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

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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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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.

Leads 359
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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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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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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Tech-Driven Healthcare: Paving the Way for Scalable Solutions 

MedCity News

There is a growing urgency for alternative solutions that support consumers where they are, and this is where the promise of digital health can be transformative. The post Tech-Driven Healthcare: Paving the Way for Scalable Solutions appeared first on MedCity News.

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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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Report warns economic instability has hit UK drug discovery

pharmaphorum

A UK report has said that inflation and geopolitical instability have led to a “dramatic drop” in investment in smaller companies developing new medicines, with a knock-on effect on the entire life sciences industry.

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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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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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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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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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Sanofi forges $1.2bn alliance with vaccines firm Novavax

pharmaphorum

Sanofi has licensed joint commercial rights to Novavax’s COVID-19 vaccine and will work with the biotech on the development of combined flu/COVID shots in a deal worth up to $1.2 billion.

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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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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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Astellas CEO Q&A (Part 1): There Is No Playbook on Cell and Gene Therapies

MedCity News

A Q&A with Naoki Okamura revealed that when it comes to cell and gene therapies, the CEO of Astellas Pharma believes risk-taking is a must for eventual success. The post Astellas CEO Q&A (Part 1): There Is No Playbook on Cell and Gene Therapies appeared first on MedCity News.

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For every million-dollar gene therapy, Peter Marks gets an email from FDA chief Robert Califf

Fierce Pharma

After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D. | After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D.

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Spectral AI nears first sales of wound care system

pharmaphorum

The first commercial sales of Spectral AI's DeepView wound imaging system for burns are due to start in the UK, its first market, later this year

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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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LogiPharma Europe 2024: Delivering Agility in Supply Chains Through Building Multimodal Cold Chain Networks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Cathy O'Brien, VP of Sales, UPS Healthcare discusses her masterclass on delivering agility in supply chains by building a multimodal cold chain network while also reducing risks at LogiPharma Europe 2024.

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FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay

MedCity News

Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process. The post FTC Seeks More Information on the $16.5B Novo-Catalent Deal, Leading to Another Delay appeared first on MedCity News.

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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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Regeneron gene therapy restores hearing in deaf child

pharmaphorum

Regeneron’s gene therapy for otoferlin-related hearing loss restored hearing to normal levels in one profoundly deaf child within just 24 weeks

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Challenges and opportunities in the CGT supply chain

European Pharmaceutical Review

the success of CGT depends on a robust and reliable supply chain” Cell and gene therapies (CGT) offer a revolutionary approach to the treatment, prevention and potential cure of diseases. These advanced medical treatments provide hope for patients suffering from conditions that have historically been poorly understood and widely considered incurable, including genetic diseases and cancers.

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Ascension Hospitals Across Several States Are Offline Following Cyberattack

MedCity News

On Wednesday, Ascension noticed that a hacker had infiltrated its systems. As the health system works with Mandiant to investigate the incident, clinical services remain disrupted at Ascension facilities across several states. The post Ascension Hospitals Across Several States Are Offline Following Cyberattack appeared first on MedCity News.

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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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RNA blood test may predict antidepressant response

pharmaphorum

Selective serotonin reuptake inhibitors (SSRIs) are the first-line drug therapy of choice for most people suffering from depression but often fail to work effectively. Now, a study suggests simple blood test could help predict those who will benefit.

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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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“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.

Medicine 105
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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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In gene therapy race, bluebird leads Vertex in activating treatment centers but trails in patient starts

Fierce Pharma

Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuti | Five months out from their twin FDA approvals in sickle cell disease (SCD), who’s winning the race to treat patients with their respective gene therapies—bluebird bio or partners Vertex Pharmaceuticals and CRISPR Therapeutics?

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New metric predicts burden of participating in trials

pharmaphorum

A new metric developed by Phesi can predict the burden that clinical trials will impose on patients, allowing amendments that can improve the design, efficiency and cost

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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.