Thu.Mar 28, 2024

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Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Fierce Pharma

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. | An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

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1 Year Later: How Has the Unwinding of Medicaid Continuous Enrollment Gone?

MedCity News

One year after the Medicaid continuous enrollment provision ended, 19.2 million people have been disenrolled from Medicaid, according to KFF. This is higher than many expected, and experts have mixed reviews on how they think this process has gone.

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Johnson & Johnson gets a new opportunity to contest science in talc litigation

Fierce Pharma

Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits that claim the company’s iconic baby powder can cause ovarian cancer. | Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits claiming that the company’s iconic baby powder can cause ovarian cancer. A New Jersey court ruled on Wednesday that J&J can contest the scientific findings that back those cases.

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Boundless Bio’s ‘BOLD’ IPO Reels In $100M for a New Kind of Cancer Drug

MedCity News

Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year.

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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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Patented AI Platform Identifies Promising Early-Stage BioPharma Assets and Companies

Fierce Pharma

Authors: | Gain the competitive edge with accurate probability of success assessments to uncover undervalued companies and early-stage assets for acquisitions.

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The Reluctant Revolution: Encouraging Interoperability Adoption in Healthcare

MedCity News

The lack of adoption of interoperability tools by healthcare providers is a complex issue that requires a multi-faceted approach

More Trending

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Nanoscope Therapeutics exhibits positive top-line Phase IIb results for MCO-010

Pharmaceutical Technology

Nanoscope Therapeutics released promising top-line results for its RESTORE trial, which is studying the gene therapy MCO-010 in patients with retinitis pigmentosa (RP).

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Aurisco Pharmaceutical Launches State-of-the-Art Manufacturing Facility for GLP-1 Peptides

Fierce Pharma

[Yangzhou, China - March 26, 2024] - Aurisco Pharmaceutical, a leading global pharmaceutical company, is excited to announce the completion of its investment in cGMP peptide manufacturing capacity | Aurisco Pharmaceutical Launches State-of-the-Art Manufacturing Facility for GLP-1 Peptides

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Measles cases continue to rise in US amid lagging vaccination rates

Pharmaceutical Technology

According to the CDC, over 64 cases of measles have been documented in the US in 2024, already exceeding 2023's total of 58.

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Fierce Pharma Asia—Big Pharma's China visit; AstraZeneca's parallel supply chains; WuXi's predicament

Fierce Pharma

Several Big Pharma CEOs gathered in Beijing to reaffirm their commitment to the Chinese market. AstraZeneca is working to separate its supply chains for the U.S. and China. U.S. | Several Big Pharma CEOs gathered in Beijing to reaffirm their commitment to the Chinese market. AstraZeneca is working to separate its supply chains for the U.S. and China.

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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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Quality risk management in radiopharmaceutical production

European Pharmaceutical Review

A paper published in Applied Sciences has described a quality risk assessment methodology for application in sterile PET radiopharmaceutical production under Good Manufacturing Practice (GMP) regulations. According to research highlighted in the paper, applying quality standards such as GMP and ISO 9001 “guarantees the quality and safety of a radiopharmaceutical and contributes to optimising the performance and efficacy of the entire production process.

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Test could give early warning of motor neuron disease

pharmaphorum

Scientists say a test for motor neuron disease, based on an aptamer for biomarker TDP-43 in brain tissue, could detect at-risk people before symptoms develop.

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Revolutionizing ICU Care: The Future of Telemedicine in Smaller Facilities

MedCity News

This technology can result in reduced readmission rates, increased patient satisfaction, and a consistent flow of post-acute care revenue, especially in rural areas.

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Beckley builds case for its psychedelic depression therapy

pharmaphorum

New data for Beckley Psytech's psychedelic therapy for treatment-resistant depression builds anticipation for a phase 2b readout later this year

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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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Pharmaceutical environmental monitoring market to value $38.1b by 2030

European Pharmaceutical Review

The global pharmaceutical and biotechnology environmental monitoring market valued $24 billion in 2023, according to a report by Verified Market Research. This figure is projected to increase to $38.1 billion by 2030. Pharmaceutical and biotechnology environmental monitoring market Influencing factors The report also covered that due to the biotechnology industry requiring sterile conditions and products, expansion of this sector creates demand for extensive environmental monitoring.

