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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Trending Sources

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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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Artificial Intelligence Changing the Landscape for Healthcare Social Media Marketing

PharmExec

Experts from Hootsuite noted that the primary social media ROI concern for healthcare companies is the time and money it takes to maintain a multi-platform presence.

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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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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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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 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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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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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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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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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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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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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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‘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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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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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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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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Roche to advance novel obesity and diabetes treatments

European Pharmaceutical Review

Roche has agreed to acquire biotech Carmot Therapeutics for an upfront purchase price of $2.7 billion, enabling the Swiss pharma company to add a range of incretin treatments for obesity and diabetes to its portfolio. Incretins are “gut hormones that are secreted after food intake and play a role in modulating blood glucose by stimulating insulin secretion and suppressing appetite,” Roche highlighted.

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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novartis secures first-of-a-kind haematology approval

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Novartis’ Factor B inhibitor, Fabhalta ® (iptacopan) provides comprehensive control of red blood cell (RBC) destruction, according to the company. Novartis releases data for potentially “practice-changing” PNH medicine Key Phase III data for iptacopan “In clinical studies, iptacopan was superior to anti-C5s in haemoglobin improv

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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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Medtronic drops $738m takeover of wearable insulin pump firm

pharmaphorum

Medtech giant Medtronic has decided not to go ahead with a planned acquisition of EOFlow, a developer of patch-based insulin pumps, saying that there have been “multiple breaches” of their takeover agreement.

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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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AbbVie to buy neuroscience specialist Cerevel Therapeutics for $8.7bn

European Pharmaceutical Review

AbbVie has signed a definitive agreement to acquire Cerevel Therapeutics and its neuroscience pipeline – including antipsychotic emraclidine – for approximately $8.7 billion. Cerevel’s pipeline includes multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson’s disease, and mood disorders.

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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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High-flying Fujifilm splashes $200M to beef up cell therapy capacity

Fierce Pharma

Fujifilm Corporation is spreading the wealth across two production units as the contract development and manufacturing organization (CDMO) juggernaut works through a cell therapy expansion. | Fujifilm is dividing $200 million between a pair of subsidiaries. Those are: Fujifilm Cellular Dynamics, which specializes in development and manufacturing of human induced pluripotent stem cells (iPSC), and the organization’s CDMO for biologics and advanced therapies, Fujifilm Diosynth Biotechnologies.

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Pharma accuses UK of ‘mixed messages’ on rebate schemes

pharmaphorum

The pharma industry and the UK government may have reached an accord on the voluntary scheme of rebates used to limit rises in medicines spending in the UK, but the alternative statutory scheme remains a prickly subject.

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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.