Wed.May 08, 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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Regeneron gene therapy improves hearing in two children

Bio Pharma Dive

The results add to an early but growing body of evidence suggesting gene therapy may improve outcomes in young kids with a genetic form of deafness.

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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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Scientists Discover a Missing Link Between Diet And Cancer Risk

AuroBlog - Aurous Healthcare Clinical Trials blog

A previously unknown mechanism for inactivating genes that suppresses tumor formation helps explain why cancer risk is associated with an unhealthy diet or unmanaged metabolic conditions like diabetes.

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BioVersys and GSK expand their partnership for TB treatment alpibectir

Pharmaceutical Technology

BioVersys and GSK have announced the expansion of their partnership to expedite the clinical development of alpibectir for tuberculosis (TB).

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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.

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Zenas raises $200m to advance autoimmune antibody therapy

Pharmaceutical Technology

Zenas signed a licencing deal for Asia-Pacific territories for the bispecific antibody, obexelimab, with Bristol Myers Squibb in September.

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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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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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How six trends are driving pharmaceutical milling  

Pharmaceutical Technology

We look at the top six most important trends in pharmaceutical milling and how they are shaping the industry.

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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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TerSera’s ZOLADEX LA gains Health Canada approval for breast cancer

Pharmaceutical Technology

TerSera has obtained Health Canada approval for ZOLADEX LA 10.8mg to manage oestrogen receptor-positive (ER+) early breast cancer.

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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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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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Biotechs must prioritise ethics to deter GenAI “bad actors”

Pharmaceutical Technology

At the London Biotechnology Show, Microsoft’s senior director of life sciences discussed the ethical use of GenAI.

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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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Spectral AI nears first sales of wound care system

pharmaphorum

The first commercial sales of Spectral AI's DeepView wound imaging system for burns are due to start in the UK, its first market, later this year

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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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Observations & Industry Predictions from Adobe Summit

Intouch Solutions

There are no shortage of detailed recaps coming out of the 2024 Adobe Summit – and no shortage of presentation recordings to view in post if you’ve found yourself abundant with extra hours – so rather than a play-by-play, here instead are some observations from the floor and a synthesis (and a few predictions) of what all that was abuzz at Adobe Summit may indicate for the work we all do.

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Regeneron gene therapy restores hearing in deaf child

pharmaphorum

Regeneron’s gene therapy for otoferlin-related hearing loss restored hearing to normal levels in one profoundly deaf child within just 24 weeks

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Courtney Noah on how its time the STEM industry provides more opportunities for women

BioPharma Reporter

Courtney Noah works in scientific affairs at BioIVT and after an amazing biology teacher in grade nine gave her a passion for science, she then followed the same teacher through her education.

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12 Questions with Ariel Buda-Levin

pharmaphorum

Get to know Ariel Buda-Levin from the IPG Health Network better with these 12 insightful questions. Learn more about her background, expertise, and experiences.

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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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AstraZeneca Withdraws COVID-19 Vaccine Worldwide as Demand Craters

BioSpace

AstraZeneca announced that it will voluntarily pull Vaxzevria from the global market amid a sharp decline in demand and following the company’s recent admission that its vaccine is linked with a rare side effect.

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RNA blood test may predict antidepressant response

pharmaphorum

Selective serotonin reuptake inhibitors (SSRIs) are the first-line drug therapy of choice for most people suffering from depression but often fail to work effectively. Now, a study suggests simple blood test could help predict those who will benefit.

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Pfizer Halts Dosing in Late-Stage DMD Study Following Death of Young Patient

BioSpace

Pfizer’s investigational Duchenne muscular dystrophy gene therapy fordadistrogene movaparvovec has been hit with another patient death, forcing the pharma to pause dosing in its Phase III study.

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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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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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Pharma gets ruthless as job losses mount across industry

pharmaphorum

As pharma R&D jobs face deep cuts, workers struggle with an uncertain future. Can the industry recover or will more jobs disappear?

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DEIB Evolves As Criticism, Changing Attitudes Continue

BioSpace

A new BioSpace report finds that life science professionals are prioritizing diversity less when job hunting. Still, DEIB programs don’t appear to be going anywhere.

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Clinical trials: Their design, location, and, potentially, their simulation

pharmaphorum

Clinical trials, their design and location, and these days their simulation, are the focus of today’s podcast with Dr Gen Li, founder and president of Phesi.

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ASGCT, Adcomm for Lilly’s Donanemab, Vertex Vs. Bluebird

BioSpace

AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.

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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.