Bio Pharma Dive
NOVEMBER 3, 2022
In a panel discussion hosted by BioPharma Dive, venture capitalists and CEOs discussed how startups can navigate a challenging market as well as possible ripple effects from the new U.S. drug pricing law.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 3, 2022
Researchers have witnessed two viruses – influenza A and respiratory syncytial virus – fuse together to form a single, hybrid virus. While competition between viruses has been researched in some detail, this new finding provides researchers with an unusual example of one virus coopting another for its own benefits. [link] “This kind of hybrid virus […].
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Bio Pharma Dive
NOVEMBER 3, 2022
The biotech dialed back its financial projections after reporting lower-than-expected sales for the shot, which currently remains the company’s only marketed product.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 3, 2022
In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022. The new draft amendment released by IPC on October 26, 2022 introduced changes to enumeration of aerobic microorganisms present in the […].
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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
NOVEMBER 3, 2022
With public offerings difficult to pull off, Artiva is focusing its energy on a cancer drug deal with the German biotech.
Worldwide Clinical Trials
NOVEMBER 3, 2022
BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. This plan, designed to help make clinical trial enrollment more representative, stands to support diversity, equity and inclusion (DEI) initiatives in R&D — a sector that certainly needs more attention across all clinical trials.
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Pharmaceutical Technology
NOVEMBER 3, 2022
Emalex Biosciences has raised Series D funds worth $250m led by Bain Capital Life Sciences to progress the development of an investigational new drug for Tourette syndrome. Paragon Biosciences, Valor Equity Partners, Fidelity Management & Research Company and various family offices took part in the financing round. The funding will be used for the Phase III clinical trial and potential marketing of the investigational compound, ecopipam, for treating Tourette syndrome patients.
Bio Pharma Dive
NOVEMBER 3, 2022
The struggling biotech’s CFO and top lawyer are also departing amid a new round of layoffs for a company formed by Flagship Pioneering and once worth nearly $2 billion.
Pharmaceutical Technology
NOVEMBER 3, 2022
GlobalData is pleased to be attending the Professional Society for Health Economics and Outcomes Research (ISPOR) Europe Conference from 6–9 November 2022. Please look out for Gustav Ando, Milena Izmirlieva, Sara Trenti, Sara Cesarec and Elliot Trofimowicz. GlobalData will be presenting the following posters: HPR82: Price Leakage Due to International Reference Pricing: Impact of Pfizer’s Not-for-Profit Pricing Initiative for LMICs on Price Levels in Other Countries , Izmirlieva MA In-Person and
NPR Health - Shots
NOVEMBER 3, 2022
In a new lawsuit, Dr. Caitlin Bernard says Indiana Attorney General Todd Rokita has sought health records for her patients, including a 10-year-old rape victim she treated.
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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
NOVEMBER 3, 2022
The Human Health Therapeutics (HHT) Research Centre of the National Research Council of Canada (NRC) has received a $1.66m grant to carry out research on paediatric acute lymphoblastic leukaemia (ALL). The Canadian Cancer Society announced the grant at an event in Montréal. . The research project will be carried out by the centre in partnership with Sainte-Justine Mother and Child University Hospital Centre (SJUHC) and Jenthera Therapeutics.
NPR Health - Shots
NOVEMBER 3, 2022
The updated recommendations seek to course correct after guidelines from 2016 were criticized for harshly limiting access to needed pain medication. (Image credit: Jose M.
Pharmaceutical Technology
NOVEMBER 3, 2022
The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients. This approval has been granted for once-a-day 25mg tablets of Vemlidy for usage in paediatric patients aged 12 years and above with compensated liver disease.
STAT News
NOVEMBER 3, 2022
The journal Nature published today global consensus recommendations to end Covid-19 as a public health threat. It took a panel of almost 400 independent-thinking scientists, doctors, and representatives of community groups from more than 100 countries (we were among the co-chairs) some 14 months to develop and agree on these recommendations. There have been times when we wondered if it was worth the effort.
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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.
Rethinking Clinical Trials
NOVEMBER 3, 2022
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 15th Annual Conference on the Science of Dissemination and Implementation in Health in Washington, DC. The workshop, “Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems.
STAT News
NOVEMBER 3, 2022
T he first time I remember hearing the words “biology’s century,” it was a sales pitch. I was standing by the Long Island Sound in Sachem’s Head, Conn., in the shadow of an 11-foot-tall granite Stonehenge replica built by Jonathan Rothberg, a biotech entrepreneur, as he talked up his newest gadget, a tabletop DNA sequencer.
