Thu.Dec 15, 2022

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For ALS patients, doctors, a new medicine reignites concerns about healthcare access

Bio Pharma Dive

Relyvrio, a drug developed by Amylyx Pharmaceuticals, is in high demand in ALS clinics across the U.S. Though some patients are already getting it, insurance coverage and out-of-pocket costs remain a source of anxiety.

Doctors 258
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Eisai and Washington University to develop neurodegenerative disease therapies

Pharmaceutical Technology

Eisai has entered a comprehensive research partnership agreement with Washington University School of Medicine in St Louis, US, to develop potential new therapies for neurodegenerative ailments. Under the deal, the parties intend to develop treatments for diseases including Alzheimer’s and Parkinson’s. The alliance will merge the capabilities of the scientists at Washington University in the basic and clinical research in neurodegenerative ailments, such as dementia, with the wide-ranging expert

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Sio Gene Therapies to dissolve after years of setbacks

Bio Pharma Dive

Having failed to find a buyer or potential partner, the biotech company has opted instead to shut down and liquidate its assets.

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Severe COVID Looks Scarily Like Old Age in The Human Brain, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

Severe COVID-19 looks scarily like old age in the human brain, according to a postmortem analysis of 54 healthy and infected individuals. The authors of the study say their research is the first to link COVID-19 to molecular signatures of brain aging. “We observed that gene expression in the brain tissue of patients who died […].

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Third Harmonic halts study of lead drug over safety risk

Bio Pharma Dive

The biotech, previously a notable success story this year, will discontinue development of its chronic hives treatment and search for alternative drug candidates.

Drugs 249
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Medicines priced under the early access programme in France see prices drop by 16%

Pharmaceutical Technology

France’s temporary authorisation system (autorisation temporaire d’utilisation, ATU) was developed to provide early market access for treatments in therapeutic areas with unmet medical need, limited therapeutic alternatives, or where no authorised alternatives are available. Last year, the French National Authority for Health (HAS) expanded its remit (previously under the control of Agence nationale de sécurité du médicament et des produits de santé [ANSM]) to include early access authorisation

Medicine 147

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EC approves Sanofi’s Dupixent to treat prurigo nodularis

Pharmaceutical Technology

The European Commission (EC) has granted expanded marketing authorisation for Sanofi ’s Dupixent (dupilumab) for the treatment of moderate-to-severe prurigo nodularis in adults. The treatment is indicated for usage in patients who are candidates for systemic therapy in the EU. . With the latest development, Dupixent became the first targeted therapy indicated for prurigo nodularis in Europe and the US.

Trials 130
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NPPA releases fourth list of draft ceiling prices for 15 formulations based on NLEM 2022

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Pharmaceutical Pricing Authority (NPPA) has released the fourth list of draft ceiling price calculations for 15 more drugs, as part of fixing the ceiling prices of medicines under the National List of Essential Medicines (NLEM), 2022, which was amended into the Schedule-I of the Drugs (Prices Control) Order, 2013. Along with the 215 […].

Medicine 144
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Global (68M) cardiomyopathies market projected to grow to $9.63bn by 2031

Pharmaceutical Technology

In an expanded version of the sales forecast from GlobalData’s June 2022 publication, Cardiomyopathies: Global Drug Forecast and Market Analysis , the global cardiomyopathies market is expected to grow from $3.07bn last year to $9.63bn in 2031. The Cardiomyopathies: 68-Market Analysis and Sales Forecast report covers a total of 68 markets across Africa, Asia-Pacific (APAC), Europe, Latin America (LATAM), the Middle East and North America.

Marketing 130
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Another Humira biosimilar approved by FDA as AbbVie patent expiry looms

Bio Pharma Dive

Fresenius Kabi is getting ready for a July launch in the U.S. of its copycat version, called Idacio, four years after it began sales in other countries.

Sales 130
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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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PrecisionLife and Ono sign multi-target partnership for CNS disorders

Pharmaceutical Technology

PrecisionLife has entered a multi-target discovery and validation partnership with Ono Pharmaceutical in the field of central nervous system (CNS) disorders. . According to the research and development (R&D) deal, the combinatorial analytics platform of PrecisionLife will be applied to patient datasets to detect several novel therapeutic targets, which will be developed by Ono. .

Genetics 130
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COVID spreading faster than ever in China. 800 million could be infected this winter

NPR Health - Shots

Scientists predict China will see the largest COVID surge of the pandemic this winter, with hundreds of millions of people infected. But some experts say that it could have been even worse.

Scientist 145
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Congenital fibrinogen deficiency market forecast to reach $800m across 3MM by 2031

Pharmaceutical Technology

The congenital fibrinogen deficiency (CFD) market is expected to grow at a compound annual growth rate (CAGR) of 1.7% through 2031, reaching over $800m across the three major markets (3MM: US, Germany, and Japan), according to GlobalData’s recent report: Congenital Fibrinogen Deficiency: Opportunity Assessment and Forecast. Major factors driving this growth include the launch of improved human fibrinogen concentrate (HFC) products, the large market potential for HFC in treating acquired fibrinog

Marketing 130
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You can order free COVID tests again by mail

NPR Health - Shots

People are gathering indoors for the holidays, and there's been an uptick in COVID-19 cases. The federal government says you should test often to try to prevent the spread of the virus.

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The New Age of Decentralized Clinical Trials

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.

