PepGen cleared by FDA to begin study of muscular dystrophy drug
Bio Pharma Dive
OCTOBER 12, 2023
The company expects to deliver first results next year from the early-stage study of people with myotonic dystrophy type 1.
Thu.Oct 12, 2023
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Doctors Discover Needle Lodged in 80-Year-Old Woman’s Brain
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 12, 2023
An elderly woman in Russia’s Far East was revealed on Wednesday to have lived for 80 years with an inch-long needle in her brain, after doctors made the unexpected discovery during a CT scan.
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IMIDomics partners with UB to advance IMIDs treatments
Pharmaceutical Technology
OCTOBER 12, 2023
IMIDomics has entered into a licence and partnership agreement with the University of Barcelona (UB) to advance treatments for IMIDs.
Parliamentary Panel asks govt to use technologies like drone to eradicate TB
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 12, 2023
A Parliamentary Panel that looked into the implementation of Pradhan Mantri TB Mukt Bharat Abhiyan (PMTBMBA) has advised the Centre to use latest technologies such as drones, data integration systems and mobile apps to strengthen surveillance in order to test, control and eradicate tuberculosis from the country.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
October 12, 2023: GRACE Team Shares Lessons About Monitoring Signals of Suicidality in Pragmatic Clinical Trials
Rethinking Clinical Trials
OCTOBER 12, 2023
In a new article published this week in Contemporary Clinical Trials Communications, the GRACE Demonstration Project team recommends that suicidality should be monitored in pragmatic clinical trials that measure depression as an outcome. The work builds on their experience conducting research involving patients with sickle cell disease and on previous work from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core.
Research group says FDA found no misconduct in Pfizer Lyme vaccine trial it helped run
Bio Pharma Dive
OCTOBER 12, 2023
Earlier this year Pfizer removed thousands of participants from a study of its Lyme disease shot over concerns the group, Care Access, wasn't meeting clinical practice standards.
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European Commission orders Illumina to divest Grail
Bio Pharma Dive
OCTOBER 12, 2023
The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.
ALK eyes label expansion after Phase III trial success
Pharmaceutical Technology
OCTOBER 12, 2023
The Phase III trial of ALK’s allergy immunotherapy tablet met its primary endpoint for the treatment of tree-pollen-induced allergics.
AstronauTx completes £48m series A financing for Alzheimer’s disease
Pharma Times
OCTOBER 12, 2023
The financing will support the biotech’s clinical study of people with AD as a lead programme - News - PharmaTimes
UK MHRA publishes guidance on medicines containing valproate
Pharmaceutical Technology
OCTOBER 12, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance on valproate-containing medicines.
University of Edinburgh to lead new Exascale supercomputer
Pharma Times
OCTOBER 12, 2023
The service will benefit major research and industry projects across the UK - News - PharmaTimes
Cellares and Bristol Myers Squibb expand agreement for CAR-T cell therapy
Pharmaceutical Technology
OCTOBER 12, 2023
Cellares entered an expanded agreement with Bristol Myers Squibb to provide proof-of-concept manufacturing for a second CAR-T cell therapy.
Pfizer, playing catch-up with Novartis, bags FDA approval for drug combo in lung cancer
Fierce Pharma
OCTOBER 12, 2023
Pfizer is expanding the reach of its BRAF-MEK combo as the pharma giant looks to further build up its oncology presence. | Pfizer is expanding the reach of its BRAF-MEK combo as the pharma giant looks to further build up its oncology presence.
Immetas and GC Biopharma team up for mRNA therapeutic research
Pharmaceutical Technology
OCTOBER 12, 2023
Immetas Therapeutics and GC Biopharma announced a collaboration for mRNA therapeutic development.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
After repeat Humira biosimilar snubs, FDA turns down Teva and Alvotech's Stelara copycat
Fierce Pharma
OCTOBER 12, 2023
Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partn | The FDA shot down Alvotech and Teva's biosimilar candidate to Johnson & Johnson's Stelara over “certain deficiencies” uncovered by the FDA during a reinspection of the company's factory in Iceland earlier this year.