BioPharma Reporter
NOVEMBER 3, 2022
The US Food and Drug Administration (FDA) has granted Priority Review to GSKâs respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.
STAT News
NOVEMBER 3, 2022
Since the late ’90s, Kathy Wallace has been battling major depression with a series of drugs — first Prozac, then three others, and back again to Prozac. But in the last six months, nothing seemed to be helping. So her psychiatrist recommended something new: Spravato, a nasal spray approved in 2019 that delivers a drug similar to the hallucinogen ketamine.
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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.
NPR Health - Shots
NOVEMBER 3, 2022
False information targeting the Latino community is surging. Much of it is designed to galvanize voters or discourage pregnant women from seeking care.
STAT News
NOVEMBER 3, 2022
“M ommy. Daddy. I can’t breathe.” Waking up to those words is terrifying for any parent. For me as a pediatric emergency physician, it was especially scary coming from my 8-year-old son while on a trip in rural New York, hours from a specialized pediatric emergency department dedicated to the care of children. As my son approached our bed, I heard stridor, the high-pitched whistling sound that signals an obstructed airway.
BioSpace
NOVEMBER 3, 2022
In spite of positive Phase IIb results from a thrombosis prevention trial, Ionis is back on the market for a new partner after Bayer returned the rights to the drug to Ionis.
STAT News
NOVEMBER 3, 2022
BALTIMORE — Providers of methadone for addiction treatment have a message for advocates seeking a giant expansion in access: Be careful what you wish for. Methadone, they acknowledge, is a highly effective medication for opioid addiction. But allowing doctors to prescribe it directly to patients could backfire, they argue, by leading to an increase in low-quality care or even overdoses on methadone itself.
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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
NOVEMBER 3, 2022
In an encouraging development for the fight against antimicrobial resistance (AMR), GSK’s novel antibiotic gepotidacin has shown efficacy in two phase 3 trials, setting up regulatory filings. If approved, gepotidacin (GSK2140944) could become the first drug in a new class of oral antibiotics for uncomplicated urinary tract infections (UTIs) in more than 20 years, according to the pharma group, which plans to submit the data to the FDA in the first half of next year.
STAT News
NOVEMBER 3, 2022
Federal health officials on Thursday updated their recommendations for using opioids to treat pain, removing specific dose and duration targets that pain experts said had caused unintended harm. The new guidance , released by the Centers for Disease Control and Prevention, reflects the evolution in thinking of how opioids should be used, and the reality of how they are being used.
XTalks
NOVEMBER 3, 2022
Eli Lilly is finding itself in an enviable position with its newly launched diabetes injection Mounjaro (tirzepatide) and blockbuster diabetes med Trulicity due to temporary shortages of competitor Novo Nordisk’s diabetes drug Ozempic (semaglutide). Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage.
STAT News
NOVEMBER 3, 2022
A leaked draft version of a trade agreement being negotiated between the United Kingdom and India has sparked concern among civil society and patient advocacy groups that the proposed deal would impede the supply of affordable generic medicines in poor countries around the world. At issue is language that would impose changes in patent and regulatory laws in India and, in doing so, contrast with provisions in a World Trade Organization agreement governing the ability of governments to sidestep p
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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.
BioSpace
NOVEMBER 3, 2022
Working to undo the sins of the past, Colossal Biosciences and the University of Melbourne are attempting to bring back the Tasmanian tiger in a project that could have big implications for human health.
STAT News
NOVEMBER 3, 2022
CRISPR, gene therapy, CAR-T, and Covid vaccines. Science is advancing at a blistering pace. But as STAT’s Matthew Herper explained in his Thursday story, “ Biology’s Century ,” we don’t always have the best possible evidence for what works and what does not.
pharmaphorum
NOVEMBER 3, 2022
In this episode of the pharmaphorum podcast, host Jonah Comstock taps XIL Health’s Susan Lang to better understand why big tech’s ventures into healthcare seem to stumble more often than not. In particular, they dig in on Amazon Care, the much-lauded but recently shuttered employer-based primary care offering. They also touch on Amazon’s other efforts – its successful, but not disruptive acquisition of PillPack and subsequent PBM work, and its failed value-based care joint venture, Haven.
STAT News
NOVEMBER 3, 2022
What’s the atom bomb of biology? Why don’t we run better clinical trials? And how is CRISPR like a Ferrari? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Matthew Herper joins us to discuss his thoughtful, personal story on how the biotech revolution that brought us genome editing, Covid-19 vaccines, and lifesaving medicines could run aground if humanity can’t get out of its own way.
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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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