Thu.Mar 21, 2024

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Despite positive trial, Roche says Enspryng fell short of expectations in myasthenia gravis

Fierce Pharma

Drug developers often try to spot tidbits of positive information from a failed clinical trial. | Drug developers often try to spot tidbits of positive information from a failed clinical trial. But Roche is doing the opposite for its positive Enspryng study in the competitive autoimmune disorder of myasthenia gravis.

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Why Health System Execs Say You Can’t Separate ‘Patient’ from ‘Consumer’

MedCity News

Many people don’t take well to the term “healthcare consumer,” or have expressed that they prefer to be referred to as a patient rather than a consumer. But in the U.S., it’s a plain fact that people have choices when it comes to their healthcare. In this piece, three health system executives give their take on why “patient” and “consumer” are often one in the same — and why hospitals need to be mindful of this.

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GSK joins AstraZeneca, Boehringer in capping US out-of-pocket inhaler prices at $35 per month

Fierce Pharma

Amid congressional scrutiny on U.S. | The drugmaker's commitment will start by January 1, 2025, and follows similar moves by peers Boehringer Ingelheim and AstraZeneca. Before the pledges, the companies—and Teva—caught Senate heat over high U.S. inhaler prices.

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Precision Medicine Startup Mirador Unveils $400M for R&D of New I&I Drugs

MedCity News

Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year.

Medicine 108
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Merck’s Lynparza-Keytruda combo sputters in 2nd lung cancer trial. Will an ADC pairing work instead?

Fierce Pharma

Merck’s attempt to use Lynparza to boost Keytruda in metastatic non-small cell lung cancer has come up short with a second pivotal trial failure. | Merck’s attempt to use Lynparza to boost Keytruda in metastatic non-small cell lung cancer has come up short with a second pivotal trial failure.

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Capital Rx, Prime Therapeutics Form Strategic Alliance

MedCity News

Through a new strategic alliance, Prime Therapeutics will be the only PBM — aside from Capital Rx — to use Capital Rx’s JUDI platform.

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Bionomics to advance non-SSRI PTSD candidate to Phase III

Pharmaceutical Technology

Bionomics plans to meet with the FDA following positive topline data from the Phase IIb ATTUNE trial of the post-traumatic stress disorder (PTSD) drug BNC210.

FDA 105
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Merck KGaA's MilliporeSigma drops €300M on Korean biologics plant with plans to create 300 new jobs

Fierce Pharma

A little less than a year after Merck KGaA unveiled designs on a new bioprocessing plant in South Korea, the company’s U.S.- and Canada-based life sciences business, MilliporeSigma, has swooped in | A little less than a year after Merck KGaA unveiled designs on a new bioprocessing plant in South Korea, the company’s U.S.- and Canada-based life sciences business, MilliporeSigma, has swooped in with a hefty investment at the site and the promise of hundreds of new jobs.

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Required: A Commitment to Funding State Child Psychiatry Access Programs

MedCity News

Surgeon General Vivek Murthy recently described mental health as “the defining public health crisis of our time.” No crisis can be tackled without the proper tools. As the burden of mental and behavioral illness continues to rise, now is the time to invest in the future well-being of our population.

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Catalent lays off 130 staffers at massive Indiana facility being sold to Novo Nordisk

Fierce Pharma

Despite a multi-billion-dollar takeover bid from Novo Holdings, contract manufacturer Catalent appears to be continuing with the internal restructuring scheme it unveiled last year. | Despite a multi-billion-dollar takeover bid from Novo Holdings, contract manufacturer Catalent appears to be continuing with the internal restructuring scheme it unveiled last year.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Clasp emerges with $150m for safer T cell engagers

pharmaphorum

Clasp Therapeutics has burst onto the T-cell engager (TCE) scene with $150 million in funding for a platform that aims to improve the safety of the class, which is currently gaining traction in cancer immunotherapy.

Safety 94
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In his swan song at Bristol Myers Squibb, former CEO Giovanni Caforio pulled down $19.7M

Fierce Pharma

In his final year as CEO at Bristol Myers Squibb, Giovanni Caforio took a slight dip in pay to $19.7 million, down from the $20.1 million he collected in 2022, according to the company’s | In his final year as CEO at Bristol Myers Squibb, Giovanni Caforio took a slight dip in pay to $19.7 million, down from the $20.1 million he collected in 2022.

