Bio Pharma Dive
MAY 10, 2024
Interim data surpassed expectations, iTeos said. Elsewhere, Acelyrin revealed chief executive officer Shao-Lee Lin is departing and Bluebird bio gave a fuller account of its gene therapy launches.
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
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Bio Pharma Dive
MAY 7, 2024
Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.
Pharmaceutical Technology
MAY 8, 2024
AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 7, 2024
When research tells us that our grandparents’ diets can affect our health decades later, it can be hard to shake the feeling that genetics spells out the trajectory of our wellbeing. But how much of our health is actually determined by our genes, and what effect does our lifestyle have, for better or worse?
Worldwide Clinical Trials
MAY 10, 2024
By: Christine Moore, PhD, Vice President, Neuroscience, Scientific Solutions Patients with borderline personality disorder (BPD) face a heightened risk of substance abuse and suicide, as well as substantial delays in receiving treatment. Despite these risks, there are no medications specifically approved to target the core symptoms of BPD; current treatments are limited to managing underlying affective symptoms.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MAY 8, 2024
Intellectual property is the foundation of the drug industry’s business model. This database will track key patent expiry dates for 30 top-selling medicines.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 9, 2024
Virus containing droplets were suspended in the CELEBS experimental device for different durations before infectivity was tested. (Allen Haddrell/University of Bristol) Keeping CO2 levels low reduces infectious airborne viral loads, new research suggests.
XTalks
MAY 10, 2024
According to the Lupus Foundation of America , approximately 1.5 million Americans, and at least 5 million people worldwide, suffer from a form of lupus. The disease predominantly affects women, particularly women of color, who are two to three times more likely to develop lupus than caucasian women. Despite its prevalence, lupus remains one of the world’s least recognizable diseases, often leading to significant delays in diagnosis and appropriate treatment.
Fierce Pharma
MAY 8, 2024
Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).
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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
Bio Pharma Dive
MAY 8, 2024
The move ends a turbulent saga for AstraZeneca, which successfully developed a coronavirus shot but struggled to sell it amid competition and the emergence of rare but serious side effects.
Pharmaceutical Technology
MAY 7, 2024
AstraZeneca has concluded an equity investment in clinical-stage biotechnology company Cellectis following a deal signed in November 2023.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 7, 2024
The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.
BioSpace
MAY 7, 2024
Since the 2022 launch of ChatGPT, biopharma has poured money into this new form of artificial intelligence, but companies remain cautious with unproven technology.
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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.
Fierce Pharma
MAY 10, 2024
Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. | Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. The new draft lays out a 2032 deadline for the separation mandate.
Pharmaceutical Technology
MAY 7, 2024
A new study has further supported psilocybin's potential to treat depression, which impacts around 300 million people globally.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 6, 2024
Aimed at driving innovation and progress in the field of microbiology, the Indian Pharmacopoeia Commission (IPC) and the CSIR-Institute of Microbial Technology (IMTech), Chandigarh, have joined forces towards advancing microbiological research and development for the betterment of public health.
BioSpace
MAY 8, 2024
In a fireside chat at the American Society of Gene & Cell Therapy conference, CBER Director Peter Marks spoke with Takeda’s Kristin Van Goor about how the regulator is approaching the exploding gene therapy space.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Fierce Pharma
MAY 8, 2024
Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.
Bio Pharma Dive
MAY 6, 2024
A 12-year-old boy in the Washington, D.C., area is set become the first patient treated with Lyfgenia since its U.S. approval last December.
Pharmaceutical Technology
MAY 9, 2024
Anixa Biosciences has expanded its partnership with Cleveland Clinic to develop additional vaccines for cancers.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 8, 2024
Indian medical care providers are exploring Health Exchange (HCX) platforms for reducing administrative tasks in insurance claims. It maximises cloud computing, allowing access in real-time, and secure information related to insurance claims. It enables seamless interoperability of health claim data between different systems, whilst safeguarding sensitive medical information at all costs.
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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
pharmaphorum
MAY 9, 2024
A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.
Fierce Pharma
MAY 6, 2024
As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.
Bio Pharma Dive
MAY 9, 2024
The company is discontinuing an array of early drug programs, including several in oncology, as it prioritizes investment in six late-stage assets.
Pharmaceutical Technology
MAY 6, 2024
The UK MHRA approved two formulations of ViiV Healthcare’s cabotegravir, offering a new prevention option for HIV-1 infection.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 9, 2024
India’s export of Ayush and herbal products has reported a growth of 3.6 per cent during the fiscal year 2023-24, at $651.17 million as compared to the same period of previous year, registering a below-five per cent growth for the second consecutive year. The country reported exports of 10.
BioSpace
MAY 10, 2024
With its $525 million investment, Royalty Pharma will acquire the royalties and milestones for ImmuNext’s anti-CD40 therapy frexalimab, which is currently in Phase III trials for multiple sclerosis.
Fierce Pharma
MAY 10, 2024
After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID ef | After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID efforts.
Bio Pharma Dive
MAY 6, 2024
With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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