Fierce Pharma

JANUARY 11, 2023

AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use. esagonowsky. Wed, 01/11/2023 - 09:03.

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FDA 280

MedCity News

JANUARY 11, 2023

In a media briefing during the J.P. Morgan Healthcare Conference in San Francisco, Paul Hudson said unlike Sanofi, large pharma companies with top-selling drugs have a portfolio akin to a leaky bathtub because in a few years, they will have to replace much of that revenue as drug patents expire.

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Fierce Pharma

JANUARY 11, 2023

JPM23: Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response. esagonowsky. Wed, 01/11/2023 - 10:34.

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FDA 254

European Pharmaceutical Review

JANUARY 11, 2023

Machine learning models used to guide the design of long-acting injectable drug formulations have been successfully tested by scientists at the University of Toronto. The research results signal the potential for machine to reduce reliance on trial-and-error testing, which slows the development of long-acting injectables (LAIs). The study was published Nature Communications and is one of the first to apply machine learning techniques to the design of polymeric long-acting injectable drug formula

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Distribution

Fierce Pharma

JANUARY 11, 2023

Lilly, Biogen and more gear up for blockbuster launches in 2023: report. kdunleavy. Wed, 01/11/2023 - 10:19.

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pharmaphorum

JANUARY 11, 2023

Over the past few decades, data generation has veritably exploded. However, the ‘Big Data paradigm’ is not so much concerned with the volume of that data, but how businesses and, indeed, industries can derive meaningful insights from what has become a glut of information. With the currently popular approach to artificial intelligence (AI) focussing on the Big Data paradigm, also, pharmaphorum spoke with Adityo Prakash, CEO of Verseon, about the whys and wherefores, delving deeper into the proces

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PharmExec

JANUARY 11, 2023

As new forms of cell and gene therapies continue to be developed, life sciences companies and payers need to find alternative ways to pay for these expensive treatments. Value-based contracts, though slow to gain traction so far, may provide the solution these groups are looking for.

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Fierce Pharma

JANUARY 11, 2023

JPM23: GSK's Luke Miels on RSV and mRNA vaccines, Blenrep and Zejula withdrawals, plus more. qanderson. Wed, 01/11/2023 - 17:28.

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MedCity News

JANUARY 11, 2023

Workers at the largest for-profit health system in the country, HCA Healthcare, have planned a rally for Thursday. The goal of the rally is to show HCA that its workers know how profitable the company is and that they won’t be able to tolerate poor staffing levels for much longer.

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Healthcare Healthcare 109

Fierce Pharma

JANUARY 11, 2023

JPM23: AbbVie 'well positioned' for this year's Humira biosimilar showdown, CEO says. zbecker. Wed, 01/11/2023 - 11:07.

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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

MedCity News

JANUARY 11, 2023

CVS Health announced investments this week in Carbon Health, Monogram Health and Array Behavioral Care. There have also been rumors that the company is exploring a $10 billion deal with primary care company Oak Street Health.

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Fierce Pharma

JANUARY 11, 2023

JPM23: Amid launch spree, Eli Lilly expects revenue growth at the 'high end of the industry,' CFO says. zbecker. Wed, 01/11/2023 - 14:42.

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MedCity News

JANUARY 11, 2023

Sara Vaezy, Providence’s chief strategy and digital officer, thinks the definition of an integrated delivery system is going to change. In her view, health systems will be more successful if they let go of the notion that they can do it all.

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European Pharmaceutical Review

JANUARY 11, 2023

The largest microbiome study conducted at the highest resolution concluded the gut microbiome is involved in multiple pathways in the pathogenesis of Parkinson’s disease (PD). The findings, published in Nature Communications , show a wide imbalance in microbiome composition in people with Parkinson’s. Investigators at the University of Alabama at Birmingham, US employed metagenomics, the study of genetic material recovered directly from the stool microbiome of individuals with PD and neurologica

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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

JANUARY 11, 2023

The funding round was led by Mercato Partners Traverse Fund and included participation from Bertelsmann Investments. In total, the company has raised $63 million. Paytient created Health Payment Accounts, which help patients pay for out-of-pocket medical expenses.

