Sat.May 14, 2022 - Fri.May 20, 2022

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Scientists home in on cause of Duchenne gene therapy side effect

Bio Pharma Dive

An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials.

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Lilly has a new blockbuster

World of DTC Marketing

If You’re Short On Time: The U.S. Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. The approval for tirzepatide—which Lilly will market under the brand name Mounjaro—isn’t for weight loss but Type 2 diabetes. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks?

Drugs 218
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Moderna’s HIV vaccine prepped for trials in Africa

pharmaphorum

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. IAVI (the International AIDS Vaccine Initiative) has started screening subjects to be included in the study, called IAVI G003, at centres in Rwanda and South Africa, said the biotech.

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Artificial intelligence stands to transform precision medicine: AiCure

Outsourcing Pharma

An expert from the AI-focused technology company shares insights as to how it can be harnessed to better interpret, and even predict, patient behavior.

Medicine 136
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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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AbbVie asks FDA to approve Parkinson's treatment

Bio Pharma Dive

The company believes the treatment, which uses prodrug versions of two commonly used Parkinson's medications, could be a longer-lasting option for patients and blockbuster product for AbbVie.

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A new era of pharma marketing?

World of DTC Marketing

Just 13% of people trust the pharma companies they interact with. 68% say the interactions feel transactional. Only a third agree that organizations know their communication preferences. Communication and transparency are vital to building trust, which necessitates a shift away from traditional DTC marketing. If pharma is going to leap to a new era of marketing, they have to get to know their audiences.

Marketing 214

More Trending

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Machine learning can unlock potential of EEG data: Beacon Biosignals

Outsourcing Pharma

A leader from the neurobiomarker platform provider tells how use of ML and other advanced analytical tools can help make better use of complex information.

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Seagen CEO Siegall resigns amid domestic violence investigation

Bio Pharma Dive

The biotech company is searching for a permanent successor to Siegall, who was arrested last month for alleged domestic violence. CMO Roger Dansey will continue as interim CEO.

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Simple blood test could save thousands from bowel cancer

Pharma Times

Comparisons with other tests available have shown that blood test has greater sensitivity for the detection of bowel cancer

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Large UK study suggests vaccination helps treat long COVID

pharmaphorum

An observational study in the UK has found evidence that COVID-19 vaccination can help alleviate the lingering symptoms that afflict some people who contract the virus, often referred to as ‘long COVID’ There have been persistent anecdotal reports that vaccines can help people with persistent symptoms get better, but the study published in the British Medical Journal is the first to explore the connection in large numbers of patients.

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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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Clinical Scientist Jobs: The Steps to Succeed in This Role

XTalks

Do you possess laboratory skills, an analytical mindset and a penchant for research? If you enjoy working with biological samples and are enthusiastic about healthcare, a career as a clinical scientist might be just right for you. To start applying to clinical scientist jobs today, head over to the Xtalks Job Search platform. Who is a Clinical Scientist?

Scientist 105
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PTC's first gene therapy gains European regulator's backing

Bio Pharma Dive

The brain-infused treatment for a rare neurological disease would be one of only three gene therapies commercially available in the EU. PTC plans to ask for FDA approval later this year.

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NIH awards $577m to antiviral drug developers

BioPharma Reporter

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.

Allergies 102
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Sleepio app for insomnia backed by NICE

pharmaphorum

After a non-committal appraisal of Big Health’s Sleepio app for insomnia last November in draft guidance from NICE, the cost-effectiveness agency has come out in favour of the digital therapy. The earlier draft guidance showed that NICE was uncertain whether Sleepio would save money for the NHS, but its latest document recommends the app as a cost-saving option for treating insomnia in primary care “for people who would otherwise be offered advice about sleep hygiene or sleeping pill

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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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Mars Recalls Select Skittles, Starbust and Life Saver Gummies over Possible Metal Contamination

XTalks

Mars Wrigley announced a voluntary recall of various candy products after consumers reported thin metal strands in the candy itself or loose in the bag. The products, which were recalled in the US, include Starburst, Skittles and Life Savers gummies. According to the company, products were manufactured by a third party and subsequently distributed across North America.

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Gilead, having resolved manufacturing issues, forges ahead with HIV drug

Bio Pharma Dive

The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

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Bacteriophage producer Locus Biosciences raises $35m in financing

BioPharma Reporter

Locus Biosciences says the US$35m in funding it has raised from a mix of old and new investors is further validation of its novel approach to treating bacterial diseases.

