November, 2022

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AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments

Fierce Pharma

AstraZeneca withdraws US COVID vaccine application, shifts focus to antibody treatments. aliu. Thu, 11/10/2022 - 09:02.

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AI will continue to attract investment in near future in the healthcare industry

Pharmaceutical Technology

Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl

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Why are Healthcare Costs So High? Blame the Middlemen

MedCity News

Large employers, particularly self-insured companies, can demand a better and fairer system. They can use their contracting power to insist that their plans cover all FDA approved drugs.

Insurance 143
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SirsiDynix CloudSource+ Now Offering Get It Now From CCC

Copyright Clearance Center

November 7, 2022, LEHI, Utah — CloudSource+ , the newest content solution for open access materials from SirsiDynix , has integrated with Get It Now from CCC (Copyright Clearance Center) to provide immediate purchase and delivery of full-text articles to unsubscribed journals. Get It Now is used by hundreds of academic libraries around the world to help expand their virtual collections.

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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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Could digital therapeutics provide a solution against opioid abuse?

pharmaphorum

Digital therapeutics are rapidly coming into the foreground to treat a variety of conditions. Ben Hargreaves discovers how chronic pain could be a key area for digital therapeutics, as they offer non-addictive and effective relief from the condition. The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium.

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Device Measures Hemoglobin More Accurately in Dark Skin

Medgadget

Researchers at the University of Texas at Arlington, in collaboration with Shani Biotechnologies, a local firm, have created a point-of-care device that can accurately measure hemoglobin levels and perform pulse oximetry in individuals with dark skin. At present, methods to determine hemoglobin levels at the point of care, such as pulse oximetry, are inaccurate in individuals with higher levels of melanin in their skin, and there is a clear need to develop alternatives that work for everyone.

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More Trending

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.

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Two Pharmacy Owners Plead Guilty in $18M Foreign Medicare Fraud Scheme

MedCity News

The scheme started in New York but became a complex international endeavor as the two men attempted to launder money received from fraudulent Medicare claims for cancer drugs during the pandemic.

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“Universal” CRISPR-edited T cells improve resistant leukaemia

European Pharmaceutical Review

Researchers at Great Ormond Street Hospital for Children (GOSH) and University College London (UCL) Great Ormond Street Institute of Child Health (UCL GOS ICH) have used “universal” CRISPR-edited cells in humans for the first time to treat B-cell acute lymphoblastic leukaemia (B-ALL) child patients with engineered donor T cells. The treatment did not require matching donor cells, a major step in developing gene-edited cells for cancer treatment.

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A Culture of Quality: The Catalyst to Accelerate Innovation

PharmExec

Why enabling a shared culture of quality across an organization is key to maintaining pharma’s recent pace of innovation wins—while inspiring new levels of confidence.

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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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Data privacy concerns don’t hinder digital health app usage

pharmaphorum

A new survey conducted by juli, an AI-powered chronic condition platform, has revealed that the value placed on digital privacy differs widely among US users. With the HLTH 2022 event now well underway, digital health industry leaders all gathered together to attend in Las Vegas this week, the juli survey results reveal consumer responses to be more varied than one would have expected when it comes to data privacy.

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Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line

Fierce Pharma

Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line. zbecker. Wed, 11/23/2022 - 10:10.

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The legacy of Glen de Vries: Our last interview with the pioneering entrepreneur

PharmaVoice

Recorded just weeks before his passing, our sit-down interview with the legendary medical sciences entrepreneur showcased his passion for pushing the industry toward its next frontier.

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Report: Health Insurance Is Influencing Americans’ Job Choices

MedCity News

More than 31% of people with employer-sponsored insurance stuck with a job they disliked for the company’s health insurance, a Forbes Advisor survey found. Another 8% of respondents left a job they liked to seek better coverage.

Insurance 136
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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FDA approves first gene therapy for Haemophilia B

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes. Standard treatment for the condition involves replacing the missing or deficient clotting factor to improve the body’s ability to stop bleeding and promot

FDA 127
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NHS expedites rollout of Bayer’s darolutamide for prostate cancer

Pharmaceutical Technology

The National Health Service (NHS) in England, UK, has expedited the rollout of Bayer ’s new life-extending drug, darolutamide, to treat the most advanced kinds of prostate cancer that have spread to other body parts. With the latest development, NHS will become the first healthcare system in Europe to offer this drug to prostate cancer patients. Nearly 9,000 men with prostate cancer will be eligible to receive this treatment.

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Novartis said to be eyeing sale of ophthalmology, respiratory units

pharmaphorum

Novartis has already spun out its eyecare business Alcon, and is now considering the sale of its ophthalmology and respiratory medicines businesses as it continues a narrowing of its focus, according to media reports. A Bloomberg article citing people close to the matter claims that Novartis is engaged in early discussions about the sale of the two units, which could raise billions of dollars in capital that could be reinvested into the pharma group’s pipeline.

