Sat.May 04, 2024 - Fri.May 10, 2024

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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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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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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The Promise of RFID for Improving Medication Inventory Management

Pharmaceutical Commerce

Radio frequency identification (RFID) not only helps hospitals boost their medication safety standards, as it also allows clinicians to continue to provide quality patient care.

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AstraZeneca to withdraw Covid-19 vaccine globally

Pharmaceutical Technology

AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.

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House lawmaker brings FDA into biosecurity crackdown on China

Fierce Pharma

Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.

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AZ oncology chief says AI can help solve cancer’s ‘ZIP code lottery’ as health disparities persist

PharmaVoice

Partnerships have been key to building the company’s AI capabilities and patient-focused R&D, said AstraZeneca’s head of U.S. oncology.

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Navigating the Complexities of Payment for Genetic Testing

MedCity News

Balancing the promise of personalized medicine with proper payment accuracy The post Navigating the Complexities of Payment for Genetic Testing appeared first on MedCity News.

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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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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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BioNTech plots first wave of cancer launches in 2026 as COVID vaccine sales continue to disappoint

Fierce Pharma

As BioNTech continues to endure a sharp decline in COVID-19 vaccine sales, the German mRNA specialist is looking ahead to the next leg of its commercial journey. | With plans to have at least 10 potentially registrational trials underway by the end of 2024, BioNTech is plotting the first wave of its market debut in oncology from 2026 onward.

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Oxford/AZ Covid-19 vaccine to be discontinued

European Pharmaceutical Review

Withdrawal of the marketing authorisation for the COVID-19 vaccine (ChAdOx1-S [recombinant]) Vaxzevria (SRD) by the European Medicines Agency on 7 May, follows a request by AstraZeneca. “Global demand for all COVID vaccines is now much lower and overall supply exceeds demand. This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries.

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Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression

MedCity News

Otsuka Pharmaceutical is launching a subsidiary that will commercialize its digital therapeutic Rejoyn — as well as other digital therapeutics and connected health products down the line. Last month, Rejoyn became the first FDA-cleared digital therapeutic for patients with depression. The post Otsuka Launches New Company to Commercialize Rejoyn, the First Digital Therapeutic for Depression appeared first on MedCity News.

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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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AlphaFold 3 takes structure predictions well beyond proteins

pharmaphorum

Google DeepMind and Isomorphic Labs' newly launched AlphaFold 3 extends the power of the AI model to 'all life’s molecules'

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Kenvue maps out hundreds of layoffs as service pact with J&J winds down

Fierce Pharma

Even after consumer outfit Kenvue split from Johnson & Johnson one year ago, the company has been performing certain services for the pharma and medtech giant as part of a transition process. | Kenvue’s board of directors on Monday approved a plan to cut 4% of the company’s global workforce. The J&J spinoff employed about 23,000 staffers at the end of last year, so the layoff initiative could affect some 920 workers.

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AstraZeneca concludes equity investment in Cellectis

Pharmaceutical Technology

AstraZeneca has concluded an equity investment in clinical-stage biotechnology company Cellectis following a deal signed in November 2023.

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Opinion: Why PHTI’s Recent Assessment of Digital Diabetes Management Tools is Inadequate

MedCity News

As we enter the digital era of healthcare at scale, we must redefine how we care for people … and how we evaluate that care. The post Opinion: Why PHTI’s Recent Assessment of Digital Diabetes Management Tools is Inadequate appeared first on MedCity News.

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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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Top charities team up with $300m for climate, health equity

pharmaphorum

The Novo Nordisk Foundation, the Bill & Melinda Gates Foundation, and Wellcome have joined forces to tackle some of the most pressing threats to human health and wellbeing. The new initiative gets underway with $300 million in funding over three years earmarked for handling infectious diseases and antimicrobial resistance (AMR), addressing climate change, and raising our understanding of how nutrition can impact immunity, disease, and the development of children.

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Amneal agrees to $272.5M settlement to resolve opioid lawsuits

Fierce Pharma

Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer | Amneal Pharmaceuticals has agreed to pay $272.5 million to settle approximately 900 lawsuits brought by state, local and Native American jurisdictions claiming that the New Jersey generics producer fueled the opioid crisis by failing to act on suspicious opioid orders.

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As drug shortages reach record highs, regulators float next steps

PharmaVoice

With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.

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Report: More Employers Are Looking To Deploy Value-Based Care

MedCity News

More than a third of employers are integrating accountable care into their health benefits, according to a new report from the Milken Institute. However, there are several barriers. The post Report: More Employers Are Looking To Deploy Value-Based Care appeared first on MedCity News.

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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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Citi analyst Andrew Baum to head Pfizer strategy team

pharmaphorum

Pfizer has named Citi analyst Andrew Baum as its chief strategy and innovation officer, taking point on portfolio management and capital deployment

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Pfizer hires Citi analyst Andrew Baum to manage portfolio strategy, business development

Fierce Pharma

“Our next question will come from Andrew Baum with Citi.” | Citi analyst Andrew Baum, after covering Pfizer for more than a decade, will join the Big Pharma company as chief strategy and innovation officer. In the role, he'll oversee the drugmaker's portfolio management and business development activities.

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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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Stark Law Crackdown Jacks Up Fines, Settlements and Physician Pressures

MedCity News

Is a widened enforcement net squeezing physicians unfairly? That’s the belief of one high-profile author and health policy expert. The post Stark Law Crackdown Jacks Up Fines, Settlements and Physician Pressures appeared first on MedCity News.

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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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Activist investor urges changes to Novavax board

pharmaphorum

Shah Capital has stepped up its campaign for change at vaccine producer Novavax, lobbying against the re-election of three directors and executive pay packages in a letter to fellow stockholders. The hedge fund says it wants to send a “strong and clear message” to the board at Novavax, reiterating the claim – first made a few weeks ago – that the company is “being hindered by an overly conservative board and management that clings to failed strategies.

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Uzedy partners Teva and MedinCell's latest long-acting schizophrenia candidate notches phase 3 win

Fierce Pharma

After bringing slow-release schizophrenia drug Uzedy to market last year, Teva and France’s MedinCell are using the same playbook for a similar candidate. | The companies second go at a long-acting schizophrenia med uses popular antipsychotic olanzapine, which Eli Lilly first marketed in the 90s but found safety issues with its own long-acting version.

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“Landmark” genetic blindness CRISPR trial outcomes released

European Pharmaceutical Review

New results from a Phase I/II clinical trial of a CRISPR/Cas9 gene editing therapy show that around 79 percent of patients with a rare form of inherited blindness experienced “measurable improvement”. The BRILLIANCE trial included 14 participants (12 adults and two children) who received an injection of EDIT-101 in one eye. These individuals had a form of Leber Congenital Amaurosis (LCA) caused by mutations in the centrosomal protein 290 (CEP290) gene.

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Biden Administration Extends ACA Coverage Eligibility to DACA Recipients

MedCity News

Under a new final rule, eligible DACA recipients will be able to enroll in a Qualified Health Plan through the ACA Marketplace or through a Basic Health Program. The post Biden Administration Extends ACA Coverage Eligibility to DACA Recipients appeared first on MedCity News.

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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.