Pharmaceutical Technology
JUNE 13, 2023
Beacon Therapeutics has kickstarted its entry into the gene therapy field with a $120m Series A financing. The British investment trust Syncona Limited launched the new ophthalmic gene therapy company by combining Applied Genetic Technologies Corporation’s (AGTC’s) late-stage X-linked retinitis pigmentosa (XLRP) programme with two proprietary preclinical programmes.
Bio Pharma Dive
JUNE 13, 2023
In a sign of the impact the downturn has had on young biotechs, Turnstone Biologics, a former partner of Takeda and AbbVie, is seeking an IPO while acknowledging there is “substantial doubt” it can survive.
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Pharmaceutical Technology
JUNE 13, 2023
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.
Bio Pharma Dive
JUNE 13, 2023
Three board members — Alex Denner, William Jones and Richard Mulligan — will not stand for re-election. Susan Langer, who was previously the company’s head of corporate strategy, has been nominated to fill one of their seats.
Pharmaceutical Technology
JUNE 13, 2023
The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). ViXome is an acellular product derived from amniotic fluid. It comprises a heterogeneous population of growth factors, exosomes, cytokines, microRNAs and chemokines. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 13, 2023
A group of researchers at the Kolkata-based S N Bose National Centre for Basic Sciences has developed non-invasive method of recognising breath patterns that can help rapid, one-step diagnosis and classification of various gastric disorders like dyspepsia, gastritis, and gastroesophageal reflux disease (GERD).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 13, 2023
Spanish Prime Minister Pedro Sánchez has called a snap general election for 23 July, throwing several significant health reform initiatives into doubt. A general election had not been expected until December, but disastrous results for the ruling Socialist Workers’ Party (PSOE) in May’s local elections prompted Sánchez to go for an “all or nothing” gamble, betting that early elections will deprive the opposition of time to organise possible coalition partners.
Rethinking Clinical Trials
JUNE 13, 2023
Wendy Weber, ND, PhD, MPH On May 16-17, 2023, over 100 members of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, for its annual Steering Committee meeting—an opportunity to network and hold rich discussions on key issues related to pragmatic research. In an interview with Wendy Weber, NIH Project Officer, and Lesley Curtis, co-principal investigator of the Coordinating Center, the pair reflected on the state of the field and opportunities for the program to further contribute.
Pharmaceutical Technology
JUNE 13, 2023
Novo Nordisk has unveiled plans to make a DKr15.9bn ($2.29bn) investment , starting from 2023, to expand its manufacturing facilities in Hillerød, Denmark. The new investment will create additional production capacity, increase the company’s capacity to meet future demand and enable the development of its future clinical late-phase product portfolio.
Pharma Times
JUNE 13, 2023
525-patient trial intends to assess ‘complement activation’ during HD in patients with end stage renal failure - News - PharmaTimes
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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 13, 2023
Idorsia has launched Quviviq (daridorexant) in Switzerland to treat chronic insomnia disorder in adult patients. The move follows the receipt of marketing authorisation from Swissmedic in December 2022. Quviviq is a dual orexin receptor antagonist that blocks the orexin receptors’ activation, which leads to wakefulness, instead of inducing sleep through broad inhibition of brain activity (sedation).
Fierce Pharma
JUNE 13, 2023
Biogen has taken a step to “significantly refresh” its board of directors, departing chair Stelios Papadopoulos, Ph.D., said. | Biogen has taken a step to “significantly refresh” its board of directors, departing chair Stelios Papadopoulos, Ph.D., said. But the reported romantic relationship between a new nominee and a departing member raises questions about one appointment.
Pharmaceutical Technology
JUNE 13, 2023
The US Food and Drug Administration (FDA) has granted approval for Ironwood Pharmaceuticals’ LINZESS (linaclotide) as a once-a-day treatment for functional constipation in paediatric patients aged between six and 17 years. Developed and marketed by AbbVie and Ironwood in the US, LINZESS was previously approved to treat irritable bowel syndrome with constipation or chronic idiopathic constipation in adult patients.
BioPharma Reporter
JUNE 13, 2023
Following its latest funding round, Rosa Biotech has announced plans to accelerate development of its bio-sensing technology, designed to enable cost effective screening of a range of diseases with high accuracy at an early stage.
