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.
Wed.Aug 02, 2023
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Tyra gains orphan drug status from FDA for achondroplasia therapy
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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Steve Jobs’ son raises $200M for cancer-focused venture fund
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.
FDA warns of reduced efficacy for oral birth control pill Tydemy
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.
Living a Varied Life Boosts Brain Connectivity in Mice
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.
Pfizer announces drop in reported net income in Q2 2023
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.
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Karyopharm cuts staff amid push to broaden use of blood cancer drug
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.
August 2, 2023: Want to Play a Game? AI and Machine Learning in This Week’s PCT Grand Rounds
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.
Vertex taking ‘flexible’ approach to pricing talks for experimental CRISPR therapy
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.
The risks of endotoxins in water systems: Where they arise and how to respond
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.
The New Age of Decentralized Clinical Trials
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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
Partnership aims to boost mental health research
Pharma Times
AUGUST 2, 2023
The University of Strathclyde, the NHS and New York University join forces to increase knowledge - News - PharmaTimes
Revolution Medicines to acquire biopharmaceutical company EQRx
Pharmaceutical Technology
AUGUST 2, 2023
Revolution Medicines has signed a definitive agreement to acquire biopharmaceutical company EQRx in an all-stock transaction.
Patient insights for Antidote’s partners [one-pager]
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.
Filings signal: Despite Covid losses, pharma earnings are promising
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.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Renaissance Pharma licenses Hu14.18 for neuroblastoma
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.
UBC to bolster safety functions with Oracle’s cloud technology
Pharmaceutical Technology
AUGUST 2, 2023
United BioSource (UBC) has selected Oracle Life Sciences’ safety case management solution to bolster its safety functions.
Understanding the Impact of Authorized Generics on Drug Pricing: The Entacapone Case Study
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.
Atantares raises $13.9m in pre-Series A funding to develop molecular chips
Pharmaceutical Technology
AUGUST 2, 2023
Atantares plans to use the $13.9m funding for research and development, service operation, and capacity expansion.
The New Age of Decentralized Clinical Trials
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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.
Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends
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
Amygdala scores $2m NIAAA grant to develop alcohol use disorder therapy
Pharmaceutical Technology
AUGUST 2, 2023
The grant will support the early development of Amygdala’s ALDH2 Inhibitor currently in pre-clinical development.
Takeda’s Dr. Karen Correa Talks True Leadership in Clinical Operations
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.
CS Pharmaceuticals snaps up AxeroVision to shore up ophthalmology portfolio
Pharmaceutical Technology
AUGUST 2, 2023
CSP will revive the development of AXR-270, a drug that previously demonstrated positive results for DED in 2021.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Intas analyst poured acid over manufacturing docs, FDA says in scathing warning letter
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.
Women in Science: How Vida Diagnostics’ Dr. Susan Wood is modernizing lung health through tech
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.
As RSV vaccine clash kicks off, GSK sues Pfizer for patent infringement
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.
Kyowa Kirin and Grünenthal collaborate on therapy portfolio
Pharma Times
AUGUST 2, 2023
The deal covers 13 brands across six therapeutic areas, mainly focused on pain treatment - News - PharmaTimes
How Machine Learning Drives Clinical Trial Efficiency
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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.
In 'advanced' settlement talks, Teva sets aside $200M to resolve US price-fixing probe
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.
Bora Pharmaceuticals Opens New Ophthalmic Manufacturing Plant in Taiwan
Pharmaceutical Commerce
AUGUST 2, 2023
CDMO’s Taoyuan City plant is set to provide customers with products ranging from emulsions to gels.
As Roche rival draws near, TG Therapeutics' stock crashes on disappointing MS drug sales
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.
Samsung seeks 'interchangeable' label for Humira biosimilar
pharmaphorum
AUGUST 2, 2023
Samsung seeks 'interchangeable' label for Humira biosimilar Phil.
Accelerating Clinical Supply Through Integrated Drug Development
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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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