Wed.Feb 28, 2024

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Beacon Therapeutics unveils promising interim results for gene therapy AGTC-501

Pharmaceutical Technology

AGTC-501 is in Phase II development for retinitis in the SKYLINE trial (NCT03316560) and addresses unmet needs within the retinitis space

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Microplastics Found in Every Human Placenta Tested, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s been over three years since scientists first found microplastics swimming in four different human placentas, and as it turns out, that was just the tip of the iceberg. A few years later, at the start of 2023, researchers announced they had found microscopic particles of plastic waste in no fewer than 17 different placentas.

Scientist 186
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Pelage secures funds to develop regenerative medicine for hair loss

Pharmaceutical Technology

Pelage Pharmaceuticals has secured $16.75m in a Series A financing round to further the development of PP405 for hair loss.

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Ginkgo adds gene editing tools in buyout of Feng Zhang-founded startup

Bio Pharma Dive

The acquisition of Proof Diagnostics, which was formed to develop a COVID-19 test, gives Ginkgo a library of novel enzymes that can be used to make genetic medicines.

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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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Amneal signs agreement with Zambon for Parkinson’s disease therapy

Pharmaceutical Technology

Amneal has signed an agreement with Zambon Biotech for IPX203 for the treatment of Parkinson's disease (PD) in certain regions.

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Incannex says psilocybin therapy lowered anxiety in small study

Bio Pharma Dive

Shares of the Australian biotech rocketed up about 55% after the company announced results from a mid-stage study in generalized anxiety disorder.

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More Trending

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Viatris pays $350M to gain two drugs from Idorsia

Bio Pharma Dive

The deal gives Viatris access to a treatment for heart attacks as well as a drug for lupus, both of which are currently in Phase 3 testing.

Drugs 161
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Beyond approval: Patients pursue alternate paths to get rare disease treatments

Pharmaceutical Technology

As post-approval boundaries disproportionately affect rare disease patients, communities are rallying behind alternative options.

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February 28, 2024: A Randomized Trial of a Food-as-Medicine Program, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern. Doyle is the Erwin H.

Medicine 141
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The importance of high-quality raw materials in the development of Regenerative Medicine

Pharmaceutical Technology

Regulatory standards concerning raw material selection are particularly stringent when it comes to Regenerative Medicines.

Medicine 243
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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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Can a Moderna co-founder change the CRO game?

Bio Pharma Dive

Well-known scientist and biotech entrepreneur Robert Langer is helping Lindus Health address longstanding challenges in contract drug research.

Scientist 152
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Parliamentary Panel asks DoP to expedite process of setting up National Standards for all medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

A Parliamentary Panel has asked the Department of Pharmaceuticals (DoP) and the Bureau of Indian Standards (BIS) to expedite the process of setting up National Standards for all types of medical devices and use of a ‘National Mark’ for all medical devices that comply with BIS/IEC standards.

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Biogen discontinues Aduhelm to focus on Leqembi for Alzheimer’s disease

Pharmaceutical Technology

The goal had been for 10,000 patients to be on Leqembi by the end of March 2024, but only 2,000 patients received the drug as of 26 January.

Drugs 130
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Women’s health company Obseva to wind down, lay off staff

Bio Pharma Dive

The company is still attempting to “monetize” its most advanced drug, a treatment to aid pregnancy via in vitro fertilization.

In-Vitro 161
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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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BeiGene’s TEVIMBRA application for gastric cancer accepted for review

Pharmaceutical Technology

BeiGene has announced the BLA acceptance by the US FDA for TEVIMBRA to treat advanced gastric or gastroesophageal junction adenocarcinoma.

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Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Lindsell, PhD)

Rethinking Clinical Trials

            Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. Lindsell, PhD Professor and co-Chief of Biostatistics, Department of Biostatistics & Bioinformatics Director, Data Science and Biostatistics, Duke Clinical Research Institute Duke University School of Medicine Editor in Chief, Journal of Clinical and translational Science Slides Keywords Decentralized Clinical Trials, Virtual

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Minerva hit with FDA rejection for schizophrenia symptom drug

Pharmaceutical Technology

Whilst Minerva deals with clinical deficiencies, eyes turn to Karuna’s PDUFA date and other key Phase III readouts later this year.

