Bio Pharma Dive
MAY 7, 2023
Patient advocates and doctors are anticipating an approval this month of a treatment they believe to be a breakthrough for a deadly disease. But it’s not clear how well the therapy really works, putting the FDA in a difficult position.
Pharmaceutical Technology
MAY 11, 2023
Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez
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Medical Xpress
MAY 10, 2023
Air pollution has been shown to have a negative effect on the prognosis of ischemic stroke, or stroke caused by reduced blood flow to the brain, but the exact mechanism is unknown. A team of researchers recently conducted a study to determine whether or not increased inflammation of the brain, also known as neuroinflammation, is the main culprit.
Rethinking Clinical Trials
MAY 11, 2023
A new article from the NIH Pragmatic Trials Collaboratory outlines stakeholder insights and ethical considerations related to sharing deidentified, participant-level data in pragmatic clinical trials. While there are numerous arguments for and against data sharing in the context of pragmatic trials, the report aims to address the gap in documented stakeholder perspectives.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Bio Pharma Dive
MAY 10, 2023
The companies’ personalized shot generated tumor-specific T cells that researchers hope could help prevent pancreatic cancer from returning after surgery.
Pharmaceutical Technology
MAY 9, 2023
In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f
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Pharma Mirror
MAY 10, 2023
Unlike compressor-based systems and cryovats, liquid nitrogen freezers safely deliver temperature-controlled freezing down to -160°C in minutes to preserve drug products, active ingredients, and biological samples For decades, the pharmaceutical industry has relied on compressor-based systems to freeze drug products, active ingredients, vaccines, protein biologics, and biospecimens in all phases from research and development to storage, transport, and manufacturing.
Bio Pharma Dive
MAY 12, 2023
Advisers voted 8-6 in favor of an accelerated approval despite uncertainty around the treatment’s benefit. The agency is set to make a final decision by May 29.
Pharmaceutical Technology
MAY 10, 2023
Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. A jury in the Delaware District Court gave a favourable verdict to the Foster City, California-headquartered company, concluding that Gilead did not infringe any of the US government’s patents.
Medical Xpress
MAY 9, 2023
Maynooth University's Kathleen Londsdale Institute for Human Health Research has just published research into the benefits of the popular obesity treatment drug, GLP-1.
Rethinking Clinical Trials
MAY 10, 2023
In this Friday’s PCT Grand Rounds, Richelle Koopman of the University of Missouri will present “Design and Pragmatic Trial of COACH: A Patient Portal/EHR Information System for Home Blood Pressure Monitoring in Hypertension.” The Grand Rounds session will be held on Friday, May 12, 2023, at 1:00 pm eastern. Dr. Koopman is professor and vice chair for research and faculty affairs in family and community medicine and the Jack M. and Winifred S.
Bio Pharma Dive
MAY 10, 2023
Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.
Pharmaceutical Technology
MAY 10, 2023
Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients. SYNB1934 consumes Phe in the gastrointestinal (GI) tract by leveraging genetic engineering of the drug or drug-carrying capsule, probiotic escherichia coli (E coli)
Medical Xpress
MAY 12, 2023
Researchers from Uppsala University have developed a method that helps immune cells exit from blood vessels into a tumor to kill cancer cells. The goal is to improve treatment of aggressive brain tumors. The study has been published in the journal Cancer Cell.
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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 10, 2023
Eli Lilly damages tripled to $184M in Medicaid rebate fraud case fkansteiner Wed, 05/10/2023 - 10:25
Bio Pharma Dive
MAY 8, 2023
The company agreed to buy Cyclica and Valence after winnowing down a list of more than 100 potential takeover targets, its CEO told BioPharma Dive.
Pharmaceutical Technology
MAY 9, 2023
Ginkgo Bioworks and Boehringer Ingelheim have collaborated to develop breakthrough therapies for hard-to-treat diseases. The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs. They will also use the metagenomic sequence database of Ginkgo Bioworks which comprises more than three terabases of sequence data and over two billion protein sequences fr
Medical Xpress
MAY 11, 2023
Blood plasma is collected from people routinely during clinical care and for research. It is potentially a rich source of protein biomarkers for diagnostic and prognostic purposes, for measuring response to treatment, and for revealing disease biology. Yet identifying such biomarkers in plasma with proteomics, our best available tool, has been a challenge: 99% of plasma consists of everyday proteins like albumin, globulins, and coagulants that essentially crowd out the needle-in-a-haystack prote
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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.
Fierce Pharma
MAY 11, 2023
Sanofi, AstraZeneca strengthen case for RSV antibody with data from real-world trial kdunleavy Thu, 05/11/2023 - 15:23
Bio Pharma Dive
MAY 10, 2023
While some see the new donanemab results as adding to a “watershed moment” in Alzheimer’s research, others say they reinforce the limitations of so-called anti-amyloid therapies.
Pharmaceutical Technology
MAY 12, 2023
The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. Blood cancer patients with E coli infection are at risk of bacteria infecting the bloodstream. An E coli infection can be fatal in these cases, with a 15-20% mortality rate.
Medical Xpress
MAY 11, 2023
Using new genetic tools to study statins in human cells and mice, Stanford Medicine researchers and collaborators have uncovered how the cholesterol-lowering drugs protect the cells that line blood vessels.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Fierce Pharma
MAY 12, 2023
As pharma fights IRA, Senate moves forward basket of bills aimed at lower drug prices aliu Fri, 05/12/2023 - 10:48
Bio Pharma Dive
MAY 8, 2023
Launched in 2020 with a "radical" vision, EQRx ran into roadblocks that stymied its efforts to develop new medicines and undercut competitors on price.
Pharmaceutical Technology
MAY 12, 2023
Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. The EHA Hybrid Congress will take place on June 8-11 in Frankfurt, Germany. Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease.
Medical Xpress
MAY 11, 2023
Ischemic stroke, caused by a blockage of blood flow to the brain, is a common cause of death and disability. Treatments are urgently needed to improve patient outcomes, because recovery currently depends largely on the timely injection of a blood clot-dissolving drug. Priorities for therapy include limiting inflammation at the ischemic site and rebuilding neuronal connections damaged by the stroke.
Fierce Pharma
MAY 11, 2023
After Shkreli's run in with the law, Pharma Bro's former company Vyera files for bankruptcy fkansteiner Thu, 05/11/2023 - 11:06
Bio Pharma Dive
MAY 8, 2023
The pharmaceutical CDMO said it found “significant” issues with its forecasts over the past year, compounding manufacturing problems at three of its plants.
Pharmaceutical Technology
MAY 12, 2023
Takeda has reported a 12.8% increase in its reported revenue to $29.96bn (Y4,027bn) during the fiscal year 2022 (FY2022) compared to that reported in FY2021. At a constant exchange rate (CER), the company’s core revenue grew by 3.5% compared to the previous year. In the FY2022 ending 31 March 2023, the company also reported a 6.4% rise in its operating profit to $3.65bn (Y490.5bn) compared to 2021.
Medical Xpress
MAY 11, 2023
Genomic studies of cancer patients have revealed thousands of mutations linked to tumor development. However, for the vast majority of those mutations, researchers are unsure of how they contribute to cancer because there's no easy way to study them in animal models.
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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.
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