first-line treatment for adult gastric cancer patients.

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AstraZeneca’s first-in-class FDA approval for Truqap marred by surprise restriction

Fierce Pharma

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.

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GSK’s endometrial cancer therapy receives Health Canada approval

Pharmaceutical Technology

GSK has obtained approval from Health Canada for Jemperli plus carboplatin and paclitaxel to treat endometrial cancer in adults.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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NHS trials artificial intelligence system to prevent avoidable admissions

Pharma Times

The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes

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Signal: Dutch health investor Gilde raises $804m for health startup fund

Pharmaceutical Technology

Gilde Healthcare now manages over $2.8bn in assets across Europe and North America, much of which is held in young companies.

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Navigating Legal Waters: Study Delves into Inequitable Conduct in Drug Patent Cases

Drug Patent Watch

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.

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Combination contraceptive pill to be made available OTC in England 

Pharmaceutical Technology

As part of the government and NHS’s primary care access recovery plan, the service aims to enhance healthcare accessibility.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Daiichi Sankyo signs pact to supply 1.4M mRNA COVID vaccine doses in Japan

Fierce Pharma

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.

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China’s NMPA grants conditional approval for Apollomics’ NSCLC drug

Pharmaceutical Technology

Apollomics’ Chinese partner, Avistone Biotechnology, received a conditional approval for velbretinib from China's NMPA.

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New NIHR Research Delivery Network in England announced by DHSC

Pharma Times

The University of Leeds and NHS organisations will host the network in 2024 - News - PharmaTimes

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AiBtl signs $667m licensing deal for ABVC’s CNS drug

Pharmaceutical Technology

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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The New Age of Decentralized Clinical Trials

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.

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The Power of Centralized Distribution in the Face of DSCSA Compliance

Pharmaceutical Commerce

With new mandates right around the corner, there is an unwavering demand for pharma operations to perform at peak efficieny.

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CH-0601 by Caelus Health for Type 1 Diabetes (Juvenile Diabetes): Likelihood of Approval

Pharmaceutical Technology

CH-0601 is under clinical development by Caelus Health and currently in Phase I for Type 1 Diabetes (Juvenile Diabetes).

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Frontiers Health 2023: Hakim Yadi, Closed Loop Medicine

pharmaphorum

Frontiers Health 2023: Hakim Yadi, Closed Loop Medicine Mike.

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Gradalis wins $9.9m grant to fund Phase II trial for bi-shRNA therapy

Pharmaceutical Technology

The pivotal Phase II trial is designed to evaluate Vigil in platinum-sensitive recurrent ovarian cancer patients.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Simplify and Accelerate Benefits Verification with a Fully Integrated, Adaptable Platform

Drug Channels

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.

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AstraZeneca’s ATP inhibitor Truqap wins FDA approval in breast cancer  

Pharmaceutical Technology

Truqap is approved in combination with Faslodex for HR-positive/HER2-negative breast cancer patients in the US.

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Interview: CRO PPD of Thermo Fisher - the processes and difficulties within rare diseases

Outsourcing Pharma

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.

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(Atorvastatin + fluconazole + minocycline) by GlobeStar Therapeutics for Relapsing Multiple Sclerosis (RMS): Likelihood of Approval

Pharmaceutical Technology

(Atorvastatin + fluconazole + minocycline) is under clinical development by GlobeStar Therapeutics and currently in Phase I for Relapsing Multiple Sclerosis (RMS).

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Digital health company BehaVR hits the merger trail again

pharmaphorum

Digital health company BehaVR hits the merger trail again Phil.

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HZB-0071 by Heilongjiang ZBD Pharmaceutical for Gastric Cancer: Likelihood of Approval

Pharmaceutical Technology

HZB-0071 is under clinical development by Heilongjiang ZBD Pharmaceutical and currently in Phase I for Gastric Cancer.

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ABPI says UK clinical trials sector ‘improving’

pharmaphorum

ABPI says UK clinical trials sector ‘improving’ Phil.

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HZB-0071 by Heilongjiang ZBD Pharmaceutical for Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

HZB-0071 is under clinical development by Heilongjiang ZBD Pharmaceutical and currently in Phase I for Adenocarcinoma.

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Accelerating Clinical Supply Through Integrated Drug Development

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.