May, 2024

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Reimagining research impact: Introducing Web of Science Research Intelligence

Clarivate

Discover how the Web of Science Research Intelligence platform will revolutionize research evaluation by driving responsible innovation and demonstrating societal impact. At Clarivate , we recognize the pivotal role that research plays in shaping the future. That’s why we’re excited to announce the development of Web of Science Research Intelligence , a next-generation software solution powered by AI that will empower researchers to accelerate breakthroughs and research institutions to better me

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Pfizer moves to settle more than 10,000 Zantac cases in state courts: Bloomberg

Fierce Pharma

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

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COVID-19 vaccinations now ‘alarmingly low’ in Europe

pharmaphorum

COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.

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Healthcare Is a Frontier Not Even Walmart Could Conquer  — And It’s Not Looking Great For Others Either

MedCity News

Walmart’s decision to shutter its healthcare division reflects just how difficult it is to achieve profitability in the primary care and telehealth markets. Experts think retailers simply aren’t prepared to handle the bevy of challenges that come along with delivering healthcare — but could this news also be a sign of the system being broken? The post Healthcare Is a Frontier Not Even Walmart Could Conquer — And It’s Not Looking Great For Others Either appeared first on MedCity News.

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

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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Potential best-in-class antibody shows “remarkable efficacy” in atopic dermatitis

European Pharmaceutical Review

New data from a Phase IIa trial in moderate-to-severe atopic dermatitis has demonstrated that a novel monoclonal antibody (mAb) could facilitate dosing every 12 weeks for induction therapy. This is due to a 31-day half-life at anticipated therapeutic dose levels, Inmagene Biopharmaceuticals confirmed. Humanised anti-OX40 IgG1 mAb IMG-007 works via a silenced antibody -dependent cellular cytotoxicity (ADCC) function, Inmagene explained.

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More Trending

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Takeda, amid restructuring campaign, plots 641 layoffs at two Massachusetts sites

Fierce Pharma

A recently announced $900 million restructuring drive is already making waves at Takeda, wi | From early July to March 2025, the Japanese drugmaker will cut 495 staffers at its Cambridge location and 146 in Lexington, Massachusetts. Takeda is the largest life sciences employer in the state.

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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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Mental Health Inequities Could Cost $1.3 Trillion in 2040. How Can the Industry Prevent This?

MedCity News

Mental health inequities are costing the U.S. $477.5 billion annually. This could rise to $1.3 trillion in 2040 if left unaddressed. The post Mental Health Inequities Could Cost $1.3 Trillion in 2040. How Can the Industry Prevent This? appeared first on MedCity News.

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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

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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 for First-in-Class IV-Administered Gene Therapy to Treat Epilepsy Presented at ASGCT 2024

PharmaTech

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

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Beyond discovery: AI and the future of the Web of Science

Clarivate

Learn about our generative AI-powered Web of Science Research Assistant, which will be available from September 2024. Last year, we announced our collaboration with the research community to bring a new generative-AI-powered capability to the Web of Science — the Web of Science Research Assistant. Since we released the beta to our development partners around the world, we have identified innovative ways to ensure the quality, strength and suitability of generative AI for academic researchers.

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At request of AstraZeneca, Europe suspends marketing authorization of COVID vaccine Vaxzevria

Fierce Pharma

Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).

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AZ’s Dato-DXd misses survival endpoint in lung cancer trial

pharmaphorum

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t what they were hoping for.

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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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SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue

MedCity News

SmarterDx — an AI startup that provides clinical review and quality audits for medical claims — closed a $50 million Series B funding round, bringing its total funding to date to $71 million. The post SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue appeared first on MedCity News.

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As Senate’s gaze lands on patents, a former US PTO chief calls the effort a ‘broad misunderstanding’

PharmaVoice

To lower drug prices, lawmakers are turning to the drug patent system to outlaw some common practices — but a former patent agency director says it’s the wrong way to go.

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MHRA publishes strategy on AI regulation

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a policy paper on its strategic approach to artificial intelligence (AI). It summarises the MHRA’s view on the UK government’s white paper on AI regulation published in 2023. Following publication of this white paper, the government requested that the MHRA outline the steps the agency is working on in relation to its expectations.

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The top pharmaceutical companies by R&D expenditure

Pharmaceutical Technology

From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.

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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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House's updated biosecurity bill sets 2032 decoupling deadline for industry's work with WuXi AppTec

Fierce Pharma

Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. | Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. The new draft lays out a 2032 deadline for the separation mandate.

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Sorcero genAI conjures plain language from scientific papers

pharmaphorum

Understanding complex scientific studies is often a challenge for patients as well as healthcare professionals, but one that may become easier thanks to artificial intelligence.

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Telehealth Is Far From Dead, Says Providence’s Virtual Care Chief

MedCity News

This year has been a messy one for virtual care companies, but that doesn’t mean that telehealth is dead, according to Eve Cunningham, Providence’s chief of virtual care and digital health. In her view, virtual care can definitely still be an important part of the care delivery model — but only if it is embedded into the greater healthcare delivery ecosystem.

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As AI proliferates in pharma, regulators look to catch up in clinical trials

PharmaVoice

The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Improving stem cell transplantation success in high-risk blood cancers

European Pharmaceutical Review

Repurposing cyclophosphamide may enable more patients with high-risk blood cancers to receive transplanted stem cells from unrelated, partially matched donors, new research suggests. These new findings, which are part of an ongoing Phase II study , will be presented at the 2024 American Society of Clinical Oncology (ASCO) meeting and the European Hematology Association ( Abstract #6503 ).

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Researchers combine herpes virus with cancer vaccine to treat brain cancer in children

PharmaTimes

High-grade gliomas are rare, malignant tumours which account for up to 12% of all childhood brain tumours

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Emergent BioSolutions to cut 300 employees, shutter 2 facilities in restructuring launched under new CEO

Fierce Pharma

Just about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. | Merely about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. And it involves a major organizational restructuring.

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

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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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Research Shows Generative AI In The EHR Can Work Well, But Only With Human Oversight

MedCity News

Mass General Brigham researchers conducted a study to learn more about the efficacy of large language models when used to draft responses to patient messages in the EHR. The results showed that these AI tools can do a good job at reducing physicians’ workloads and improving patient education — but also that these tools have limitations that require human oversight.

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Can robots break the cell therapy bottleneck?

PharmaVoice

A partnership between the cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could bring the manufacturing bottleneck under control, the CEOs said.

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AstraZeneca and Nona Biosciences sign agreement for monoclonal antibody

Pharmaceutical Technology

AstraZeneca has entered into a worldwide licence and option agreement with Nona Biosciences for a preclinical monoclonal antibody.

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Bristol Myers Squibb Plans 10-Year Strategy to Expand Access to Medications

PharmaTech

The company is collaborating with the Access to Oncology Medicines Coalition to expand patient access to immuno-oncology therapy Opdivo.

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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.