Bio Pharma Dive
MAY 17, 2022
An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.
World of DTC Marketing
MAY 16, 2022
If You’re Short On Time: The U.S. Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. The approval for tirzepatide—which Lilly will market under the brand name Mounjaro—isn’t for weight loss but Type 2 diabetes. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks?
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Pharma Times
MAY 17, 2022
Authorisation of the treatment is based on results from the phase 3 trial
pharmaphorum
MAY 19, 2022
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. IAVI (the International AIDS Vaccine Initiative) has started screening subjects to be included in the study, called IAVI G003, at centres in Rwanda and South Africa, said the biotech.
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
MAY 20, 2022
The company believes the treatment, which uses prodrug versions of two commonly used Parkinson's medications, could be a longer-lasting option for patients and blockbuster product for AbbVie.
World of DTC Marketing
MAY 17, 2022
Just 13% of people trust the pharma companies they interact with. 68% say the interactions feel transactional. Only a third agree that organizations know their communication preferences. Communication and transparency are vital to building trust, which necessitates a shift away from traditional DTC marketing. If pharma is going to leap to a new era of marketing, they have to get to know their audiences.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
MAY 18, 2022
FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Bakul Patel. Patel – who is currently director for digital health at the FDA – said on social media that he is “looking forward to learning from the teams in health across Google and Alphabet and helping build a unified digital health and regulatory strategy.” He was also involved in the creation of the FDA’s Dig
Bio Pharma Dive
MAY 16, 2022
The biotech company is searching for a permanent successor to Siegall, who was arrested last month for alleged domestic violence. CMO Roger Dansey will continue as interim CEO.
Pharma Times
MAY 19, 2022
Comparisons with other tests available have shown that blood test has greater sensitivity for the detection of bowel cancer
Worldwide Clinical Trials
MAY 20, 2022
Life after cancer is about more than just survival. It’s not just the length of life that matters, but also the quality of that life. Join us as we celebrate cancer research awareness month and clinical trials awareness month. The Patient Experience. The thing that really motivates me in cancer research is seeing how, in the last couple of decades, the landscape has evolved to where we’re not only focusing on curative intent but also on improving the patient’s experience with the illness.
Pharma Mirror
MAY 17, 2022
California, Crown Bioscience and Medical & Biological Laboratories (MBL), JSR Life Sciences companies, today announced the formation of a joint venture, to further expand the provision of Crown Bioscience’s preclinical services to Japanese customers. The new entity named “Crown Bioscience & MBL”, is a long-term strategic partnership that is expected to accelerate growth for both companies.
Bio Pharma Dive
MAY 20, 2022
The brain-infused treatment for a rare neurological disease would be one of only three gene therapies commercially available in the EU. PTC plans to ask for FDA approval later this year.
Outsourcing Pharma
MAY 18, 2022
A leader from the neurobiomarker platform provider tells how use of ML and other advanced analytical tools can help make better use of complex information.
Worldwide Clinical Trials
MAY 20, 2022
The past few years we’ve had exciting opportunities to work on more cell and gene therapy programs for our sponsors. The industry is just at the tip of the iceberg for exploring the potential of these therapies in revolutionizing how we treat disease, and as the approvals start to trickle in, the pipeline only grows. (For a full look at the cell and gene therapy landscape, check out our webinar titled: “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapy.”)
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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
pharmaphorum
MAY 19, 2022
An observational study in the UK has found evidence that COVID-19 vaccination can help alleviate the lingering symptoms that afflict some people who contract the virus, often referred to as ‘long COVID’ There have been persistent anecdotal reports that vaccines can help people with persistent symptoms get better, but the study published in the British Medical Journal is the first to explore the connection in large numbers of patients.
Bio Pharma Dive
MAY 17, 2022
The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.
Pharma Times
MAY 20, 2022
Scientists demonstrated that AZD1236 halts oedema while reducing spinal cord breakdown at site of injury
Worldwide Clinical Trials
MAY 19, 2022
At Worldwide Clinical Trials, we are passionate about the work we do every day and its impact on countless patients and their families around the world. For International Clinical Trials Day 2022, take a moment to learn more about what it means to be part of a Contract Research Organization (CRO) – and how you can join our global team of experts. We have opportunities for all types of professionals from various industries and backgrounds.
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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.
pharmaphorum
MAY 20, 2022
After a non-committal appraisal of Big Health’s Sleepio app for insomnia last November in draft guidance from NICE, the cost-effectiveness agency has come out in favour of the digital therapy. The earlier draft guidance showed that NICE was uncertain whether Sleepio would save money for the NHS, but its latest document recommends the app as a cost-saving option for treating insomnia in primary care “for people who would otherwise be offered advice about sleep hygiene or sleeping pill
Bio Pharma Dive
MAY 17, 2022
The treatment, which is designed to treat Sanfilippo syndrome, could become Ultragenyx's first gene therapy to reach market in the U.S., according to the biotech's CEO.
Pharma Times
MAY 18, 2022
Device delivers currents to the brain to restore activity usually lowered in depression patients
BioPharma Reporter
MAY 20, 2022
The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.
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.
pharmaphorum
MAY 16, 2022
Adele Waugaman, senior digital health coordinator of the COVID-19 response at the United States Agency for International Development (USAID), tells us what the agency focuses on to strengthen digital health infrastructure globally and improve and expand healthcare access. USAID learned a great deal from the Ebola outbreak in West Africa concerning effective digital health distribution and strategies for digital health implementation that were then applied to its COVID-19 response globally – alth
Bio Pharma Dive
MAY 20, 2022
The German drugmaker will hand back rights to two CAR-T cell therapies it was developing with Atara, which said it would reassess its strategy for the programs.
Pharma Times
MAY 19, 2022
Gifford is supporting the launch with a philanthropic donation of £14.
BioPharma Reporter
MAY 19, 2022
Locus Biosciences says the US$35m in funding it has raised from a mix of old and new investors is further validation of its novel approach to treating bacterial diseases.
pharmaphorum
MAY 16, 2022
Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. Eli Lilly’s Mounjaro (tirzepatide) was given the green light by the US Food and Drug Administration after the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 glucagon-like peptide-1 (GLP-1 ) receptor agonist showed its effectiveness when used in conjunction with diet and exercise.
Bio Pharma Dive
MAY 16, 2022
Sub-visible particles can lower the effectiveness of a drug, which is why regulatory authorities are demanding processes be developed, validated and set up in such a way as to minimize all forms of contamination.
Pharma Times
MAY 17, 2022
Team at Imperial College London will expand MELODY study to include immunosuppressed young people
XTalks
MAY 19, 2022
Mars Wrigley announced a voluntary recall of various candy products after consumers reported thin metal strands in the candy itself or loose in the bag. The products, which were recalled in the US, include Starburst, Skittles and Life Savers gummies. According to the company, products were manufactured by a third party and subsequently distributed across North America.
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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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