Crucial Data Soutions
FEBRUARY 5, 2024
Clinical trial imaging is different. There is a lot of variability involved with data collection. For studies engaging multiple sites, The post 8 Reasons to Move Your Clinical Trial Imaging to TrialKit Right Now appeared first on Crucial Data Solutions.
Bio Pharma Dive
FEBRUARY 5, 2024
The pharma disclosed positive results from two studies testing its antibody drug nipocalimab in generalized myasthenia gravis or Sjögren's disease.
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AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 5, 2024
If you’re one of the one in three people whose New Year’s resolution involved losing weight, it’s likely you’re now contemplating what weight-loss goal you should actually be working towards. But type “setting a weight loss goal” into any online search engine and you’ll likely be left with more questions than answers.
Bio Pharma Dive
FEBRUARY 5, 2024
In a related deal, Novo Holdings subsidiary Novo Nordisk will buy three major Catalent factories for $11 billion as it works to keep pace with demand for its obesity and diabetes medicines.
Pharmaceutical Technology
FEBRUARY 5, 2024
Regeneron Pharmaceuticals' application for linvoseltamab has received acceptance from the EMA for review to treat multiple myeloma.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 5, 2024
In order to ensure the seamless transition of accredited laboratories, the National Accreditation Board for Laboratories (NABL) has announced an extension of the transition period for accredited laboratories from the initial deadline of December 31, 2023 to the revised date of August 31, 2024.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
FEBRUARY 5, 2024
The company said it will invest the sale proceeds into testing of an experimental Lyme disease shot and of Ixchiq, its new chikungunya vaccine.
Pharmaceutical Technology
FEBRUARY 5, 2024
V-116 is a conjugate vaccine commercialized by Merck, with a leading Pre-Registration program in Streptococcal Pneumonia.
Fierce Pharma
FEBRUARY 5, 2024
Less than two months after the FDA approved the combination treatment of Astellas and Pfizer’s Padcev and Merck’s Keytruda in first-line bladder cancer, the Japanese company has
Pharmaceutical Technology
FEBRUARY 5, 2024
Novo Holdings announced a merger agreement with Catalent, selling three manufacturing facilities to Novo Nordisk.
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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
Fierce Pharma
FEBRUARY 5, 2024
After leading Novartis and Roche through pivotal years in 2023, the CEOs of the Swiss drug giants each netted multimillion-dollar compensation packages. | After leading Swiss drug giants Novartis and Roche through pivotal years, their CEOs have each netted multimillion-dollar compensation packages for 2023.
Pharmaceutical Technology
FEBRUARY 5, 2024
AbbVie has reported a decrease in net revenues to $54.32bn for the FY 2023, marking a 6.4% decline from the previous year's $58.05bn.
pharmaphorum
FEBRUARY 5, 2024
Data science in healthcare is transforming the industry, from drug discovery to patient care. Learn about the role of data, artificial intelligence (AI), and the impact of initiatives like the NHS Datastore in revolutionising healthcare outcomes.
Pharmaceutical Technology
FEBRUARY 5, 2024
Inmagene has exercised its option to secure a licence for HUTCHMED’s two drug candidates to treat immune and inflammatory ailments.
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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
Pharma Times
FEBRUARY 5, 2024
The aggressive brain cancer is responsible for over 3,000 cases in the UK every year
Pharmaceutical Technology
FEBRUARY 5, 2024
The EMA has validated the MAA for review of Genmab and Pfizer’s tisotumab vedotin to treat recurrent or metastatic cervical cancer.
Outsourcing Pharma
FEBRUARY 5, 2024
No new treatments to combat the major public health issue of alcohol use disorder (AUD), have been brought to market for ten years - and with half of heavy drinkers refusing the abstinence route, new drug could be the answer.
Pharmaceutical Technology
FEBRUARY 5, 2024
Valneva will use the voucher sale funds for R&D projects, including a Lyme disease vaccine being co-developed with Pfizer.
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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.
Outsourcing Pharma
FEBRUARY 5, 2024
Life sciences technology company ArisGlobal, has announced the formal charter for the new generative AI Council, which will sit for the first time this month in a bid to advance life sciences innovation.
Pharmaceutical Technology
FEBRUARY 5, 2024
The HHS released new research that highlights US prescription drug prices are nearly triple those of 33 other OECD countries.
Fierce Pharma
FEBRUARY 5, 2024
If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. | If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. multiple myeloma market with its previously withdrawn BMCA-targeted antibody-drug conjugate, Blenrep.
Pharmaceutical Technology
FEBRUARY 5, 2024
AnaMar’s AM1476 received FDA and EMA orphan drug designations, with the Swedish biotech now planning a Phase II trial.
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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.
Fierce Pharma
FEBRUARY 5, 2024
As new legislation stands to threaten the U.S. business of certain Chinese biopharma companies, CDMO giant WuXi AppTec has stepped in to make a case for itself. | The company's executives inked an open letter after the recent BIOSECURE act flagged WuXi AppTec and other Chinese drugmakers as potential national security threats.
Pharmaceutical Technology
FEBRUARY 5, 2024
Tividenofusp alfa is a fusion protein commercialized by Denali Therapeutics, with a leading Phase III program in Mucopolysaccharidosis II (MPS II) (Hunter Syndrome ).
pharmaphorum
FEBRUARY 5, 2024
A bladder cancer study prompts Astellas to lift peak sales prediction for Padcev, although its menopause therapy Veozah isn’t ramping up as hoped.
Pharmaceutical Technology
FEBRUARY 5, 2024
CB-012 is a gene-modified cell therapy commercialized by Caribou Biosciences, with a leading Phase I program in Relapsed Acute Myeloid Leukemia.
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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
FEBRUARY 5, 2024
Better-than-expected sales of some of its new products, including Skyrizi and Rinvoq, helped AbbVie handle a sharp decline in sales of former cash-cow product Humira in the last quarter of 2023.
Pharmaceutical Technology
FEBRUARY 5, 2024
Lepodisiran sodium is an antisense rnai oligonucleotide commercialized by Eli Lilly and Co, with a leading Phase II program in Atherosclerosis.
Fierce Pharma
FEBRUARY 5, 2024
Late last month, Novo Holdings’ CEO Kasim Kutay hinted that the fund manager was eyeing buyouts as an outlet for its trove of Wegovy cash. Now, a major deal has materialized. | Late last month, Novo Holdings’ CEO Kasim Kutay hinted that the fund manager was eyeing buyouts as an outlet for its trove of Wegovy cash. Now, a major deal has materialized.
Pharmaceutical Technology
FEBRUARY 5, 2024
Apraglutide is a synthetic peptide commercialized by Ironwood Pharmaceuticals, with a leading Phase III program in Short Bowel Syndrome.
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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.
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