GSK gives Wave a lift with genetic medicine deal
Bio Pharma Dive
DECEMBER 14, 2022
A four-year agreement between the companies comes with $170 million in cash and equity for Wave, which in recent years has dealt with clinical setbacks.
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GSK and Wave Life Sciences partner to develop oligonucleotide therapeutics
Pharmaceutical Technology
DECEMBER 14, 2022
GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The alliance will merge the PRISM oligonucleotide platform of Wave and the capabilities of GSK in genetics and genomics. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.
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Lilly lays out ambitious plans for 2023
Bio Pharma Dive
DECEMBER 14, 2022
Expected increases in sales and spending will be accompanied by a lengthy clinical and regulatory agenda in diabetes, obesity and Alzheimer’s disease.
Harrow agrees to acquire US rights to Novartis’ ophthalmic products
Pharmaceutical Technology
DECEMBER 14, 2022
Harrow has signed a binding agreement to acquire exclusive US commercial rights to five ophthalmic products of Novartis. These products, namely, Ilevro, Vigamox, Maxidex, Nevanac and Triesence, have received approval from the Food and Drug Administration (FDA). According to the deal, Novartis will receive a one-time payment of $130m from Harrow at closing.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Cytokinetics heart drug voted down by FDA panel
Bio Pharma Dive
DECEMBER 14, 2022
Following years of development, the biotech’s heart failure drug now faces another hurdle in its regulatory path forward, after a group of FDA advisers took issue with its trial evidence.
Takeda to acquire Nimbus Therapeutics’ allosteric TYK2 inhibitor
Pharmaceutical Technology
DECEMBER 14, 2022
Takeda has entered an agreement for the acquisition of Nimbus Therapeutics’ allosteric tyrosine kinase 2 (TYK2) inhibitor, NDI-034858. An oral therapy, NDI-034858 is being analysed to treat various autoimmune ailments. According to the deal, Nimbus will receive $4bn in upfront payment from Takeda, which will also make two milestone payments worth $1bn each upon meeting annual net sales of $4bn and $5bn.
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Syncing Menstrual Cycles With Workouts May Help With Fitness, If You Can Do It
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 14, 2022
If you’re someone who has to deal with a period regularly, you’re probably all too familiar with just how much your energy levels can change throughout your cycle thanks to hormonal fluctuations. Not only can this sometimes make even the simplest daily tasks challenging, it can make it even harder to stay motivated to keep […].
Merck and Synplogen to develop viral vector gene therapies
Pharmaceutical Technology
DECEMBER 14, 2022
Merck and Synplogen have signed a non-binding Memorandum of Understanding (MoU) to expedite the development and manufacturing of viral vector-based gene therapy applications. The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan. Under the deal, Merck will license its VirusExpress 293 Adeno-Associated Virus (AAV) Production Platform.
DBT to support multi institutional CoEs for nano-vaccines and nano-adjuvants development
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 14, 2022
The Department of Biotechnology (DBT) is extending support to the institutions and scientists to set up Centres of Excellence in the country for nano-vaccines and nano-adjuvants, to treat cancer and other diseases.The Department has invited Letters of Intent (LoIs) for ‘Setting up of CoE in Nano-Vaccines & Nano-Adjuvants’ for a period of five years for […].
Bacteriophages: the viruses that can actually be good for you
Pharmaceutical Technology
DECEMBER 14, 2022
As the UK tackles a significant number of Strep A infections among children in the final months of 2022, the topic of antimicrobial resistance (AMR), has once again been brought to the fore. By 2050, AMR is expected to become one of the leading causes of death worldwide, causing up to 10 million deaths per year by 2050 according to the World Health Organization (WHO).