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PharmaTech

JANUARY 11, 2023

We have proposed a comprehensive capping index parameter which is a ratio of compact anisotropic index to material anisotropic index. This study will help to design or select right tooling for successful tablet manufacturing.

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Manufacturing 98

MedCity News

JANUARY 11, 2023

The FDA approved Airsupra, an asthma rescue inhaler that administers two different medications, one that opens up airways and another that treats inflammation. The inhaler stems from a partnership between AstraZeneca and Avillion.

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FDA Medical Biopharma Pharma 104

PharmExec

JANUARY 11, 2023

As they are forced to do more with less, pharma commercial leaders should rethink their incentive programs to ensure their sales teams remain strong drivers of growth.

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Sales Pharma 96

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Safety

pharmaphorum

JANUARY 11, 2023

AbbVie and Anima Biotech have announced that they are collaborating in a deal worth up to over $580 million to discover and develop drugs that modulate mRNA biology for three targets in cancer and immunology. Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-tra

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PharmaVoice

JANUARY 11, 2023

The chief strategy officer of Form Bio is harnessing the new company’s computing power and bioinformatics to spur a genomic revolution.

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European Pharmaceutical Review

JANUARY 11, 2023

Eisai has submitted a Marketing Authorisation Application (MAA) for lecanemab, for early Alzheimer’s (mild cognitive impairment due to Alzheimer’s (AD) and mild AD dementia) patients in Europe. This application was submitted to the European Medicines Agency (EMA). The submission comes just after lecanemab’s recent accelerated approval by the US Food and Drug Administration (FDA).

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Pharma Pathway

JANUARY 11, 2023

Alembic Pharmaceuticals Ltd- Opening for Manufacturing / Engineering -Apply Now. Job Description. Alembic Pharmaceuticals Ltd. is one of the leading API & Formulations manufacturing and marketing pharmaceutical Company. We continue to enjoy leadership positions in antibiotics, anti -infective, anti -cough and also have significant worldwide presence in specialty therapeutic area such as cardiology, neurology, diabetology, etc.

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Engineering Manufacturing Pharmaceutical Leads 86

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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

PharmExec

JANUARY 11, 2023

The parameters governing pharma promotional speech in digital and social media have struggled to keep pace with the rapidly evolving healthcare communications landscape. How can FDA play catch-up in advancing an agenda more reflective of industry and patient needs?

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Media Government FDA Pharma 72

PharmaTimes

JANUARY 11, 2023

Candidate will go through the development programme, which includes safety and tolerability studies

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Safety 96

PharmExec

JANUARY 11, 2023

Natalie Bickford, chief people officer at Sanofi, reveals how she approaches the employee experience, which ultimately influences employee retention, and discusses the importance of a corporate DE&I strategy in those efforts.

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Pharmaceutical Technology

JANUARY 11, 2023

BioNTech has signed an agreement to buy UK-based artificial intelligence (AI) and machine learning (ML)-based products developer InstaDeep in a deal valued at about $440m (£362m) in cash and shares. InstaDeep shareholders will also receive up to $243.1m (£200m) in additional performance-based future milestone payments. The latest move follows an initial equity investment made by BioNTech as part of the Series B financing round of InstaDeep in January last year.

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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

PharmExec

JANUARY 11, 2023

The steps companies can take now to better protect themselves and their data.

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Pharma 109

PharmaTimes

JANUARY 11, 2023

Global preclinical programme has the potential for disease modifying therapeutics

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Pharmaceutical Technology

JANUARY 11, 2023

AbbVie has collaborated with Anima Biotech for the discovery and development of mRNA biology modulators against three oncology and immunology targets. The collaboration will use the mRNA Lightning platform from Anima and AbbVie’s oncology and immunology expertise to discover new mRNA biology modulators against the targets. AbbVie will get exclusive rights to license and develop and market the programmes.

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Leads Pharmaceutical Marketing Sales 59

PharmExec

JANUARY 11, 2023

What a changing economy and related trends could mean for 2023.

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Biopharma 98

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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Patients