Tue.Oct 10, 2023

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Bayer opens California plant to make cell therapies

Bio Pharma Dive

The pharma plans for the new Berkeley facility to produce clinical, and potentially commercial, supplies of a Parkinson’s disease cell therapy being tested by its subsidiary BlueRock.

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How commercial employer plans and coverage matter for orphan drugs

Pharmaceutical Technology

In a two-part column, F. Randy Vogenberg delves into why it is important to address emerging challenges in the employer-based US commercial insurance landscape.

Drugs 246
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After summer slump, biotech M&A has a good week

Bio Pharma Dive

There have been few bigger-ticket acquisitions recently. But a string of deals announced in early October may affirm the forecasts of analysts who expect M&A to tick up in the coming months.

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Long COVID Patients Are Far More Likely to Have Multiple Organ Abnormalities

AuroBlog - Aurous Healthcare Clinical Trials blog

It wasn’t that long ago that some people speculated that long COVID was all in the mind – a psychosomatic illness. Thankfully, that period of speculation is now behind us. We have compelling evidence that long COVID is very real and can affect major organs in people who were previously hospitalised with the disease.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Gates Foundation announces $40m for mRNA vaccine platform

Pharmaceutical Technology

The Gates Foundation is providing $40m in funding to advance the accessibility of Quantoom Biosciences' affordable mRNA vaccine platform.

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October 10, 2023: Ethics Consultation Documents Now Available for BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE

Rethinking Clinical Trials

Ethics and regulatory onboarding documentation for the NIH Pragmatic Trials Collaboratory’s newest Demonstration Projects are now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the BEST-ICU, Chat 4 Heart Health, and TAICHIKNEE studies. The consultations took place by video conference and included representation from the studies’ principal investigators, members of the NIH Coll

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More Trending

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Akero drug for NASH misses goal in mid-stage study

Bio Pharma Dive

The biotech claimed the results still showed promise for its experimental fatty liver disease treatment, but shares sank sharply on the news.

Drugs 156
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Could greater adoption of remote nursing visits lead to faster study results?

Pharmaceutical Technology

As sponsors seek to minimize trial delays and get new therapies to market faster, we explore whether increased adoption of a more patient-centric approach could make a difference to timelines.

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Merck data show survival benefit to early Keytruda treatment

Bio Pharma Dive

In perioperative setting, Merck says its immunotherapy helps patients live longer, with an approval decision expected later this month.

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ABVC BioPharma obtains patent for MDD treatment in Taiwan

Pharmaceutical Technology

ABVC BioPharma has obtained a patent in Taiwan for the usage of PDC-1421 in ABV-1504, an asset intended for major depressive disorder.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Merck's Keytruda hits overall survival goal in early lung cancer as FDA decision nears

Fierce Pharma

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Ke | What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s Keytruda.

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Salipro partners with Icosagen to develop monoclonal antibody therapies

Pharmaceutical Technology

The companies will develop multiple monoclonal antibodies against membrane proteins, such as GPCRs and SLC transporters.

Antibody 147
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UKRI awards £41m to enhance UK research and innovation

Pharma Times

The scheme will help ten projects establish research and innovation clusters - News - PharmaTimes

Research 145
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Theramex gains European rights to Duphaston and Femoston from Viatris

Pharmaceutical Technology

Theramex has added the synthetic hormones to its portfolio as Viatris divests its businesses and sells assets.

Hormones 147
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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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Behind the Scenes with a Study Coordinator for a Potential Breakthrough Breast Cancer Vaccine

ACRP blog

In recognition of October being Breast Cancer Awareness Month , ACRP recently went behind the scenes with a clinical research coordinator on the study team for a bold Cleveland Clinic investigation of a vaccine aimed at preventing triple-negative breast cancer (TNBC), the most aggressive and lethal form of the disease. Emily (Esakov) Rhoades, PhD, Multisite Investigator Initiated Trial (IIT) Program Manager for the Cleveland Clinic’s Taussig Cancer Institute, provided insights on how the study,

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UPS Healthcare debuts healthcare logistics service in Europe

Pharmaceutical Technology

The logistics service is taking another step in becoming a leader in healthcare and pharmaceutical logistics.

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CRF study smashes diversity targets in trials with three times national average

Outsourcing Pharma

Complete clinical trials solution company, Hawthorne Effect, announced today (October 10) announced it had successfully recruited more than 1,000 patients in 48 states plus Hawaii for a study to qualify the prevalence of valvular heart disease (VHD).

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CanariaBio partners with Hikma MENA FZE for oregovomab

Pharmaceutical Technology

CanariaBio has entered into a distribution and licence agreement with Hikma MENA FZE for oregovomab to treat advanced ovarian cancer.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Bayer christens $250M cell therapy 'launch facility' in Berkeley

Fierce Pharma

Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. | Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.

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Sosei and PharmEnable collaborate on another neurological drug

Pharmaceutical Technology

The partnership builds on their existing drug discovery agreement to develop a neurological disease target.

Drugs 147
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Move Over, White Whales – Zebras Are Here

Intouch Solutions

Fact 1: Pharma is in the business of discovering, developing, and producing drugs with the aim of treating, curing, or preventing diseases…ultimately leading to healthier communities around the world. Fact 2: Pharma is just that – a business. Both facts are true. Both facts co-exist. And both facts impact how society views our industry. On that last point, there have clearly been times where Fact 2 has a direct influence on Fact 1.

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Bayer makes $250m investment in Berkeley cell therapy plant 

Pharmaceutical Technology

Bayer has invested $250m in a manufacturing plant at Berkeley, California, US, to produce cell therapies for use across the globe.

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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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Kansas children’s hospital first to use world’s most advanced genomic sequencing

BioPharma Reporter

Childrenâs Mercy Kansas City, an independent pediatric health organization, has become the first health care system to replace old genetic tests, such as rapid exome and chromosomal microarray analysis, with the worldâs most-advanced genomic sequencing technology from PacBio.

Genome 101
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EASD 2023: efficacy of initial TCT in drug-naïve patients with T2D

Pharmaceutical Technology

Kim and colleagues investigated the efficacy and tolerability of an initial TCT with metformin, dapagliflozin, and saxagliptin.

Drugs 130
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OrganaBio unveils new division for vaccine and cell and gene therapy clinical trials

BioPharma Reporter

OrganaBio, a contract technology development and manufacturing organization (CTDMO) specializing in solutions for cell and immunotherapy development, has launched a new division.

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Co-bots and automatons: the divergent futures of robotics

Pharmaceutical Technology

Robots are already vital in a number of sectors, from manufacturing to retail, and their use will only grow.

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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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Study reveals diagnosis and treatment inequalities in NHS heart care

Pharma Times

Researchers focused on four of the most common heart conditions in the UK - News - PharmaTimes

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Scotland accepts a fresh wave of therapies into the NHS

Pharmaceutical Technology

The Scottish Medicines Consortium accepted 12 new treatments for conditions ranging from cancer to obesity.

Medicine 130
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Economist Impact’s Future of Health Europe summit: Building a sustainable, inclusive, and digital health system

pharmaphorum

Economist Impact’s Future of Health Europe summit: Building a sustainable, inclusive, and digital health system Mike.

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Point of Care Personalization: A Conversation with Veradigm

Fierce Pharma

Personalization—we’re all talking about it, and we’re all trying to do it better. So what sets Veradigm apart? | Veradigm has insights as to how personalized and targeted messaging can drive awareness and engagement, ultimately improving the patient experience.

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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.