Wed.Aug 10, 2022

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GentiBio partners with Bristol Myers as cell therapy for immune disease gains momentum

Bio Pharma Dive

The deal, worth as much as $2 billion, is the latest sign of industry interest in treatments that harness regulatory T cells, an approach behind several recent biotech startups.

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Why DTC isn’t, and is, marketing

World of DTC Marketing

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. But, in pharma marketing, the changes affect every product category. Consumers share more information online than ever as inflation cuts into their disposable income. I’ve seen posts on everything from opinions on detergents to the best and more inexpensive ice cream.

Marketing 252
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Bristol Myers claims success in study testing earlier CAR-T use in multiple myeloma

Bio Pharma Dive

Abecma, which 2Seventy bio helps develop and sell, is currently approved for patients who have tried at least four other medicines for the blood cancer.

Medicine 317
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Cerevance and Merck partner to detect new Alzheimer’s targets

Pharmaceutical Technology

Cerevance has entered a multi-year strategic research partnership with Merck (MSD outside North America) to discover new targets for Alzheimer’s disease. Under the alliance, the companies will use the Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform of Cerevance to identify the targets. Furthermore, Cerevance will simultaneously out-license a discovery-stage programme to Merck under the partnership.

Licensing 223
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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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Gemini’s fall gives Disc a way around biotech’s IPO slump

Bio Pharma Dive

The biotech’s failed attempt to develop an eye disease drug has ended in a reverse merger that gives startup Disc Medicine a fast path to the public markets.

Medicine 293
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Pathogenic Diseases Are Exacerbated by Climate Change, Scientists Warn

AuroBlog - Aurous Healthcare Clinical Trials blog

There are more than a thousand different ways that climate change can cause outbreaks of infectious disease in humans, according to a new review. When analyzing the literature on 375 human pathogens, researchers from the University of Hawai?i at M?noa and the University of Wisconsin-Madison in the US found 58 percent of these diseases were, at […].

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Catalent to purchase Metrics Contract Services from Mayne Pharma

Pharmaceutical Technology

Catale n t has signed an agreement for the acquisition of full-service specialty Contract Development and Manufacturing Organization (CDMO) Metrics Contract Services for $475m from Mayne Pharma. The takeover of Metrics will bolster the expertise of Catalent in the development of integrated oral solid formulation, production and packaging to aid customers in streamlining and expediting their programmes.

Packaging 147
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R&D funding through BIRAC declines in three years

AuroBlog - Aurous Healthcare Clinical Trials blog

The amount released by the Central government towards drug development and research and development (R&D) through the Biotechnology Industry Research Assistance Council (BIRAC) has come down by almost 50 per cent in the last two fiscal years. The disbursement declined drastically in 2020-21, during when the Covid-19 pandemic hit the country and the government allocated […].

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August 10, 2022: NIH Pragmatic Trials Collaboratory Announces Grand Rounds Series on Ethical and Regulatory Challenges in Pragmatic Trials

Rethinking Clinical Trials

Steven Joffe, MD, MPH, will give a keynote presentation on Sept. 9. The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems.

Trials 130
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North America is seeing a hiring boom for AI roles in the pharmaceutical industry

Pharmaceutical Technology

North America extended its dominance for artificial intelligence (AI) hiring among pharmaceutical industry companies in the three months ending June. The number of roles in North America made up 53.2% of total AI jobs - up from 47.6% in the same quarter last year. That was followed by Asia-Pacific, which saw a 0.9 year-on-year percentage point change in AI roles.

Marketing 130
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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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Their mentor was attacked. Now young OB-GYNs may leave Indiana

NPR Health - Shots

Dr. Caitlin Bernard was publicly vilified for providing abortion care to a 10-year-old rape victim. And that's got some medical residents who were open to practicing in Indiana thinking again.

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Industrial automation hiring levels in the pharmaceutical industry rose to a year-high in July 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for industrial automation related positions rose in July 2022 compared with the equivalent month last year, with 58.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 48.8% of companies who were hiring for industrial automation related jobs a year ago and an increase compared to the figure of 53.9% in June 2022.

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Polio vaccine boosters are offered to London children as the virus spreads

NPR Health - Shots

Children were made eligible for booster doses after health authorities reported finding evidence the virus has spread in multiple areas of London but found no cases of the paralytic disease in people.

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CMO checklist: Selecting a partner that’s right for you?

Pharmaceutical Technology

Working with a contract manufacturing organization (CMO) in the pursuit of bringing a new product to market can deliver a range of significant benefits. A good CMO can assist with everything from clinical supply and formulation challenges to risk mitigation, as well as general challenges that can arise through the scale-up process, such as market demand fluctuation.

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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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STAT+: Everything you need to know before the next big Alzheimer’s readout

STAT News

With the tumultuous rollout of Aduhelm behind them, partners Biogen and Eisai have the rare opportunity for a do-over, with all-important data on their next Alzheimer’s disease therapy expected next month. By the end of September, the world will learn whether lecanemab, another treatment aimed at toxic brain plaques called amyloid, can significantly slow the cognitive decline that characterizes Alzheimer’s.

