Bio Pharma Dive
SEPTEMBER 28, 2022
The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.
Pharmaceutical Technology
SEPTEMBER 28, 2022
Emergent BioSolutions has acquired exclusive global rights for oral smallpox antiviral, Tembexa (brincidofovir), from Chimerix. Tembexa has two formulations, a 100mg tablet form and 10mg/mL oral suspension, indicated to be administered once a week for two weeks. In June last year, the US Food and Drug Administration (FDA) granted approval for the antiviral therapy to treat human smallpox disease in adult as well as paediatric patients, including neonates.
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Bio Pharma Dive
SEPTEMBER 28, 2022
The company and its development partner, CRISPR Therapeutics, will begin submitting a rolling application in November. The blood disease treatment is the first of its kind to near an FDA review.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 28, 2022
The next time a fly lands on your food, you might want to consider throwing that bite away. A new review suggests the muck that flies regurgitate could very well be infected with a pathogen. When you think of a disease-carrying insect, chances are you imagine a blood-sucking mosquito or tick. But recent findings suggest […].
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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
SEPTEMBER 28, 2022
A former Biogen employee sued in 2012, alleging the company paid physician fees to encourage prescribing of its drugs. Biogen did not admit wrongdoing as part of the settlement.
Pharmaceutical Technology
SEPTEMBER 28, 2022
Seagen and Lava Therapeutics have entered an exclusive licence agreement for the development, manufacturing and commercialisation of the latter’s LAVA-1223 for solid tumours. An advanced preclinical asset, LAVA-1223 is a bispecific T cell engager. It can act on and activate V?9V?2 (gamma delta) T cells in epidermal growth factor receptor (EGFR)-expressing tumour cells’ presence.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
SEPTEMBER 28, 2022
HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside
Bio Pharma Dive
SEPTEMBER 28, 2022
The California biotech will receive $25 million upfront from Sanofi, which plans to use Scribe’s platform to edit natural killer cells for cancer treatment.
NPR Health - Shots
SEPTEMBER 28, 2022
These Black men saved lives a half-century ago. A new book highlights their successes and the challenges they had to face. Some now want to make sure that memory is not forgotten.
Bio Pharma Dive
SEPTEMBER 28, 2022
The CEO resuscitated the sector’s first “public benefit corporation” during the pandemic, building an unusually transparent model for biotechs. Now, he’s spun out a startup and is planning for more.
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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
pharmaphorum
SEPTEMBER 28, 2022
The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.
NPR Health - Shots
SEPTEMBER 28, 2022
Across the U.S., many hospitals have become wealthy, even as their bills force patients to make gut-wrenching sacrifices. This pattern is especially stark for health care systems in Dallas-Fort Worth.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 28, 2022
The Delhi High Court has quashed four demand notices raised by the National Pharmaceutical Pricing Authority (NPPA) against Bharat Serums and Vaccines Ltd and medical devices manufacturer Bard Healthcare India Pvt Ltd for overcharging on non-scheduled drugs and medical devices, finding the move as unjustifiable as it does not allow rounding off principle to non-scheduled […].
STAT News
SEPTEMBER 28, 2022
The Food and Drug Administration on Tuesday published a list of artificial intelligence tools that should be regulated as medical devices, in some cases appearing to expand its oversight of previously unregulated software products. In a new final guidance for industry, the agency specified that tools designed to warn caregivers of sepsis, a life-threatening complication of infection, should come under regulatory review.
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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.
NPR Health - Shots
SEPTEMBER 28, 2022
People with disabilities, people who can't afford it and people who don't want to abandon their pets are among the many who can't easily get up and leave before a hurricane.
STAT News
SEPTEMBER 28, 2022
A new study suggests there may be a link between aluminum used in vaccines that are given to young children in the first two years of life and the risk of developing asthma before age 5. The findings are preliminary and both the authors and others who have studied the data urge caution in the interpretation of the results. Based on the findings, the possible association needs to be further explored, said the authors, who nonetheless are worried that in an era of rampant vaccine misinformation an
NPR Health - Shots
SEPTEMBER 28, 2022
Throughout the pandemic, some people have avoided catching COVID — despite multiple exposures. Do their immune systems have some type of protection that others are missing?
