Sat.Aug 20, 2022 - Fri.Aug 26, 2022

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Safety worries spur Novartis to suspend drug dosing in Huntington’s trial

Bio Pharma Dive

Researchers reported signs of nerve damage in patients treated with the drug branaplam, which is among the most advanced candidates now in testing.

Drugs 286
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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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What should DTC do?

World of DTC Marketing

Consumers would ask their doctor about an advertised prescription drug in a perfect world. In our REAL world, that isn’t the way it happens. Is there a disconnect between what DTC marketers think will happen and what happens with DTC? The research was straightforward. Ask current patients what drove them to get an Rx for a branded product (MS drug).

Branding 243
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August 24, 2022: Diuretic Comparison Project, a Point-of-Care Clinical Trial, to Be Featured in PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Dr. Areef Ishani of the University of Minnesota will present “The Diuretic Comparison Project: A Large Pragmatic Clinical Trial.” The Grand Rounds session will be held on Friday, August 26, 2022, at 1:00 pm eastern. The Diuretic Comparison Project is a large, national “point-of-care clinical trial” comparing the effects of 2 thiazide-type diuretics, hydrochlorothiazide and chlorthalidone, on cardiovascular outcomes in older veteran

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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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Moderna follows Pfizer in asking FDA to approve updated COVID shot

Bio Pharma Dive

The companies are moving quickly to supply vaccines targeting currently circulating omicron variants in time for the Biden administration's planned fall vaccination campaign.

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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

More Trending

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Kid Cudi says he had a stroke at 32. Hailey Bieber was 25. How common are they?

NPR Health - Shots

Strokes in adults under 45 are on the rise. Now artist Kid Cudi — long considered an ambassador for mental health issues — and model Hailey Bieber have opened up about their experiences.

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Pfizer follows GSK with positive Phase 3 results for RSV vaccine

Bio Pharma Dive

In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.

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PAN-TB’s Phase II trials take a shot at shorter TB regimens

Pharmaceutical Technology

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is banking on a collaborative approach to scientific innovation to address the growing problem of drug resistance in tuberculosis (TB). Last week, the collaborative announced that it is executing a joint development agreement (JDA) to advance two novel drug regimens to Phase II clinical trials by 2023.

Trials 246
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What is pharma’s responsibility for online health information?

World of DTC Marketing

Research has shown that 74% of all U.S. adults use the Internet, and 61% have looked for health or medical information on the Internet. Additionally, 49% have accessed a website that provides information about a specific medical condition or problem. Many people get health information from the Internet but are left on their own to determine if it’s credible.

Doctors 227
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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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It's definitely not a good year to be a motorcycle taxi driver in Nigeria

NPR Health - Shots

They've been banned in many districts in bustling Lagos. Commuters who rely on the taxis are in a pickle. And the drivers can't earn a living. What's behind this prohibition?

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Next-generation RNA technologies: making longer-lasting drugs with a broader reach

Bio Pharma Dive

At least 10 biotechnology startups are trying to use RNA molecules in new ways to make medicines. Here’s a look at where they stand.

RNA 332
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ElevateBio and Pittsburgh University to establish biomanufacturing centre

Pharmaceutical Technology

ElevateBio has signed a long-term strategic collaboration with the University of Pittsburgh, US, to establish a biomanufacturing centre for expediting cell and gene therapy development. Under the 30-year deal, ElevateBio will set up its next BaseCamp process development and Good Manufacturing Practice (GMP) manufacturing facility in Pittsburgh. This centre will be equipped with its supporting technologies, such as gene editing induced pluripotent stem cell (iPSC) and cell, vector and protein eng

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Opinion: Surgeons fold against Medicare’s stacked deck

STAT News

Casinos dazzle you with flashing lights, high-stakes tables, and the chance to win millions of dollars. The house always wins, but casinos still trick people into thinking they will make money. Substitute Medicare for casinos and you can see what physicians who take risks with the country’s largest health payer are up against. I’m an orthopedic surgeon, so I’ll focus here on this specialty.

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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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Why stinky sweat is good for you

NPR Health - Shots

So sweat doesn't really smell bad at all. But when bacteria eat the sweat — nostrils, look out! Only it turns out that these sweat-eating critters are responsible for a big health benefit.

