Drug Discovery World

APRIL 13, 2023

The R21/Matrix-M malaria vaccine has received regulatory clearance for use in Ghana by the country’s Food and Drugs Authority, making it the first country to approve the vaccine. R21/Matrix-M was developed by the University of Oxford and manufactured and scaled up by the Serum Institute of India (SIIPL), leveraging Novavax’s adjuvant technology. The vaccine has been approved for use in children aged five to 36 months, the age group at highest risk of death from malaria.

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Drug Discovery Today

APRIL 14, 2023

Through a series of exclusive interviews and a survey of industry insiders, Connect in Pharma names the top pharmaceutical and manufacturing-related trends of 2023

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Drug Patent Watch

APRIL 13, 2023

Annual Drug Patent Expirations for ZOSYN+IN+PLASTIC+CONTAINER Zosyn In Plastic Container is a drug marketed by Wyeth Pharms and is included in one NDA. It is available from two suppliers. There… The post New patent expiration for Wyeth Pharms drug ZOSYN IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Channels

APRIL 12, 2023

In Drug Channels Institute’s list of the top 15 pharmacies of 2022 , we show that central-fill, mail pharmacies operated by large PBMs and health insurers have displaced retail chains as the largest prescription drug dispensers by revenues. To complement that broader ranking, we rummaged around our DreamHouse to update our exclusive list of the top 15 pharmacies based on specialty drug dispensing revenues in 2022.

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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.

Clinical Trials

Drug Discovery World

APRIL 11, 2023

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AstraZeneca’s Tezspire (tezepelumab). The drug is approved for use within NHS England and NHS Wales and as add-on maintenance therapy in adult and adolescent patients, 12 years and older, with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment and have had three or more exacerbations in the previous

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Antidote

APRIL 12, 2023

Every April is National Minority Health Month , organized by the U.S. Department of Health and Human Services. This month is intended to highlight the focus on improving the health of racial and ethnic minorities by reducing health disparities and increasing equal access to care.

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Drug Channels

APRIL 14, 2023

Today’s guest post comes from Edward Hensley, Chief Commercial Officer at AssistRx. Edward discusses how a technology-first approach automates manual processes for therapy initiation. He argues that such an approach can increase patient adherence, speed access to therapy, and improve the healthcare providers’ workflow. To learn about AssistRx’s technology-first solutions, click here to schedule a meeting at Asembia’s Specialty Pharmacy Summit.

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Drug Discovery World

APRIL 14, 2023

Oliver Schon, PhD, is VP Research & Development at BiVictriX Therapeutics, a UK-based emerging drug discovery and development company generating a pioneering first-in-class next-generation ADC anti-cancer therapeutics which exhibit superior selectivity towards cancer. Dr Schon is applying his broad expertise from lead discovery to manufacture in order to progress differentiated, safe and developable bi-specific therapeutic ADC candidates to clinical development.

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FDA Law Blog: Biosimilars

APRIL 13, 2023

By Larry K. Houck — Eric Idle, as a body collector, immortalized the phrase, “Bring out your dead,” in the 1975 comedy classic, Monty Python and the Holy Grail. The Drug Enforcement Administration (“DEA”) could voice a modern variation, “Bring out your meds,” as the agency and its law enforcement partners host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, April 22, 2023, from 10:00 a.m. to 2:00 p.m. local time.

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NIOSH Science Blog: Drugs

APRIL 10, 2023

As a critical part of their job, firefighters often climb aerial ladders up to 30 meters (or 98 feet) long and positioned at various angles. Aerial ladders are mechanically-operated, long, extendable ladders mounted on fire trucks and are used to reach high places for extinguishing fires and rescue operations. While climbing, firefighters typically wear heavy protective equipment and may also carry additional equipment related to fighting fires or rescuing occupants from burning buildings.