Drugs 130
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Seeking blockbuster status, UCB eyes four new indications for psoriasis med Bimzelx in 2024

Fierce Pharma

After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels. | After an initial FDA approval came later than anticipated, UCB is looking to quickly grow Bimzelx. The company is eying four new indications and potential peak sales of 4 billion euros.

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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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Grifols prepares for late-stage plans with plasma-derived medicines in 2024

Pharmaceutical Technology

In an interview with Pharmaceutical Technology, the company’s chief scientific officer detailed the company’s upcoming 2024 plans.

Medicine 130
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After steep cost cuts, Novavax's fourth-quarter performance falls short of expectations

Fierce Pharma

As Novavax emerges from its “transition year” in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024. | As Novavax emerges from its “transition year” in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024.

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AbbVie licenses OSE’s chronic inflammation therapy for $48m upfront

Pharmaceutical Technology

AbbVie will pay $48m in upfront costs and up to $665m in milestone payments to license OSE’s monoclonal antibody OSE-230.

Licensing 130
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Power of digital technology and partnership to accelerate delivery of new medicines to patients

pharmaphorum

Discover how digital technology and strategic partnerships are revolutionising the pharmaceutical industry, enabling faster delivery of life-saving medicines to patients, while advancing humanity's fight against diseases.

Medicine 116
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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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FDA approves Allecra’s EXBLIFEP for cUTI treatment

Pharmaceutical Technology

The US FDA has granted approval for Allecra Therapeutics’ EXBLIFEP to treat complicated urinary tract infections.

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AbbVie inks $713m deal for OSE chronic inflammation drug

pharmaphorum

AbbVie has made another bolt-on deal in the immunology and inflammation category, paying $48 million upfront for rights to an antibody in preclinical development at OSE Immunotherapeutics. There’s another $665 million in potential milestones and a royalty tied to the deal, which focuses on OSE-230, billed as a potentially first-in-class activator of ChemR23, a G-protein coupled receptor (GPCR) found on some white blood cells.

Protein 115
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Biotechs heed political headwinds for drug pricing negotiations and partnerships

Pharmaceutical Technology

Biotechs need to navigate US-China relations when pursuing collaborations and drug manufacturing partnerships.

Drugs 130
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After Idorsia deal, Viatris' dealmaking appetite remains strong, CEO says

Fierce Pharma

On the back of its $350 million deal for two late-stage Idorsia assets, Viatris will continue to be “opportunistic” when it comes to making future business development grabs—especially on the comme | On the back of its $350 million deal for two late-stage Idorsia assets, Viatris will continue to be “opportunistic” when it comes to making future business development grabs—especially on the commercial side—executives said Wednesday.

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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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Biotech execs say IRA is causing unintended effects for cancer drug development

Pharmaceutical Technology

IRA regulations have changed how pharma is approaching innovation in cancer drug discovery and development.

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PHTI to review digital hypertension, mental health tools

pharmaphorum

Peterson Health Technology Institute will review the clinical effectiveness and economic impact of digital health technologies (DHTs) for hypertension and mental health.

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ICON's Kathleen Mandziuk's journey from nursing to respected drug development innovator

BioPharma Reporter

Mandziuk is vice president of real world solutions and tokenisation and says nothing could have prepared the health industry for the global impact the Covid pandemic has had.

Nurses 102
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Janux plans $200m offer on back of prostate cancer readout

pharmaphorum

Buoyed by data from a trial of its T-cell engager (TCE) therapy in prostate cancer that almost tripled its share price, Janux Therapeutics has moved quickly to file a stock offering that could add around $200 million to its cash position. The San Diego biotech is offering $175 million in a public offering that could rise to $201.5 million if underwriters take up an option, less discounts and commissions.

Trials 107
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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.