Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.

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Clinical Trials Clinical Trials Drugs Trials 354

Bio Pharma Dive

AUGUST 10, 2022

The deal, worth as much as $2 billion, is the latest sign of industry interest in treatments that harness regulatory T cells, an approach behind several recent biotech startups.

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World of DTC Marketing

AUGUST 7, 2022

According to a 2021 study , 1.1 million deaths—including one in two of those under 65, thanks in large part to our abysmal health care system—”would have been averted if the U.S. had the mortality rates of other wealthy nations. One in three GoFundMe campaigns is now for healthcare-related costs, and it’s getting worse. The passage of the Inflation Control bill is an excellent first step in limiting high drug costs, but our healthcare system is still built for profit at the expense

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2022

When babies in the African countries of Guinea Bissau and Uganda were given the tuberculosis vaccine, something remarkable happened. Instead of the vaccine only protecting against the target bacteria – Myocbacterium tuberculosis – the tuberculosis vaccine offered broad protection against a range of unrelated infections, including respiratory infections and serious complications such as sepsis.

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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.

Clinical Trials

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Proteus’s profile grew considerably; it was soon valued at $1.5 billion. The enthusiasm for digital approaches involving sensors, apps, and wearables that could transmit information across systems, commonly grouped under the term Internet of Things , also s

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Bio Pharma Dive

AUGUST 9, 2022

The CEO recently led Upstream through a $200 million financing that will support development of an inflammatory disease drug. “We have what investors probably want at this time,” she told BioPharma Dive.

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 8, 2022

In mammals, blood carries oxygen and nutrients to the body’s organs and cells. But if blood flow stops, these cells will quickly die and organs are injured. This death can be slowed in organs and tissues removed from the body, buying time for organ transplantation. However, preserving entire organ systems minutes after the heart stops […].

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Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). A new chemical entity and NMDA receptor (NMDAR) channel blocker, REL-1017 acts on hyperactive channels while preserving physiological glutamatergic neurotransmission. Presently, the therapy is being analysed in late-stage studies.

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Bio Pharma Dive

AUGUST 9, 2022

Boston-based Cerevance uses samples of healthy and diseased human brain tissue to find new targets for central nervous system diseases.

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World of DTC Marketing

AUGUST 10, 2022

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. But, in pharma marketing, the changes affect every product category. Consumers share more information online than ever as inflation cuts into their disposable income. I’ve seen posts on everything from opinions on detergents to the best and more inexpensive ice cream.

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The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 11, 2022

US President Joe Biden’s government on Thursday declared monkeypox a public health emergency, a move that should free up new funds, assist in data gathering, and allow the deployment of additional personnel in the fight against the disease. Skip advert The move came as nationwide cases topped 6,600, around a quarter of them from New York […].

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Pharmaceutical Technology

AUGUST 12, 2022

More than a year and a half after the Brexit deal came into effect, the UK’s pharmaceutical industry is still trying to determine the likely impacts. In principle, the deal could create new opportunities for British pharma companies – not least the chance to work under a more supportive regulatory framework. However, in practice we are seeing a climate of real uncertainty.

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Bio Pharma Dive

AUGUST 9, 2022

The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.

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World of DTC Marketing

AUGUST 8, 2022

Consumers have changed their shopping behavior due to the pandemic, and some of those changes are relevant for pharma marketers. The days of someone seeing an ad for a prescription drug and rushing to ask their doctor about it have replaced the quest for more information, usually online. CPG brands have finally admitted that consumers are changing how they purchase products and brands.

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Drugs Doctors Doctor Marketing 226

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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.

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 10, 2022

There are more than a thousand different ways that climate change can cause outbreaks of infectious disease in humans, according to a new review. When analyzing the literature on 375 human pathogens, researchers from the University of Hawai?i at M?noa and the University of Wisconsin-Madison in the US found 58 percent of these diseases were, at […].

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Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. The treatment is indicated for such patients whose tumours have activating HER2 (ERBB2) mutations and previously received systemic therapy. .

