First-of-its-kind Type 1 diabetes drug wins FDA approval
Bio Pharma Dive
NOVEMBER 18, 2022
Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes. To be sold as Tzield, the drug will cost $193,900 for a typical full regimen.
Fri.Nov 18, 2022
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EC approves BeiGene’s chronic lymphocytic leukaemia therapy
Pharmaceutical Technology
NOVEMBER 18, 2022
The European Commission (EC) has approved BeiGene’s Brukinsa (zanubrutinib) to treat chronic lymphocytic leukaemia (CLL) in adult patients. The small-molecule Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa has been approved to treat treatment-naïve (TN) or relapsed/refractory (R/R) CLL in adult patients. It was specifically designed to provide targeted and sustained BTK protein inhibition by optimising bioavailability, selectivity, and half-life.
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FDA approves Rezvoglar as second ‘interchangeable’ insulin biosimilar
Bio Pharma Dive
NOVEMBER 18, 2022
Eli Lilly’s long-acting copycat drug, first approved in late 2021, now has a designation that will allow pharmacists to swap it for Sanofi’s Lantus.
Regeneron and CytomX partner to develop bispecific cancer therapies
Pharmaceutical Technology
NOVEMBER 18, 2022
Regeneron Pharmaceuticals has entered a collaboration and licensing agreement with CytomX Therapeutics for developing conditionally-activated bispecific cancer therapies. Under the deal, the companies will work together on the discovery activities for identifying and validating the conditionally active bispecific antibodies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.
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
Holmes gets more than 11 years in prison for Theranos scam
STAT News
NOVEMBER 18, 2022
A federal judge on Friday sentenced disgraced Theranos CEO Elizabeth Holmes to more than 11 years in prison for duping investors in the failed startup that promised to revolutionize blood testing but instead made her a symbol of Silicon Valley’s culture of audacious self-promotion. The sentence imposed by U.S. District Judge Edward Davila was shorter than the 15-year penalty requested by federal prosecutors but far tougher than the leniency her legal team sought for the mother of a year-o
He started protesting about his middle school principal. Now he's taking on Big Oil
NPR Health - Shots
NOVEMBER 18, 2022
This year, Chima Williams of Nigeria was a winner of the Goldman Environmental Prize for his activism, targeting Shell for an oil spill in his homeland. Here's how the case went.
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Flying toilets! Sobering stats! Poo Guru's debut! Yes, it's time for World Toilet Day
NPR Health - Shots
NOVEMBER 18, 2022
November 19 is World Toilet Day, created by the U.N. in 2013. At issue: Billions of people do not have access to a safe toilet. But how do you get the world to pay attention to this forgotten problem?
STAT+: Biosplice, once the most valuable biotech startup, sees a pair of osteoarthritis trials fail
STAT News
NOVEMBER 18, 2022
Biosplice’s bid to transform the treatment of everything from arthritis to cancer ran into a snag this week, with the San Diego biotech announcing that its experimental osteoarthritis drug failed to benefit patients in a pair of Phase 3 clinical trials. The results, presented at the American College of Rheumatology conference in Philadelphia, show that the small-molecule drug lorecivivint failed to significantly soothe the pain of osteoarthritis patients.
Down syndrome, like Alzheimer's, is a double-prion disorder
Medical Xpress
NOVEMBER 18, 2022
The brains of people with Down syndrome develop the same neurodegenerative tangles and plaques associated with Alzheimer's disease and frequently demonstrate signs of the neurodegenerative disorder in their forties or fifties. A new study from researchers at UC San Francisco shows that these tangles and plaques are driven by the same amyloid beta (Aß) and tau prions that they showed are behind Alzheimer's disease in 2019.
