Bio Pharma Dive
DECEMBER 8, 2022
As the success of drugs like Enhertu catalyzes new investment in antibody-drug conjugates, the California startup is launching with plans to develop more potent versions of the targeted cancer medicines.
Pharmaceutical Technology
DECEMBER 8, 2022
Kite Pharma and Daiichi Sankyo have updated a partnership agreement signed in 2017 for the former’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Subsequently, in the same year, Gilead Sciences acquired Kite.
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Bio Pharma Dive
DECEMBER 8, 2022
The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result.
Pharmaceutical Technology
DECEMBER 8, 2022
The US Food and Drug Administration (FDA) has granted an amendment to the Emergency Use Authorization (EUA) for Pfi z er and BioNTech’s Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for usage in children aged six months to four years. The vaccine is indicated for use as a third 3µg dose in the three-dose initial regimen for children of this age group.
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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
Bio Pharma Dive
DECEMBER 8, 2022
The big biotech is paying Entrada Therapeutics $250 million up front to grab rights to an experimental treatment for myotonic dystrophy type 1 in the latest bid to build its pipeline.
Pharmaceutical Technology
DECEMBER 8, 2022
Touchlight and Odimma Therapeutics have entered an agreement for the development and supply of clinical material for usage in the latter’s neoantigen programme for cancer. According to the agreement, Odimma will obtain access to the doggybone deoxyribonucleic acid (dbDNA) vector technology of Touchlight. . This will back and strengthen their immunotherapy cancer treatment candidate’s development.
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NPR Health - Shots
DECEMBER 8, 2022
The experimental drug lecanemab was able to slow down Alzheimer's in a large study. Many researchers think the drug will become the first to help large numbers of patients.
STAT News
DECEMBER 8, 2022
Doctors across the country, especially those in primary care, have been up in arms about Medicare’s proposed cuts in reimbursement that are scheduled to go into effect on January 1. They are concerned — rightfully so — that these cuts will be ruinous to their practices and compromise the care they can provide to their patients. As an emergency physician, I worry about the cuts for a different reason: emergency departments might soon be filled with more and more people who ca
Medical Xpress
DECEMBER 8, 2022
Florida State University College of Medicine researchers have linked aspartame, an artificial sweetener found in nearly 5,000 diet foods and drinks, to anxiety-like behavior in mice.
BioPharma Reporter
DECEMBER 8, 2022
Emmes has announced the creation of a dedicated center for cell and gene therapy research: which will focus on supporting clinical trials for the Clinical Research Organizationâs (CRO) clients.
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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
STAT News
DECEMBER 8, 2022
Ramesh Balwani, the chief operating officer of Theranos, was sentenced on Wednesday to nearly 13 years in prison for defrauding investors and patients about the company’s technology. Elizabeth Holmes, his boss, co-conspirator, and former girlfriend, was earlier found guilty of one count of conspiracy to defraud investors, as well as three wire fraud counts tied to specific investors.
NPR Health - Shots
DECEMBER 8, 2022
The decision aims to better protect the littlest kids amid an uptick in COVID-19 cases around the country. The Centers for Disease Control and Prevention is expected to sign off soon. (Image credit: Ted S.
STAT News
DECEMBER 8, 2022
The Biden administration is rolling out a new tool meant to help prevent drug deaths: a nationwide database that tracks nonfatal overdoses. The dashboard , known as the Non-Fatal Opioid Overdose Surveillance Tracker, will offer fresh insights about overdose rates, the drug supply, and the effectiveness of local emergency response efforts, the White House said.
Medical Xpress
DECEMBER 8, 2022
Babies born to Black mothers in richer countries are more likely to be stillborn or die in the first four weeks of life than those born to white women, new research has found.
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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.
STAT News
DECEMBER 8, 2022
In his latest bid to expand access to lower-cost medicines, Mark Cuban’s Cost Plus Drug Company will offer discounts directly to a company run by a coalition of 40 large private and public employers, cutting out the usual middlemen in the nation’s opaque pharmaceutical supply chain. The effort involves a partnership with the Purchaser Business Group on Health, whose members will be able to fold the medicines sold by Cuban’s company into existing health benefit plans.
pharmaphorum
DECEMBER 8, 2022
Ramesh “Sunny” Balwani, the former business partner of Theranos founder Elizabeth Holmes, has been sentenced to nearly 13 years in prison after being convicted of wire fraud. His sentencing comes after ex-Theranos chief executive Holmes was given more than 11 years in prison last month after also being found guilty of defrauding investors in Theranos, which said it had developed technology that could diagnose a host of diseases with just a few drops of blood taken with a finger prick, rather tha
Medical Xpress
DECEMBER 8, 2022
Antibodies produced against the commonly used antibiotic, gentamicin, appear to increase the risk of type 1 diabetes in children already genetically at risk, scientists say.
