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 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.
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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)
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 10, 2023
Swedish Orphan Biovitrum (Sobi) has entered into a definitive agreement to buy biopharmaceutical company CTI BioPharma in an all-cash deal valued at $1.7bn. Sobi will start a tender offer through its wholly owned indirect subsidiary to buy all outstanding CTI shares for $9.10 for each share of common stock in cash. The acquisition will strengthen Sobi’s haematology medicines portfolio with the addition of CTI’s lead product Vonjo (pacritinib), a novel oral kinase inhibitor of JAK2, IRAK1 a
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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 10, 2023
Vaccines, which have been crucial to curbing the virus’ spread, will remain free for the vast majority of people in the U.S., but over-the-counter tests will no longer be covered for most.
Pharmaceutical Technology
MAY 10, 2023
Amgen will use TScan’s target discovery platform to identify potential targets for Crohn’s disease. As part of the multi-year collaboration , TScan will receive $30m upfront and a possible $500m in clinical, regulatory, and commercial milestones, in addition to royalty payments. TScan’s TargetScan identifies natural targets of T cell receptors. Amgen will use the technology to create novel therapeutics for Crohn’s disease.
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.
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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
MAY 10, 2023
Roche has acquired the worldwide rights to develop and commercialise Chinese biotechnology company Zion Pharma’s lead programme, ZN-A-1041. Roche will handle the global development, manufacturing and commercialisation activities of ZN-A-1041, after an initial transition period. Zion Pharma will receive an upfront payment of $70m, along with near-term milestone payments.
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.
Pharmaceutical Technology
MAY 10, 2023
Alvotech has signed an exclusive agreement with Polifarma to commercialise AVT06, a planned biosimilar to Eylea (aflibercept), in Turkey. Alvotech will oversee the development and production of AVT06 while Polifarma will handle the market registration and commercialisation of the biosimilar candidate. In July 2022, Alvotech commenced a trial to compare AVT06 and Eylea for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD).
Medical Xpress
MAY 10, 2023
Shortages of health workers such as doctors, nurses and midwifery staff are strongly associated with higher death rates, especially for certain diseases such as neglected tropical diseases and malaria, pregnancy and birth complications, diabetes and kidney diseases, finds an analysis of 172 countries and territories, published by The BMJ today.
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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 10, 2023
The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Farxiga (dapagliflozin) to reduce the risks of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) emergency care visits in HF adult patients. The regulator approved Farxiga in 2020 for reducing the risk of hHF and CV death in HF adult patients with reduced ejection fraction (HFrEF).
Rethinking Clinical Trials
MAY 10, 2023
Speaker Joshua C. Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.
Pharmaceutical Technology
MAY 10, 2023
Gilead Sciences has acquired biotech company XinThera in an effort to bolster its oncology and inflammation pipeline. The acquisition will give Gilead Sciences access to XinThera’s portfolio of two small molecule inhibitor programmes, one of which targets PARP1 to treat cancer and the other of which targets MK2 for inflammatory diseases. XinThera’s therapy targeting MK2 is expected to enter clinical trials later in 2023.
Medical Xpress
MAY 10, 2023
An international study led by MELIS-UPF researchers from the Infection Biology and Molecular Virology laboratories has identified and characterized Schlafen 12 (SLFN 12) as a novel HIV restriction factor. SLFN 12 shuts down viral protein production and helps virus-infected cells to escape from anti-HIV therapy and immune responses. These findings pave the way for improving therapeutic strategies that aim to cure HIV infections.
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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.
Pharmaceutical Technology
MAY 10, 2023
Innovent Biologics and Eli Lilly and Company have announced approval by the National Medical Products Administration (NMPA) of China for the supplemental New Drug Application (sNDA) for a combination therapy to treat patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor (TKI) therapy.
Medical Xpress
MAY 10, 2023
People who have sleep apnea and spend less time in deep sleep may be more likely to have brain biomarkers that have been linked to an increased risk of stroke, Alzheimer's disease and cognitive decline, according to new research published in Neurology. The study does not prove that these sleep disturbances cause the changes in the brain, or vice versa.
Antidote
MAY 10, 2023
One of the questions most frequently asked by patients is, “Do I have to pay to participate in a clinical trial?” While patients typically will not incur expenses for taking part in a research study, in some instances, they may be responsible for copays and payments towards their deductible depending on their insurance plan.
Medical Xpress
MAY 10, 2023
New research has found that the risk of long COVID is strongly associated with area-level deprivation, with the odds of having long COVID 46% higher for people from the most deprived areas, compared to those in the least deprived areas.
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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.
XTalks
MAY 10, 2023
Just ahead of having nabbed a historic approval for its respiratory syncytial virus (RSV) vaccine, GlaxoSmithKline (GSK) launched ad campaigns to promote RSV awareness, particularly among older adults. This includes the ‘Cut Short by RSV’ and ‘Sideline RSV’ campaigns launched in April and March, respectively. For its ‘Sideline RSV’ campaign, GSK teamed up with NBA legend Earvin ‘Magic’ Johnson to help raise awareness among communities about the risk RSV could pose to older adults.
Medical Xpress
MAY 10, 2023
Using a specially designed capsule, researchers can now voyage through the digestive system, collecting new data about digestion and microorganisms. The work by a team including researchers at the University of California, Davis, Stanford University and Envivo Bio Inc., is published May 10 in papers in Nature and Nature Metabolism.
XTalks
MAY 10, 2023
Mother’s Day is a time to celebrate and honor the mothers in our lives who have nurtured us and helped shape who we are today. One way to show appreciation is to support mother-owned food brands that have made a mark in the food industry. The mothers behind brands like Garden Lites and Sweet Loren’s have been able to turn their passion for food into successful businesses, creating innovative products and driving growth in the industry.
Medical Xpress
MAY 10, 2023
Scientists at Simon Fraser University (SFU) and the Lankenau Institute for Medical Research (LIMR) near Philadelphia have found that a drug discovered at SFU and patented several years ago may have potential lifesaving results in the treatment of conditions leading to sudden cardiac death.
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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.
Drug Channels
MAY 10, 2023
Yesterday’s reflections on Asembia’s Specialty Pharmacy Summit included a link to the general session slides. My portion of the deck included an updated mapping of vertical integration among insurers, PBMs, specialty pharmacies, and providers within U.S. drug channels. Many readers asked for a standalone version of this infamous chart. So, for your viewing and slide making pleasure, below you’ll find my latest illustration of the major vertical business relationships among the largest companies.
Medical Xpress
MAY 10, 2023
Researchers at the University of São Paulo (USP) in Brazil have created an exercise training program that survivors of severe COVID-19 can safely perform at home as rehabilitation therapy for persistent symptoms after they are discharged from hospital.
Pharma Times
MAY 10, 2023
Transfer marks start of vital development stage as company expands its range of synthesized DNA
Medical Xpress
MAY 10, 2023
Doctors have long stressed the importance of maintaining a healthy weight for improving overall health, but a large new study also suggests it could also reduce future gastrointestinal cancer (GI) risk.
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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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