pharmaphorum
SEPTEMBER 28, 2022
The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.
MedCity News
SEPTEMBER 28, 2022
The American Diabetes Association recently launched the Amputation Prevention Alliance — a three-year effort to decrease the number of diabetes-related amputations in the country — along with five partner organizations. The organizations will work together to advocate for policy changes, increase clinician education about caring for diabetic complications, and improve patients’ awareness of warning signs to watch out for.
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PM360
SEPTEMBER 28, 2022
For life sciences commercial teams, effectively engaging physicians and supporting them with education on the evolving science around products and conditions requires a deep understanding of physician content needs and channel preferences. These are dynamic factors, playing out differently across specialty groups and stages of the patient journey, as well as the condition being treated.
MedCity News
SEPTEMBER 28, 2022
The FDA will limit fewer Covid-19 diagnostics submitted for emergency use authorization. The policy update follows an Office of Inspector General report that found the urgency to increase testing availability led to problems, including the authorization of many low-quality tests.
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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
PM360
SEPTEMBER 28, 2022
The rising prevalence of type 2 diabetes has attracted the attention of many major drugmakers in recent decades, leading to innovations such as novel insulins and easier-to-use glucagon injections. However, despite being one of the biggest markets in pharma, diabetes drugmakers have a hard time standing out in the crowded field, and many patients still aren’t confident in their ability to manage their disease.
MedCity News
SEPTEMBER 28, 2022
The webinar, Coding for the Future: Lessons Learned, Emerging Technologies & Future Opportunities, scheduled for October 19 from 1-2 pm ET and sponsored by Nym Health, will explore how medical coding has evolved and the skills that will be necessary to prepare the next generation of medical coders. Register today!
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
SEPTEMBER 28, 2022
The partnership is with PlanSource, a benefits administration company. By working with PlanSource, Wysa can be offered as a mental health benefit option for PlanSource’s network of small to mid-sized employers.
PM360
SEPTEMBER 28, 2022
Health marketers learned many valuable lessons during the pandemic. Above all was the importance of delivering the right information to diverse groups in an age of misinformation and inequitable distribution of care. Health marketers have a responsibility to move away from homogenous media plans that assume the general population can be targeted and reached in broad, sweeping strokes.
PharmExec
SEPTEMBER 28, 2022
Wednesday, September 28, 2022, 11 am ET Join this webinar to hear industry thought leaders discuss issues that impede cell and gene therapy development. They will cover new approaches for expanding viral vector manufacturing capacity with appropriate quality, share recommendations for streamlining clinical trial design and process development, explore opportunities for adapting the regulatory framework for cell and gene therapy technologies, and examine innovative pricing and contracting models.
MedCity News
SEPTEMBER 28, 2022
People with type 2 diabetes often face an overly complex and confusing environment as they learn to manage their condition. Device and supply distributors can leverage their underutilized points of contact to provide services and support to patients.
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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.
European Pharmaceutical Review
SEPTEMBER 28, 2022
The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. The proposed cannabis monograph provides scientifically validated methods, information on physical reference standards and acceptance criteria to establish the identity of cannabis chemotypes and content of cannabinoids and terpenes, as well as setting l
PharmaVoice
SEPTEMBER 28, 2022
Swiss-based Stalicla is banking on an AI-driven precision medicine discovery platform to deliver needed therapies in the autism space.
MedCity News
SEPTEMBER 28, 2022
Sanofi is collaborating with Scribe Therapeutics to use the startup’s CRISPR technology to create cell therapies based on natural killers, a type of immune cell that has cancer-killing capabilities. The pharma giant is paying Scribe $25 million up front to kick off the deal.
European Pharmaceutical Review
SEPTEMBER 28, 2022
In a study published in the Microchemical Journal , investigators outlined the development and validation of a HPLC-MS/MS (high-performance liquid chromatography-mass spectrometry) for the determination and quantification of N -nitrosodimethylamine (NDMA) in olmesartan medoxomil. The method was able to detect, separate and quantify NDMA in the active pharmaceutical ingredient (API), manufactured tablets and marketed tablets.
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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.
MedCity News
SEPTEMBER 28, 2022
AI bridges the gap of human error and maximizes the potential success rates of IVF. AI’s ability to analyze big data paves the way for improving IVF outcomes and the development of evidence-based parameters that establish a consistent standard of care.
pharmaphorum
SEPTEMBER 28, 2022
Martin Mendoza, PhD, director of health equity and health science policy for the All of Us Research Program at the National Institutes of Health (NIH), tells pharmaphorum about the programme and how it will accelerate research for the benefit of all patients. NIH’s All of Us is building an extensive, diverse biomedical dataset to learn how biology, lifestyle, and environment affect one’s health, and to accelerate research and improve personalised medicine options. “The All of U
Copyright Clearance Center
SEPTEMBER 28, 2022
The post CCC Hosts Eli Lilly and Company for Panel Discussion on Innovation and Copyright Compliance appeared first on Copyright Clearance Center.