STAT News
DECEMBER 8, 2022
Stanford University has hired an outside law firm to lead the investigation of its president over allegations of research misconduct, a decision that comes in the wake of criticisms over potential conflicts of interest in the school’s internal review process. Mark Filip, a former federal judge and Department of Justice official who now defends white-collar clients, will lead the investigation into Stanford president Marc Tessier-Lavigne, the university said in a statement on Wednesd
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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.
Medical Xpress
DECEMBER 8, 2022
There are some benefits and potentially serious risks when people with heart failure use complementary and alternative medicines (CAM), to manage symptoms, so involving the health care team is important for safety, according to a new American Heart Association scientific statement published today in the Association's flagship, peer-reviewed journal Circulation.
STAT News
DECEMBER 8, 2022
Young women diagnosed with breast cancer often must delay pregnancy for years while they take hormone-blocking pills. A reassuring new study finds they can take a two-year break from these drugs to get pregnant without raising their short-term risk of cancer coming back.
pharmaphorum
DECEMBER 8, 2022
Just as the life sciences industry is getting vocal about how it’s faring, given the prospect of having to pay back the government 30% of NHS branded medicines sales in 2023, and as it needs to negotiate a new deal on branded medicines pricing and access that will apply from 2024 onwards – there’s been more talk about the Life Sciences Council (LSC).
Medical Xpress
DECEMBER 8, 2022
Modern Papuans' immune system likely evolved with a little help from the Denisovans, a mysterious human ancestor who interbred with ancient humans, according to a new study led by Irene Gallego Romero of the University of Melbourne, Australia, published December 8, 2022, in the open access journal PLOS Genetics.
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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.
STAT News
DECEMBER 8, 2022
Over the past few years, the biopharmaceutical industry has revved up efforts to diversify clinical trials. But clinical trials for rare diseases are still too often homogeneous. Rare disease experts at the Milken Institute Future of Health Summit on Tuesday had words of warning for biopharma: Don’t let equity efforts peter out. Pharmaceutical companies can’t keep developing trials for rare disease treatments without solving for equity, said Tamar Thompson, head of corporate affair
Medical Xpress
DECEMBER 8, 2022
Learning a new task, mastering a musical instrument or being able to adapt to the constantly changing environment are all possible thanks to the brain's plasticity, or its ability to modify itself by rearranging existing neural networks and forming new ones to acquire new functional properties. This also helps neural circuits to remain healthy, robust and stable.
STAT News
DECEMBER 8, 2022
The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older. Previously, the bivalent boosters, which protect against two different strains of the SARS-CoV-2 virus, were only available to children 5 years of age and older.
Medical Xpress
DECEMBER 8, 2022
In good news for those who don't like playing sport or going to the gym, new research finds just three to four one-minute bursts of huffing and puffing during daily tasks is associated with large reductions in the risk of premature death, particularly from cardiovascular disease.
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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.
STAT News
DECEMBER 8, 2022
WASHINGTON — The Centers of Disease Control and Prevention needs Congress to help it collect more data from state, local, and tribal public health departments, Director Rochelle Walensky said Wednesday evening. “There have been numerous pieces written about how the CDC is not sharing the data on ‘x,’ and I just say, ‘Boy, would I love to share the data on “x.
Pharmaceutical Commerce
DECEMBER 8, 2022
Stakeholders are investing heavily in their ability to curate appropriate data sets and devise advanced data-analytics capabilities to harness real-world evidence (RWE) across the entire pharma lifecycle—from drug discovery and development through product launch and commercialization.
STAT News
DECEMBER 8, 2022
Who gets dibs on in-demand medicines? Can you get a refund on an $8 billion buy? And what happens when sweetheart deals go bad? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. STAT’s Elaine Chen joins us to explain how the escalating demand for a potent diabetes drug is putting patients with obesity in a difficult situation.
Medical Xpress
DECEMBER 8, 2022
Tech companies have developed many devices that work outside the body, such as cell phones, smart watches, tablets and hundreds of others. Inside the body, though? That's obviously trickier for several reasons, but power for a device is a big one.
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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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