Fierce Pharma

APRIL 9, 2024

Even as Novartis rolls ahead with a global restructuring campaign targeting thousands of job cuts, the Swiss drug giant has blueprinted several hundred layoffs in its development organizational uni | Even as Novartis rolls ahead with a global restructuring campaign targeting thousands of job cuts, the Swiss drug giant has blueprinted several hundred layoffs in its development organizational unit.

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MedCity News

APRIL 9, 2024

At a recent conference, executives from across the industry shared their thoughts on how the healthcare sector can ensure its use of AI is ethical and responsible. They highlighted the need for collaboration, trust building and pragmatic thinking. The post How Can Healthcare Ensure Responsible AI Use? appeared first on MedCity News.

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Healthcare Healthcare Ethics 137

Fierce Pharma

APRIL 9, 2024

About 15 years ago, Carl Ola Landgren, M.D. Ph.D., noticed an encouraging yet potentially concerning trend in the treatment of multiple myeloma. | At an FDA advisory committee meeting this Friday, two teams will present their studies examining the utility of minimal residue disease (MRD) as a potentially approvable endpoint in multiple myeloma. For this report, Fierce Pharma spoke with experts to learn about what's at stake, including the need to bring new treatments to patients earlier.

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FDA Pharma Patients 288

MedCity News

APRIL 9, 2024

Seaport Therapeutics’ drug candidates are delivered through the lymphatic system, an approach that could overcome some limitations of neuropsychiatric medicines, including products from Sage Therapeutics. The startup stems from the research of PureTech Health. The post PureTech Startup Gets $100M to Try For Success Where Sage & Others Fall Short in Depression appeared first on MedCity News.

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Medicine Biopharma 122

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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

Fierce Pharma

APRIL 9, 2024

Though gene therapy manufacturing specialist Ascend Advanced Therapies just launched a little more than a year ago, the CDMO is already on the hunt to expand. | Ascend, which bills itself as a “total solutions gene therapy development partner,” has picked up the manufacturing team and site of Beacon Therapeutics in Alachua, Florida. As part of the deal, Ascend has also agreed to a long-term partnership with Beacon to produce its ocular gene therapies for clinical and commercial use.

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Manufacturing 268

MedCity News

APRIL 9, 2024

Pelago’s new contingency management program rewards patients for engaging in treatment, such as completing a survey, completing app check-ins, attending appointments and completing cognitive behavioral therapy exercises. The post Pelago Unveils Contingency Management Program To Support Those With Substance Use Disorder appeared first on MedCity News.

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Management Patients 120

pharmaphorum

APRIL 9, 2024

Great Ormond Street Hospital is applying for the license to a gene therapy for rare disease ADA-SCID that was abandoned by a biotech developer on commercial grounds.

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Fierce Pharma

APRIL 9, 2024

Researchers plan to run biomarker analyses of patients in the KEYLYNK-008 trial to see whether any subsets may benefit from the addition of Lynparza.

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Patients 254

MedCity News

APRIL 9, 2024

The finalists for the Payer/Provider track are applying their health tech solutions to addressing burnout and operational efficiency. The post Which Health Tech Startups Will Present in the Payer/Provider Track of INVEST Pitch Perfect? appeared first on MedCity News.

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pharmaphorum

APRIL 9, 2024

A UK report has found that people from minority ethnic backgrounds face an average delay of a year between first noticing symptoms and gaining a diagnosis, which is more than twice as long as white people.

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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

ALULA

APRIL 9, 2024

It’s been somewhat of an annual tradition for me to attend the Women in Leadership panel at the American Manufacturing Summit and share the highlights. This year’s panel discussion brought together five senior leaders: Joy Malinowski from Constellation Brands, Elena Bernado from Hello Fresh, Susanne Lauda from AGCO, Donna Deyo from Paccar, and Angela Reamer from Monin.

