Fierce Pharma

MAY 8, 2024

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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European Pharmaceutical Review

MAY 8, 2024

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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MedCity News

MAY 7, 2024

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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ALULA

MAY 9, 2024

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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pharmaphorum

MAY 8, 2024

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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Fierce Pharma

MAY 8, 2024

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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MedCity News

MAY 7, 2024

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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Healthcare Healthcare 109

Pharmaceutical Commerce

MAY 6, 2024

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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Medical Management Safety Patients 102

pharmaphorum

MAY 9, 2024

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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Medicine 99

Fierce Pharma

MAY 8, 2024

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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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.

Safety

Pharmaceutical Technology

MAY 8, 2024

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

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MedCity News

MAY 5, 2024

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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PharmaVoice

MAY 8, 2024

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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Patients 96

pharmaphorum

MAY 9, 2024

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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Advertiser: ZoomInfo

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

Competition

Fierce Pharma

MAY 7, 2024

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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Pharma 283

Pharmaceutical Technology

MAY 3, 2024

UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.

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MedCity News

MAY 7, 2024

Geneoscopy received approval for its noninvasive colorectal cancer screening test, which the FDA designated as a breakthrough device. This marks only the second time the FDA has issued an approval for a molecular diagnostic test for colorectal cancer — and the first time the agency has done so for a colorectal cancer test that uses RNA. The post FDA Grants First-Ever Approval to an RNA-Based Diagnostic for Colorectal Cancer appeared first on MedCity News.

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European Pharmaceutical Review

MAY 9, 2024

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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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.

FDA

pharmaphorum

MAY 3, 2024

Walgreens’ plans to disrupt the clinical trials sector have taken a step forward with a high-profile partnership with Boehringer Ingelheim

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Fierce Pharma

MAY 6, 2024

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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Pharmaceutical Technology

MAY 9, 2024

Anixa Biosciences has expanded its partnership with Cleveland Clinic to develop additional vaccines for cancers.

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MedCity News

MAY 8, 2024

Transcarent recently announced that it raised $126 million in Series D funding led by General Catalyst and 7wireVentures. When asked what his exit strategy is, CEO Glen Tullman said he does not want to sell Transcarent, but sees an initial public offering as an option. The post Glen Tullman Has ‘No Interest’ In Selling Transcarent, But IPO Is a Possibility appeared first on MedCity News.

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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

Distribution

PharmaVoice

MAY 6, 2024

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

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pharmaphorum

MAY 7, 2024

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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Fierce Pharma

MAY 6, 2024

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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Pharmaceutical 279

Pharmaceutical Technology

MAY 7, 2024

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

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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.

Specialization

MedCity News

MAY 9, 2024

Many consumers leave their provider because of navigation problems, while many leave their insurer because of experience issues, a new Accenture report found. The post Why Consumers Leave Their Payer/Provider appeared first on MedCity News.

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European Pharmaceutical Review

MAY 9, 2024

Regulatory agencies in the US across three sectors: agriculture and environmental, have produced a joint plan to “update, streamline, and clarify” regulations and oversight mechanisms for biotechnology products. The plan, developed by the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA), helps to address US President Biden’s related goals, including and improving the “transparency, predictability, coordination, and

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pharmaphorum

MAY 6, 2024

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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Fierce Pharma

MAY 9, 2024

As argenx continues to scoop up biologics market share with its antibody fragment Vyvgart in generalized myasthenia gravis (gMG), the Dutch immunology outfit is confident that it’s “just at the beg | As argenx continues to scoop up biologics market share with its antibody fragment Vyvgart in generalized myasthenia gravis, the Dutch immunology outfit is confident that it’s “just at the beginning of the growth curve” in its inaugural indication.

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Marketing 220

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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.

Management