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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 13, 2023
The United States Patent and Trademark Office (USPTO) has issued a notice of allowance for Windtree Therapeutics’ patent application covering a group of SERCA2A [a key protein in the cycle of heart failure] activators with a dual mechanism. The company stated that the family of drug candidates of SERCA2a activators has similar mechanisms of action to those of istaroxime, a first-in-class dual mechanism therapy.
BioSpace
JUNE 13, 2023
The biotech company is collaborating with Israel’s NeuroSense to study how the latter’s amyotrophic lateral sclerosis candidate affects plasma neurofilament levels in patients.
Fierce Pharma
JUNE 13, 2023
After Ipsen made a splash at this year's J.P. | After Ipsen made a splash at this year's J.P. Morgan Healthcare Conference by scooping up liver disease specialist Albireo, the centerpiece of the buyout, Bylvay, has won a coveted label expansion.
Drug Channels
JUNE 13, 2023
Time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. This year’s review includes the following 10 companies: Eli Lilly and Company, Genentech, GlaxoSmithKline, Janssen, Merck, Novartis, Novo Nordisk, Sanofi, Takeda, and UCB. You can find links to each company’s data below. When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2022.
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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.
Fierce Pharma
JUNE 13, 2023
As Amgen and Horizon pursue their $27.8 billion merger, they're facing off against the U.S. Federal Trade Commission and its lawsuit to block the deal. | As the FTC seeks to block Amgen's $28 billion buyout of Horizon with a lawsuit, the two companies have fired back with a response that says the agency's accusations are "simply made up.
BioSpace
JUNE 13, 2023
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
Fierce Pharma
JUNE 13, 2023
By: William Blake, Chief Technology Officer, Human-Based R&D | Danaher Life Sciences companies are ushering in a new era of engineering biology, partnering with biopharma leaders to deploy automation, AI and other engineering practices from early research through manufacturing.
BioSpace
JUNE 13, 2023
The biopharma company’s plan to issue and sell $100 million of shares of its common stock comes just days after releasing late-breaking Phase I/II data for menin inhibitor ziftomenib.
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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.
Cloudbyz
JUNE 13, 2023
1.Introduction: Clinical trials are essential for evaluating the safety and efficacy of new medical treatments, therapies, and interventions. Developing an accurate and comprehensive budget is crucial for successful trial planning and execution. This report explores the considerations and best practices involved in developing clinical trial budgets. 2.Key Considerations 2.1 Protocol Complexity: The complexity of the clinical trial protocol plays a significant role in determining the budget.
BioSpace
JUNE 13, 2023
The pendulum has swung back in favor of employees, and employers are struggling to retain employees as workers become less engaged.
pharmaphorum
JUNE 13, 2023
Has a biosimilar tipping point been achieved in the US? Mike.
BioSpace
JUNE 13, 2023
The industry, seen as a lucrative target, has been victim of more and more cybersecurity breaches since the start of the COVID-19 pandemic.
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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.
Trialfacts
JUNE 13, 2023
Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center: Study Location Research Center: ACRC Trials Location: Village Health Partners-8080 Independence Pkwy, Suite 200, Plano, TX 75025 Lead Researcher: Madhavi Ampajwala, M.D. IRB: This study has been reviewed and approved by the Advarra Institutional Review Board About the Study Cytomegalovirus, commonly known as CMV, is the most common viral infection that is passed from mother to
BioSpace
JUNE 13, 2023
The cell therapy company said Seattle Children’s, its partner, paused the Phase I trial for acute myeloid leukemia after a recent Grade 5 (fatal) serious adverse event. The cause is under investigation.
Drug Patent Watch
JUNE 13, 2023
Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are eight patents… The post New patent for Sun Pharm drug WINLEVI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
JUNE 13, 2023
Cellular Origins, a company focused on enabling scalable, cost-effective and space-efficient manufacture of cell and gene therapies (CGTs), has launched Constellation, its closed, configurable, robotic platform at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting 2023. Designed to automate the manufacturing of advanced therapies without significant process redevelopment, Constellation combines aseptic fluid handling technologies with advanced automation from the indust
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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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