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STAT+: AbbVie exits major pharmaceutical industry lobbying groups

STAT News

WASHINGTON — The maker of one of the world’s most profitable medicines is exiting the pharmaceutical industry’s two major lobbying organizations next year, just as Washington pledges to crack down on high drug costs. AbbVie, which for years has fought off competition for its blockbuster autoimmune drug Humira — the world’s top-selling medicine before Pfizer’s Covid-19 vaccine hit the market — has been the target of congressional hearings and legis

Medicine 126
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Why the government fails to limit many dangerous chemicals in the workplace

NPR Health - Shots

The U.S. agency that's supposed to protect workers' health has all but given up on setting limits on a dangerous chemical released in tire manufacturing. Meanwhile, workers are dying.

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STAT+: Inflation caused another big drop in net drug prices, analysis finds

STAT News

Amid ongoing debate over the cost of prescription medicines, a new analysis finds that brand-name drugmakers increased their wholesale prices by 4.8% in the third quarter this year, up slightly from 4.2% a year earlier and 4.9% in the previous quarter. But when accounting for inflation, wholesale prices fell by 3.1%, and inflationary pressures are likely to push wholesale prices still higher.

Branding 119
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Law requires former research chimps to be retired at a federal sanctuary, court says

NPR Health - Shots

The ruling is the latest twist in a long-running dispute over where dozens of federally-supported former research chimps should live out the remainder of their days.

Research 118
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Accelerating Clinical Supply Through Integrated Drug Development

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.

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STAT+: Amid criticism over unaffordable insulin, Lilly strikes a manufacturing deal to supply Africa

STAT News

In a bid to widen access to insulin in primarily low-income nations in Africa, Eli Lilly has agreed to sell active pharmaceutical ingredients and transfer technology to an Egyptian company that expects to supply the life-saving diabetes treatment to as many as 1 million people by 2030. The 10-year agreement calls for Lilly to sell the ingredients needed to manufacture both human and analogue insulin at a “significantly reduced” price to EVA Pharma and also provide “pro bono&

Insulin 115
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'Contaminated' spinach causes hallucinations in Australia

Medical Xpress

Health authorities in Australia have said nine people in Sydney suffered "toxic reactions"—including hallucinations—from a batch of spinach thought to contain an "accidental contaminant".

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NICE backs use of Boehringer’s Ofev in IPF from diagnosis

pharmaphorum

Thousands more UK patients with idiopathic pulmonary fibrosis (IPF) will now be eligible for treatment with Boehringer Ingelheim’s Ofev, following new guidance from health technology assessment agency NICE. Ofev (nintedanib) has been recommended since 2015 for NHS use in IPF patients who have a forced vital capacity (FVC) value of 50% to 80% of normal, but will now be an option for people with less severe disease, i.e. an FVC of more than 80%.

Doctors 105
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Killing pancreatic cancer with T cells that supercharge themselves

Medical Xpress

Scientists at UC San Francisco (UCSF) have engineered T cells to produce a potent anti-cancer cytokine, but only when they encounter tumor cells. The immunotherapy eliminated melanoma and pancreatic cancer in mice without major side effects, and it offers a promising new strategy for fighting these and other hard-to-treat cancers.

Engineer 105
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Children's hospitals are struggling to cope with a surge of respiratory illness

NPR Health - Shots

Pediatric cases of RSV and flu have sent families crowding into ERs, as health systems struggle with staff shortages. In Michigan, only 9 out of more than 130 hospitals have a pediatric ICU.

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Explosion in US adolescent overdoses, mainly fentanyl

Medical Xpress

Drug overdoses among people aged 10 to 18 more than doubled in the United States between 2019 and 2021, according to a study released Thursday by health authorities, who warned in particular of the risks of counterfeit pills containing fentanyl.

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Listen: Leaky health data, ASH22, & what it takes to get booed by your peers

STAT News

Why do billionaires get booed? How does Facebook end up with sensitive health data? And does biotech have a dribbling problem? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Katie Palmer, STAT’s health tech correspondent, joins us to explain how the explosive popularity of telehealth is putting sensitive patient information into the hands of Facebook, TikTok, and other big tech firms.

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Activated vitamin D3 treatment may reduce the risk of arsenic-mediated skin cancer

Medical Xpress

According to recent estimates, over 140 million people from 50 countries regularly get exposed to arsenic through drinking water. The exposure level significantly exceeds the guideline value (10 μg/L) stipulated by the World Health Organization. It is an established fact that chronic arsenic exposure from drinking water causes a variety of cancers including skin cancer.

Research 102
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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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Merck lines up agreement to advance development and manufacturing of viral vector based gene therapy applications in Japan

BioPharma Reporter

Merck has signed a Memorandum of Understanding (MoU) with Synplogen, a startup spun out of Kobe University's Graduate School of Science, Technology and Innovation.

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The evolving role of social media in healthcare

pharmaphorum

In recent years, social media has evolved into an essential part of pharma operations, for better or worse. Within the life sciences space, traditional ways of leveraging social media include marketing and spreading awareness of a disease or treatment. In addition, many organisations are now also using social media for non-accredited medical education, social listening, and facilitation of networking and best practice sharing.

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STAT+: Biden administration takes aim at Medicare Advantage care denials, misleading ads

STAT News

The Biden administration has unveiled its plan for attacking people’s chief concerns about privatized Medicare for older adults: care denials and scammy ads. The agency that runs Medicare said it received almost 4,000 comments on how to improve the popular Medicare Advantage program starting in 2024, when it’s expected to cover the majority of Medicare beneficiaries.

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FDA Finalizes Guidance Re Enforcement Policy for Homeopathic Drugs

FDA Law Blog

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. As we reported previously, here , and here , as a result of the growth of the industry and safety issues, in 2015 FDA started the reevaluation of its regulatory framework for homeopathic products.

Drugs 98
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.