Sat.Dec 02, 2023 - Fri.Dec 08, 2023

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AI’s Role in Transforming Healthcare

MedCity News

Embracing the possibilities that AI unlocks, our commitment to seamlessly integrating AI into healthcare workflows reflects our belief that technology should melt into the background, empowering human caregivers to focus on delivering compassionate patient care.

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FDA approves bluebird's sickle cell disease gene therapy. Can Lyfgenia overcome CRISPR’s halo?

Fierce Pharma

Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell | Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell disease (SCD).

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FDA Grants Breakthrough Designation to Johnson & Johnson’s Novel Treatment for HR-NMIBC

PharmExec

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.

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AbbVie swoops on Pfizer spin-out Cerevel with $8.7bn offer

pharmaphorum

AbbVie has announced its second major takeover deal in the space of a few days, offering $8.7 billion to buy central nervous system drug specialist Cerevel Therapeutics which spun out of Pfizer in 2018.

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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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ChatGPT Does a Bad Job of Answering People’s Medication Questions, Study Finds

MedCity News

Researchers recently tested ChatGPT’s ability to answer patient questions about medication, finding that the AI model gave wrong or incomplete answers about 75% of the time. Providers should be wary of the fact that the model does not always give sound medical advice, given many of their patients could be turning to ChatGPT to answer health-related questions.

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Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy

Fierce Pharma

Groundbreaking? Game-changing? Transformational? Historic? | Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. The transformational treatment is a potential cure for the debilitating and life-threatening disease which affects more than 100,000 in the United States, most of them Black.

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Seattle Children’s Hospital launches BrainChild Bio for CNS therapies

Pharmaceutical Technology

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

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Moving Beyond Medicine To Treat Chronic Pain

MedCity News

I look at non-pharmacological approaches like digital therapeutics as having the potential to give someone like me living with chronic pain everything I need to make a healthy recovery: access to digital treatments and clinicians, to community, coaching, and navigation services.

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As Biden administration eyes 'march-in' rights to lower drug prices, pharma gears up for battle

Fierce Pharma

While so-called “march-in” rights have yet to materialize in the United States, the controversial measure to cut drug prices appears to be gaining traction with the government. | While so-called “march-in” rights have yet to materialize in the United States, the controversial measure to cut drug prices appears to be gaining traction with the government.

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FDA Approves Two Landmark Cell-Based Gene Therapies for Sickle Cell Disease

PharmExec

FDA approval of bluebird bio’s Lyfgenia and Vertex Pharmaceuticals' and CRISPR Therapeutics’ Casgevy marks significant milestone in the treatment of sickle cell disease.

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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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Roche makes obesity play with $2.7bn deal to buy Carmot

pharmaphorum

Roche has agreed a deal to acquire US biotech Carmot Therapeutics that if consummated will thrust it into the increasingly competitive market for incretin-based therapies for diabetes and obesity. The Swiss pharma group has agreed to pay $2.7 billion upfront in cash when the deal closes, with shareholders in the US company also in line for up to $400 million if the drug programmes covered by the agreement meet various milestones.

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Which Digital Health Startups Shined the Brightest in 2023?

MedCity News

CB Insights released a list of what it deems to be the 50 most promising digital health companies of 2023. The market research firm said that the startups on the list are working to improve four main aspects of healthcare: personalization, efficiency, equity and accessibility.

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FDA endorses Novartis' 'pipeline in a pill,' granting first nod for potential blockbuster Fabhalta

Fierce Pharma

With an FDA approval in PNH, Novartis has gained its first nod for iptacopan, dubbed two months ago “a pipeline in pill," by analysts at ODDO BHF.

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Common drug could facilitate “huge step-change” in managing type 1 diabetes

European Pharmaceutical Review

Results from a world-first human trial, published in the New England Journal of Medicine , has shown that a drug called baricitinib has promise as the first disease-modifying treatment of its kind for type 1 diabetes, that can be administered as a tablet.  baricitinib… [demonstrated an ability to] preserve the body’s own insulin production and suppress the progression of type 1 diabetes in people who initiated treatment within 100 days of diagnosis” The researchers noted that baricit

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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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Biden may order compulsory licensing in drug pricing move

pharmaphorum

The White House said today that it may take enforced ownership of patents on medicines developed with public funding if their manufacturers set their prices too high. The proposed framework for so-called ‘march-in rights’ on taxpayer-funded drugs and other inventions is the latest entry in the US federal government’s playbook to limit price increases for drugs, and will no doubt throw it once again into open contention with the pharma industry.

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‘Increasingly Concerned’ Senators Launch Investigation Into Private Equity’s Effect on Healthcare

MedCity News

This week, two bipartisan members of the Senate Budget Committee launched an investigation into private equity and its impact on healthcare. They initiated the probe to get answers about “questionable financial transactions” that could be hurting care quality for patients at hospitals owned by private equity firms.