STAT News
SEPTEMBER 28, 2022
The Food and Drug Administration’s approach to reviewing updates to software products is far slower than consumers have come to expect for apps, a top agency official acknowledged Tuesday. Unlike many commonly used apps, which are frequently updated as developers fix bugs and add new features, updates to regulated digital health products often require a lengthy review.
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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.
ACRP blog
SEPTEMBER 28, 2022
It wasn’t just the resignation of yet another clinical research coordinator (CRC) that Christina Brennan, MD, CCRC, vice president for clinical research at Northwell Health, had to contend with earlier this year. “The employee gave me only a few days’ notice because she would lose her time-sensitive bonus from the sponsor that recruited her” if she waited too long to start for them, Brennan recalls.
STAT News
SEPTEMBER 28, 2022
An investigational Alzheimer’s disease treatment from Biogen and Eisai slowed the rate of cognitive decline by 27% in a clinical trial, the companies said Tuesday, meeting the goals of a closely tracked study and strengthening the drug’s case for approval as early as January. The positive result is welcome news for the millions of people living with Alzheimer’s and a big win for Eisai and Biogen, giving the companies a potential blockbuster product in the intravenous medicin
Pharma Times
SEPTEMBER 28, 2022
Phase 1b study evaluates effects of sevuparin on the symptoms of volunteer participants
STAT News
SEPTEMBER 28, 2022
Imagine if Medicare covered treatments for stage 1 or stage 4 cancers, but nothing in between. Absurd, right? Yet that is how Medicare approaches treatment for substance use disorders for its 64 million beneficiaries. This federal health insurance program currently pays for only the least intensive level and most intensive level of substance use care, denying millions of people access to other forms of evidence-based and lifesaving treatments, such as intensive outpatient and residential treatme
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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.
pharmaphorum
SEPTEMBER 28, 2022
Martin Mendoza, PhD, director of health equity and health science policy for the All of Us Research Program at the National Institutes of Health (NIH), tells pharmaphorum about the programme and how it will accelerate research for the benefit of all patients. NIH’s All of Us is building an extensive, diverse biomedical dataset to learn how biology, lifestyle, and environment affect one’s health, and to accelerate research and improve personalised medicine options. “The All of U
STAT News
SEPTEMBER 28, 2022
The Supreme Court’s decision to overturn Roe v. Wade opened the door to allow states to ban or severely restrict abortion. But as biotech CEO Aoife Brennan and her colleagues are coming to realize, it will also affect how — and perhaps where — clinical trials are conducted. Pregnancy tests are an important, and sometimes required, part of clinical research, a way to ensure that an experimental drug does not harm a fetus.
Outsourcing Pharma
SEPTEMBER 28, 2022
Outsourcing-Pharma caught up with Esther Mahillo, VP of Operational Strategy and Feasibility, Precision for Medicine to talk about advancements in patient enrollment in oncology and rare disease clinical trials.
STAT News
SEPTEMBER 28, 2022
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday. Google’s wearables plan takes shape. If you’ve been wondering how the tech titan planned to blend Fitbit with its analytics business, Mario’s got you covered.
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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.
Eye on FDA
SEPTEMBER 28, 2022
FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC). First, just a note on why the research is of importance at all.
pharmaphorum
SEPTEMBER 28, 2022
Roche’s Genentech division has formed an R&D partnership with Arsenal Biosciences focusing on developing and refining the biotech’s programmable T cell-based therapies platform. Genentech is providing $70 million in funding for the multi-year project, which is aimed at identifying “critical success circuits” in T cell therapies used to treat cancer, along with undisclosed milestone payments.
FDA Law Blog
SEPTEMBER 28, 2022
By Steven J. Gonzalez & Jeffrey N. Wasserstein — The New Jersey Supreme Court, in its August 25, 2022 opinion in Mirian Rivera v. Valley Hospital, Inc. , 2022 N.J. LEXIS 679 (NJ Aug. 25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages.
pharmaphorum
SEPTEMBER 28, 2022
Vertex Pharma and partner CRISPR Therapeutics will start a rolling marketing application in the US for their gene-editing drug for sickle cell disease (SCD) and beta thalassaemia later this year. The rolling application for exagamglogene autotemcel (exa-cel) – formerly known as CTX001 – will start in November while a filing in Europe is also expected by the end of the year, said the two partners.
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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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