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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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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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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Honoring Asian American, Native Hawaiian, and Pacific Islander Heritage Month (Part 1 of 4)

ALULA

In the US alone, 6.2 percent of the total population identify as AANHPI (Asian American, Native Hawaiian, Pacific Islander). May is dedicated to honoring people in the US with AANHPI heritage , so it’s a great time to celebrate their voices and experiences – and to reflect on how we can integrate their stories into our lives all year long , especially with our colleagues and teams.

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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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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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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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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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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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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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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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WestGene wins FDA approval for mRNA vaccine to treat certain cancers

Pharmaceutical Technology

The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.

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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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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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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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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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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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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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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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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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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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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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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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“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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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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Pfizer pauses DMD gene therapy trial after boy’s death

pharmaphorum

Pfizer has paused dosing in a study of its Duchenne muscular dystrophy gene therapy after a sudden patient death in another trial

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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.

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Psilocybin effective in treating depression

Pharmaceutical Technology

A new study has further supported psilocybin's potential to treat depression, which impacts around 300 million people globally.

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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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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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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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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.