Fierce Pharma

JANUARY 29, 2024

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.

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Pharmaceutical Technology

JANUARY 29, 2024

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

Healthcare 144

Healthcare Healthcare 144

Fierce Pharma

JANUARY 29, 2024

New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. | New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. WuXi Bio, for its part, says it's not affiliated with the military in China.

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Biopharma 291

MedCity News

JANUARY 29, 2024

Science 37 rode the trends of Covid-19 technologies and SPAC mergers to a more than $1 billion valuation. But revenue for the decentralized clinical trials software firm stopped growing, and it’s now going private valued at just $38 million.

Biopharma 116

Biopharma Pharma 116

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Distribution

Fierce Pharma

JANUARY 29, 2024

Grifols has filed a lawsuit against Gotham City that accuses the hedge fund of manipulating "the value of Grifols’ stock for their own monetary gain.

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MedCity News

JANUARY 29, 2024

This month, the World Health Organization released new guidelines on the ethics and governance of LLMs in healthcare. Reactions from the leaders of healthcare AI companies have been mainly positive. However, one leader pointed out that fear or the risks associated with LLMs shouldn’t hinder innovation, and another noted that the guidance may have failed to mention a major topic.

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Healthcare Healthcare Ethics Government 115

Pharmaceutical Commerce

JANUARY 29, 2024

In an interview with Pharma Commerce Associate Editor Don Tracy, Ron Lanton, Partner, Lanton Law PLLC, discusses recent moves by CVS and Express Scripts to follow Mark Cuban's drug plus model.

Pharma 110

Pharma 110

MedCity News

JANUARY 29, 2024

When it comes to AI, the consensus is that healthcare organizations have an opportunity right now to take an enterprise-wide approach that encompasses everything from workforce to infrastructure to governance and beyond. Here are these ten essential elements of an enterprise-wide AI strategy for healthcare organizations.

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Government Healthcare Healthcare Biopharma 103

Pharmaceutical Technology

JANUARY 29, 2024

The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.

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Leads 111

MedCity News

JANUARY 29, 2024

Instacart and DispatchHealth recently launched a partnership that allows DispatchHealth to provide food interventions to patients in need of nutrition support.

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Food Patients 109

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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

pharmaphorum

JANUARY 29, 2024

Spanish drugmaker Grifols has hit back at hedge fund Gotham City Research, which claimed it had fraudulently manipulated its financial reporting, with a lawsuit filed in New York. The complaint has been brought against Gotham City and co-founders Daniel Yu and Cyrus de Weck, along with other defendants, and accuses them of being “predatory short sellers…who illicitly profit from their rigged short-and-distort schemes.

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European Pharmaceutical Review

JANUARY 29, 2024

N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. 1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way t

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Pharmaceutical Food and Drug Administration Medicine FDA 98

MedCity News

JANUARY 29, 2024

Sanofi and Synthekine will work together to develop cytokine therapies for inflammatory diseases. This new alliance comes as Sanofi is salvaging a different cytokine therapy that showed disappointing efficacy in Phase 2 after the pharma giant acquired it in a $2.5 billion deal.

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Pharma Biopharma 94

PharmaVoice

JANUARY 29, 2024

In addition to the chronic disease, the non-opioid drug may have applications in other painful conditions.

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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

JANUARY 29, 2024

In response to emailed questions, Kismet Health Co-founders CEO Dr. Cierra Gromoff and COO Christie Sander talked about why they started the business.

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pharmaphorum

JANUARY 29, 2024

Bristol-Myers Squibb is getting closer to offering a subcutaneous version of its cancer immunotherapy Opdivo to patients after it matched the current intravenous formulation in a head-to-head trial in kidney cancer.

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Patients 87

MedCity News

JANUARY 29, 2024

While the term ‘CPQ’ — Configure, Price, Quote — might seem distanced from direct patient care, these tools are, in fact, pivotal for a modern, patient-centric healthcare system. Far from being just business-centric, CPQ tools are a fundamental component in the healthcare delivery chain.

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Healthcare Healthcare Patients 88

Pharmaceutical Technology

JANUARY 29, 2024

An eye-catching milestone in hand, Ascidian will begin the Phase I/II STELLAR study of ACDN-01 for Stargardt disease in H1 2024.

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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.

Safety

European Pharmaceutical Review

JANUARY 29, 2024

In the published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. Also covered in the guideline are “the methods and criteria used to assess whether exposure to a constituent is without appreciable harm”. As highlighted by the International Organization for Standardization (ISO), the process described in the standard is relevant to chemical characterisation, such as extractable data or leachable data ( E&L ), information obta

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Food and Drug Administration Medical Safety Food 83

Pharmaceutical Technology

JANUARY 29, 2024

The full potential of cell and gene therapies (CGTs) has not yet been discovered as these therapies promise life-changing treatments.

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Pharmaceutical 97

pharmaphorum

JANUARY 29, 2024

MSD’s Keytruda is the first cancer immunotherapy to improve survival when used as adjuvant therapy in renal cell carcinoma (RCC).

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Pharmaceutical Technology

JANUARY 29, 2024

The EMA CHMP has recommended marketing authorisation for Bristol Myers Squibb’s Abecma for multiple myeloma.

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Marketing 104

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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

JANUARY 29, 2024

GSK has claimed EU approval of Omjjara for the treatment of splenomegaly or symptoms in adult myelofibrosis patients with moderate-to-severe anaemia

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Patients 89

PharmaTimes

JANUARY 29, 2024

A total of 103,277 general and acute beds are now available to NHS patients

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Patients 96

pharmaphorum

JANUARY 29, 2024

AstraZeneca and Daiichi Sankyo’s Enhertu could become the first therapy approved by the FDA for use in any HER2-positive cancer, regardless of its location in the body. The US regulator has started a priority review of the HER2-targeting antibody-drug conjugate (ADC) for the treatment of adults with unresectable or metastatic HER2-positive solid tumours who have been treated previously or have limited treatment options.

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FDA 72

Pharmaceutical Technology

JANUARY 29, 2024

The US FDA has granted priority review to the sBLA for ENHERTU, a treatment developed by Daiichi Sankyo and AstraZeneca for solid tumours.

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FDA 64

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

pharmaphorum

JANUARY 29, 2024

Orion licenses digital pain therapeutic from Newel Health Phil.

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Pharmaceutical Technology

JANUARY 29, 2024

The upcoming OCT West Coast 2024 conference will feature experts talking about emerging techologies, clinical trial operations for pharma and medical devices, and patient participation in studies.

Pharma 52

Pharma Medical Patients 52

Quantified

JANUARY 29, 2024

A sales kickoff (SKO) sets the tone for big projects, campaigns, or annual strategies. However, SKOs can come with a high price tag of approximately $2,500 to $5,500 per attendee as of 2021. That makes it even more important to provide as much value as possible during every minute of the SKO. But this doesn’t mean packing the entire event with lots of calls, meetings, speeches, and happy hours, with a combination of in-person and virtual segments.

Sales 52

Sales Training Sales goal Sales tools 52

Clarify Health

JANUARY 29, 2024

Care transitions are often critical periods where patients may be vulnerable to complications or relapses. Ensuring effective management of care transitions is not just a matter of patient convenience; it is pivotal to enhancing patient outcomes, improving population health, and reducing unnecessary medical spend. Poor care transition management can lead to fragmented healthcare delivery, often leading to increased patient readmissions, compromised health outcomes, and elevated costs.

Management 52

Management Healthcare Provider Safety Healthcare 52

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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