A once buzzy gene therapy startup lays off staff and shuts down
Bio Pharma Dive
AUGUST 2, 2023
Intergalactic, a developer of non-viral gene therapies built by ex-Biogen executive Michael Ehlers, is folding less than two years after its launch.
Bio Pharma Dive
AUGUST 2, 2023
Intergalactic, a developer of non-viral gene therapies built by ex-Biogen executive Michael Ehlers, is folding less than two years after its launch.
Pharmaceutical Technology
AUGUST 2, 2023
Tyra Biosciences has received orphan drug designation (ODD) from the US FDA for TYRA-300 to treat achondroplasia, a common form of dwarfism.
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Bio Pharma Dive
AUGUST 2, 2023
Yosemite is one of a new class of biotech venture funds that also includes the recently launched Dimension and Cure Ventures.
Pharmaceutical Technology
AUGUST 2, 2023
Two lots of Lupin’s Tydemy have been recalled due to a decrease in ascorbic acid levels leading to reduced effectiveness.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 2, 2023
The brains in mice benefit from an active and varied lifestyle by forming enhanced neural connections.Researchers in Germany compared the brain activity of mice raised in different environments and found those raised in an ‘enriched’ environment had more activity in their hippocampus, suggesting the presence of a more robust and connected neural network.
Pharmaceutical Technology
AUGUST 2, 2023
Pfizer has posted a reported net income of $2.36bn for Q2 2023, a drop of 77% from nearly $10bn in the same quarter of 2022.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
AUGUST 2, 2023
The biotech, which has struggled to grow sales of its medicine Xpovio, is laying off 20% of its staff and focusing on late-stage studies in endometrial cancer and myelofibrosis.
Rethinking Clinical Trials
AUGUST 2, 2023
Dr. Eric Perakslis In this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University will present “AI & ML: Want to Play a Game?” The Grand Rounds session will be held on Friday, August 4, 2023, at 1:00 pm eastern. Bergstrom is a professor in population health sciences and the chief research technology strategist in the Duke University School of Medicine.
Bio Pharma Dive
AUGUST 2, 2023
The company is discussing various payment models for its sickle cell treatment with government and commercial insurers ahead of an FDA approval decision later this year.
Pharmaceutical Technology
AUGUST 2, 2023
Purifying water may kill bacteria but can also result in contaminants in the form of endotoxins. We explore the risks and how to manage risks.
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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
Pharma Times
AUGUST 2, 2023
The University of Strathclyde, the NHS and New York University join forces to increase knowledge - News - PharmaTimes
Pharmaceutical Technology
AUGUST 2, 2023
Revolution Medicines has signed a definitive agreement to acquire biopharmaceutical company EQRx in an all-stock transaction.
Antidote
AUGUST 2, 2023
At Antidote, our mission is to connect patients with clinical trials is only possible when we understand the individuals that make up the patient population. One way we are able to gain this understanding is by providing our clinical trial search tool, Antidote Match , at no cost to over 300 organizations that we partner with.
Pharmaceutical Technology
AUGUST 2, 2023
Despite losing out on Covid sales as government funding drops off, pharma earnings look promising in the second half of 2023.
Drug Discovery World
AUGUST 2, 2023
Renaissance Pharma has announced its first development programme focused on Hu14.18, a humanised anti-GD2 monoclonal antibody (mAb), licensed from St Jude Children’s Research Hospital for the treatment of newly diagnosed high-risk neuroblastoma. Fifty percent of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over five years.
Pharmaceutical Technology
AUGUST 2, 2023
United BioSource (UBC) has selected Oracle Life Sciences’ safety case management solution to bolster its safety functions.
Drug Patent Watch
AUGUST 2, 2023
In the world of prescription drugs, brand-name manufacturers have employed various strategies to maintain revenue streams in the face of generic competition. One such strategy is the use of “authorized… The post Understanding the Impact of Authorized Generics on Drug Pricing: The Entacapone Case Study appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
AUGUST 2, 2023
Atantares plans to use the $13.9m funding for research and development, service operation, and capacity expansion.
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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.
XTalks
AUGUST 2, 2023
In a world where health is paramount, the pharmaceutical industry stands as a formidable pillar, relentlessly pursuing scientific breakthroughs and life-saving innovations. With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future
Pharmaceutical Technology
AUGUST 2, 2023
The grant will support the early development of Amygdala’s ALDH2 Inhibitor currently in pre-clinical development.
Fierce Pharma
AUGUST 2, 2023
Intas Pharmaceuticals’ new warning letter from the U.S. FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022. The company got dinged for lapses in quality control, incomplete lab records, testing shortfalls and more.
Pharmaceutical Technology
AUGUST 2, 2023
CSP will revive the development of AXR-270, a drug that previously demonstrated positive results for DED in 2021.
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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
XTalks
AUGUST 2, 2023
What does it take to be a leader in clinical trials right now? With over 30 years of clinical research experience, Dr. Karen Correa, PhD, BCMAS, Vice President, Head of Global Clinical Operations at Takeda, is undoubtedly an authority on the topic of leadership in this complex and unpredictable industry. To tap into this knowledge, Xtalks recently spoke with Dr.
Fierce Pharma
AUGUST 2, 2023
In the latest clash of the vaccine titans, GSK is locking horns with Pfizer over claims the company’s competing respiratory syncytial virus (RSV) shot Abrysvo treads on patents belonging to its own | GSK says Pfizer’s vaccine RSV vaccine Abrysvo—approved in late May—infringes four patents related to its RSV antigen shot Arexvy, which itself snagged a green light in the U.S. earlier that same month.
Pharma Times
AUGUST 2, 2023
The deal covers 13 brands across six therapeutic areas, mainly focused on pain treatment - News - PharmaTimes
Fierce Pharma
AUGUST 2, 2023
Teva has long maintained its innocence in the face of a far-reaching price-fixing indictment by the U.S. Department of Justice (DOJ). | Teva has long maintained its innocence in the face of a far-reaching price-fixing indictment by the U.S. Department of Justice. Now, the company is earmarking a sizable chunk of cash in an attempt to put the charges to bed.
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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.
Outsourcing Pharma
AUGUST 2, 2023
Dr. Susan Wood is CEO and president of VIDA Diagnostics. She has over 25 years of experience championing clinical intelligence solutions into routine clinical use.
Fierce Pharma
AUGUST 2, 2023
The convenience of shorter infusion time is a big selling point for TG Therapeutics’ newly FDA-approved multiple sclerosis drug Briumvi. | The convenience of shorter infusion time is a big selling point for TG Therapeutics’ newly FDA-approved multiple sclerosis drug Briumvi. But an under-the-skin version of Roche’s well-established Ocrevus could pose a threat to TG’s lone offering.
Pharmaceutical Commerce
AUGUST 2, 2023
CDMO’s Taoyuan City plant is set to provide customers with products ranging from emulsions to gels.
Fierce Pharma
AUGUST 2, 2023
Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen | Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen.
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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.
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