This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
No matter how much technology we have, study success comes down to people and processes, says Wendy Tate, PhD, MS, Product Strategy Senior Director at Advarra. Clinical research is a business that should focus on viable studies. Decisions can be supported using data already collected as part of the clinical research enterprise.
Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.
Click here Diagnostics + Font Resize – NABL launches comprehensive training programme to enhance competence in reference material production Shardul Nautiyal, […]
Of the changes sparked by value-based care, perhaps the most valuable for the biopharmaceutical industry to embrace is the use of health economics and outcomes research (HEOR) to better understand a product’s value.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? This new guidance will clearly impact the clinical research field, but how? Explore the limitations of what we know about prescription drug dosing The future of Clinical Research April 12, 2023 at 11:00 am PDT, 2:00 pm EDT, 7:00 pm GMT
FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. What is Research and Development (R&D)? This category highlights companies that have advanced drug development research.
Oxford Medical Products has shared promising safety data from a first-in-human study for its ‘mechanical’ weight loss pill. Oxford’s device showed a favorable safety profile, with no serious adverse events reported, and no participants withdrew from the study due to product-related issues.
Indian pharmaceutical company Laurus Labs has signed a memorandum of agreement (MoA) with the Indian Institute of Technology, Kanpur (IIT Kanpur) to bring new gene therapy products to the market. Laurus Labs will be responsible for launching these products in India and emerging markets.
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA).
The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) (..)
Exports of Ayush and herbal products have reported a growth of 20.33 per cent during the first month of the current fiscal year, at $51.44 million as compared to $42.75 million during the same month of previous fiscal year. Exports during the month of April, in Rupee terms, have reported a 21 per cent growth, […]
The Central Drugs Standard Control Organisation (CDSCO) has released an updated version of the guidance for Post Approval Changes in Biological Products, regarding the quality, safety and efficacy documents in order to align with the updated standards and digital formats developed after the previous version was rolled out. of […]
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
These issues carry substantial personal and societal costs, impacting daily life and productivity. Another unique challenge in psychiatry trials is the placebo response, which is notably high in mental health research.
Sanofi has signed an agreement with the Queensland Government in Australia to establish a $190m (A$280m) research facility in Brisbane. The hub will connect Queensland scientists with the teams at Sanofi’s mRNA Centre of Excellence in the US and France, putting them at the front of international vaccine development and biomedical research.
Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinical research for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.
Exports of Ayush related products from the country have gone up around 53 per cent in five years from the financial year 2016-17 to 2020-21, according to the Ministry of Ayush. The imports, on the other hand, has increased around 42 per cent during the period, with a majority of the products based on the […]
The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]
In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022.
per cent of India’s Ayush and herbal products during the fiscal year 2023-24. The top 10 destinations led by USA, Germany and Italy accounted for almost 63.3 Exports to these 10 countries together stood at $412 million, with a growth of 5.10 per cent compared to the $392 million exports to top 10 destinations during […]
While several therapeutics are available for treating symptoms associated with epilepsy, researchers and patients have strongly called out the need for more holistic treatments that would address the condition as a whole. Meanwhile, others are researching the link between gene variation and different responses to treatments.
a global leader in analytical and clinical laboratory technologies, announced that it has received two prestigious awards from SelectScience: Best New Drug Discovery & Development Product of 2023 and Drug Discovery & Development Webinar of the Year. Agilent Technologies Inc.,
Biopharmaceutical involves substantial investments in research, clinical trials, regulatory compliance, and manufacturing. Pricing of biopharmaceutical medicines are influenced by various factors, and the cost of research and development (R&D) plays a significant role in determining drug prices, […]
This requires significant investments in research and development, as well as the implementation of cutting-edge technologies like single-use bioreactors and advanced analytics. So, what can biosimilar manufacturers do to address these supply chain challenges and bring their products to market efficiently and effectively?
Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.
By taking advantage of pre-filed DMFs, researchers benefit from the value, time savings and reduced complexities of having someone else do the heavy lifting for key components of the final drug product.
Clinical research is a vital driver of medical progress. With more than three decades of experience, Advarra is dedicated to advancing clinical research by providing expert oversight. Clinical research tests new treatments and therapies to determine their safety, effectiveness, and potential to improve health outcomes.
According to the deal, Cyagen will leverage its artificial intelligence (AI)-driven high-throughput platform for discovering new AAV vectors with enhanced tissue targeting expertise, tissue specificity and productivity. . Both companies will assess the new AAV vectors’ functional effects in rodent and NHP models.
The presenters of this seminar have been researching strategies to implement holistic pain management strategies in the Military Health System and evaluating ways to provide pain care that aligns with the DoD/VA Stepped Care Model for Pain Management. Registration is required for participation this live web conference, but there is no cost.
A recent report from the Assistant Secretary for Planning and Evaluation in the US Department of Health and Human Services outlines 36 projects funded by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund (OS-PCORTF). Read the full report.
For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. This is a mechanism for experts to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products.
The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development.
The shift to digital advertising doesn’t make sense when pharma product websites don’t meet consumers’ needs. From the research I have read and conducted over the last few years the answer is NO. TV is still the best way to introduce a new product provided it has a big audience. But is this the right strategy?
(Bambu Productions/DigitalVision/Getty Images) Of all the advice on preventing hangovers, drinking water to prevent dehydration seems like the most sensible. An international team of researchers led by […]
(SimpleImages/Getty Images) A high-cholesterol animal product eaten by billions of people worldwide is not as bad for your health as it’s often cracked up to be. Researchers at the University of California San Diego have now analyzed the health data of 890 men and women and found that […] It might even be good for you.
The alliance will utilise the cancer-fighting potential of iADCs as a new modality, along with the expertise of Sutro to engineer complex conjugated antibodies and the global oncology research and development (R&D) capabilities of Astellas. on meeting development, regulatory and commercial milestones for each product candidate.
The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases.
If theres one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, its change. Its a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country. This is a sponsored message.
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content