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Akebia joins GSK in US market for oral CKD anaemia drugs

pharmaphorum

Akebia’s Vafseo has been approved in the US as a treatment for anaemia caused by chronic kidney disease in dialysis patients, the first direct rival to GSK’s Jesduvroq.

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Strand Therapeutics develops new class of mRNA molecules for cancer

PharmaTimes

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases

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Blackstone bankrolls Moderna’s flu shot with $750m

pharmaphorum

Moderna’s development of mRNA vaccines for influenza will be backed by up to $750m in funding from Blackstone in a risk-sharing deal

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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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PMLiVE’s T40 – open for submissions!

PharmaTimes

Healthcare agencies can submit their entries free of charge with a deadline of 30 April

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Can Google Street View data provide heart health insights?

pharmaphorum

Study finds AI analysis of Google Street View images could reveal how built environment factors affect the risk of cardiovascular disease

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University of Liverpool to lead £125m research facility supported by UKRI investment

PharmaTimes

Set to open in 2032, the RUEDI facility is funded by the UKRI’s recent infrastructure fund worth £388m

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Gen AI and its use in medical devices and SaMD

Pharmaceutical Technology

AI is fast becoming a valuable tool for developers of regulated health apps. In an exclusive Q&A, SaMD solutions provider Huma tells us how AI is allowing clinicians to make better decisions and why the human factor will remain a critical element of healthcare.

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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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Pharma Pulse 3/28/24: Do Mixed Results Impact Potential Real-World Effectiveness? FDA Issues Letters Over Unapproved, Misbranded OTC Analgesic Products & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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March Fundraising Roundup: 7 Provider Tech Startups That Closed Rounds This Month

MedCity News

Here is a list of some of the most notable funding round announcements that took place this March in the provider technology space.

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4D Molecular Therapeutics gets grant for recombinant aav for muscle cell infectivity with heterologous peptide

Pharmaceutical Technology

Discover how 4D Molecular Therapeutics Inc's patented variant AAV capsid proteins enhance muscle cell infectivity for gene therapy, revolutionizing treatment for genetic disorders.

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Univercells and Andelyn Biosciences Form Separate Drug Development Partnerships

PharmaTech

Univercells and Altamira Therapeutics are collaborating on nanoparticle-delivered mRNA vaccines, while Andelyn Biosciences and Grace Science are partnering on novel therapies for NGLY1 deficiency.

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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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Addressing Uncertainties Associated Medication Approved Through Accelerated Approval Pathway

PharmExec

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses how healthcare providers and patients navigate the potential benefits and uncertainties associated with a medication approved through the accelerated approval pathway.

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CRISPR drug licensing deals secure $21bn in top three therapy areas over five years

Pharmaceutical Technology

Licensing agreements for innovator drugs utilising clustered regularly interspaced short palindromic repeats (CRISPR) technologies saw oncology, immunology, and central nervous system as the top three therapy areas by total deal value with a combined $21bn over the past five years.

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The Future of Orthopedic Medical Device Sales and the Hiring The Right Reps with Chad Casey

Evolve Your Success

Embark on a journey into the heart-pounding, adrenaline-charged world of medical sales with your host, Samuel Adeyinka, and special guest, Chad Casey , VP of Sales at Zimmer Biomet. Chad is currently the Vice President of Sports Medicine, Extremities, Trauma, and ASC strategy for Zimmer Biomet Carolinas. He is a successful sales executive with over 23 years of experience.

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Lantern Pharma gets grant for treatment of atypical teratoid/rhabdoid tumor using hydroxyureamethyl acylfulvene

Pharmaceutical Technology

Discover a groundbreaking patent for treating atypical teratoid/rhabdoid tumors with HydroxyUreaMethyl Acylfulvene. Learn how this method targets SMARCB1 gene alterations and enhances efficacy with radiation therapy. Explore the potential of this innovative treatment option today.

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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.