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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Discovering new insights from early-career scholarship through the addition of >172M linked cited references from ProQuest dissertations and theses on the Web of Science

Clarivate

Students and researchers can easily locate new sources of research on diverse topics with the enriched ProQuest Dissertations & Theses Citation Index, as well as easily showcase their work and monitor impact over time. An academic career can be rewarding, but also marked by high stress [1]. Today’s researchers are challenged to balance multiple priorities and deadlines – from securing adequate funding for their work, to meeting the demands of a full teaching workload — all while publishing r

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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.

FDA 116
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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.

Medical 125
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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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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 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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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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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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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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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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‘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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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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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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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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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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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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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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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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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Q&A: Tackling the rise of fake anti-obesity drugs on the market

Pharmaceutical Technology

Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.

Marketing 111
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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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UK’s entrance into Horizon Europe finalised

European Pharmaceutical Review

With the UK set to become an associated country to Horizon Europe on 1 January 2024, the political agreement on UK’s association to Horizon Europe has been adopted. Now, this final step in the process has been implemented by the EU-UK Specialised Committee on Participation in Union Programmes (SCPUP), the European Commission (EC) has announced. The programme is the EU’s key funding initiative for research and innovation with a budget of €95.5 billion for 2021-27.

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Canopy Emerges from Stealth Selling ‘a Wearable Panic Button’ for Healthcare Workers

MedCity News

Canopy has emerged from stealth as a startup focused on protecting healthcare staff from increasing levels of violence. The company’s product, called Canopy Protect, involves wearable monitors that healthcare staff can press when they feel threatened, as well as a system that allows a hospital to monitor all physical areas of the organization.

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Merck and Eisai's Keytruda-Lenvima combo comes up short yet again, this time in endometrial cancer

Fierce Pharma

Merck and Eisai’s combo of Keytruda and Lenvima has missed the mark yet again, rounding out a year of multiple trial flops for the pairing. | The combo missed both endpoints in a phase 3 study in certain patients with advanced or recurrent endometrial carcinoma, adding yet another entry to a long list of recent trial failures.

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Japan approves BMS’ Abecma for multiple myeloma treatment

Pharmaceutical Technology

Japan has granted approval for the sBLA of Bristol-Myers Squibb (BMS) for Abecma to treat relapsed or refractory multiple myeloma (RRMM).

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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.