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Clinical Trials

Drug Patent Watch

APRIL 14, 2023

Annual Drug Patent Expirations for PRESTALIA Prestalia is a drug marketed by Adhera and is included in one NDA. There are two patents protecting this drug and one Paragraph IV… The post New patent expiration for Adhera drug PRESTALIA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

APRIL 14, 2023

LyGenesis and Imagine Pharma have entered into a joint research collaboration to develop novel cell therapies for patients with type 1 diabetes. The research collaboration will use Imagine Pharma’s Type 1 Diabetes Activated Islet Progenitor Cells (T1D AIPCs) and LyGenesis’ allogeneic cell therapy platform to develop therapies for type 1 diabetes.

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FDA Law Blog: Biosimilars

APRIL 10, 2023

By Larry K. Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. 21 U.S.C. § 812(b)(1). Last month bipartisan legislation, S. 689 and H. 1393 introduced in the Senate and the House, would facilitate removing barriers to research and compassionate use for schedule I co

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Cytel

APRIL 14, 2023

Real-world data and evidence are increasingly being used in health care decisions and publications. However, there are challenges in identifying suitable data for external control arms, and researchers need to consider solutions to address issues like data quality, bias, and selection bias when using real-world evidence for comparative efficacy analyses.

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Clinical Trials

Drug Patent Watch

APRIL 14, 2023

Annual Drug Patent Expirations for EYSUVIS Eysuvis is a drug marketed by Alcon Labs Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Alcon Labs drug EYSUVIS appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

APRIL 14, 2023

News round-up for 10-14 April by DDW Digital Content Editor Diana Spencer. The headlines our attention this week all represent significant breakthroughs in the treatment of various diseases and could make a huge difference to the lives of these patients. Perhaps most significantly, Ghana accepted the R21/Matrix-M malaria vaccine for use in children, Moderna revealed that cancer vaccines could be ready by 2030, and a new treatment for long Covid fatigue could be available soon.

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LifeSciVC

APRIL 14, 2023

Times remain tough for private biotech venture capital funding. Access to capital is more constrained than it’s been in years, and companies are starting to feel the pinch. Yet, despite the pain after a cycle of excess, perhaps this return towards more discipline should be embraced. As has already been widely reported , aggregate venture capital funding in the first quarter of 2023 is well off its peaks of 2020-2022.

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FDA Law Blog: Biosimilars

APRIL 12, 2023

On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C. will present a webinar entitled “ Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” John will provide participants with a greater understanding of new guidance implications, as well as recent guidance on delaying, denying, limiting, or refusing an inspection, and the DOJ’s revised Corporate Enforcement Policy, which altered the way the agency reviews corporate criminal prosecution

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Drug Patent Watch

APRIL 14, 2023

Annual Drug Patent Expirations for PHENYLEPHRINE+HYDROCHLORIDE Phenylephrine Hydrochloride is a drug marketed by Akorn, Mankind Pharma, Paragon Bioteck, Accord Hlthcare, Amneal, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd,… The post New patent for HIKMA drug PHENYLEPHRINE HYDROCHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

APRIL 14, 2023

Researchers from the University of Oxford have reported findings from a Phase II clinical trial investigating the efficacy of an investigational treatment against long Covid fatigue. The study found that participants given the treatment, AXA1125, developed by US pharmaceutical company Axcella Therapeutics, felt less fatigued than those given a placebo.

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Drug Target Review

APRIL 12, 2023

Artificial intelligence (AI) AI has seen quite a boom in the last couple of years, overcoming challenges such as limited and low-quality data. Researchers can avoid numerous delays by employing AI for drug discovery, often using computational approaches in combination with their own techniques, for a faster and smoother path to the clinic. 1 Getting to grips with what AI can do and how best to acquire and utilise its skills.

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Crown Bioscience

APRIL 12, 2023

The development of new drugs and biological products has traditionally mandated animal testing, but the FDA Modernization Act 2.0 allows for alternative non-clinical testing, allowing reliable alternatives for drug discovery and biological product applications.