The New Age of Decentralized Clinical Trials
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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
December 14, 2022: This Friday’s PCT Grand Rounds Highlights EHR-Based Clinical Decision Support for Prevention of Thromboembolism
Rethinking Clinical Trials
DECEMBER 14, 2022
In this Friday’s PCT Grand Rounds, Alex Spyropoulos and Jeffrey Solomon of the Feinstein Institutes for Medical Research will present “The Use of EHR-Agnostic Clinical Decision Support to Prevent Thromboembolism in Hospitalized Medically Ill Patients.” The Grand Rounds session will be held on Friday, December 16, 2022, at 1:00 pm eastern.
Opinion: Hospice care needs saving
STAT News
DECEMBER 14, 2022
Hospice in America is gravely ill. An extensive investigation jointly published by The New Yorker and ProPublica documented outright fraud, predatory practices, and flagrant mistreatment by specific publicly traded and private equity-owned hospice companies.
Trial on safety and immunogenicity of Ebola vaccines yields promising results
Medical Xpress
DECEMBER 14, 2022
Ebola epidemics occur periodically in various sub-Saharan African countries. While vaccines exist and have already received WHO Prequalification against the Zaire ebolavirus species, it is essential to pursue and intensify efforts to supplement the available data to develop a safe and effective Ebola vaccine strategies in adults and children alike.
STAT+: Nine in 10 health care companies with financial stress are owned by private equity
STAT News
DECEMBER 14, 2022
Almost 90% of the health care companies deemed to be under financial stress by a leading credit rating agency are owned by private equity , a stark indicator of the toll financial investors have taken on a vital sector. The striking finding is part of a new Moody’s Investors Service report released this week that shows broad turbulence throughout an industry weakened by private equity’s practice of loading companies with debt, making them less resilient to challenges like Covid-19,
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Lessons from Germany to help solve the U.S. medical debt crisis
NPR Health - Shots
DECEMBER 14, 2022
What would a world without medical debt look like? In Germany's former coal-mining region medical debt is almost unknown, despite economic challenges and health problems. Here's why.
Grand Rounds Ethics and Regulatory Series December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)
Rethinking Clinical Trials
DECEMBER 14, 2022
. Speakers. Monica Taljaard, PhD. Senior Scientist, Clinical Epidemiology Program. Ottawa Hospital Research Institute. Full Professor, Epidemiology and Community Medicine. University of Ottawa. David Magnus, PhD. Thomas A. Raffin Professor of Medicine and Biomedical Ethics and Professor of Pediatrics, Medicine, and by courtesy of Bioengineering.
Tips to keep you and your family safe from the tripledemic during the holidays
NPR Health - Shots
DECEMBER 14, 2022
NPR asked a handful of public health experts how to approach a holiday season with not one but three respiratory pathogens helping fill hospitals: COVID, the flu and RSV. (Image credit: Mark J.
Hundreds of incarcerated people are dying of hep C — even though we have a simple cure
STAT News
DECEMBER 14, 2022
FALLS CITY, Neb. — John Ritchie shouldn’t have died. He knew he had hepatitis C. And he knew, too, about the simple, once-daily pills that could fully cure him of the potentially deadly viral infection in about 12 weeks.
The New Age of Decentralized Clinical Trials
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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.
Public health experts urge US health officials to correct e-cigarette misinformation
Medical Xpress
DECEMBER 14, 2022
Leading e-cigarette researchers are urging the U.S. Centers for Disease Control & Prevention (CDC) to correct misinformation overstating the dangers of e-cigarettes as part of its "Moving Forward" initiative.
Despite federal disclosure rules, state prisons hide information on hepatitis C-related deaths
STAT News
DECEMBER 14, 2022
It’s virtually impossible to get information from states and correctional facilities about why people die in prison. For more than two years, STAT endeavored to document the number of incarcerated people who died due to complications from hepatitis C, part of a broad investigation into prisons’ failures to prevent avoidable death and suffering related to the condition.
