Bio Pharma Dive
JUNE 9, 2023
The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.
Pharmaceutical Technology
JUNE 9, 2023
WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.
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Bio Pharma Dive
JUNE 9, 2023
In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.
Pharmaceutical Technology
JUNE 9, 2023
Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat the signs and symptoms of dry eye disease. VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.
Bio Pharma Dive
JUNE 9, 2023
CMS named 43 Part B drugs for which prices rose more than inflation, and which will have lower coinsurance rates next quarter as a result.
Pharmaceutical Technology
JUNE 9, 2023
Clinical-stage biotech company Upstream Bio has raised $200m in a Series B financing round to advance its UPB-101 to treat allergic and inflammatory diseases. Co-led by Venrock Healthcare Capital Partners (Venrock) and Enavate Sciences, the financing round has seen participation from new investors Wellington Management and Bain Capital Life Sciences.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 9, 2023
Astellas Pharma (Astellas) has entered an exclusive licence deal with Kate Therapeutics (KateTx) to develop and commercialise KT430. KateTx will receive an undisclosed upfront payment from Astellas for an exclusive global licence to develop, manufacture and commercialise KT430. KateTx will also receive additional payments linked to development, regulatory and commercial milestones, and royalties on the global sales of the product.
Bio Pharma Dive
JUNE 9, 2023
The pharma is the latest large drugmaker to show interest in the emerging technology, following similar deals by Bristol Myers and Regeneron.
Pharmaceutical Technology
JUNE 9, 2023
Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). RP-A601 is an adeno-associated virus-based gene therapy currently being evaluated as a one-time, potentially curative treatment to improve survival and quality of life for PKP2-ACM patients.
Fierce Pharma
JUNE 9, 2023
After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.
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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
JUNE 9, 2023
The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The new 244,000ft² facility represents Bristol Myers Squibb’s third commercial CAR T [chimeric antigen receptor T-cell] manufacturing facility in the country and the second significant expansion of its 89-acre Devens site.
Pharma Times
JUNE 9, 2023
Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma - News - PharmaTimes
Pharmaceutical Technology
JUNE 9, 2023
GSK-4406371Ais under clinical development by GSK and currently in Phase II for Rubella (German Measles).
Antidote
JUNE 9, 2023
Talk of the Towne is Antidote’s podcast that bridges the gap between clinical discussion and patient centricity, hosted by Dr. Richard Towne, PharmD, Antidote’s Senior Clinical Informatics Manager. Each episode, Talk of the Towne features a new guest from an Antidote partner organization, and takes an in-depth look at particular therapeutic areas, zeroing in on the story that our data is telling about how best to connect patients and 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
Pharmaceutical Technology
JUNE 9, 2023
The Asia-Pacific pharma industry experienced a 2% rise in new job postings in Q1 2023 compared with the previous quarter, with the highest share accounted for by Biocon with 8,387 job postings, according to GlobalData’s analysis of pharma company job postings. Buy the report here. Notably, Management Occupations jobs accounted for a 20% share of the Asia-Pacific pharma industry’s total new job postings in Q1 2023, rise 20% over the prior quarter.
XTalks
JUNE 9, 2023
Consistency is a key factor in any successful life science content marketing strategy. Maintaining consistency throughout the content you develop is essential to establish credibility and loyalty. Developing consistent content that resonates with your audience means listening to the needs of the audience, finding their pain points, responding to their questions with thoughtful pieces of content and boosting interactivity with a consistent presence.
BioSpace
JUNE 9, 2023
Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
Pharmaceutical Technology
JUNE 9, 2023
MBF-015is under clinical development by Medibiofarma and currently in Phase I for Parkinson's Disease.
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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.
Cloudbyz
JUNE 9, 2023
Cloudbyz, a global leader in digital transformation, announces an ambitious sustainability initiative that will set new standards in the technology industry and beyond. In a world where climate change threatens the very existence of life, our project aims to respond by converting barren lands into verdant, thriving forests, a testament to our commitment to the environment, regenerative agriculture, and biodiversity.
Pharma Times
JUNE 9, 2023
International data questions the assumption that chronic myeloid leukaemia is now a ‘solved’ disease - News - PharmaTimes
BioSpace
JUNE 9, 2023
The Centers for Medicare & Medicaid Services announced Friday it will impose inflation penalties on 43 Medicare Part B drugs in the third quarter of 2023. The action follows fines on 27 drugs in March.
Fierce Pharma
JUNE 9, 2023
After overhauling Amarin’s board earlier this year, activist investor Sarissa Capital has set its sights on Alkermes. | Activist investor Sarissa Capital believes Alkermes' long-time CEO Richard Pops has "far too much control" of the board. It's asking for representation after years of rejections.
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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.
BioSpace
JUNE 9, 2023
The company paid $85 million upfront to Quell Therapeutics to develop Treg therapies for Type 1 diabetes and inflammatory bowel disorder, with the deal potentially worth more than $2 billion.
pharmaphorum
JUNE 9, 2023
One size does not fit all: Why a shift is needed in how we treat depression Mike.
BioSpace
JUNE 9, 2023
The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
pharmaphorum
JUNE 9, 2023
AstraZeneca inks $2bn Treg cell therapy deal with Quell Phil.
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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 Patent Watch
JUNE 9, 2023
Annual Drug Patent Expirations for KALYDECO Kalydeco is a drug marketed by Vertex Pharms Inc and Vertex Pharms and is included in two NDAs. It is available from one supplier.… The post New patent for Vertex Pharms drug KALYDECO appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JUNE 9, 2023
Developing bold medicines to preserve vision and transform the treatment landscape for DME Mike.
Pharma Packaging Solutions
JUNE 9, 2023
Quality medical device packaging is crucial for the health and well-being of countless people all around the world. It keeps life-saving medical devices safe and secure throughout the supply chain. With such an important job to do, it’s essential that the medical device packaging you choose for your product is up to the task. Here are a few factors to take into consideration when selecting medical device packaging.
Drug Discovery World
JUNE 9, 2023
Bellerophon Therapeutics has announced it will close its Phase III study of INOpulse, its treatment for fibrotic Interstitial Lung Disease (fILD), after the trail failed to meet its primary endpoint. The REBUILD clinical trial was designed as a randomised, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of INOpulse for the treatment of patients with fILD.
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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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