Takeda withdraws FDA approval application for dengue vaccine
Bio Pharma Dive
JULY 11, 2023
While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.
Bio Pharma Dive
JULY 11, 2023
While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2023
Being surrounded by people who don’t see the world quite like you do increases your risk of feeling lonely, even if you’re friends with them. Neuroimaging tests on 66 young adults discovered significant contrasts in the way lonely people’s brains process information compared to their peers.
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Bio Pharma Dive
JULY 11, 2023
The companies’ decision to end their partnership on a TIGIT-blocking drug raises new doubts over a mechanism of action that has already produced setbacks for Roche and Merck.
Pharmaceutical Technology
JULY 11, 2023
Iovance Biotherapeutics completes a preliminary analysis after the US' FDA found the trial design acceptable for accelerated approval.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 11, 2023
The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June.
Pharmaceutical Technology
JULY 11, 2023
Study shows patients taking abatacept, cenicriviroc, or Remicade in addition to SOC do not recover quicker compared to placebo.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
JULY 11, 2023
Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.
Bio Pharma Dive
JULY 11, 2023
Keisuke Naito, the son of Eisai’s CEO, will replace Cheung as the company’s global Alzheimer’s disease head. The change in leadership comes days after Eisai won full U.S. approval of its drug Leqembi.
Rethinking Clinical Trials
JULY 11, 2023
The NIH Collaboratory is excited to announce the addition of LE8 Bot + BackUp (or Using Artificially Intelligent Text Messaging Technology to Improve American Heart Association's Life's Essential 8 Health Behaviors) to its portfolio of innovative Demonstration Projects. The American Heart Association (AHA) identifies Life's Essential (LE8) lifestyle factors as blood glucose, cholesterol, blood pressure, physical activity, weight, diet, smoking, and sleep.
Bio Pharma Dive
JULY 11, 2023
RA Capital led a Series B financing round that drew participation from more than a dozen blue-chip venture backers, including new investors Goldman Sachs and Vertex Ventures.
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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
Pharmaceutical Technology
JULY 11, 2023
Astellas Pharma has entered into an agreement to license 4DMT's R100 vector for a genetic target associated with rare ophthalmic ailments.
Bio Pharma Dive
JULY 11, 2023
The pharma, which had largely exited the field several years ago, will pay nearly $100 million combined to the two biotechs for rights to several experimental candidates.
Pharmaceutical Technology
JULY 11, 2023
Fulcrum Therapeutics has signed a licence agreement with CAMP4 Therapeutics to develop new therapies to treat Diamond-Blackfan anaemia.
Pharmaceutical Commerce
JULY 11, 2023
The National Alliance of Healthcare Purchaser Coalitions releases resources for employers/health plan purchasers to offer insights on PBMs role in high prescription drug costs.
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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
Pharmaceutical Technology
JULY 11, 2023
BeiGene has signed an agreement with DualityBio for the acquisition of an exclusive licence for an ADC therapy to treat solid tumours.
BioSpace
JULY 11, 2023
With funding and business-friendly incentives more challenging to come by in constricting Western economies, some life sciences companies partner with Middle Eastern governments, which are rolling out the red carpet.
Pharmaceutical Technology
JULY 11, 2023
Elsie has signed a research collaboration agreement with GSK to accelerate the development of its oligonucleotide discovery platform.
FDA Law Blog
JULY 11, 2023
By Sara W. Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme. While it is exceedingly obvious that some products, like eyeshadow for example, are cosmetics, or a pacemaker is a device, it can get thorny where the disti
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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.
Pharmaceutical Technology
JULY 11, 2023
The European Commission has granted conditional marketing authorisation for Columvi to treat relapsed or refractory DLBCL in Europe.
BioSpace
JULY 11, 2023
Severe respiratory problems killed seven patients and affected five others, though the company said that most of these were likely unrelated to the drug.
Pharmaceutical Technology
JULY 11, 2023
Pluri signed a 3-year contract to develop cell therapy to treat acute radiation syndrome in collaboration with the US Army.
Fierce Pharma
JULY 11, 2023
The race for competitive advantage for pharma today is about far more than just innovative new molecules. | Pharma's new race for competitive advantage requires embracing transformation across product, company, and market categories and addressing the needs of patients and health systems by developing new products, services and digital ecosystems.
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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.
Pharmaceutical Technology
JULY 11, 2023
Preclinical work is currently underway for all three candidates, with the first two trials set to start by mid-2024.
Fierce Pharma
JULY 11, 2023
U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. | U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. After an ominous delay, Takeda has decided to withdraw the FDA application for its dengue vaccine candidate after the agency raised concerns about data collection.
BioSpace
JULY 11, 2023
Bristol Myers Squibb is paying a total of $95 million to the two companies for exclusive global rights to programs developed within long-term partnerships designed to further BMS’ neuro pipeline.
Fierce Pharma
JULY 11, 2023
After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead. | After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead.
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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.
Drug Discovery World
JULY 11, 2023
Evotec and Bristol Myers Squibb (BMS) have entered into an exclusive global licence agreement, extending their neuroscience partnership. The agreement covers selected late-stage discovery programmes that were developed and progressed within the collaboration between the two companies. Evotec and BMS originally entered their neurodegeneration partnership in 2016.
Fierce Pharma
JULY 11, 2023
Right after Leqembi's full approval from the U.S. FDA, Eisai’s global Alzheimer’s disease officer is getting ready to hang up his hat. | Ivan Cheung, Eisai's American CEO and global Alzheimer's disease officer, will retire at the end of the month. With Cheung headed for the exit, Keisuke Naito—the 34-year-old son of Eisai’s CEO Haruo Naito—has taken up the lead Alzheimer’s mantle, the company said Tuesday.
Outsourcing Pharma
JULY 11, 2023
A licensing agreement between Evotec SE and Bristol Myers Squibb Company (BMS) that will âbolster a pipeline of programmes targeting several neurodegenerative conditionsâ was announced today (July 11).
BioSpace
JULY 11, 2023
After three cases of self-harm and suicidal ideation, the European Medicines Agency is reviewing Novo Nordisk’s diabetes drug Ozempic and weight-loss medication Saxenda for potential risks.
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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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