AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 25, 2024
Epstein-Barr virus, a common virus that infects most people at some point in their lives, has long been suspected as a trigger of multiple sclerosis, an autoimmune disease affecting around 36 people in every 100,000 worldwide.
Bio Pharma Dive
JANUARY 25, 2024
The company is developing an oral alternative to J&J’s lung cancer medicine Rybrevant, and adds to a trend of late-stage drugmakers finding investor demand on Wall Street.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 25, 2024
The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers in the country.
Bio Pharma Dive
JANUARY 25, 2024
Two “global biopharmaceutical companies” made bids to buy the radiopharma specialist, but lost out to Bristol Myers, which negotiated aggressively to secure a $4.1 billion buyout.
Pharmaceutical Technology
JANUARY 25, 2024
Evaxion Biotech has announced plans to develop customised cancer vaccines by targeting a category of AI-discovered tumour antigens.
Bio Pharma Dive
JANUARY 25, 2024
A two-day workshop highlighted the lack of investment and inadequate understanding of what causes early births, making development efforts more challenging.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JANUARY 25, 2024
The pharma veteran will take over the AI-focused biotech after a year that included a restructuring, job cuts and the resignation of its CFO.
Pharmaceutical Technology
JANUARY 25, 2024
The milestone-based payment came from Roche after Repare dosed the first patient with personalised solid-tumour treatment camonsertib.
Antidote
JANUARY 25, 2024
Recruiting patients for clinical trials is a common challenge for study sponsors conducting research. For this reason, it is often a wise strategy to work with an agency that specializes in outreach. These agencies excel at helping sponsors achieve their research goals within defined timelines and budgets.
Pharmaceutical Technology
JANUARY 25, 2024
Kyowa Kirin has acquired Orchard Therapeutics, a developer of hematopoietic stem cell gene therapies, for an equity value of $477.6m.
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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
Outsourcing Pharma
JANUARY 25, 2024
Meghan Harrington recently joined Medidata as vice president of product, clinical trial financial management and is responsible for driving the strategic direction of the grants manager and payments products.
Pharmaceutical Technology
JANUARY 25, 2024
MSD will supply Keytruda to be evaluated as a combination treatment with Lava’s LAVA-1207 in an ongoing Phase I/IIa study.
pharmaphorum
JANUARY 25, 2024
Discover the role of GenAI in life sciences in 2024. Explore how artificial intelligence and machine learning techniques like GenAI are revolutionising drug development, diagnostics, and research. Learn how industry leaders, including Google, are leveraging GenAI to advance healthcare and enhance patient outcomes.
Pharmaceutical Technology
JANUARY 25, 2024
Theratechnologies has received a CRL from the US Food and Drug Administration (FDA), denying approval for its F8 formulation of tesamorelin.
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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
Fierce Pharma
JANUARY 25, 2024
Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more information on the cases that it has seen.
Pharmaceutical Technology
JANUARY 25, 2024
Synnovation Therapeutics has launched with a $102m Series A financing to progress the development its pipeline of targeted therapies.
pharmaphorum
JANUARY 25, 2024
On today’s podcast, host Jonah Comstock is joined by Arturo Araya, EVP of commercialisation at Cellares, a company that is attempting to create a new kind of contract manufacturing organisation for the rapidly crystalizing world of cell and gene therapy.
Pharmaceutical Technology
JANUARY 25, 2024
As a new variant spearheads a Covid-19 infection Winter spike, the range of vaccines and antivirals is very different today to 2020.
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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
JANUARY 25, 2024
Around 50% of babies born with the condition are affected by heart defects
Pharmaceutical Technology
JANUARY 25, 2024
The US FDA has requested a different safety label for Gilead’s Tecartus compared to other approved CAR-T cell therapies.
pharmaphorum
JANUARY 25, 2024
UK government is reported to be considering financial aid for AstraZeneca to seal a deal to expand a vaccines manufacturing facility in Speke
Pharmaceutical Technology
JANUARY 25, 2024
We speak with BAP Pharma to learn more about the challenges and possible benefits of medicines access solutions.
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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
JANUARY 25, 2024
A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end. | A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end.
pharmaphorum
JANUARY 25, 2024
NICE firms up guidance backing NHS use of five digital health wearables for remote monitoring of Parkinson's disease patients
Fierce Pharma
JANUARY 25, 2024
Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Ther | Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Therapeutics was on its way to becoming a “leaner and stronger company.” Part of that mission will come to fruition later this year with a move of its headquarters in Cambridge, Massachusetts.
Outsourcing Pharma
JANUARY 25, 2024
Patients with diabetic retinopathy as a result of diabetes, could benefit from a small molecule drug.
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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.
Fierce Pharma
JANUARY 25, 2024
Last year proved a challenging year for contract manufacturers across the board, but Korea’s Samsung Biologics appears to have bucked the losing trend by charting what it called an “exceptional" pe | Last year proved a challenging year for contract manufacturers across the board, but Korea’s Samsung Biologics appears to have bucked the losing trend by charting what it called an “exceptional" performance.
pharmaphorum
JANUARY 25, 2024
Our latest crop of biotech financings features rounds for Synnovation Therapeutics and Adicet Bio, Calluna Pharma, Accent Therapeutics, GenEdit and IMU Bio
Fierce Pharma
JANUARY 25, 2024
The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. | The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. AstraZeneca has won a world-first approval for its rare blood disorder add-on therapy in Japan.
pharmaphorum
JANUARY 25, 2024
Indian pharma Glenmark has licensed rights to subcutaneous PD-L1 inhibitor envafolimab from China’s Alphamab and 3D Medicines
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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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