Bio Pharma Dive
AUGUST 11, 2021
While the decision was expected after a negative advisory panel last month, it's a significant setback that could trigger cost-cutting at the biotech, which said it will discuss next steps with partner AstraZeneca.
Camargo
AUGUST 11, 2021
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process.
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Bio Pharma Dive
AUGUST 11, 2021
The biotech company is working with regulatory T cells, an immune cell type that's become the focus of several newly launched drugmakers like Abata Therapeutics and Sonoma Biotherapeutics.
World of DTC Marketing
AUGUST 11, 2021
SUMMARY: DTC metrics change by product life cycle and DTC managers usually have to justify their budgets. Never report just raw numbers. You should tell a story on the value of your marketing using metrics that senior managers understand. That which you can’t measure shouldn’t be done? That’s what most DTC marketers believe because management wants concrete results.
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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
BioPharma Reporter
AUGUST 11, 2021
Moderna has signed a Memorandum of Understanding with the government of Canada to build a mRNA vaccine manufacturing facility in the country: which could serve as a model for similar partnerships around the world.
pharmaphorum
AUGUST 11, 2021
Merck & Co is looking at a decision from the FDA in December on its application to market Keytruda as a post-surgery treatment for people with kidney cancer, after a priority review. The drugmaker – known as MSD outside the US and Canada – is seeking approval of Keytruda (pembrolizumab) as an adjuvant treatment for renal cell carcinoma (RCC) patients who have undergone surgery for the cancer and are at risk of relapse.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
AUGUST 11, 2021
When we think of functional foods, chocolate may not be the first thing that comes to mind. But with time, innovation, a shift in perspective and creative marketing, Mid-Day Squares is turning the concept of functional foods on its head. The Montreal, Canada-based chocolate company is not only redefining what it means to eat chocolate, but also how to run a successful food business that doesn’t take itself too seriously. .
pharmaphorum
AUGUST 11, 2021
South Korea’s SK Bioscience has been given the all-clear to start a phase 3 trial of its COVID-19 vaccine GBP510 that will compare the shot directly with AstraZeneca’s Vaxzevria. It is the first COVID-19 vaccine developed in South Korea to reach the pivotal trial stage, and from the earliest stages of its development has been earmarked as a possible candidate for rollout at scale across developing countries via the COVAX programme.
Pharma Marketing Network
AUGUST 11, 2021
Tune in with the Pharma Marketing Network for an insightful conversation with R.J. Lewis and Diane Bartoli, VP and General Manager of epocrates, as she shares her background with eCME, how COVID-19 has been driving it’s rapid growth, the other digital channels that have come into play, the term “snackable eCME” and how we can expect eCME to trend in a post-COVID sense.
BioSpace
AUGUST 11, 2021
Citing a study from Johns Hopkins University, researchers found that immunocompromised people are 485 times more likely to end up in the hospital or die from COVID-19.
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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
Pharma Times
AUGUST 11, 2021
US biotech company says European payers have ‘not yet evolved their approach to gene therapy’
BioSpace
AUGUST 11, 2021
Aubrey de Grey has been accused by two women of predatory behavior, an allegation de Grey denies. SENS has placed him on administrative leave pending further investigation.
pharmaphorum
AUGUST 11, 2021
A jury in the US has charged a Florida man who owns multiple telemedicine companies in connection with a massive healthcare scam that involved a massive $784 million in fraudulent claims being submitted to Medicare. Creaghan Harry (53) is accused of conspiracy to commit health care fraud and wire fraud, and four counts of income tax evasion, activity which allowed him to live a “lavish lifestyle,” according to the Department of Justice, which said it is “one of the largest Med
Outsourcing Pharma
AUGUST 11, 2021
The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products.
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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.
Pharma Times
AUGUST 11, 2021
Collaboration will drive medicines discovery in areas of unmet patient need
BioSpace
AUGUST 11, 2021
Artiva Biotherapeutics is quadrupling its footprint in San Diego with a 52,000 square-foot corporate HQ, R&D and manufacturing center opening next year.
Pharma Times
AUGUST 11, 2021
The clinical development programme is now known as TAK-524
BioSpace
AUGUST 11, 2021
?Antheia has joined forces with Ginkgo Bioworks to strengthen its efforts in developing and producing essential medicines to treat a wide range of diseases.
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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.
Pharma Times
AUGUST 11, 2021
Phase III trial showed a reduction in annual relapse rate
BioSpace
AUGUST 11, 2021
Aprea’s clinical trial is evaluating a combination of eprenetapopt with acalabrutinib or with venetoclax and rituximab.
pharmaphorum
AUGUST 11, 2021
After rejecting Eli Lilly’s Verzenio for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant. A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast cancer in England and Wales.
BioSpace
AUGUST 11, 2021
An informational interview is a one-on-one conversation with a professional who is doing something or working somewhere that’s interesting to you.
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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.
Drug Channels
AUGUST 11, 2021
The Medicare Payment Advisory Commission (MedPAC), the independent agency that advises Congress on the Medicare program, recently released its latest Health Care Spending and the Medicare Program databook. This annual report is a treasure trove of useful and fascinating data. The July 2021 edition provides us with the latest pre-pandemic details on the buy-and-bill market in Medicare Part B.
BioSpace
AUGUST 11, 2021
The U.S. FDA greenlit the combination of Keytruda and Eisai’s Lemvima as a first-line treatment for adult patients with advanced renal cell carcinoma.
ECRG Media's Clinical Research Podcast
AUGUST 11, 2021
Interning To Get Clinical Research Experience Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite
XTalks
AUGUST 11, 2021
In this episode, Ayesha discussed a presentation about a study on the impacts of COVID-19 on cognitive health presented at this year’s Alzheimer’s Association International Conference (AAIC) 2021. The study, conducted at New York University Langone Health, found that in cognitively normal COVID-19 patients that experienced the neurological symptom of confusion due to toxic-metabolic encephalopathy (TME), levels of serum biomarkers associated with neuroinflammation, neuronal injury and Alzheimer’
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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.
ECRG Media's Clinical Research Podcast
AUGUST 11, 2021
Interning To Get Clinical Research Experience. Don't forget to Subscribe for new content! Subscribe: [link]. Call or Text: 910-502-3732. Email: eliteclinicalgroup@gmail.com. Podcast: [link]. Steemit: [link]. Advertise: eliteclinicalgroup@gmail.com. Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education
pharmaphorum
AUGUST 11, 2021
The FDA has demanded another clinical trial of FibroGen and AstraZeneca’s roxadustat for anaemia caused by chronic kidney disease (CKD) before it will consider approval, setting up a lengthy delay to the programme. The need for a new trial is something of a worst-case scenario for roxadustat, although a rejection was expected after an FDA advisory committee voted 13 to one against approval of the drug at a meeting last month.
Clinical Trial Gurus
AUGUST 11, 2021
Clinical research sites reach a point where they start receiving more study opportunities than they could possibly work on. In this video I analyze when sites should say yes to clinical trials and when they would be better off saying no!
pharmaphorum
AUGUST 11, 2021
The FDA was supposed to be delivering its verdict on Axsome Therapeutics’ depression therapy AXS-05 in less than a fortnight – but instead has delivered the company a letter outlining deficiencies in its marketing application. The problem for the company is that it doesn’t yet know what those deficiencies are, and that uncertainty weighed heavily on its shares, which dropped by around 50% in the wake of the announcement.
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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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