Birmingham researchers develop nanobodies for platelet disorders
Pharmaceutical Technology
OCTOBER 12, 2023
The institute aims to use these nanobodies to develop validated clinical assays for testing patients with platelet disorders.
MHRA pledges two-week review for low-risk clinical trials
pharmaphorum
OCTOBER 12, 2023
MHRA pledges two-week review for low-risk clinical trials Phil.
WHO announces €1.1bn collaboration to eradicate polio
Pharmaceutical Technology
OCTOBER 12, 2023
The investment will ensure that 370 million children in low-income countries will be vaccinated against polio each year.
After Novo's Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts
Fierce Pharma
OCTOBER 12, 2023
An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. | Based on the inclusion criteria for Novo Nordisk’s chronic kidney disease trial, dialysis bigwig DaVita believes there may only be “limited application” of the study’s findings to the overall CKD population.
HF drugs market estimated to grow at rate of 5.2%
Pharmaceutical Technology
OCTOBER 12, 2023
A large proportion of chronic HF patients are taking suboptimal doses of relevant medications, leading to a worsening of symptoms.
Incyte’s oral vitiligo drug heading for phase 3
pharmaphorum
OCTOBER 12, 2023
Incyte’s oral vitiligo drug heading for phase 3 Phil.
Birmingham researchers develop nanobodies to understand platelet disorders
Pharmaceutical Technology
OCTOBER 12, 2023
Researchers at the University of Birmingham have developed antibody fragments, called nanobodies, in a bid to understand platelet disorders such as thrombosis.
The New Age of Decentralized Clinical Trials
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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.
After FDA snub, Lilly's mirikizumab looks to regain momentum with phase 3 Crohn's win
Fierce Pharma
OCTOBER 12, 2023
After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 C | A majority of Crohn's disease patients experienced a clinical response and clinical remission after treatment with mirikizumab, the company said. The results provide a boost after mirikizumab's surprise manufacturing-related FDA rejection in April.
Astria to license Ichnos Sciences’ OX40 portfolio
Pharmaceutical Technology
OCTOBER 12, 2023
Astria Therapeutics has signed a global exclusive agreement to license Ichnos Sciences’ OX40 portfolio for treating atopic dermatitis (AD).
Envisioning a World Without Disease
pharmaphorum
OCTOBER 12, 2023
Envisioning a World Without Disease Mike.
Reducing interactions between drug packaging and product with film-coated sealing solutions
Pharmaceutical Technology
OCTOBER 12, 2023
Leading parenteral packaging company Datwyler has extended its range of coating options with UltraShield™, a high-performance film-coated solution for safely storing innovative drugs.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Biogen's Aduhelm headache returns as appeals court revives part of investor lawsuit
Fierce Pharma
OCTOBER 12, 2023
For more than a year, Biogen has been working to turn the page from its Aduhelm fiasco and focus on | One single comment from a conference call was enough for an appeals court to revive part of an investor lawsuit centered on Biogen's Aduhelm.
FDA quells Care Access misconduct concern in Pfizer’s Lyme disease vaccine trial
Pharmaceutical Technology
OCTOBER 12, 2023
Care Access has been exonerated of wrongdoing at its clinical sites, but Pfizer and Valneva’s Phase III trial is now one year behind schedule.
Closing Out Q3 With In-Person Gatherings
Intouch Solutions
OCTOBER 12, 2023
To wrap up Q3, our U.S.-based offices celebrated in person with an End of Summer Fair complete with nostalgic carnival treats and games, caricatures, a photo booth and more! Most importantly, these gatherings gave us time away from our desks to spend time with one another. At EVERSANA INTOUCH we value building relationships with one another and keeping our one-of-a-kind culture alive.
Almirall signs $210m bispecifics deal with EpimAb
pharmaphorum
OCTOBER 12, 2023
Almirall signs $210m bispecifics deal with EpimAb Phil.
How Machine Learning Drives Clinical Trial Efficiency
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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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