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Drug Patent Watch

APRIL 13, 2023

Annual Drug Patent Expirations for ZOSYN Zosyn is a drug marketed by Wyeth Pharms and is included in two NDAs. There are three patents protecting this drug and two Paragraph… The post New patent expiration for Wyeth Pharms drug ZOSYN appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

APRIL 14, 2023

The American Association for Cancer Research (AACR) will honour the following cancer researchers, physician-scientists, advocates, and journalists during its annual meeting to be held April 14-19 at the Orange County Convention Center in Orlando, Florida. Carl H June, MD, FAACR – Lifetime Achievement in Cancer Research June, a Fellow of the AACR Academy, is the Richard W Vague Professor in Immunotherapy, Director of the Center for Cellular Immunotherapies, and Director of the Parker Institute fo

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Crucial Data Solutions

APRIL 11, 2023

RENO, Nev.–(BUSINESS WIRE)–Crucial Data Solutions (CDS), a provider of innovative technologies to advance clinical research, announced today that industry veteran. The post Jim Bob Ward Appointed as Chief Strategy Officer at eClinical Provider Crucial Data Solutions appeared first on Crucial Data Solutions.

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Crown Bioscience

APRIL 12, 2023

Although radiotherapy (also called radiation therapy ) is an important aspect of cancer treatment, it has limitations, including its potential for damaging healthy tissues, induction of radiotherapy resistance, requiring well-oxygenated tumors, and potentially increasing the risk for generating metastases. There remains an unmet need for ways to enhance radiotherapy.

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Drug Patent Watch

APRIL 13, 2023

Annual Drug Patent Expirations for EDURANT Edurant is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are four patents… The post New patent expiration for Janssen Prods drug EDURANT appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

APRIL 14, 2023

By Lucy Radley , Senior Vice President, Head of European Regulatory Development at ProPharma Group. Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. However, despite their deep importance to the wellbeing of patients, persistent inequalities continue to plague the industry, particularly in regard to the underrepresentation of diverse groups and genders in the

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Cytel

APRIL 11, 2023

Commonly used methods to handle the complexities of effect modification in indirect treatment comparisons (ITCs) often rely on the shared effect modifier (SEM) assumption, that is, that the effect modifiers impact a set of treatments in the evidence network in the same way. However, it has been argued that this assumption is limiting and often unreasonable to make.

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ACTO

APRIL 11, 2023

An insightful piece from the Life Sciences Trainers & Educators Network (LTEN) focusing on Building the Right Learning Technology Architecture sparked a conversation at ACTO about determining the value that your learning technology stack delivers and the importance of defining that correctly. In the LTEN article, Rich Baron aptly stated, “It’s not about which technology is best.

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Drug Patent Watch

APRIL 12, 2023

Annual Drug Patent Expirations for QINLOCK Qinlock is a drug marketed by Deciphera Pharms and is included in one NDA. It is available from one supplier. There are ten patents… The post New patent for Deciphera Pharms drug QINLOCK appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery World

APRIL 13, 2023

SLAS Europe has revealed details of the Biology Unveiled track at the upcoming meeting in Brussels, Belgium on May 23-26. The other three tracks are Frontiers in Technology, Shaping the Future of Therapeutics and Bio-Entrepreneurship in Europe. The Biology Unveiled track will feature scientific sessions focusing on the hot topic of personalised medicine, along with advances in the uses of CRISPR and vessels-on-a-chip.

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Advarra

APRIL 11, 2023

Effective participant recruitment is crucial to a successful clinical trial, but recruiting eligible participants in sufficient numbers has long been a challenge. As trials become more complex, and calls for appropriate diversity in participant populations increase, the problem is intensifying. Smaller sites often have the most difficulty, and fewer resources for meeting the challenges.

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Antidote

APRIL 11, 2023

Asthma is a condition that can impact anyone — and currently, it affects over 26.5 million people in the United States. In spite of available treatments, asthma is responsible for 1.3 million emergency room visits and over 3,500 deaths every year. Additionally, asthma’s impact is not evenly distributed; the condition impacts a disproportionate number of women, children, and minority populations, and has a direct correlation with an individual’s socioeconomic status.

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