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UK advanced therapies to get £17.9 million boost

European Pharmaceutical Review

A new £17.9 million strategic initiative is set to support UK advanced therapy medicinal product (ATMP) clinical trials, and help the region maintain its position as a leader in clinical research. An additional four years of funding for the Advanced Therapy Treatment Centre ( ATTC ) network is available through this programme. Collaborators include the National Institute for Health and Care Research (NIHR), Innovate UK, the ATTC network and the Cell and Gene Therapy Catapult (CGT Catapult).

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An ocean of answers in a single cell — how proteomics can lead to better drugs

PharmaVoice

New tools that allow researchers to separate single cells can help map the complex web of proteins that lead to disease, providing new targets for biopharma.

Leads 98
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Control strategy could facilitate faster bioburden detection

European Pharmaceutical Review

Biopharma and bioprocessing experts have proposed an approach that uses a two-tiered control strategy for rapid bioburden testing, that can beneficially, “leverage faster detection times”. It comprises of a “fast (but possibly less sensitive) test” for process monitoring which then initiates “action for a second, longer duration test which is used to confirm and quantify the presence of bioburden and identify the [ microbial ] organism.

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Merck to invest €300m in South Korean bioprocessing centre

Pharmaceutical Technology

Merck KGaA has announced an investment of over €300m ($326.1m) to establish a new bioprocessing production centre in Daejeon, South Korea.

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Eisai backs Leqembi’s Japan rollout with insurance policy

pharmaphorum

A partnership between Eisai and Lifenet that aims to improve insurance cover for people with early dementia has generated its first policy, part of an effort by the pharma group to develop an ‘ecosystem’ to support patients.

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BMS’ cell therapy Abecma gains EC approval for multiple myeloma

Pharmaceutical Technology

The EC has approved BMS' Abecma (idecabtagene vicleucel; ide-cel) to treat adults with relapsed and refractory multiple myeloma (RRMM).

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Parkinson’s UK grants funding of up to nearly £450,000 to four new research projects

PharmaTimes

The globally fast-growing progressive neurological condition affects around 153,000 people in the UK

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Capstan secures $175m Series B funds for CAR-T therapy

Pharmaceutical Technology

Capstan Therapeutics has secured $175m Series B financing to advance its lead in vivo CAR-T candidate, CPTX2309, for autoimmune disorders.

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Scientists hail first pig-to-man kidney transplant

pharmaphorum

Surgeons in the US have carried out the world’s first transplant of a pig kidney into a human, a feat made possible by genetic modification of the organ and an experimental immunosuppressant drug regimen to prevent rejection. The recipient, 62-year-old Richard Slayman of Weymouth in Massachusetts, had end-stage renal disease and was dependent on dialysis.

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Delivery tech remains challenging with gene therapies for brain disorders

Pharmaceutical Technology

Biotech executives discuss why developing gene therapies for central nervous system disorders remains difficult at a recent conference.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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MS research network taps Seqster for data sharing

pharmaphorum

Novartis-supported multiple research project will use Seqster's data-sharing platform to support R&D and evidence-based care

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PAP 2024: The Glass is Half Full

Pharmaceutical Commerce

A multiple myeloma survivor shares his story, including how patient assistance made a positive impact.

Patients 104
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How Integrated Real-World Data Leads to More Meaningful Results

MedCity News

In order to understand the current state of the healthcare system it is essential to have comprehensive sources of real-world and integrated data linked with data from across the healthcare ecosystem.

Leads 67
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UK Government Bans 15 Synthetic Opioids

PharmaTech

More synthetic opioids have been placed under the strictest controls in the United Kingdom.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Researchers reveal protein found in human sweat could protect against Lyme disease

PharmaTimes

The bacterial infection transmitted by ticks affects nearly half a million people in the US every year

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Exploring the Earnings Landscape of Medical Sales Representatives

Rep-Lite

Healthcare professionals come in all forms: pharmaceutical sales reps, surgical sales reps, biotech sales reps, etc. However, for this exploration, we will be using the umbrella term, medical sales representative. Medical sales representatives are healthcare professionals who promote medical equipment, pharmaceuticals, or services to hospitals, clinics, and physicians.

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PAP 2024: Tiara Green Discusses Challenges of Patient Assistance Organizations

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Tiara Green, Interim CEO, Accessia Health offers insight on challenges faced by patient assistance organizations and how to face them.

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FDA Fast Tracks ImmVira's Oncolytic Herpes Simplex Virus Therapy for Head and Neck Squamous Cell Cancer

PharmExec

MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy.

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Accelerating Clinical Supply Through Integrated Drug Development

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.