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Bristol Myers Squibb bids farewell to dealmaking czar Elizabeth Mily

Fierce Pharma

Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. | Three years on, Bristol Myers Squibb is bidding adieu to its top dealmaker. Elizabeth Mily, who replaced BMS’ former M&A czar Paul Biondi back in 2020, is headed for the exit, the company confirmed Friday.

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Prevalence of Eight Chronic Health Conditions Reach Unprecedented Levels in US

PharmExec

Arthritis, asthma, cancer, cardiovascular diseases, chronic kidney disease, COPD, depression, and diabetes reach the highest recorded levels since the America’s Health Rankings Annual Report began tracking them in 1990.

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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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Trial finds Lilly’s Olumiant could treat type 1 diabetes

pharmaphorum

Treatment with Eli Lilly’s JAK inhibitor Olumiant has been shown to preserve the function of insulin-producing pancreatic beta cells in patients with type 1 diabetes, potentially opening up a whole new avenue of therapy.

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Rising Cost of New Medications, Will the People Who Need Them Most be able to Afford them?

MedCity News

Healthcare has traditionally been built around the convenience of the provider and not the patient. Worse, it tends to treat all patients the same regardless of the condition they are trying to manage. If we want to improve medication compliance, we have to make access, support, and most importantly financial assistance a priority.

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Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls

Fierce Pharma

When it comes to manufacturing cell therapies, it's often said that the "process is the product." But churning out these complex, individualized drugs has routinely tripped up even the industry's l | In recent months, Novartis has faced scrutiny from the FDA over Kymriah production shortfalls, a newly posted letter shows. The company says it's working to address the situation.

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AbbVie Collaborates with BigHat Biosciences on Next-Gen Therapeutic Antibodies

PharmaTech

This collaboration will combine BigHat Biosciences’ AI/ML-guided Milliner platform with AbbVie's expertise in oncology and neuroscience to develop next-generation antibodies.

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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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Novel generalised myasthenia gravis treatment approved

European Pharmaceutical Review

The European Commission (EC ) has authorised ZILBRYSQ ® (zilucoplan)▼ as the first once-daily subcutaneous (SC), targeted peptide inhibitor of complement component 5 (C5) inhibitor for generalised myasthenia gravis ( gMG ). It is also the only C5 inhibitor approved for self-administration by adult patients who are AChR antibody-positive with this disease.

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Are Registered Dietitians the Key To Optimizing Weight Loss With GLP-1s?

MedCity News

Prescriptions for GLP-1s are soaring, but fewer than a third of people prescribed the costly drugs will continue taking them one year later without personalized support. Without the expert guidance of a registered dietitian, you risk not achieving the significant clinical benefits these drugs offer and forfeiting the potential for sustainable, transformative health outcomes.

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As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

Fierce Pharma

As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs.

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Sanofi expands genAI drug discovery pact with Aqemia

pharmaphorum

Sanofi has deepened an existing collaboration with artificial intelligence specialist Aqemia in the latest among a flurry of collaborations between pharma companies and generative AI (genAI) companies. The French pharma group has signed a multi-year agreement with Paris-based Aqemia, focused on the discovery of small-molecule drug candidates across multiple therapeutic categories, through the application of genAI and deep physics algorithms that can model molecular interactions.

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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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Phase III data for novel telomerase inhibitor released

European Pharmaceutical Review

Results from Geron’s Phase III IMerge trial evaluating its first-in-class investigational telomerase inhibitor imetelstat, have shown long-term and durable response in participants with a rare haematologic malignancy. Efficacy of the treatment was compared to placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).

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How IT Became So Integral in Healthcare in So Little Time

MedCity News

Looking back 20 years, when fewer than 18% of physician practices used electronic health records, few experts would have anticipated how information technology has changed healthcare. Thanks to IT, the volume and types of data generated and the speed at which they can be analyzed are vastly different than decades ago.

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Lilly's Jaypirca blazes leukemia trail with FDA nod, fast confirmatory trial filing

Fierce Pharma

As AbbVie, Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class. | As AbbVie and Johnson & Johnson, AstraZeneca and BeiGene are battling it out in the same BTK inhibitor market, Eli Lilly is trailblazing a new path for the blood cancer drug class with an accelerated approval in post BTK/BCL-2 chronic lymphocytic leukemia.

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Wischenbart Report On Global 50 Publishers Arrives

Copyright Clearance Center

Books remain a dominant format, though reading and discussing stories, as well as the IP generated from books, have become integrated in consumers’ experiences and on publishers’ spreadsheets.

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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.