Tue.Jul 04, 2023

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Digital health tech: a solution to substance use disorders?

Pharmaceutical Technology

Substance use disorders leave people with long-term negative mental and physical health implications and can lead to death.

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Complex road ahead, despite phase 3 progress, for Annovis’ buntanetap in Parkinson’s Disease

Outsourcing Pharma

Drugs like Annovis Bioâs buntanetap and prasinezumab have the potential to ârevolutionize the treatment of Parkinsonâs Diseaseâ says analytics company, GlobalData, an analytics company, but it is a complex road ahead.

Drugs 111
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Rationing strategies proliferate with cancer drugs in short supply

Pharmaceutical Technology

While drug shortages have been a major cause for concern over the past few years, medications to treat cancer are in particularly short supply.

Drugs 279
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Reality Test of Medicine Shop without Registered Pharmacist

Pharma Tutor

Reality Test of Medicine Shop without Registered Pharmacist admin Tue, 07/04/2023 - 15:39 ABOUT AUTHOR Dr. R. S. Thakur Renowned Professor of Pharmaceutical Fraternity & Former Member of Pharmacy Council of India. Email : drramsthakur@gmail.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Abeona Therapeutics raises funds to launch cell therapy

Pharmaceutical Technology

Abeona Therapeutics has raised $25m from its current select investors to launch and commercialise its cell therapy, EB-101.

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Clerkenwell Health to sponsor Psych Symposium London as it urges NHS to ‘embrace’ psychedelics

Outsourcing Pharma

Clerkenwell Health, a specialist clinical research organisation (CRO) focused on supporting clients with the design and delivery of psychedelic-assisted therapy trials, is sponsoring the upcoming Psych Symposium 2023 on Thursday 6 July in London.

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Teva reveals critical Ajovy data

Pharma Times

Therapy has been developed to reduce the frequency, duration and severity of migraine attacks - News - PharmaTimes

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US FDA declines to approve Amneal’s Parkinson’s treatment

Pharmaceutical Technology

The US FDA has issued a complete response letter to Amneal Pharmaceuticals, declining to approve its IPX203 to treat Parkinson’s disease.

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Patients achieve 19% weight loss in obesity drug trial

Drug Discovery World

New data from Boehringer Ingelheim and Zealand Pharma has demonstrated superior efficacy with survodutide (also known as BI 456906) versus placebo in people with overweight or obesity without type 2 diabetes after 46 weeks of treatment. The findings were presented at the 2023 American Diabetes Association’s 83rd Scientific Sessions in San Diego, CA, US.

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Moderna seeks EMA approval for modified Covid-19 vaccine

Pharmaceutical Technology

Moderna has filed a regulatory application seeking EMA approval for its modified Covid-19 vaccine targeting the XBB.1.5 sub-variant.

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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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King’s College London and Pioneer Group in incubator link-up

Pharma Times

Collaboration aims to revitalise two empty sites on the South Bank of London by providing several laboratories - News - PharmaTimes

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Three ways to improve participant engagement in your digital clinical trials

Pharmaceutical Technology

How can you reduce drop-out, save time and resources, and maintain participant engagement throughout the entirety of your trial?

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Sosei Heptares doses first patient in schizophrenia drug trial

BioPharma Reporter

Sosei Heptares has dosed the first subject in a phase 1 trial evaluating HTLâ149, a first-in-class GPR52 agonist, which represents a novel mechanism of action for the treatment of schizophrenia and related neurological diseases.

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NorthX acquires Valneva’s biologics production unit

Pharmaceutical Technology

NorthX Biologics has acquired Valneva’s clinical trial manufacturing unit in Stockholm, Sweden to bolster its expertise.

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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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Providing access to quality vaccines in low- and middle-income countries

pharmaphorum

Providing access to quality vaccines in low- and middle-income countries Mike.

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Cancer Immunotherapy Month – 2022 saw a record number of approvals

Pharmaceutical Technology

Over the last ten years, the number of approved innovator immuno-oncology therapies (immunotherapies) has increased.

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Janssen celebrates positive results for JNJ-2113A in psoriasis trial

pharmaphorum

Janssen celebrates positive results for JNJ-2113A in psoriasis trial Eloise.

Trials 87
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Venous thromboembolism market projected to grow at 2.6% CAGR between 2022 and 2032

Pharmaceutical Technology

The venous thromboembolism (VTE) market is expected to grow from $3.6bn to $4.6bn globally, according to GlobalData.

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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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Camena Bioscience closes $10m financing as demand for DNA synthesis technology grows

BioPharma Reporter

Camena Bioscience, a synthetic biology company providing genes to the pharmaceutical and biotechnology industries, has closed a $10 million Series A financing round, led by Mercia.

DNA 52
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Tonix acquires Upsher-Smith’s migraine products

Pharmaceutical Technology

Tonix Pharmaceuticals and Tonix Medicines have acquired two migraine products from Upsher-Smith Laboratories.

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Psychedelics and mental health: The time is now?

pharmaphorum

Psychedelics and mental health: The time is now? Nicole.

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Labcorp forms spin-off of Fortrea

Pharmaceutical Technology

The spin-off will create a new global Phase I-IV CRO, patient access and technology solutions.

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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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New tentative approval for Mylan Labs drug posaconazole

Drug Patent Watch

[![posaconazole structure]([link] Posaconazole is the generic ingredient in three branded drugs marketed by Msd Merck Co, Merck Sharp Dohme, Par Sterile Products, Schering, Hikma, Actavis Labs Fl Inc, Aet Pharma,… The post New tentative approval for Mylan Labs drug posaconazole appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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AstraZeneca stock value falls by 8%

Drug Discovery World

Shares in AstraZeneca fell by 6% on July 3 when the company published the first results from its Phase III trial for datopotamab deruxtecan (Dato-DXd) and continued to fall throughout the day, though there was some recovery on July 4. It was reported that the therapy demonstrated statistically significant improvement in progression-free survival vs docetaxel in previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).

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First patient dosed in Enterome’s metastatic colon cancer trial

BioPharma Reporter

Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases, has announced that the first patient has been dosed in its phase 1/2 trial evaluating EO4010.

Trials 52
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Eli Lilly’s ulcerative colitis drug approved in Great Britain

Drug Discovery World

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Eli Lilly’s mirikizumab for moderately to severely active ulcerative colitis. The drug is approved in adult patients who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

Drugs 52
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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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Retaining the human quality of healthcare in DTx

pharmaphorum

Retaining the human quality of healthcare in DTx Mike.

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European life sciences investor raises over €95 million

Drug Discovery World

Vesalius Biocapital, a life sciences venture capital investor, has closed its fourth fund, Vesalius Biocapital IV, securing over €95 million of commitments. The company plans to invest in first and best-in-class European life science companies in drug development and digital health. The goal is to build a portfolio of 10-15 companies, providing capital and the Vesalius team’s experience and expertise to support their development.

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So it begins: next Humira biosimilars launch in US

pharmaphorum

So it begins: next Humira biosimilars launch in US Nicole.

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mRNA: New uses for this exciting technology

Drug Discovery World

Download this In Focus eReport to gain a full understanding of the current market for mRNA vaccines and therapeutics and the areas of greatest commercial potential for the future. The eReport includes: In-depth analysis of regional markets An overview of the likely challenges and opportunities The companies taking the lead on mRNA development Insights on the future of nucleic acid-based drug discovery and development The therapeutic areas where mRNA could make the biggest impact The potential ro

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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.