Bio Pharma Dive

APRIL 28, 2023

Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

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Vaccination Vaccine 319

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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Bio Pharma Dive

APRIL 28, 2023

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

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Sales 287

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. PREVNAR 20 has been designed to avert IPD caused by 20 streptococcus pneumoniae (pneumococcal) serotypes. It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained

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Vaccination Vaccine FDA Approval Trials 147

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Clinical Supply

Medical Xpress

APRIL 28, 2023

Neuroscientists have uncovered how exploratory actions enable animals to learn their spatial environment more efficiently. Their findings could help build better AI agents that can learn faster and require less experience.

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Pharmaceutical Technology

APRIL 28, 2023

Ocugen has received orphan drug designation from the US Food and Drug Administration for its OCU410ST (AAV5-hRORA) to treat ABCA4 – linked retinopathies. OCU410ST is an adeno-associated virus (AAV) serotype 5 capsid protein, which comprises a gene construct that encodes human retinoic acid receptor (RAR)-related orphan receptor alpha. It is intended to treat ABCA4-linked retinopathies including retinitis pigmentosa 19 (RP19), Stargardt disease and cone-rod dystrophy 3 (CORD3).

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Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn. Originally granted approval in its largest market, the US, in 2017, Ozempic has subsequently obtained approval for three distinct dosages, 0.5mg, 1.0mg, and 2.

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Medical Xpress

APRIL 28, 2023

Gone are the days of dictatorial leaders in sport, screaming from the side-lines and insulting their players, and instead we are seeing an era of emotionally intelligent leaders who demonstrate an understanding of other people while getting effective results.

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Research 128

Pharmaceutical Technology

APRIL 28, 2023

An EU study claims that building more API facilities in Central and Eastern Europe could help solve drug shortages and weaknesses in the supply chain. The literature review suggests the Czech Republic, Poland, and Hungary as sites for new production locations in Europe given that their staff costs are lower than in Western Europe, but notes that higher-income countries, such as Germany, the Netherlands, and Belgium also make attractive production locations.

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Medical Xpress

APRIL 28, 2023

The National Institutes of Health (NIH) spent $187 billion for basic or applied research related to 354 of the 356 drugs approved by the FDA from 2010 to 2019, according to a new study from Bentley University's Center for Integration of Science and Industry. The study, published in JAMA Health Forum, shows that the amount invested per approved drug by the NIH is comparable to that of reported investment by the biopharmaceutical industry.

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Drugs Research 122

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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

Clinical Trials

Pharmaceutical Technology

APRIL 28, 2023

Otsuka America Pharmaceutical and Lundbeck have received approval from the US Food and Drug Administration (FDA) for a new drug application for Abilify Asimtufii (aripiprazole) to treat schizophrenia or for maintenance monotherapy treatment of bipolar I disorder in adult patients. Abilify Asimtufii is a long-acting, extended-release injectable suspension offering sustained therapeutic concentrations via one dose every two months through intramuscular injection in the gluteal muscle.

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Medical Xpress

APRIL 28, 2023

There has been widespread speculation about how advances in artificial intelligence (AI) assistants like ChatGPT could be used in medicine.

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Medicine 137

Pharmaceutical Technology

APRIL 28, 2023

Biotechnology company Therini Bio has raised $36m in a Series A financing round to develop fibrin-targeted therapies to treat neurodegenerative and retinal diseases. This brings the total amount raised by the company to date to $62m. MRL Ventures Fund, Dementia Discovery Fund, Sanofi Ventures and SV Health Investors’ Impact Medicine Fund have co-led the financing round, which has also seen participation from existing investors including Dolby Family Ventures, the Foundation for a Better World an

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Medical Xpress

APRIL 28, 2023

A new Parkinson's disease clinical trial with patients wearing laser light helmets has shown "promising results," as the therapy helped "improve motor function" for those facing the progressive neurological condition.

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Clinical Trials Clinical Trials Research Trials 111

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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

Clinical Research

Pharmaceutical Technology

APRIL 28, 2023

Tavros Therapeutics has signed a collaboration agreement with OpenBench, expanding a previous deal made in December 2021 to discover small molecule modulators of up to five oncology targets. The partnership, which streamlines drug development for new cancer therapies, will be valid for an initial period of 18 months. OpenBench will receive an upfront payment for its services.