Bacteria 143
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Ovid turns to gene therapy startup to restock drug pipeline

Bio Pharma Dive

The New York biotech will invest in and develop up to three drugs with Gensaic, an emerging startup aiming to use the viruses that infect bacteria to deliver genetic medicines.

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Novartis announces plans to spin off Sandoz business

Pharmaceutical Technology

Novartis has announced plans to completely spin off its generics and biosimilars division, Sandoz, to create a new publicly traded standalone firm. The latest development is intended to increase shareholder value by establishing a top European generics firm and a leader in biosimilars internationally. This will aid shareholders of Novartis to entirely take part in possible upside for Sandoz and Novartis Innovative Medicines businesses in the future.

Medicine 147
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Opinion: To improve children’s health in low-income countries, put pediatric surgery on par with preventing malaria or HIV

STAT News

The devastation caused by malnutrition, HIV, tuberculosis, and malaria in low income countries is well known in the U.S. and other high-income countries, due in part to masterful marketing that has elevated these diseases into the collective consciousness — and convinced many people to open their wallets. But this narrow focus on fundraising and aid limits the public good that comes from investing in child health.

Marketing 137
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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For one rape survivor, new abortion bans bring back old, painful memories

NPR Health - Shots

The story of a young rape victim in Ohio who had to travel out of state for an abortion this summer is recalling painful memories for an older generation.

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Merck backs radiopharmaceutical startup Aktis, joining other high-profile backers

Bio Pharma Dive

The pharma contributed to an $84 million round for the new cancer drugmaker, which attracted Novartis and Bristol Myers Squibb in an earlier fundraise.

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PathAI expands AI-driven partnership with BMS

Pharmaceutical Technology

PathAI has expanded a multi-year partnership agreement with Bristol Myers Squibb (BMS) to leverage artificial intelligence (AI)-powered pathology in translational research and clinical trials. In the initial stage, the deal will focus on key translational research in oncology, fibrosis and immunology areas to advance the work into clinical development.

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In early research, an AI model detects signs of Parkinson’s using breathing patterns

STAT News

James Parkinson first flagged a link between changes in breathing patterns and the debilitating disease that now bears his name. But since his work in the early 19th century, only minimal progress has been made in treating a condition that has become alarmingly prevalent. A study published Monday offers a glimmer of new hope.

Research 137
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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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Moderna sues Pfizer over COVID-19 vaccine patents

NPR Health - Shots

The vaccine maker alleges that its rivals Pfizer and BioNTech used some patented features of its mRNA technology to develop their COVID vaccines. (Image credit: Rogelio V.

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Backed by $40M, a biotech startup targets cancer with help from the immune system

Bio Pharma Dive

After several years in stealth, 3T Biosciences is launching publicly with plans to develop newer types of T cell receptor-based treatments.

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Monkeypox vaccine: First EUA for Bavarian Nordic amid worldwide shortages

Pharmaceutical Technology

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On August 4, the US Department of Health and Human Services (HHS) declared monkeypox a public health emergency, a move required to grant EUAs.

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The FDA stands by as the vaping industry flouts its orders

STAT News

WASHINGTON — The Food and Drug Administration has spent more than four years trying to decide whether retailers should be able to sell products like cotton candy-flavored liquids, vapes made to look like fidget spinners, and disposables filled with more nicotine than 200 cigarettes. And so far, the agency has explicitly ordered hundreds of them off the market.

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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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Late-stage cervical cancer cases are on the rise

NPR Health - Shots

Researchers found an overall 1.3% increase per year in advanced stages of the disease, with the greatest increase taking place among white women in the South aged 40 to 44.

Research 135
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Novartis begins plans to spin off generic drug business

Bio Pharma Dive

After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.

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Sonoma signs deal to set up manufacturing centre for cell therapies

Pharmaceutical Technology

Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. The centre, which will expand the company’s operations in Seattle, US, will aid in the R&D and manufacturing at scale its gene-modified regulatory T cell (T reg ) therapy pipeline for autoimmune and inflammatory ailments.

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White House directs agencies to make federally funded studies free to access

STAT News

The White House on Thursday directed health and science agencies to make federally funded studies immediately available to the public after publication, a move that open access advocates have long pressed for but one that threatens to upend the business models of scientific journals. The guidance from the White House’s Office of Science and Technology Policy effectively ushers in a sea change in the publishing industry, which currently places federally funded research papers behind a payw

Research 133
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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.