Fri.Oct 28, 2022

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Gilead, fueled by latest approval, sees CAR-T sales take off

Bio Pharma Dive

After a slow start, Gilead’s CAR-T business is growing fast, enabling it to pull ahead of rival cell therapy developers like Bristol Myers Squibb and Johnson & Johnson.

Sales 342
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Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.

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EMA looks to follow the FDA in limiting use of certain immune-regulating drugs

Bio Pharma Dive

The new recommendations could further curtail the use of so-called JAK inhibitors, though the restrictions imposed in Europe are less severe than they are in the U.S.

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Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine

Pharmaceutical Technology

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy.

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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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Sanofi reveals setback for cancer drug acquired in Synthorx buyout

Bio Pharma Dive

Disappointing study results have led the French pharma company to take a $1.6 billion impairment charge and plan new early-stage trials for a drug executives once called a potential “foundation” for newer immunotherapy combinations.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Part of this is ensuring that all sources of variability affecting a process are identified, explained and managed by appropriate measures so that the finished medicine consistently meets its predefined characteristic

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PTC and Blackstone enter financing partnership of up to $1bn

Pharmaceutical Technology

PTC Therapeutics has signed a strategic financing partnership worth up to $1bn with funds managed by Blackstone to back the development of the former’s innovative product pipeline. Through the funding, PTC intends to attain a constant state of making available a minimum of one therapy every two to three years to continue to deliver transformative therapies to patients across the globe. .

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STAT+: Death of patient in closely watched Alzheimer’s trial raises concern about risk for some groups

STAT News

The experimental Alzheimer’s drug lecanemab, hailed after it slowed patients’ cognitive decline in a clinical trial, may have contributed to the death in June of a patient in the study, STAT has learned. One investigator on the study flagged the death, noting it came after the patient experienced bleeding in the brain, and concluded it was related to the drug, according to documents obtained by STAT.

Trials 130
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Merck reports 14% rise in worldwide sales in Q3 2022

Pharmaceutical Technology

Merck (MSD outside North America) has reported a 14% rise in worldwide sales to $15bn in the third quarter (Q3) of 2022 as against $13.15bn in the year-ago quarter. For the quarter, pharmaceutical sales were recorded at $13bn compared to $12.7bn in Q3 2021, indicating a 13% growth. Sales from Lagevrio alone contributed to $436m. In Q3 2022, sales from Gardasil/Gardasil 9 were reported to be $2.3bn, a growth of 15% from Q3 2021.

Sales 130
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Innovative Medicines Fund and the opportunity for ICSs to mobilise NICE approvals

pharmaphorum

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Join us on Wednesday 23rd November at 12:30 GMT / 13:30 CET / 7:30 am EST as the panel discuss how the Innovative Medicines Fund works, what the implications are for industry organisations in securing fu

Medicine 122
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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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Lay of the land: Understanding lay summary requirements and the challenges they bring

Pharmaceutical Technology

The pharmaceutical industry has undergone a significant shift towards patient-centred services with an emphasis on transparency in recent years. A natural consequence of this movement has been a rethink over how the industry approaches lay summaries. Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clin

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False information is everywhere. 'Pre-bunking' tries to head it off early

NPR Health - Shots

The idea is to show people the tactics and tropes of misleading information before they encounter it in the wild — so they're better equipped to recognize and resist it.

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2seventy and JW Therapeutics partner to develop immunotherapies

Pharmaceutical Technology

2seventy bio has announced a strategic collaboration with JW Therapeutics to expedite the research and development of T cell-based immunotherapies. Under the alliance, the companies will create a translational and clinical cell therapy development platform to quickly analyse such immunotherapy products in the Chinese mainland, Hong Kong (China), and Macao (China).

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STAT+: How experts think we can put health data back ‘in the hands of the patient’

STAT News

Two decades ago, the Bush administration threw a wrench in health data privacy, making it possible for many health care organizations to share medical information without patients’ consent so long as it was being used to improve treatment or streamline business operations. Today, the health data marketplace looks vastly different. Medical records are being amassed by commercial data brokers and sold to insurance companies, and drug and device manufacturers, along with personal information

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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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Making new product planning for life science more effective with human-centred design

pharmaphorum

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This is particularly true in the highly complex ecosystem of drug and device development, where the end consumer is only one of multiple decision-makers in the purchase process.

