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.

Leads 353

Leads Pharmaceutical 353

MedCity News

MAY 1, 2024

Walmart’s decision to shutter its healthcare division reflects just how difficult it is to achieve profitability in the primary care and telehealth markets. Experts think retailers simply aren’t prepared to handle the bevy of challenges that come along with delivering healthcare — but could this news also be a sign of the system being broken? The post Healthcare Is a Frontier Not Even Walmart Could Conquer — And It’s Not Looking Great For Others Either appeared first on MedCity News.

Retail 131

Retail Healthcare Healthcare Marketing 131

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.

Safety 119

Safety Patients Medicine Medical 119

Pharmaceutical Technology

MAY 1, 2024

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

145

145

Advertisement

Distribution

Clarivate

MAY 1, 2024

Learn about our generative AI-powered Web of Science Research Assistant, which will be available from September 2024. Last year, we announced our collaboration with the research community to bring a new generative-AI-powered capability to the Web of Science — the Web of Science Research Assistant. Since we released the beta to our development partners around the world, we have identified innovative ways to ensure the quality, strength and suitability of generative AI for academic researchers.

Engineering 119

Engineering Leads Government 119

PharmaVoice

MAY 1, 2024

The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.

Pharma 114

Pharma FDA 114

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.

Physicians 111

Physicians Education Patients 111

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.

Medical 102

Medical Management Safety Patients 102

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.

99

99

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

107

107

Advertisement

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 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.

102

102

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.

FDA 302

FDA Pharmaceutical 302

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.

Pharma 114

Pharma Leads Biopharma 114

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.

Safety 102

Safety Medicine Government Medical 102

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

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.

86

86

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

120

120

Pharmaceutical Technology

MAY 8, 2024

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

116

116

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.

Sales 314

Sales Marketing 314

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

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.

97

97

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.

Medicine 101

Medicine Manufacturing Biopharma Engineering 101

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.

Specialization 97

Specialization Education 97

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.

Medicine 91

Medicine 91

Advertisement

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

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.

Pharmaceutical 111

Pharmaceutical Leads 111

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.

Pharma 303

Pharma 303

MedCity News

MAY 1, 2024

In a discussion led by Aneesh Chopra, president of CareJourney, health tech organizations and providers discussed the protected health information (PHI) consent gaps and complex workflows impeding interoperability, and how companies such as Docusign are addressing them. The post The Evolution of eConsent Management for Mental Health, Substance Use Disorders Data appeared first on MedCity News.

Management 101

Management 101

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.

Patients 96

Patients 96

Advertisement

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

European Pharmaceutical Review

MAY 1, 2024

By providing pharma companies with a real-life replicable model of a cloud-first manufacturing facility, we will drive forward the digital capability of pharma manufacturers” A new digital collaboration is set to take advantage of a manufacturing facility model featuring innovative technologies, accelerating how fast new medicines are made. The Centre for Process Innovation (CPI), academia, and the pharma industry will work together to develop the model which will harness artificial intell

Medicine 94

Medicine Manufacturing Pharma Government 94

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

FDA 116

FDA 116

Pharmaceutical Technology

MAY 3, 2024

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

FDA 105

FDA Safety 105

Fierce Pharma

MAY 1, 2024

Just about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. | Merely about two months into his CEO job at Emergent BioSolutions, Joseph Papa has laid out his turnaround plan for the CDMO-turned-biopharma company. And it involves a major organizational restructuring.

Biopharma 299

Biopharma 299

Advertisement

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