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Drugs Development 130

Medical Xpress

APRIL 28, 2023

A new study has identified potential broad-spectrum antiviral agents that can target multiple families of RNA viruses that continue to pose a significant threat for future pandemics. The study, led by Gustavo Garcia Jr. in the UCLA Department of Molecular and Medical Pharmacology, tested a library of innate immune agonists that work by targeting pathogen recognition receptors, and found several agents that showed promise, including one that exhibited potent antiviral activity against members of

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Pharmaceutical Technology

APRIL 28, 2023

Generate Biomedicines has signed a co-development and commercialisation agreement with the University of Texas MD Anderson Cancer Center to expedite the development of new protein therapeutics for oncology using generative AI. Under the multi-year collaboration, the two parties will work together on the discovery and development of new protein therapies for up to five targets in advanced cancers, including small-cell and non-small-cell lung cancer.

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Medical Xpress

APRIL 28, 2023

Older breast cancer survivors often have other medical issues and a shorter life expectancy than younger breast cancer survivors. What's more, their cancers are often slow-growing, and surveillance may lead to over-treatment of cancers that won't kill them, researchers say.

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Research 105

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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.

Clinical Trials

Pharmaceutical Technology

APRIL 28, 2023

AbbVie has reported global net revenues of $12.23bn for the first quarter (Q1) of 2023, representing a decline of 9.7% on a reported basis and 8.3% on an operational basis from Q1 2022. During Q1 2023, net revenues from the company’s immunology portfolio fell to $5.59bn, down by 9% on a reported basis and 7.8% on an operational basis. Global net revenues from the drug Humira were $3.54bn, a 25.2% decline on a reported basis, or 24.3% on an operational basis, from the same quarter of the previous

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Drugs 130

Medical Xpress

APRIL 28, 2023

The prevalence of suicidal thoughts and behaviors increased among female high school students from 2019 to 2021, according to research published in the April 28 issue of the U.S. Centers for Disease Control and Prevention MMWR Supplements.

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Research 102

Drug Discovery World

APRIL 28, 2023

UK company Plasticell and Singapore-based LambdaGen have entered into a strategic collaboration to exploit genome editing technologies based on synthetic lambda integrases that allow specific insertion of large gene cassettes into the human genome. The UK-Singapore partnership is in part financed by a EUREKA GlobalStars competitive grant. The funding has been awarded to enable the two organisations to carry out a project – valued at £400,000 ($499,000) – which aims to create a broadly-applicable

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Medical Xpress

APRIL 28, 2023

Cystic fibrosis transmembrane conductance regulator (CFTR) modulators were a breakthrough for cystic fibrosis, improving the movement of chloride and water and moistening mucus secretions. But these drugs are expensive, don't work in all patients with cystic fibrosis, and have side effects and interactions with other drugs. People who do respond to CFTR modulators must take them for a lifetime.

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Gene Therapy Gene Regulation Drugs 107

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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.

Clinical Supply

Eye on FDA

APRIL 28, 2023

In today’s Federal Register , the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range of topics, including an assessment of terms and phrases commonly used in prescription drug promotion, studying the comprehension and understanding of multiple indications used in consumer television advertisements, and endorser status and explicit

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Research Drugs Production Development 96

Medical Xpress

APRIL 28, 2023

Even in the best of times, loneliness can contribute to psychological issues—depression, anxiety—and physical health problems whose effects on mortality rank with smoking 10-plus cigarettes a day. In the worst, like the onset of the isolating COVID-19 pandemic, that loneliness and its downstream effects can extract an even greater toll.

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Pharma Times

APRIL 28, 2023

Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis

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Medical Xpress

APRIL 28, 2023

Understanding the meaning of social interactions is an important human ability that relies on deciphering different kinds of social information. For example, perceiving body and face information, and understanding others' intentions. Through extensive social experience, adults can understand complex social scenarios with relative ease. By contrast, children must learn to master complex social abilities, and understanding how this is achieved is an important goal for developmental psychology and

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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

Pharma Times

APRIL 28, 2023

Kite’s two CAR T-Cell therapies involve treating several different types of blood cancer

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Medical Xpress

APRIL 28, 2023

Metabolic disorders play a central role in many common conditions, including Alzheimer's, depression, diabetes and cancer, which call for reliable as well as non-invasive diagnostic procedures. Until now, radioactive substances have been administered as part of the process of mapping glucose metabolism in the brain.

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Fierce Pharma

APRIL 28, 2023

EU plots major pharma reforms—but industry is already pushing back zbecker Fri, 04/28/2023 - 18:04

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Medical Xpress

APRIL 28, 2023

Rural women are six times more likely to get timely breast, cervical and colorectal cancer screening with remote outreach that involves interactive education and follow-up support by telephone, according to a new study.

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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.

Clinical Supply