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Opinion: How motivational interviewing can improve health workforce well-being

STAT News

The National Academy of Medicine launched its National Plan for Health Workforce Well-Being in early October. Citing years of research defining the causes and effects of burnout in health professions, internationally recognized leaders in health care devoted two hours to a launch event for an all-hands-on-deck call to action supporting their plan, which had been developed over the course of several years by the academy’s Action Collaborative on Clinician Well-Being and Resilience.

Medicine 105
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Reuters Pharma 2022 – medical affairs and technology with Lance Hill

pharmaphorum

During Reuters Pharma 2022, in Nice, France, pharmaphorum web editor Nicole Raleigh briefly spoke to Within3’s CEO Lance Hill, following his talk, “Medical affairs takes over: technologies to help unlock the power of insights and gain strategic ground”. In the video below, Hill discusses the recent fusion of people and technology and how medical affairs can bring real-world insights and real-world science to the table, as well as real-time understanding.

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STAT+: Pharmalittle: Drugmaker raises price of old chemo med 10-fold amid shortages; Alnylam cites drug-price law in halting trial

STAT News

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured moment to daydream about weekend plans. Our agenda is still shaping up. For now, we plan to hang with Mrs. Pharmalot, romp with the official mascot, and search for the Great Pumpkin. And what about you? This remains a fine time to enjoy the great outdoors.

Drugs 98
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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.

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Stop TB Partnership sounds the alarm on tuberculosis funding crisis

Pharma Times

TB deaths increase for second year in a row and cases rise for the first time in 20 years

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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A new law in California protects transgender youth who come for medical care

NPR Health - Shots

California is now a sanctuary for transgender youth who come for medical care. A new law protects families traveling from places where there are efforts to criminalize gender-affirming care.

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Opinion: STAT+: The need for regulatory grade evidence: Are you in the stadium or the sandbox?

STAT News

As real-world data (RWD) and real-world evidence (RWE) continue to share the limelight in pharmacoepidemiologic and pharmacoeconomic journals and congresses, the demand for defining RWD and RWE as well as a framework for leveraging real-world research has never been greater. One of the most pressing concerns involves what constitutes “regulatory grade” real-world data and real-world evidence, and when sponsors need to ensure that research conducted using data other than those gener

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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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A doctor's Ebola memoir is all too timely with a new outbreak in Uganda

NPR Health - Shots

Dr. Benjamin Black talks about Belly Woman: Birth, Blood and Ebola — the inside story of what it was like to face a terrifying epidemic in West Africa.

Doctors 98
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PhoreMost enters multi-target collaboration with Arvinas

Pharma Times

PhoreMost to deploy its Siteseeker protein platform to enable drug discovery

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Labor shortages close Kansas nursing homes

NPR Health - Shots

A shortage of nursing home staff is easing in some states. But in other states like Kansas, it's still critical. The state's aging population could continue to propel the industry into crisis.

Nurses 78
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New patent for Global Blood drug OXBRYTA

Drug Patent Watch

Annual Drug Patent Expirations for OXBRYTA Oxbryta is a drug marketed by Global Blood Theraps and is included in two NDAs. There are nine patents protecting this drug. This drug…. The post New patent for Global Blood drug OXBRYTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Siblings forged an unbreakable bond after leprosy tore apart their family

NPR Health - Shots

The Hawaiian island of Molokai was once the site of America's largest leprosy colony. A brother and sister in Hawaii discuss how their lives were shaped by leprosy, also known as Hansen's disease.

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New patent for Axsome Malta drug SUNOSI

Drug Patent Watch

Annual Drug Patent Expirations for SUNOSI Sunosi is a drug marketed by Axsome Malta and is included in one NDA. It is available from one supplier. There are nine patents…. The post New patent for Axsome Malta drug SUNOSI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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EMA accelerates assessment of drug for rare disease APDS

Drug Discovery World

A potential new treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) has been validated for scientific evaluation under an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP). . Pharming’s investigational drug leniolisib, a selective phosphoinositide 3-kinase delta (PI3K?) inhibitor, will be evaluated as a therapy in adolescents and adults 12 years or older. .

Drugs 52
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New patent for Ardelyx Inc drug IBSRELA

Drug Patent Watch

Annual Drug Patent Expirations for IBSRELA Ibsrela is a drug marketed by Ardelyx Inc and is included in one NDA. There are four patents protecting this drug. This drug has…. The post New patent for Ardelyx Inc drug IBSRELA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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.