Bio Pharma Dive
JUNE 8, 2023
Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.
Pharmaceutical Technology
JUNE 8, 2023
Each week, Pharmaceutical Technology’s editors select a deal that illustrates the themes driving change in our sector. The deal may not always be the largest in value, or the highest profile. But it will tell us where the leading companies are focusing their efforts, and why. This new, thematic deal coverage is driven by our underlying Disruptor data which tracks all major deals, patents, company filings, hiring patterns and social media buzz across our sectors.
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Bio Pharma Dive
JUNE 8, 2023
Two-year-old Kate Therapeutics is launching publicly with $51 million in funding and a licensing deal with Astellas Pharma for a neuromuscular disease gene therapy.
Pharmaceutical Technology
JUNE 8, 2023
The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). DTx-1252 is a fatty acid ligand conjugated oligonucleotides (FALCON) small interfering RNA (siRNA) therapeutic which represses the PMP22 gene in Schwann cells. It induces remyelination of axons to normal levels, increases muscle coordination, agility, mass, grip and strength, and improves electrophysiological measurem
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 8, 2023
The artificial sweetener sucralose (marketed as Splenda) is widely used and found in products like diet soda and chewing gum. According to a new study, it’s also capable of damaging the DNA material inside our cells.
Pharmaceutical Technology
JUNE 8, 2023
The use of 4D Molecular Therapeutics’ (4DMT) aerosolised gene therapy 4D-710 has improved the quality-of-life and spirometry-measured outcomes in three cystic fibrosis patients , based on early results from a Phase I/II study presented at this year’s annual meeting of the European Cystic Fibrosis Society (ECFS). While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the dr
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 8, 2023
The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults. Last month, Arexvy received approval from the US Food and Drug Administration (FDA ) for the same indication.
Bio Pharma Dive
JUNE 8, 2023
The biotech’s experimental drug, currently in Phase 1 testing, has drawn investor attention despite a difficult funding environment for drug startups.
Rethinking Clinical Trials
JUNE 8, 2023
The Long-Term Care (LTC) Data Cooperative this week announced a request for applications for the newly established 2023 Real World Data Scholars Program. This program supports the development of advanced graduate students, postdoctoral fellows, and early-career faculty who are interested in developing their expertise and experience in working with electronic health record (EHR) data.
Pharmaceutical Technology
JUNE 8, 2023
GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. The core objective of the collaboration is to make the therapies affordable and accessible to patients. The companies will offer a comprehensive suite of cell therapy services to biotech, pharmaceutical and government entities, and to hospitals.
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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
Drug Patent Watch
JUNE 8, 2023
17th Edition Project Portfolio and Resource Management Excellence for Pharma July 11-13, 2023 | Sheraton Philadelphia University City Hotel | Philadelphia, PA Mastering Resource and Project Prioritization, Operational Excellence, and People Development… The post 17th Edition Project Portfolio and Resource Management Excellence for Pharma appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JUNE 8, 2023
Gritstone bio has reported interim results from an ongoing Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against Covid-19 (CORAL-BOOST). According to the US-based company, the results demonstrate that Gritstone’s samRNA vaccine candidate boosted immunity for at least 6 months in previously vaccinated older adults.
Drug Patent Watch
JUNE 8, 2023
DrugChatter recently launched as an experimental AI chat-based business intelligence tool. Here’s some of the more interesting questions it’s been asked: Cost savings for bulk lipitor Who Invented Advil? What… The post DrugChatter Featured Questions appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
JUNE 8, 2023
Biotechnology company Hopewell Therapeutics has raised $25m in seed financing to accelerate the development of next-generation lipid nanoparticles for targeted delivery of genomic medicines. Participants in the funding round, which was raised in multiple tranches, include IMO Capital, 5Y Capital, BOPU Capital, WS Investments, Mass Ave Capital and HIKE Capital.
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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
JUNE 8, 2023
Laboratory space will accelerate the development of potentially life-saving cell therapies - News - PharmaTimes
Pharmaceutical Technology
JUNE 8, 2023
Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit. The cell therapy facility will be used for the large-scale production of vididencel, Mendus’s lead programme.
XTalks
JUNE 8, 2023
Over the past few years, there has been a significant expansion in the cell and gene therapy landscape, with an increasing number of therapies entering clinical trials and receiving regulatory approvals. The selection of a contract research organization (CRO) to support a cell or gene therapy program is crucial during the product’s development, as it can determine the success or failure of a study in meeting timelines and gathering the necessary data for approval.
Pharmaceutical Technology
JUNE 8, 2023
The UK’s medicines and healthcare products regulatory agency (MHRA) has granted approval for a new indication for Merz Therapeutics’ XEOMIN (incobotulinumtoxinA) to treat focal spasticity of the lower limbs affecting the ankle joint. The therapy was previously approved in the UK to treat upper limb spasticity. The expanded approval allows the company to provide holistic support to those living with spasticity who need comprehensive treatment.
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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.
Drug Discovery World
JUNE 8, 2023
Axol Bioscience has signed an exclusive agreement with StrataStem to access and commercialise its collection of Alzheimer’s Disease (AD) patient samples. Harnessing its stem cell expertise, Axol will reprogramme these patient samples into induced Pluripotent Stem Cells (iPSCs) that can then be differentiated into a range of brain cells, including neurons and neuroinflammatory cells.
Pharmaceutical Technology
JUNE 8, 2023
UI-035is under clinical development by Korea United Pharm and currently in Phase I for Cognitive Disorders.
Pharmaceutical Commerce
JUNE 8, 2023
Sy Pretorius, COO & president of outsourced solutions at Eversana, dives into his new role in the space, after being a veteran in the clinical development sector.
Pharma Times
JUNE 8, 2023
Emergence of quick test follows recent dramatic increase in sexually transmitted infections - News - PharmaTimes
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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
JUNE 8, 2023
Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle. | Seeking to launch their RSV prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.
BioSpace
JUNE 8, 2023
A class-action lawsuit from thousands of third-party payers alleges that the companies broke racketeering laws to market their diabetes drug Actos, while not disclosing its bladder cancer risk.
Fierce Pharma
JUNE 8, 2023
Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline | Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline in revenue every year since 2016. But the slide could end soon as the company projects sales of its pipeline products to add $3 billion to the top line over the next five years, thanks largely to biosimilars.
BioSpace
JUNE 8, 2023
The company said Thursday it has closed $200 million in Series B financing—on top of last year’s $200 million Series A haul—to help initiate a registrational Phase II study for its lead candidate UPB-101.
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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
JUNE 8, 2023
After Merck filed a bombshell lawsuit contesting the negotiation measures in the Inflation Reduction Act (IRA), the company’s shareholders at the Interfaith Center on Corporate Responsibility (ICCR | After Merck's bombshell lawsuit contesting the Inflation Reduction Act, shareholders at the Interfaith Center on Corporate Responsibility are asking the company to reconsider.
BioSpace
JUNE 8, 2023
Bitterroot Launches with $145M Series A to Advance Cardio-Immuno Therapies - read this article along with other careers information, tips and advice on BioSpace
Fierce Pharma
JUNE 8, 2023
Fierce Pharma Asia—Eisai and Biogen's Leqembi progress; AZ and Daiichi's Enhertu data; Samsung Biologics' manufacturing deal zbecker Thu, 06/08/2023 - 19:34
BioSpace
JUNE 8, 2023
With the 2023 American Society of Clinical Oncology meeting in the history books, BioSpace takes a look back at the presented data that oncologists think will be most practice-changing.
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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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