Sat.Nov 19, 2022 - Fri.Nov 25, 2022

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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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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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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.

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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

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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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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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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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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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J&J's nasal spray Spravato bests former AZ drug Seroquel XR in treatment-resistant depression trial

Fierce Pharma

J&J's nasal spray Spravato bests former AZ drug Seroquel XR in treatment-resistant depression trial. fkansteiner. Wed, 11/23/2022 - 09:26.

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Taking the right forecasting approach for rare diseases

pharmaphorum

There are approximately 7,000 different types of rare disease and researchers estimate that there are more than 300 million people worldwide living with such a condition, according to the National Institutes of Health (NIH). However, only 5% of rare diseases are estimated to have at least one approved treatment, known as “orphan” therapies. A rare disease is any disease that affects a small percentage of the population.

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The Future of Digital Health and Healthcare IT in a Post-Covid World

MedCity News

Implementing and pursuing innovation in digital health and healthcare IT should be a priority for all U.S. healthcare providers and payers — especially as the lessons and response to the Covid-19 pandemic become permanently part of our everyday lives.

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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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Ozempic compensating for Wegovy’s supply shortage due to high demand

Pharmaceutical Technology

In recent months, Wegovy (semaglutide), indicated for obesity, has been subjected to widespread supply shortages due to high demand, in addition to manufacturer production problems, with Novo Nordisk intending to relaunch Wegovy by the end of 2022. In the meantime, however, Novo Nordisk’s Ozempic, another version of semaglutide indicated particularly for patients with type 2 diabetes, has picked up the slack by being used off-label for obesity patients.

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On a roll, Takeda's dengue vaccine shifts into FDA's fast review lane

Fierce Pharma

On a roll, Takeda's dengue vaccine shifts into FDA's fast review lane. kdunleavy. Wed, 11/23/2022 - 09:35.

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Provention prices type 1 diabetes drug Tzield at $194,000

pharmaphorum

Provention Bio has priced its new type 1 diabetes (T1D) prevention therapy Tzield at $13,850 per vial – equivalent to almost $194,000 for its 14-day course – a higher level than had been predicted by industry observers. The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D.

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Unpaid Caregiving: A Growing Healthcare Burden Requiring Societal Intervention

MedCity News

November is National Family Caregivers Month in the US, an opportunity to honor those who have taken on this critical role of caring for loved ones, while raising awareness of the challenges they face daily and what needs to be done to drive tangible changes.

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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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NICE questions value and efficacy of five Covid-19 drugs with rejection

Pharmaceutical Technology

The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK.

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ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win

Fierce Pharma

ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win. aliu. Mon, 11/21/2022 - 16:29.

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Why You Need an ADA Compliant Healthcare Website—and How to Get One

Healthcare Success

Just like your brick-and-mortar business has to be ADA compliant, your healthcare website must also be accessible to people with disabilities. The problem? The ADA doesn’t offer clear regulations for a compliant website. The bigger problem? ADA accessibility lawsuits are on the rise. If your website isn’t accessible to people with disabilities, you could risk lawsuits, financial liabilities, and damage to your brand reputation.

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When It Comes to Dental Care, Convenience Isn’t a Luxury

MedCity News

For far too long, dentists have focused on drilling and billing rather than optimizing the patient experience — and that’s driving many of our patients away, with terrible results for their dental health.

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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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Umoja and IASO partner to develop therapies for haematological malignancies

Pharmaceutical Technology

Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. Under the alliance, the companies will assess the induced cytotoxic innate lymphocytes (iCIL) platform of Umoja with chimeric antigen receptors (CARs) of IASO to develop the next generation of widely accessible, easily available cell therapies.

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Shionogi's COVID-19 antiviral nabs Japanese approval to rival drugs from Pfizer, Merck

Fierce Pharma

Shionogi's COVID-19 antiviral nabs Japanese approval to rival drugs from Pfizer, Merck. fkansteiner. Tue, 11/22/2022 - 10:07.

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Why should pharma invest in digital products for those living with rare diseases?

pharmaphorum

Each person living with a rare disease has a unique experience of their condition, but all will have faced similar challenges. They have suffered from an overwhelming diagnosis experience that has left them feeling misunderstood, isolated, and desperate for someone to help them connect symptoms and make sense of the sheer volume of information. Many will also face barriers to care, where access to specialists is limited and often geographically out of reach.

Pharma 109
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CSL’s Gene Therapy Approval Marks First for Hemophilia B and New High in Pricing

MedCity News

CSL Behring’s hemophilia B gene therapy, Hemgenix, carries a $3.5 million list price. But the company contends that by reducing economic burdens associated with bleeding and prophylactic infusions, the one-time treatment will save money over time.

FDA 114
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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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Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Pharmaceutical Technology

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive unresectable or recurrent breast cancer in adults. The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy a

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'Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says

Fierce Pharma

'Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says. kdunleavy. Tue, 11/22/2022 - 11:13.

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Ex-Theranos CEO Elizabeth Holmes sentenced to 11 years

pharmaphorum

Elizabeth Holmes, the founder and former chief executive of blood testing biotech Theranos, has been sentenced after being convicted of defrauding investors in the company earlier this year, receiving a prison sentence of more than 11 years in a California court. That’s shorter than the 15 years sought by prosecutors, but considerably longer than the 18 months’ house arrest that Holmes’ defense attorneys had pushed for, and there is likely to be an appeal against the sentence,

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Physicians, Heal Thy Billing Systems

MedCity News

Practices don’t need to lose out on uncollected payments from insurers. Here are steps you can take to better manage coding, tracking, communications and rise above byzantine insurance practices.

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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.

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How Clinical Trials Can Thrive in the Digital Era

PharmExec

The Digital Medicine Society (DiMe) CEO Jennifer Goldsack and Takeda’s Head of Digital Health Sciences, Data Sciences Institute Shoibal Datta describe the current landscape of digitized clinical trials and the decisions needed to fully utilize their potential.

Medicine 104
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Teva, AbbVie's Allergan lock in $6.6B deal to settle thousands of US opioid lawsuits

Fierce Pharma

Teva, AbbVie's Allergan lock in $6.6B deal to settle thousands of US opioid lawsuits. fkansteiner. Wed, 11/23/2022 - 08:05.

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mRNA can deliver universal flu vaccine, say US researchers

pharmaphorum

Scientists in the US say they have developed an mRNA-based vaccine that encompasses all 20 known subtypes of influenza that could form the basis of a future universal jab. While the shot is still in preclinical development, if it works in human trials it could raise the prospect of eventually sidestepping the annual scramble to guess the most likely strains to be circulating in the following flu season, and protect against future flu pandemics.

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CMS: 3.4M People Have Enrolled in ACA Marketplace Health Plans

MedCity News

This represents a 17% increase in total ACA plan selections — both through HealthCare.gov and state-based Marketplaces — compared with last year, CMS said. Enrollment through the federal HealthCare.gov has especially seen a rise of 40% from the same period last year.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.