Sat.May 04, 2024 - Fri.May 10, 2024

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Drug patents protect pharma profits. Track when they’ll expire here.

Bio Pharma Dive

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.

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AstraZeneca to withdraw Covid-19 vaccine globally

Pharmaceutical Technology

AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.

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A Healthy Lifestyle Could Offset Genetic Risk For Early Death by a Hopeful 62%

AuroBlog - Aurous Healthcare Clinical Trials blog

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?

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Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Fierce Pharma

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

Drugs 143
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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ASGCT2024: FDA’s Marks on Accelerated Approval, Gene Therapy Costs and More

BioSpace

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.

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Patient dies in Pfizer study of Duchenne gene therapy

Bio Pharma Dive

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.

More Trending

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WestGene wins FDA approval for mRNA vaccine to treat certain cancers

Pharmaceutical Technology

The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.

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Higher CO2 Levels Have a Concerning Effect on Viruses Floating Through The Air

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

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AstraZeneca withdraws COVID-19 vaccine, citing declining demand

Bio Pharma Dive

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.

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At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

Fierce Pharma

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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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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ESCMID 2024: Emerging bacterial infections in neonates and children

Pharmaceutical Technology

Coinfections can complicate disease management and hence continued surveillance and targeted intervention strategies are needed.

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IPC and CSIR-IMTech forge strategic partnership to advance research in microbiology

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Research 175
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iTeos shares jump on TIGIT update; Acelyrin swaps CEOs

Bio Pharma Dive

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.

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House's updated biosecurity bill sets 2032 decoupling deadline for industry's work with WuXi AppTec

Fierce Pharma

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.

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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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Shionogi secures licence for Maze’s Pompe disease treatment

Pharmaceutical Technology

Shionogi has concluded an exclusive global licence agreement for Maze Therapeutics’ MZE001 aimed at treating Pompe disease.

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CDSCO centralises powers to issue NOC for unapproved, banned & new drugs solely for exports

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Drugs 171
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FDA delays decision on Moderna RSV vaccine

Bio Pharma Dive

The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

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For every million-dollar gene therapy, Peter Marks gets an email from FDA chief Robert Califf

Fierce Pharma

After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D. | After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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AstraZeneca concludes equity investment in Cellectis

Pharmaceutical Technology

AstraZeneca has concluded an equity investment in clinical-stage biotechnology company Cellectis following a deal signed in November 2023.

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Indian medical care providers explore HCX platforms to reduce administrative tasks in insurance claims

AuroBlog - Aurous Healthcare Clinical Trials blog

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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Bluebird preps for first commercial use of sickle cell gene therapy

Bio Pharma Dive

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.

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BioNTech plots first wave of cancer launches in 2026 as COVID vaccine sales continue to disappoint

Fierce Pharma

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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Psilocybin effective in treating depression

Pharmaceutical Technology

A new study has further supported psilocybin's potential to treat depression, which impacts around 300 million people globally.

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Exercising in Midlife May ‘Reverse’ Years of Inactivity, Large Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

As the world’s aging population grows, and dementia, cardiovascular disease, and osteoporosis reach epidemic levels, people of all ages want to know how they can live healthier, not just longer, lives. For women in their 40s and 50s, it’s not too late to take action.

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Takeda targets ‘efficiency’ in restructuring, pipeline cuts

Bio Pharma Dive

The company is discontinuing an array of early drug programs, including several in oncology, as it prioritizes investment in six late-stage assets.

Drugs 237
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Kenvue maps out hundreds of layoffs as service pact with J&J winds down

Fierce Pharma

Even after consumer outfit Kenvue split from Johnson & Johnson one year ago, the company has been performing certain services for the pharma and medtech giant as part of a transition process. | Kenvue’s board of directors on Monday approved a plan to cut 4% of the company’s global workforce. The J&J spinoff employed about 23,000 staffers at the end of last year, so the layoff initiative could affect some 920 workers.

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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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Anixa expands cancer vaccine collaboration with Cleveland Clinic

Pharmaceutical Technology

Anixa Biosciences has expanded its partnership with Cleveland Clinic to develop additional vaccines for cancers.

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Indian medical care providers explore HCX platforms to reduce administrative tasks in insurance claims

AuroBlog - Aurous Healthcare Clinical Trials blog

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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As drug shortages reach record highs, regulators weigh next steps

Bio Pharma Dive

With many chemotherapy and ADHD drugs stuck in stubbornly short supply, several agencies are looking for new solutions.

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House lawmaker brings FDA into biosecurity crackdown on China

Fierce Pharma

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.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.