Bio Pharma Dive
SEPTEMBER 2, 2020
Data published Wednesday describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder.
Pharma Mirror
SEPTEMBER 4, 2020
The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry. From challenges like lack of regulatory systems to its new found potential of manufacturing indigenous products on a large scale, the summit successfully addressed discussions on new.
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Camargo
SEPTEMBER 2, 2020
Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo.
Pharma Times
SEPTEMBER 1, 2020
Rybelsus is the world’s first and only oral GLP-1 receptor agonist
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
Bio Pharma Dive
SEPTEMBER 1, 2020
Amid reports the U.S. might fast-track AstraZeneca and the University of Oxford's experimental shot, the company pledged to "follow the science.
BioSpace
SEPTEMBER 1, 2020
A group of researchers at Oak Ridge National Lab used the Summit supercomputer, the second-fastest in the world, to analyze data on more than 40,000 genes from 17,000 genetic samples related to COVID-19.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
SEPTEMBER 3, 2020
Scientists have discovered that hard-to-treat pancreatic cancer hijacks a key immune system response
Bio Pharma Dive
AUGUST 31, 2020
Debunking myths around working with the FDA for oncology drug approval.
BioSpace
SEPTEMBER 2, 2020
A study published in the journal npj Precision Oncology on Sept. 1 featured data that suggested honeybee venom can potentially destroy triple-negative breast cancer and HER2-enriched breast cancer cells.
pharmaphorum
SEPTEMBER 2, 2020
While the effects of COVID-19 have been devastating for many industries, its positive impact on accelerating the uptake of digital health technologies and virtual collaboration solutions is undeniable. This has been a long time coming and there are countless reasons why I believe virtual collaboration and medical education are here to stay, long after there is a vaccine for COVID-19 and physical distancing guidelines have been lifted. 1.
Pharma Times
SEPTEMBER 2, 2020
The decision allows use of the therapy in the EU in children as young as six years of age
Bio Pharma Dive
SEPTEMBER 3, 2020
The biotech's drug was found to be less safe than an injectable anemia medicine in a Phase 3 trial, dimming its potential approval chances.
BioSpace
AUGUST 31, 2020
The U.S. expansion will recruit up to 30,000 adults over the age of 18 years from a broad range of racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions.
pharmaphorum
SEPTEMBER 2, 2020
The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. This would see the UK mirroring decisions made by the European Medicines Agency, while also laying out a process should companies wish to file for a separate approval in the UK.
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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
SEPTEMBER 1, 2020
Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa
Bio Pharma Dive
AUGUST 31, 2020
The Swiss firm will take over the launch of Aimmune's Palforzia, sales of which have disappointed since its approval in January.
BioSpace
AUGUST 31, 2020
Another Kevzara study in hospitalized COVID-19 patients failed to meet primary and secondary endpoints.
pharmaphorum
SEPTEMBER 2, 2020
Digital health firm Mobio Interactive has closed a $1.8 million seed fund to advance development of its meditation app Am Mindfulness. Mobio said that the app, known as Am for short, is the first and only meditation app to outperform placebo in randomised controlled trials. MI’s Seed raise was led by the Singapore-based Verge HealthTech Fund along with Atlas Asset Management , Creative Ventures and VC giant SOSV.
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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.
Pharma Times
SEPTEMBER 3, 2020
NICE has concerns with the evidence submitted but Janssen insists the nasal spray is a cost-effective use of NHS resources
Bio Pharma Dive
AUGUST 31, 2020
The two companies, chasing rival treatments from Eli Lilly, Regeneron and more, aim to produce their first study results by the end of the year.
BioSpace
AUGUST 30, 2020
On Sunday, U.S. Food and Drug Administration Commissioner Stephen Hahn told the Financial Times that he would potentially fast-track a COVID-19 vaccine before clinical trials are done if it was “appropriate.
pharmaphorum
SEPTEMBER 3, 2020
UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms. In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharma Times
SEPTEMBER 1, 2020
Sanofi and Regeneron do not anticipate carrying out further research on Kevzara in COVID-19
Bio Pharma Dive
SEPTEMBER 1, 2020
Initial vaccine supplies will be limited. Advisory groups, most recently that of the National Academies, are developing plans to figure out who should get access first.
BioSpace
SEPTEMBER 3, 2020
When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up.
pharmaphorum
SEPTEMBER 3, 2020
NICE has rejected regular NHS funding for Janssen’s depression spray Spravato (esketamine) for a second time, although the company says it could salvage the situation by providing further data and “additional discussions”. This will likely see the company drop its price further after already offering a commercially confidential discount to the NHS following European approval late last year.
Pharma Times
SEPTEMBER 2, 2020
The test can typically identify SARS-CoV-2 infection within 15 minutes
Bio Pharma Dive
SEPTEMBER 4, 2020
The licensing deal hands AbbVie exclusive rights to a drug that targets CD47, a protein which has caught the attention of other large drugmakers like Gilead and Celgene.
BioSpace
AUGUST 30, 2020
When Bionano Genomics acquired Lineagen, Inc. in August, the genomic analysis company gained the final piece it needed to provide comprehensive structural variation detection for researchers and drug developers and a reimbursement pathway for clinicians who want to use its technology to replace c.
pharmaphorum
SEPTEMBER 3, 2020
GlaxoSmithKline is opening a £10 million artificial intelligence (AI) research hub in King’s Cross, London, according to a press report. The area is being reimagined as a life sciences and technology hub and is already home to the Francis Crick Institute biomedical research organisation. King’s Cross is also home to Google’s DeepMind artificial intelligence company, which has already been involved in life sciences projects such as using the technology to predict acute kidney injury.
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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.
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