Mon.Jul 22, 2024

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Ionis plots next steps for Angelman drug Biogen passed on

Bio Pharma Dive

The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

Drugs 282
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How NVIDIA grew with the healthcare market instead of pushing into it

Pharmaceutical Technology

As the use of AI soared across healthcare, NVIDIA fit the bill in providing the necessary technology – and its stock tells the same story.

Marketing 258
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Breakthroughs in immunotherapy: glycoproteins as predictive biomarkers for therapeutic response

Bio Pharma Dive

Serum-based glycoproteins demonstrate success in predicting immune checkpoint inhibitor therapy outcomes.

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Going from Zero to 100: Generating Evidence through Pragmatic Research to Address the Pressing (July 2024)

Rethinking Clinical Trials

July 15-16, 2024 : The NIH Pragmatic Trials Collaboratory hosted a Workshop at the 2023 AcademyHealth 16th Annual Conference on the Science of Dissemination and Implementation in Health. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Research 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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US government declines to clear Bluebird fertility support for Zynteglo patients

Bio Pharma Dive

The Health and Human Services' inspector general issued a "negative opinion" on Bluebird's request one week after Vertex sued the federal government over access to fertility preservation services.

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Breakthrough Test Predicts Whether Organ Transplants Will Be Rejected

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have figured out a non-invasive way to determine if a transplanted organ is failing to take in a patient – no matter if it’s a kidney, liver, lung, or heart.

Scientist 130

More Trending

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How a potential Harris presidency could influence US healthcare

Pharmaceutical Technology

As VP Kamala Harris enters the presidential race, her strong stances for reproductive rights and drug access offer insights into future actions.

Drugs 130
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Clinical data registries: Transforming the future of medical research

Bio Pharma Dive

Clinical data registries have become invaluable for generating unique insights for life sciences. Read on to learn more.

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UK NICE recommends Accord’s Relugolix for prostate cancer

Pharmaceutical Technology

The UK NICE has recommended Accord's Relugolix as a treatment for advanced hormone-sensitive prostate cancer in its final draft guidance.

Hormones 130
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Pharma exports report 9.3% growth in Q1, FY25

AuroBlog - Aurous Healthcare Clinical Trials blog

Exports of drugs and pharmaceuticals from the country registered a 9.3 per cent growth in the first three months of the fiscal year from April to June, 2024, while imports reported a jump of 12.4 per cent, compared to the corresponding quarter of previous year. The exports during the three months stood at $7.

Drugs 100
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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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How NIVIDIA grew with the healthcare market instead of pushing into it

Pharmaceutical Technology

As the use of AI soared across healthcare, NVIDIA fit the bill in providing the necessary technology – and its stock tells the same story.

Marketing 130
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J&J seeks expanded approval for antidepressant Spravato

Bio Pharma Dive

The company is seeking a monotherapy approval for Spravato, sales of which have climbed in recent quarters.

Sales 124
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Astellas and Osaka University to develop cell therapy

Pharmaceutical Technology

Astellas Pharma subsidiaries and Osaka University in Japan link to develop pluripotent stem cell-derived cartilage organoid cell therapy.

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Agilent Technologies lays out $925M to acquire Canadian specialty CDMO Biovectra

Fierce Pharma

After changing hands several times throughout the 2010s, Canadian specialty contract development and manufacturing organization (CDMO) Biovectra has agreed to fly the Agilent flag. | Agilent has revealed that it’s signed a definitive agreement to acquire Biovectra for $925 million through a mix of cash and debt financing. The deal is expected to close this year.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Navigating the challenges of bringing cell and gene therapies to market

Pharmaceutical Technology

Understanding of cell therapies is rapidly improving, but there remain significant challenges in getting new therapies onto the market.

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Study finds wearables deliver key insights in heart disease

pharmaphorum

Consumer wearables have shown a benefit when used to monitor treatment responses in patients with atrial fibrillation and heart failure.

