Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.
Bio Pharma Dive
MAY 19, 2023
The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.
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Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Whilst there is a range of FDA-approved biologics for Crohn’s disease, Rinvoq is the first approved oral product for the moderate to severe type of the disease.
Bio Pharma Dive
MAY 19, 2023
The panel voted 14-0 that Pfizer’s data showed its shot to be effective. The vaccine could be the first for protecting infants by maternal immunization.
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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
MAY 19, 2023
Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Led by Hatteras Investment Partners, the financing round has seen participation from existing investors, including 8VC, Alexandria Venture Investments and Newpath Partners, along with new investors Moore Strategic Ventures and ARCH Venture Partners.
Rethinking Clinical Trials
MAY 19, 2023
Speaker Richelle J. Koopman, MD, MS Jack M. and Winifred S. Colwill Professor and Vice Chair Department of Family and Community Medicine University of Missouri Slides Keywords Electronic Health Record, Pragmatic Clinical Trial Key Points Patients bring patient-generated home blood pressure data into the clinical workflow.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
MAY 19, 2023
Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25
Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The new investigational therapeutic product candidate STS101 is a nasal powder formulation of dihydroergotamine mesylate (DHE), an anti-migraine drug, which is given through the company’s nasal delivery device.
Fierce Pharma
MAY 19, 2023
Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30
Pharmaceutical Technology
MAY 19, 2023
The US Supreme Court has unanimously voted in favour of Sanofi and Regeneron in a years-long legal feud with Amgen over the potential patent infringement surrounding the companies’ anti-cholesterol drugs. This marks a milestone in the dispute nearly a decade after the first lawsuit filed by Amgen against the two companies. After previously receiving the arguments from both companies on March 27, the Supreme Court delivered its verdict on May 18.
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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
Fierce Pharma
MAY 19, 2023
AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21
Pharmaceutical Technology
MAY 19, 2023
Alimera Sciences has acquired the US commercialisation rights for Yutiq (fluocinolone acetonide intravitreal implant) 0.18mg from EyePoint Pharmaceuticals. Yutiq is indicated to treat chronic, non-infectious uveitis that affects the posterior segment of the eye. It received approval from the US Food and Drug Administration in October 2018. Alimera Sciences has exclusive global rights to Yutiq excluding Southeast Asia, Hong Kong, Macau, China and South Korea, where the therapy was previously lice
Fierce Pharma
MAY 19, 2023
Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39
Pharmaceutical Technology
MAY 19, 2023
SiteOne Therapeutics has received a $15m grant from the National Institute on Drug Abuse (NIDA) to develop the investigational selective NaV1.8 inhibitor, STC-004, as a non-opioid therapeutic for acute and chronic pain conditions. The funding was awarded through the National Institutes of Health’s (NIH) Helping to End Addiction Long-term Initiative (NIH HEAL), a trans-agency effort for the development of scientific solutions to the US national opioid public health crisis.
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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.
Drug Discovery World
MAY 19, 2023
Pancreatic cancer cells can change their ‘diet’ to keep growing, by switching from the sugar glucose to a back-up fuel called uridine, new research has revealed. The findings suggest that blocking the availability of uridine using new drugs could become a new treatment strategy for the most common and aggressive form of pancreatic cancer. The researchers believe uridine could help fuel other cancers too – such as lung, stomach and brain cancer.
Pharmaceutical Technology
MAY 19, 2023
OncoResponse has secured a $13m grant from the Cancer Prevention and Research Institute of Texas (CPRIT) and raised an additional $14m in funding from investors for advancing OR502 to investigational new drug (IND) and clinical trials. The $14m funding initiative was led by RiverVest Venture Partners and also included Takeda Ventures, 3B Future Health Fund, ARCH Venture Partners, Canaan Partners, Bering Capital and InterVest.
XTalks
MAY 19, 2023
Clinical trials play a vital role in advancing patient treatment and medical care. Their significance continues to rise as our understanding of diseases expands. This article delves into ten trends and statistics in the world of clinical trials for 2023. And don’t forget to explore the upcoming webinars about clinical trials on Xtalks to see what piques your curiosity about the latest clinical trial solutions. 1.
Pharmaceutical Technology
MAY 19, 2023
ImmunoForge has expanded its licence agreement with Duke University in North Carolina, US, to jointly improve research and drug development opportunities. ImmunoForge will expedite the development of new drugs based on the elastin-like polypeptide (ELP) platform technology originally developed by Duke’s Professor Ashutosh Chilkoti. ImmunoForge chief technology officer Dr Jim Balance pioneered the clinical development of peptide drugs genetically fused to ELPs.
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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.
Pharma Times
MAY 19, 2023
Screening patients to assess their clopidogrel resistance status will allow for alternative treatments
Pharmaceutical Commerce
MAY 19, 2023
Document reveals that 20 of 28 of participating Big Pharma manufacturers saw their DIO increase by an average of 5%, suggesting that large amounts of inventory do not necessarily offer protection from running low on medication.
Pharma Times
MAY 19, 2023
Treatment concerns up to 150,000 patients in England with chronic heart failure
pharmaphorum
MAY 19, 2023
Epiphany moments in an industry starved of insights Mike.
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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.
Outsourcing Pharma
MAY 19, 2023
With an increase in clinical studies demanding an increase in CRAs, we spoke to Sara Brannon, director of quality and training development, at ICON, to find out their approach to recruiting and how the industry is suffering due to a global shortage because of the demand for experienced associates.
pharmaphorum
MAY 19, 2023
Teva is eyeing $2.5bn in Austedo sales in 2027 Phil.
The Pharma Data
MAY 19, 2023
ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s TactiFlex™ Ablation Catheter, Sensor Enabled™ , the world’s first ablation catheter with a flexible tip and contact force technology.
Drug Patent Watch
MAY 19, 2023
Annual Drug Patent Expirations for PROMACTA+KIT Promacta Kit is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are three patents… The post New patent expiration for Novartis drug PROMACTA KIT appeared first on DrugPatentWatch - Make Better Decisions.
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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.
The Pharma Data
MAY 19, 2023
Seventy-sixth World Health Assembly to focus on “saving lives, driving health for all” as WHO turns 75 As the world faces ongoing health and humanitarian emergencies, the Seventy-sixth World Health Assembly will focus on driving forward health for all. This year’s session of the World Health Assembly will determine the immediate and longer-term future of WHO, starting with the program budget for the next two years, key decisions about the sustainable financing of the Organization and changes put
Drug Patent Watch
MAY 19, 2023
Annual Drug Patent Expirations for LYNPARZA Lynparza is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are eleven patents protecting… The post New patent for Astrazeneca drug LYNPARZA appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
MAY 19, 2023
HIGH SCHOOL SCIENTISTS AND ENGINEERS WIN NEARLY $9 MILLION AT THE REGENERON INTERNATIONAL SCIENCE AND ENGINEERING FAIR 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN ) and Society for Science (the Society) announced that Kaitlyn Wang, 17, of San José, CA, won the $75,000 top award in the 2023 Regeneron International Science and Engineering Fair (Regeneron ISEF), the world’s largest global pre-college science and engineering competition, for a project that explored planets that orbit very clo
Drug Patent Watch
MAY 19, 2023
Annual Drug Patent Expirations for PROMACTA Promacta is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eight patents protecting… The post New patent expiration for Novartis drug PROMACTA appeared first on DrugPatentWatch - Make Better Decisions.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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