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Bio Pharma Dive

AUGUST 10, 2022

Abecma, which 2Seventy bio helps develop and sell, is currently approved for patients who have tried at least four other medicines for the blood cancer.

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Rethinking Clinical Trials

AUGUST 11, 2022

The Helping to End Addiction Long-Term Initiative?, or NIH HEAL Initiative?, recently published 2 funding opportunity announcements soliciting applications focused on sickle cell disease (SCD) pain management. The effort is co-led by the National Center for Complementary and Integrative Health and the National Heart, Lung, and Blood Institute, with support from other NIH Institutes, Centers, and Offices.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 7, 2022

Imagine you’ve just completed a tough upper-body workout. Your muscles feel a bit tired, but all in all, you’re able to go about the rest of your day just fine. The next morning, you wake up and realize the back of your shoulder blade feels stiff. When you rub your shoulder muscles, it feels like […].

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Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. The treatment is indicated for patients who have previously received chemotherapy in the metastatic setting or recurred during or within six months of receiving adjuvant chemotherapy.

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Bio Pharma Dive

AUGUST 10, 2022

The biotech’s failed attempt to develop an eye disease drug has ended in a reverse merger that gives startup Disc Medicine a fast path to the public markets.

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Rethinking Clinical Trials

AUGUST 10, 2022

Steven Joffe, MD, MPH, will give a keynote presentation on Sept. 9. The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems.

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Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 10, 2022

The amount released by the Central government towards drug development and research and development (R&D) through the Biotechnology Industry Research Assistance Council (BIRAC) has come down by almost 50 per cent in the last two fiscal years. The disbursement declined drastically in 2020-21, during when the Covid-19 pandemic hit the country and the government allocated […].

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The plan, which was released in late June, outlines a science strategy to improve research efforts for ALS. Its content is pertinent given the upcoming FDA Advisory Committee (AdCom) for Amylyx Pharmaceuticals’ ALS drug AMX0035 on 7 September.

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Bio Pharma Dive

AUGUST 11, 2022

The companies could face liability related to their sales of the heartburn drug, which was withdrawn from market in the U.S. and other countries after impurities related to a likely carcinogen were detected.

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pharmaphorum

AUGUST 12, 2022

Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, because the government has shelved plans to offer treatment with AstraZeneca’s antibody therapy Evusheld. That’s the position of multiple patient organisations, clinicians and medical groups, who have criticised the Department of Health’s decision to defer procurement of Evusheld supplies until cost-effectiveness agency

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As demand for advanced therapies increases, so does the need for more specialized supply chain support, as these products have strict transportation and handling requirements. Deviations from the intended supply chain can delay timelines and affect these high value products, which can be detrimental to budgets, but more importantly can have dire effects on the patients whose lives depend on receiving these critical doses safely and on time.

Gene Therapy

NPR Health - Shots

AUGUST 10, 2022

Dr. Caitlin Bernard was publicly vilified for providing abortion care to a 10-year-old rape victim. And that's got some medical residents who were open to practicing in Indiana thinking again.

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Pharmaceutical Technology

AUGUST 9, 2022

Health Canada has accepted the New Drug Submission (NDS) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients. The treatment is intended for such patients who are not well-controlled with standard therapy. The regulatory agency is anticipated to provide a decision on whether cenobamate tablets can be commercialised and sold in Canada under this NDS in the middle of next year.

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Clinical Development Life Science Drugs Trials 246

Bio Pharma Dive

AUGUST 9, 2022

A treatment that AstraZeneca acquired for up to $6 billion in 2020 is showing early promise as a combination agent in lung cancer, where it’s being tested alongside Merck & Co.’s Keytruda.

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Drugs 281

STAT News

AUGUST 10, 2022

The explosive trajectory of monkeypox to nearly 90 countries since the current outbreak was detected in the United Kingdom in mid-May has caught many governments off-guard , and created confusion about how monkeypox spreads from person to person. In some ways, the virus is acting differently than it has in the past. For decades, researchers in West and Central Africa, where the virus is endemic, have observed that outbreaks there tend to be self-limiting.

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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