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Manufacturing 98

European Pharmaceutical Review

APRIL 9, 2024

Research published in Biosensors reports the strong potential of using 3D printed substrates in bacterial analysis. The study by Childs et al. utilised a rapid 3D printed µbiochamber with a laser-ablated interdigitated electrode. This system was developed for biofilm analysis of Pseudomonas aeruginosa , Acinetobacter baumannii and Bacillus subtilis using electrochemical biological impedance spectroscopy (EBIS) across a four-hour spectrum.

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Media Pharmaceutical Management 91

pharmaphorum

APRIL 9, 2024

The team that brought you Karuna, recently sold to Bristol-Myers Squibb for $14 billion, has set up a neuropsychiatry-focused biotech called Seaport Therapeutics

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European Pharmaceutical Review

APRIL 9, 2024

Delpharm has acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. Meppel will be used to manufacture products for Astellas, according to the terms of the original agreement. “We are delighted to further expand our operations in the Netherland with this [third] site,” commented Nicolas Ragot, Managing Director of Delphar

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Management 91

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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

APRIL 9, 2024

People with Cushing’s syndrome can sometimes take years to get a diagnosis, but a new project hopes to shorten that timeline with the help of artificial intelligence.

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PharmaTech

APRIL 9, 2024

In this latest installment of the Europa Perspectives series, Alexander Natz, Secretary General at EUCOPE, delves into the European Commission’s new measures aimed at making lifecycle management more efficient across the European Union.

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Management 78

pharmaphorum

APRIL 9, 2024

Bayer enlists the aid of Google Cloud to develop its AI platform for radiologists, adding genAI capabilities

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PharmaTimes

APRIL 9, 2024

Hepatocellular carcinoma is one of the leading causes of cancer-related deaths worldwide

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Leads 101

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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

Copyright Clearance Center

APRIL 9, 2024

April 9, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, has been named to the Top Workplaces USA 2024 list by USA Today for the third consecutive year. The Top Workplaces USA awards offer recognition to mid-size and large organizations with at least 150 employees, including those with operations in multiple geographic markets.

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Education Competition Marketing 64

PharmaTimes

APRIL 9, 2024

Both will validate the clinical performance of two new diagnostic tests for regulatory submission

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PharmaVoice

APRIL 9, 2024

Biosimilars promise market competition for branded biologics, which in theory could drive down prices. But so far, winning market share has been a struggle.

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Competition Marketing 59

Contrarian Sales Techniques

APRIL 9, 2024

As the moon heralds the arrival of Eidul Fitr this April, it's not just a celebration marking the end of Ramadan, but a moment of reflection and gratitude for the journey we've embarked upon in 2024. This year, amidst its challenges and rewards, has been a testament to the resilience and spirit of our community. As we gather with our loved ones to celebrate this joyous occasion, it's a poignant reminder of the beauty of the present moment and the myriad reasons we have to be grateful.

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Marketing 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

PharmaVoice

APRIL 9, 2024

More than 20% of Americans are forgoing prescription medications due to costs, but the industry continues to fight policy measures.

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Prescription Medical 64

PharmExec

APRIL 9, 2024

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, talks about the ethical and regulatory problems weight loss companies like WW, Noom, and Ro present.

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Ethics Pharmaceutical 52

PharmaTech

APRIL 9, 2024

With the launch of a new manufacturing service, Memel Biotech will offer services for discovery through to formulation for advance therapy medicinal products.

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Manufacturing Medicine 52

PharmExec

APRIL 9, 2024

A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia.

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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

Pharmaceutical Technology

APRIL 9, 2024

BrainStorm Cell Therapeutics has faced a few hurdles along the way towards the development of its lead candidate, NurOwn for ALS.

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FDA Leads 59

PharmExec

APRIL 9, 2024

Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis.

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Pharmaceutical Technology

APRIL 9, 2024

Pfizer intends to submit data from MONeT to regulatory agencies in a bid to expand the vaccine’s indicated treatment population.

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Pharmacy Times

APRIL 9, 2024

In March 2024, the label for bempedoic acid was expanded to reduce cardiovascular risk and expand the low-density lipoprotein-C (LDL-C) lowering in both primary and secondary prevention patients.

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Patients 57

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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