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GRO Biosciences secures Series B funding for gout treatment

Pharmaceutical Technology

GRO Biosciences has secured $60.3m in a Series B financing round to progress the clinical development of its lead programme for gout.

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Innovent throws its hat further into China's GLP-1 ring

pharmaphorum

Innovent Biologics is planning a second filing for its dual GLP-1/glucagon agonist mazdutide in China, as it tries to carve out a share of a market currently dominated by Novo Nordisk and Eli Lilly.Mazdutide – a once-weekly injectable Innovent licensed from Lilly – was submitted to China's National Medical Products Administration (NMPA) earlier this year for weight management in overweight and obesity, and will soon be submitted for type 2 diabetes as well after a second positive phase 3 trial,

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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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UK MHRA approves Lupin and Zentiva’s raltegravir for HIV

Pharmaceutical Technology

The UK MHRA has granted approval for the use of Lupin Healthcare and Zentiva Pharma’s generic raltegravir medicines for treating HIV.

Medicine 130
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New study shows wearable trackers provide clinical use for heart disease patients

Pharma Times

Cardiovascular disease, including coronary heart disease, currently affects around seven million people in the UK

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EMA accepts GSK’s Blenrep MAA for multiple myeloma for review

Pharmaceutical Technology

The EMA has accepted for review GSK’s MAA for Blenrep for relapsed or refractory multiple myeloma (r/r MM).

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Valneva gets $41m grant to roll out chikungunya vaccine

pharmaphorum

Valneva has been awarded funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and EU to expand access to its recently approved vaccine for chikungunya, a potentially life-threatening mosquito-borne disease.

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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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Altamira’s drug-delivering nanoparticles could treat AAA

Pharmaceutical Technology

The SOD2 mRNA delivered with SemaPhore technology showed improved survival rates for mice with abdominal aortic aneurysm.

Drugs 130
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Sinking prices for generic meds a major factor in US shortage crisis: report

Fierce Pharma

As lawmakers and industry groups seek to get a handle on U.S. | As lawmakers and industry groups seek to get a handle on U.S. drug shortages, a new white paper from German market analytics firm QYOBO supports the thesis that disproportionately low prices for generic medicines can make it difficult for drugmakers to keep supplies afloat.

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SIGA scores HHS contract for smallpox vaccine Tpoxx worth $113m

Pharmaceutical Technology

The company’s Tpoxx vaccine is used to treat orthopoxvirus but is only approved for treating smallpox by the US FDA.

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Bluebird bio's gene therapy fertility support program gets thumbs down from HHS inspector general

Fierce Pharma

The door is closing on bluebird bio’s attempt to secure Medicaid coverage for its fertility support program, which is already offered to patients with commercial insurance who receive its gene ther | The door is closing on bluebird bio’s attempt to secure Medicaid coverage for its fertility support program, which is already offered to patients with commercial insurance who receive its gene therapies.

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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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UNAIDS boss calls on Gilead to provide ‘miracle’ drug to developing countries

Pharmaceutical Technology

UNAIDS executive director Winnie Byanyima called upon Gilead to allow generics to be made of lenacapavir now.

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President Biden touts drug pricing achievements as he steps down from re-election campaign

Fierce Pharma

At his vacation home in Delaware, President Joe Biden made the striking announcement that he is dropping out of the 2024 | While President Joe Biden is officially out for the 2024 election, his term has certainly made a mark in the healthcare realm.

Drugs 65
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UNAIDS boss calls on Gilead to provide ‘miracle’ drug to developing countries

Pharmaceutical Technology

UNAIDS executive director Winnie Byanyima called upon Gilead to allow generics to be made of Sunlenca now.

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Apollo Therapeutics and University of Oxford collaborate to revolutionize drug development

Outsourcing Pharma

Apollo Therapeutics and the University of Oxford have embarked on a collaborative journey in drug discovery and development.

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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.