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USAID on expanding digital health globally – part one

pharmaphorum

Adele Waugaman, senior digital health coordinator of the COVID-19 response at the United States Agency for International Development (USAID), tells us what the agency focuses on to strengthen digital health infrastructure globally and improve and expand healthcare access. USAID learned a great deal from the Ebola outbreak in West Africa concerning effective digital health distribution and strategies for digital health implementation that were then applied to its COVID-19 response globally – alth

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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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New patent for Ironwood Pharms drug DUZALLO

Drug Patent Watch

Annual Drug Patent Expirations for DUZALLO Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug. DUZALLO drug…. The post New patent for Ironwood Pharms drug DUZALLO appeared first on DrugPatentWatch - Make Better Decisions.

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Ultragenyx strikes deal with struggling Abeona for rare disease gene therapy

Bio Pharma Dive

The treatment, which is designed to treat Sanfilippo syndrome, could become Ultragenyx's first gene therapy to reach market in the U.S., according to the biotech's CEO.

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How Heart Attack Survivors Can Improve Lifestyle Factors with a Text Messaging Program

XTalks

Results of an Australian study published in the American Heart Association’s flagship, peer-reviewed journal Circulation show that a text messaging program designed to remind, support and motivate heart attack survivors to take their medication helped them improve their weight and eat more fruits and vegetables but interestingly, did not improve medication adherence.

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Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

pharmaphorum

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. Eli Lilly’s Mounjaro (tirzepatide) was given the green light by the US Food and Drug Administration after the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 glucagon-like peptide-1 (GLP-1 ) receptor agonist showed its effectiveness when used in conjunction with diet and exercise.

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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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Possible discovery of mechanism behind mysterious COVID-19 symptoms

Scienmag

In patients with serious and long-term COVID-19, disturbed blood coagulation has often been observed. Now, researchers at Linköping University (LiU), Sweden, have discovered that the body’s immune system can affect the spike protein on the surface of the SARS-CoV-2 virus, leading to the production of a misfolded spike protein called amyloid. The discovery of a possible […].

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Making sub-visible particles visible

Bio Pharma Dive

Sub-visible particles can lower the effectiveness of a drug, which is why regulatory authorities are demanding processes be developed, validated and set up in such a way as to minimize all forms of contamination.

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Abbott Builds Upon Diversity in Clinical Trials Initiative by Partnering with Women as One

XTalks

The partnership between Abbott and non-profit Women as One will train female and underrepresented physicians to help improve diversity in clinical trials. Research from recent years shows that representation of women and ethnic minorities, especially African Americans, still needs to be improved in most drug development programs approved by the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER).

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Coalition aims to improve cancer drug access in poorer nations

pharmaphorum

Several of the top pharmaceutical companies have joined a new coalition that aims to improve access to cancer medicines in low- and lower-middle-income countries (LLMICs). The new initiative – called ATOM (Access to Oncology Medicines) – pledges to tackle the issue that fewer than 50% of the cancer medicines on the World Health Organization’s essential medicines list are available in developing nations around the world.

Drugs 108
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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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Birmingham research shows promise for spinal cord injury patients

Pharma Times

Scientists demonstrated that AZD1236 halts oedema while reducing spinal cord breakdown at site of injury

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Bayer backs out of Atara cell therapy deal

Bio Pharma Dive

The German drugmaker will hand back rights to two CAR-T cell therapies it was developing with Atara, which said it would reassess its strategy for the programs.

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Boochcraft Becomes First Hard Kombucha Brand to Earn B-Corp Status

XTalks

Boochcraft, which claims to be America’s favorite hard kombucha brand, recently became a Certified Benefit Corporation (B-Corp), a label awarded to companies that voluntarily meet high social and environmental performance standards. Notably, Boochcraft is the first hard kombucha brand to achieve B-Corp status and will join more than 4,000 B-Corps across more than 70 countries and 150 industries.

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Accelerator aims to promote digital health innovation in Italy

pharmaphorum

A digital health startup accelerator is launching in Italy, with more than €6 million backing the new enterprise. Called VITA, the accelerator will support up to 10 startups focused on digital transformation of the health system. The project is backed by asset management company CDP Venture Capital SGR, with help from digital health consultancy Healthware Group (pharmaphorum’s parent company) and Danish accelerator Accelerace.

Doctors 109
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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.