Potential new treatment for 'brain fog' in long COVID patients
Medical Xpress
DECEMBER 14, 2022
Individuals with long COVID, sometimes referred to as "long-haulers," experience symptoms that may persist for weeks, months, or even years after their acute viral infection. While symptoms vary widely, a common complaint among patients is "brain fog"—a colloquial term for significant, persistent cognitive deficits, with consistent impairment of executive functioning and working memory.
Legal and medical experts say denying hepatitis C care is cruel and unusual punishment, but the courts are still catching up
STAT News
DECEMBER 14, 2022
The final years of Carl Hoffer’s life were, in his words, “living hell.” His legs were so swollen they’d crack and leak white fluid. When he was hospitalized in August 2016, hospital staff used a needle to drain 7 liters of fluid from his abdomen.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
More exercise linked to less-severe COVID-19 outcomes
Medical Xpress
DECEMBER 14, 2022
Kaiser Permanente members who were more physically active prior to being diagnosed with COVID-19 had a lower risk of severe outcomes, according to research published Dec. 15, 2022, in the American Journal of Preventive Medicine.
How did COVID warp our sense of time? It's a matter of perception
NPR Health - Shots
DECEMBER 14, 2022
Many people reported a distortion in their sense of time during the pandemic, but the individual experience is highly dependent on a range of factors from emotional state to culture.
Health virtual reality startups BehaVR and OxfordVR merge
pharmaphorum
DECEMBER 14, 2022
Two virtual reality startups operating in the health category – BehaVR and OxfordVR – have agreed to pool their efforts on the development of digital therapeutics (DTx) for mental illnesses via a merger. The combined company will operate under the BehaVR brand, and starts operations with a $13 million cash injection from a Series B financing led by Oxford Science Enterprises and Optum Ventures with participation from Confluent Health, Accenture Ventures, Chrysalis Ventures, and Thornton Capital.
These 8 states are doing the worst job of treating hepatitis C in prisons
STAT News
DECEMBER 14, 2022
In 2022, whether an incarcerated person gets cured of hepatitis C is largely determined by where they’re locked up. If you’re sentenced for breaking a state law in most of middle America, you’re likely out of luck. Iowa treated less than 4% of its hepatitis C-positive prison population last year with the new class of curative antiviral pills.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Competition is on the horizon for costly narcolepsy treatments
pharmaphorum
DECEMBER 14, 2022
People who live with narcolepsy — about one out of every 2,000 Americans — don’t have many options when it comes to treatment. The milder form of narcolepsy includes symptoms of excessive daytime sleepiness and can be treated with a stimulant like Provigil, Adderall, or Dexedrine in order to get people through their day. In addition to excessive daytime sleepiness, up to 60% of narcolepsy cases include cataplexy, which is a sudden loss of muscle control.
Watch: With little more than a typewriter, an Idaho man overturns the entire state’s policy on hepatitis C treatment in prison
STAT News
DECEMBER 14, 2022
BOISE, Idaho — When he took on the state department of corrections, Phil Turney didn’t have a computer, let alone internet access. For two weeks, hunched around bankers boxes in the Idaho State Correctional Center’s multipurpose room, he toiled on his Smith Corona Wordsmith 200 typewriter, lifting legalese from a copy of the Prisoner’s Self-Help Litigation Manual and an earlier lawsuit in Minnesota.
Tips to keep you and your family safe from the tripledemic during the holidays
NPR Health - Shots
DECEMBER 14, 2022
NPR asked a handful of public health experts how to approach a holiday season with not one but three respiratory pathogens helping fill hospitals: COVID, the flu and RSV. (Image credit: Mark J.
For families, grieving an incarcerated person’s death adds complexity to an already painful process
STAT News
DECEMBER 14, 2022
PLEASANTON, Texas — The only thing worse than caring for a sick loved one in prison is watching them die of a treatable condition, like hepatitis C. Families feel helpless as the symptoms escalate — the swelling, the jaundice, the confusion — all from an infection they know could be cured with a short course of treatment with a pill, if only he or she wasn’t incarcerated.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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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