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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Leads Pharmaceutical 353

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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Safety Patients Medicine Medical 120

PharmaTech

MAY 8, 2024

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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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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Physicians Education Patients 113

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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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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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Marketing Medicine 341

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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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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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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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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FDA Pharmaceutical 307

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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

European Pharmaceutical Review

MAY 2, 2024

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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Safety Medicine Government Medical 102

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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Healthcare Healthcare Patients 93

MedCity News

MAY 2, 2024

Mariana Oncology brings Novartis a lead radiopharmaceutical program in development for small cell lung cancer. The deal is the latest in a string of big pharma M&A moves in the red-hot radiopharmaceuticals space. The post Novartis Extends Its Reach in Radiopharmaceuticals With $1B Mariana Oncology Acquisition appeared first on MedCity News.

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Pharma Leads Biopharma 113

Pharmaceutical Technology

MAY 7, 2024

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

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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 318

European Pharmaceutical Review

MAY 2, 2024

Recent developments in the biologic therapies sector include the authorisation of Pyzchiva ® (biosimilar ustekinumab) by the European Commission, and promising 12-month data for Roche’s subcutaneous injection of OCREVUS ® (ocrelizumab) for relapsing or primary progressive multiple sclerosis. The biologics market is expected to continue its fast growth despite the slowdown in funding observed in the past year.

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Medicine Manufacturing Biopharma Engineering 101

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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MedCity News

MAY 8, 2024

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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Medicine 89

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

Copyright Clearance Center

MAY 2, 2024

May 2, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announced today that it has earned five 2023 Top Workplaces Culture Excellence Awards from Energage LLC for Compensation & Benefits; Leadership; Work-Life Flexibility; Innovation; and Purpose & Values for the second consecutive year.

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Specialization Education 97

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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Sales Marketing 332

Pharmaceutical Technology

MAY 2, 2024

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

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Pharmaceutical Leads 111

pharmaphorum

MAY 3, 2024

Apple gets FDA okay to use the atrial fibrillation history tool incorporated in some of its Apple Watch devices in clinical trials

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FDA 118

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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

MedCity News

MAY 8, 2024

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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FDA Pharmaceutical Patients Biopharma 86

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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Fierce Pharma

MAY 8, 2024

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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Safety Marketing 270

Pharmaceutical Commerce

MAY 7, 2024

The acquisition, the parties say, will benefit pharma and biotech in the clinical and commercial stages.

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Pharma 103

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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

pharmaphorum

MAY 6, 2024

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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Management 97

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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European Pharmaceutical Review

MAY 6, 2024

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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Medicine Safety Patients Medical 81

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 293

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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