STAT+: Nectar bats are ‘wonderful, majestic’ and sugar-obsessed. This researcher wants to know how they stay healthy
STAT News
NOVEMBER 18, 2022
Nectar bats may have nature’s biggest sweet tooth. Each night, the creatures scour the jungle for blossoming flowers in order to consume as much as 150% of their body weight in liquid sugar. Such a feat would leave other mammals in shock or in a coma. But nectar bats push biology to the limit — making them “wonderful, majestic flying superheroes,” in the words of Jasmin Camacho, a postdoctoral researcher at the Stowers Institute for Medical Research who was recently n
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
How repairing the gut saves brain function after stroke
Medical Xpress
NOVEMBER 18, 2022
Stroke is a leading cause of death, dementia and serious long-term disability. According to the American Heart Association, stroke patients also have a greater risk of depression, which negatively affects functional and cognitive recovery.
mRNA drugs with a built-in ‘copy machine’ could lead to safer, more effective therapies
STAT News
NOVEMBER 18, 2022
This story has been adapted from the STAT Report “The future of messenger RNA: Covid-19 vaccines are just the beginning.” R emember that messenger-RNA-based Covid-19 vaccine you got? Just a few days later, the teeny molecular messengers contained in the shot were already gone.
Novel AI blood test detects liver cancer
Medical Xpress
NOVEMBER 18, 2022
A novel artificial intelligence blood testing technology developed and used by Johns Hopkins Kimmel Cancer Center researchers to successfully detect lung cancer in a 2021 study has now detected more than 80% of liver cancers in a new study of 724 people.
Regeneron, CytomX announce bispecific therapeutics for cancer collab
pharmaphorum
NOVEMBER 18, 2022
Regeneron Pharmaceuticals, Inc. and CytomX Therapeutics, Inc. have announced a strategic research collaboration within the field of conditionally activated bispecific therapeutics for the treatment of cancer. Using CytomX’s Probody and Regeneron’s Veloci-Bi platforms, the collaboration and licensing agreement aims to enable the development of investigational next-generation bispecific immunotherapies.
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.
Dietary change starves cancer cells, overcoming treatment resistance
Medical Xpress
NOVEMBER 18, 2022
A dietary change could be a key to enhancing colon cancer treatment, a new study from the University of Michigan Rogel Cancer Center finds.
Kidney Cancer UK receives commission from NICE
Pharma Times
NOVEMBER 18, 2022
The charity commissioned a two-year service quality audit of over 18,000 kidney cancer patients
'Viral jambalaya': Early flu adding to woes for US hospitals
Medical Xpress
NOVEMBER 18, 2022
As Americans head into the holiday season, a rapidly intensifying flu season is straining hospitals already overburdened with patients sick from other respiratory infections.
STAT+: Sales of antibiotics for food-producing animals dropped by nearly half in Europe over the past decade
STAT News
NOVEMBER 18, 2022
Amid ongoing concerns over the use of medically important antibiotics given to food-producing livestock and farmed fish, sales of veterinary medicines across Europe dropped by nearly half between 2011 and 2021, which regulators reported is the biggest drop ever recorded and a sign that campaigns to reduce use are working. At issue is the extent to which antibiotics are given to food-producing livestock to prevent and treat disease — a practice that has contributed to an alarming rise in a
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.
Researchers exploring long-term effects of COVID-19 in diabetics
Medical Xpress
NOVEMBER 18, 2022
Can a COVID-19 infection have long-term health effects on people with diabetes, including advancing their risk for heart disease?
'A historic moment': Provention Bio’s Tzield becomes first FDA-approved drug to delay onset of type 1 diabetes
BioPharma Reporter
NOVEMBER 18, 2022
The US Food and Drug Administration (FDA) has approved Provention Bioâs Tzield (teplizumab-mzwv) to delay the onset of stage 3 type 1 diabetes: with the American Diabetes Association welcoming it as a 'tremendous accomplishment'.
Lung Cancer Awareness Month: Helping patients through research
Antidote
NOVEMBER 18, 2022
Lung Cancer Awareness Month occurs every November with the purpose of increasing general knowledge of lung cancer and the treatment options available to patients who have been diagnosed. While lung cancer is still a prevalent disease, there have been many advancements in the lung cancer treatment space over the years, and medical research studies are consistently underway to find better solutions for patients.