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August 10, 2022: PCT Grand Rounds to Highlight Strategies for Including Diverse Participants in Pragmatic Trials

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Dr. Consuelo Wilkins of Vanderbilt University will present “Equitably Including Diverse Participants in Pragmatic Clinical Trials.” The Grand Rounds session will be held on Friday, August 12, 2022, at 1:00 pm eastern. Dr. Wilkins is senior vice president and senior associate dean for health equity and inclusive excellence and a professor of medicine at Vanderbilt University Medical Center.

Trials 130
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New research finds blood tests can predict severe outcomes of brain injury

STAT News

Simple blood tests taken on the day of a traumatic brain injury (TBI) can predict with fairly high reliability which patients are likely to die and which are likely to survive with severe disability, according to a study published Wednesday in Lancet Neurology. The rapid assay looks for two protein biomarkers — GFAP, found in glial cells, and UCH-L1, found in neurons.

Research 116
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Mentorship Presents Opportunities to Address Disparities in the Clinical Research Workforce

ACRP blog

As the issues surrounding clinical trial participant diversity become better understood globally, more eyes are turning to the next frontier in drug development diversity, equity, and inclusion: the clinical research workforce. In the forthcoming August 2022 issue of Clinical Researcher from ACRP, the authors of an expanded and updated study of principal investigators, nurses, and other allied health professionals focus on understanding the motivations of these professionals for joining the heal

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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.

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SMC approve Johnson & Johnson’s systemic light chain amyloidosis therapy

Pharma Times

Newly diagnosed patients will become the first to access systemic light chain amyloidosis treatment in the UK

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Opinion: Implant recipients shouldn’t be left in the dark when a device maker cuts off support

STAT News

Imagine having an impaired sense restored by an innovative device, only to suddenly lose that function again because the company that developed the device folded, or stopped supporting it and pivoted to other products. Then imagine having no one to turn to — not the company, not the government, and not the medical community — to deal with the aftermath.

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AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer

XTalks

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. Enhertu is an antibody-drug conjugate (ADC) consisting of Roche’s Herceptin (trastuzumab), a monoclonal antibody against HER2 (human epidermal growth factor receptor 2), and the topoisomerase I inhibitor deruxtecan.

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Opinion: PCR testing can help clarify confusion over Covid-19 rebound and isolation

STAT News

President Biden’s recent case of Covid-19 , its rebound , and his extended isolation offers an opportunity to consider how more precise interpretation of viral load via PCR testing might be used to safely return people to work or school earlier. Biden tested positive for SARS-CoV-2, the virus that causes Covid-19, on July 21 , after beginning to experience a runny nose, dry cough, and fatigue the night before.

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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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Environmental Sustainability: An Imperative for the Life Sciences Sector

Pharmaceutical Commerce

Recognizing the sustainability issue is an important step, but the biopharmaceutical sector encompasses a complex set of networks and supply chains, so it is not straightforward to shift towards net zero across all operations.

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STAT+: Amid Aduhelm woes, Biogen moves to pare back office space

STAT News

Biogen is moving to scale back its real estate footprint in Kendall Square and   in Weston, as the Cambridge-based biotech company aims to cut $1 billion in costs in the wake of a disastrous rollout of its Alzheimer’s drug Aduhelm. Biogen is looking to sublease more than 183,000 square feet at 300 Binney St. in Cambridge — across the street from its headquarters — and   is also subleasing two floors, or 80,000 square feet, at one of its two properties at 133 Boston

Drugs 98
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Biden to sign a bill that would care for veterans made sick by toxic exposures

NPR Health - Shots

President Biden on Wednesday will sign the PACT Act, a bill to care for veterans exposed to toxins that is considered the biggest expansion of veterans' health care in U.S. history.

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Opinion: Real-world data can help expedite drug approvals for serious diseases with few options

STAT News

My grandmother was diagnosed with dementia in the early 2000s. We started taking it seriously when she began letting strangers into her Brooklyn brownstone. From there, her behavior quickly deteriorated. She would try to catch her excrement when using the bathroom because she believed it would clog the plumbing. She stashed bottles of whiskey under her bed to cope with insomnia.

Drugs 98
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

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Cerevance establishes strategic research collaboration with Merck

Pharma Times

Partnership will focus on the discovery of novel targets in Alzheimer’s disease

Research 104
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STAT+: Pharmalittle: Endo bankruptcy filing over opioid crisis appears imminent; U.S. to allow fractional doses of monkeypox vaccine

STAT News

Good morning, everyone, and how are you today? We are doing just fine, thank you, despite the persistently muggy temperatures enveloping the Pharmalot campus. After all, the birds are still chirping and the skies are crystal clear. Moreover, this marks the middle of the week, which means we have managed to survive this far. And this calls for celebration, yes?

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Volunteer escorts at clinics that provide abortions are shifting their focus

NPR Health - Shots

Volunteer escorts typically walk patients to and from the doors of abortion providers. But as more clinics close, such volunteers are navigating an increasingly precarious reality.

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New patent for Aurinia drug LUPKYNIS

Drug Patent Watch

Annual Drug Patent Expirations for LUPKYNIS Lupkynis is a drug marketed by Aurinia and is included in one NDA. There are two patents protecting this drug. This drug has one…. The post New patent for Aurinia drug LUPKYNIS appeared first on DrugPatentWatch - Make Better Decisions.

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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.