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.

Drugs 334
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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.

Vaccine 299
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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?

Genetics 240
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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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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Including Patients with Borderline Personality Disorder in Clinical Trials

Worldwide Clinical Trials

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.

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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.

Vaccine 312
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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).

Vaccine 140
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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 231
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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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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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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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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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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 226
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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.

Vaccine 279
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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.

Vaccine 246
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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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NHS to roll out fibre optic laser therapy to prevent seizures in epileptic patients

Pharma Times

The chronic brain disease that causes seizures currently affects around 600,000 people living in the UK

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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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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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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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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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Chiesi and Gossamer collaborate to develop drug to treat respiratory diseases

Pharma Times

Gossamer’s seralutinib is designed to treat pulmonary arterial hypertension and other indications

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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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Oregon and Lantern collaborate to develop drug candidate for various cancer indications

Pharma Times

Anticancer drugs will be responsible for 90% of nearly 612,000 predicted US cancer deaths in 2024

Drugs 134
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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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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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UK MHRA approves ViiV Healthcare’s cabotegravir formulations for HIV-1

Pharmaceutical Technology

The UK MHRA approved two formulations of ViiV Healthcare’s cabotegravir, offering a new prevention option for HIV-1 infection.

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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.