Map My Customers
SEPTEMBER 28, 2022
When was the last time you looked at a map? Chances are it was probably pretty recently. From ride sharing, to food delivery, to figuring out what to do on a Friday night, maps help us make decisions all the time. By visually analyzing the distances around us, and the options available within those distances, they can instantly provide much more information than just text or lists can.
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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.
Copyright Clearance Center
SEPTEMBER 28, 2022
The post Discovering the Unknown – How Deep Search Capabilities Advance Science appeared first on Copyright Clearance Center.
PharmaTimes
SEPTEMBER 28, 2022
Phase 1b study evaluates effects of sevuparin on the symptoms of volunteer participants
European Pharmaceutical Review
SEPTEMBER 28, 2022
A new investigation funded by the US Centers for Disease Control and Prevention (CDC) studying the effectiveness of messenger RNA (mRNA) COVID-19 vaccines during pregnancy, concluded that vaccinating women who plan to become pregnant or who are currently pregnant offers considerable protection against being admitted into emergency care or hospitalisation after contracting the virus.
pharmaphorum
SEPTEMBER 28, 2022
Roche’s Genentech division has formed an R&D partnership with Arsenal Biosciences focusing on developing and refining the biotech’s programmable T cell-based therapies platform. Genentech is providing $70 million in funding for the multi-year project, which is aimed at identifying “critical success circuits” in T cell therapies used to treat cancer, along with undisclosed milestone payments.
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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.
Pharmaceutical Technology
SEPTEMBER 28, 2022
Emergent BioSolutions has acquired exclusive global rights for oral smallpox antiviral, Tembexa (brincidofovir), from Chimerix. Tembexa has two formulations, a 100mg tablet form and 10mg/mL oral suspension, indicated to be administered once a week for two weeks. In June last year, the US Food and Drug Administration (FDA) granted approval for the antiviral therapy to treat human smallpox disease in adult as well as paediatric patients, including neonates.
pharmaphorum
SEPTEMBER 28, 2022
Vertex Pharma and partner CRISPR Therapeutics will start a rolling marketing application in the US for their gene-editing drug for sickle cell disease (SCD) and beta thalassaemia later this year. The rolling application for exagamglogene autotemcel (exa-cel) – formerly known as CTX001 – will start in November while a filing in Europe is also expected by the end of the year, said the two partners.
European Pharmaceutical Review
SEPTEMBER 28, 2022
Results from the first study comparing four type 2 diabetes medications found that insulin glargine and liraglutide, two popular medications, performed best. US participants took the medications in addition to metformin, a common type 2 diabetes drug, as type 2 diabetic patients often need to be prescribed more than one medicine to control their blood sugar levels.
pharmaphorum
SEPTEMBER 28, 2022
The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm. The move is an attempt by the US regulator to encourage sponsors to run paediatric studies – where it is appropriate – and solve the problem of new drugs, biologics, and medical devices coming to market with very little information on how they should be used in young people. “Historically, children were not included in clinical trials bec
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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
Eversana Intouch
SEPTEMBER 28, 2022
Your TV watching habits have probably changed a great deal over the last few years, so you can guess that ad buying, and its measurement, has too. But how does that affect what you need to be doing for your brand? I run our Video Investment team, so this is a conversation I have all day. There are three main points you need to know… Let’s sum them up quickly!
Scott Burrows
SEPTEMBER 28, 2022
The World Doesn’t “Get” Your Biggest Fear Given my work as an inspirational healthcare speaker, I have the ongoing privilege of talking to healthcare workers throughout the country.
Pharmaceutical Technology
SEPTEMBER 28, 2022
Seagen and Lava Therapeutics have entered an exclusive licence agreement for the development, manufacturing and commercialisation of the latter’s LAVA-1223 for solid tumours. An advanced preclinical asset, LAVA-1223 is a bispecific T cell engager. It can act on and activate V?9V?2 (gamma delta) T cells in epidermal growth factor receptor (EGFR)-expressing tumour cells’ presence.
pharmaphorum
SEPTEMBER 28, 2022
Sponsored by: Microgenetics. Co-chairs Di Morris, Clinical Auditor, AstraZeneca and Nigel Cryer, Deputy Director Global Audit, Sanofi. Harnessing Alternative Rapid Microbial Methods for a Successful Contamination Control Strategy. We are delighted to announce SAE’s 11th Annual Pharmaceutical Microbiology Europe Conference taking place in London, UK on the 16-17 January 2023.
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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.
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