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Senator aims to cut biosimilar 'red tape' with proposal to eliminate interchangeable status

Fierce Pharma

Senator aims to cut biosimilar 'red tape' with proposal to eliminate interchangeable status. kdunleavy. Wed, 11/23/2022 - 07:18.

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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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Implantable Device Adheres to Muscle, Treats Atrophy

Medgadget

Scientists at the Wyss Institute for Biologically Inspired Engineering at Harvard have developed a mechanically active gel-elastomer-nitinol tissue adhesive, otherwise known as MAGENTA. The implantable device functions as a soft robot, and it can be adhered to the outside of a muscle. When an electrical charge is applied to the device, a spring inside made from nitinol (a shape memory alloy) heats up and begins to actuate, creating a contraction and stretching effect on the attached muscle.

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Firefly, Sprinter Team Up to Close the Loop on Virtual Primary Care

MedCity News

Sprinter Health is integrating its at-home clinical and diagnostic services into Firefly Health’s virtual primary care model. Firefly’s members will be able to receive common medical services from Sprinter clinicians in their homes — such as vital checks, blood draws, electrocardiograms, diabetic eye exams and diabetic foot screenings.

Medical 135
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First-in-human gene therapy trial for major cardiac syndrome

European Pharmaceutical Review

The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). SRD-001, the adenovirus associated virus (AAV)-based gene therapy is delivered to cardiac ventricular muscle cells via an intracoronary infusion system (produced by Sardocor, a clinical-stage gene therapy subsidiary of Medera), to increase the protein expression and functional activity of sarcoplasmic reticulum calcium ATPase

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Pfizer records 6% decline in revenue in Q3 2022

Pharmaceutical Technology

Pfizer has reported a 6% decline in revenue to $22.6bn in the third quarter (Q3) of 2022 as against $24bn in the same quarter last year. In the quarter, revenues rose 2% operationally on omitting contributions from Covid-19 therapies, Paxlovid and Comirnaty. Reduction in revenues from Comirnaty outside the US and reduced revenues for some Comirnaty-linked manufacturing works carried out on behalf of BioNTech, Xeljanz and Sutent worldwide were the key drivers that contributed to the revenue dec

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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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First human trials of lab-grown red blood cells start in UK

pharmaphorum

Blood cells grown in a laboratory have been given to people for the first time in a clinical trial being carried out by researchers in the UK, in the hope that plentiful supplies of rare blood groups can be manufactured to order. A team from the universities of Bristol and Cambridge, NHS trusts and NHS Blood and Transplant (NHSBT) have started giving small quantities of the lab-grown red blood cells – a couple of teaspoons full – to two healthy volunteers to see if they are safe.

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Nothing to sneeze at: AstraZeneca donates thousands of nasal spray flu vaccines after Swiss pricing row

Fierce Pharma

Nothing to sneeze at: AstraZeneca donates thousands of nasal spray flu vaccines after Swiss pricing row. fkansteiner. Thu, 11/17/2022 - 13:27.

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5 enduring mysteries of the Barry and Honey Sherman murders

PharmaVoice

After nearly five years, the homicide case involving pharma billionaires continues to perplex investigators.

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Beware of a False Sense of Cybersecurity

MedCity News

Based on some independent research that my company commissioned with more than 200 companies, we came to several conclusions that are highlighted in the article. Broadly, however, it signals the false sense of (cyber)security that many companies are currently harboring.

Patients 130
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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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MHRA approves first gene therapy for infusion into the brain

European Pharmaceutical Review

Upstaza (eladocagene exuparvovec) is the first and only approved treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and is the first marketed gene therapy for direct infusion into the brain. The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain.

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AstraZeneca enters $320m deal to acquire Neogene

Pharmaceutical Technology

AstraZeneca has signed an agreement for the acquisition of all outstanding equity of clinical-stage biotechnology firm Neogene Therapeutics in a deal totalling up to $320m. Neogene focuses on discovering, developing and producing next-generation T-cell receptor therapies (TCR-Ts) that provide a new cell therapy approach for fighting cancer. TCR-Ts can detect intracellular targets such as cancer-specific mutations to unlock targets which were not accessible earlier using cell therapies.

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FDA starts speedy review of Takeda’s dengue vaccine

pharmaphorum

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. The Japanese pharma said it has filed for approval of TAK-003 with the FDA for the prevention of dengue disease caused by any dengue virus serotype in individuals aged four through 60.

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NICE gives thumbs-down to 5 COVID-19 drugs including AZ's Evusheld and Merck's Lagevrio

Fierce Pharma

NICE gives thumbs-down to 5 COVID-19 drugs including AZ's Evusheld and Merck's Lagevrio. kdunleavy. Wed, 11/16/2022 - 09:44.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.