Opinion: STAT+: Removing barriers to biosimilar adoption in the United States
STAT News
NOVEMBER 18, 2022
Biosimilars, a much-lauded approach to reducing drug costs in the United States, are still underused here, even as they are proving successful in Europe. Why? Two key reasons are misperceptions of inferiority and the intricacies of U.S. market access. As the head of U.S. market access for Samsung Bioepis, a South Korean developer and manufacturer of biosimilars, I routinely introduce our capabilities to key stakeholders in the U.S. health care market.
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.
Despite pleas from pediatric groups, Biden balks at declaring RSV a health emergency
Medical Xpress
NOVEMBER 18, 2022
The Biden administration on Thursday offered assistance to communities and hospitals dealing with a surge in cases of pediatric respiratory illnesses, but it did not declare a national public health emergency.
STAT+: Pharmalittle: WHO pandemic accord may force pharma to disclose prices; FDA OKs first therapy to delay type 1 diabetes
STAT News
NOVEMBER 18, 2022
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall our treasured signal to daydream about weekend plans. Our agenda is in the proof-of-concept phase, but we hope to promenade with the official mascot, hang with Mrs. Pharmalot, catch up on our reading, and nap extensively. And what about you? Those of you on this side of the pond may want to prepare for an upcoming celebration, although we hear turkeys are pricey, so perhaps pivoting to som
Genetic analysis of the most common type of bladder cancer yields guidance on treatment options
Medical Xpress
NOVEMBER 18, 2022
A comprehensive genomic analysis in more than 200 patients with metastatic urothelial carcinomas may help inform how a patient would respond to immunotherapy, report UNC Lineberger Comprehensive Cancer Center researchers and colleagues. About 90% of urothelial carcinomas are bladder cancers. These results, derived from a computational model based on the initial molecular findings of the UC-GENOME study, are published in Nature Communications.
STAT+: Up and down the ladder: The latest comings and goings
STAT News
NOVEMBER 18, 2022
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
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.
COVID-19's lessons for future pandemics
Medical Xpress
NOVEMBER 18, 2022
As SARS-CoV-2 seems to settle into the background of our lives, transitioning from an unprecedented crisis to a routine threat alongside influenza and other, more familiar viruses, scientists have begun to turn their attention to the future of the COVID-19 pandemic as the virus continues to change and, just as important, the future of pandemics that may be triggered by other pathogens.
Takeda’s Iclusig bests imatinib in first-line leukaemia trial
pharmaphorum
NOVEMBER 18, 2022
Takeda has a chance of breaking into new territory with its blood cancer therapy Iclusig, after the drug performed better than mainstay therapy imatinib in a phase 3 study of adults with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). The PhALLCON trial compared Iclusig (ponatinib) to imatinib – sold by Novartis as Glivec/Gleevec, but also available as a generic – on top of a reduced-intensity chemotherapy regimen in 230 patients with this type of leukae
Sleep dysregulation ups risk for inflammatory bowel disease
Medical Xpress
NOVEMBER 18, 2022
Short sleep duration and daytime napping appear to increase the risk for inflammatory bowel disease (IBD), according to a study published online Nov. 9 in Alimentary Pharmacology & Therapeutics.
After disappointing trial, Editas puts lead CRISPR drug up for sale
pharmaphorum
NOVEMBER 18, 2022
Gene-testing specialist Editas Medicine has halted development of its lead clinical programme for congenital eye disorders after it generated lacklustre results in a phase 1/2 trial. The BRILLIANCE study of EDIT-101 in Leber congenital amaurosis type 10 (LCA10) – an inherited form of blindness – was reported to be the first ‘in vivo’ CRISPR/Cas9 medicine to be administered to a patient when it started in 2020.
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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