Sat.Jul 02, 2022 - Fri.Jul 08, 2022

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Misjustice benefits pharma

World of DTC Marketing

Endpoint News reported “Three major drug distributors are off the hook for what may have been a $2.5 billion payment after a federal judge found them not liable for the opioid epidemic in parts of West Virginia, one of the hardest-hit areas of the country. This is beyond outrageous it’s a classic example of abuse of power. Despite distributing more than 51.3 million doses of oxycodone and hydrocodone to pharmacies in Cabell County and the city of Huntington over less than a decade, M

Pharma 238
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Healthcare leaders are optimistic about metaverse disruption, report says

MedCity News

The metaverse has significant potential to disrupt traditional healthcare delivery in the long term, according to a recent Accenture report. While it will likely take time for providers to begin building their own digital environments in the metaverse, healthcare leaders said they believe metaverse technologies will have a positive impact on healthcare.

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Controlling contamination by material transfer

European Pharmaceutical Review

Ensuring potential microbial contaminants are not transferred into cleanroom environments is a key aspect of risk mitigation strategies. In a review, pharmaceutical microbiologist and contamination control expert Tim Sandle, reviewed several methods of material transfer, listing the decontamination methods based on efficacy and commenting on their weaknesses. .

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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

Marketing 129
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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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Getting an Rx does not address health problems

World of DTC Marketing

Imagine a medicine that reduced the death rate of breast cancer and risk of recurrent breast cancer by 50% lowered the risks of colon cancer and type 2 diabetes by two-thirds, and those of heart disease, hypertension, and Alzheimer’s’ disease by 40%. On top of that, it can be as effective as antidepressants or cognitive behavioral therapy in countering depression.

Insurance 200
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Pharma’s spend on AI in drug discovery ‘could top $3bn by 2025’

pharmaphorum

The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. That’s the conclusion of a GlobalData report , which notes that AI is being used to enhance computer-aided drug design (CADD) in a bid to reduce the time and costs involved in getting a new drug to market.

Marketing 130

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GSK acquires US-based Sierra Oncology for $1.9bn

Pharmaceutical Technology

GlaxoSmithKline (GSK) has completed the acquisition of all outstanding shares of US-based Sierra Oncology in a deal totalling $1.9bn (£1.6bn), in cash. In April this year, GSK entered an agreement for the acquisition of Sierra Oncology for $55 per share. The conclusion of the deal comes after the shareholders of Sierra Oncology approved the takeover on 29 June this year.

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Microbial risks presented by aging facilities

European Pharmaceutical Review

As established facilities age, various risk considerations emerge. While some may continue to function effectively without any additional considerations, many will require additional checks and assessment. In an article published in the Journal of Validation Technology (JVT), pharmaceutical microbiologist and contamination control expert Tim Sandle identified ten categories of risk presented by aging.

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AstraZeneca agrees $1.3bn deal to buy oncology player TeneoTwo

pharmaphorum

AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for haematological cancers. The big pharma is paying $100 million upfront for the company, and offering up to $805 million in milestone payments if TeneoTwo’s drug candidates meet development objectives, plus up to $360 million if they hit sales targets.

Pharma 124
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FQHCs must collaborate with each other to remain independent of hospital affiliation, report says

MedCity News

Most federally qualified health centers are committed to remaining independent of hospital affiliation. In order to maintain their independence, it is critical that FQHCs face work together more closely on data pooling and and sharing best practices for improving community health, according to a recent report.

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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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Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. Compared with other emerging pharmaceutical markets (such as India and China, covered in previous Emerging Market Outsourcing Reports), Russian facilities lack many US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, meaning Russian manufacturing is more focused on

Pharma 122
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Self-Powered Implant Tracks Spinal Fusion Healing

Medgadget

Engineers at the University of Pittsburgh created a self-powered implant that can track spinal healing while also providing mechanical support. The device can be 3D printed so that it fits a given patient perfectly and the mechanical properties can also be easily tuned to customize for each situation. The spinal fusion cage contains a triboelectric nanogenerator that creates electricity when it is pressurized by the spine.

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Pfizer to reach carbon net-zero by 2040

European Pharmaceutical Review

After more than 20 years of environmental action, Pfizer has committed to further reduce its greenhouse gas (GHG) emissions and aims to achieve the voluntary Net-Zero Standard by 2040 – a full 10 years ahead of the standard’s proposed timeline. To achieve these goals, Pfizer aims to decrease its GHG emissions by 95 percent and its value chain emissions by 90 percent from 2019 levels by 2040.

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FDA says pharmacists can prescribe Covid treatment

MedCity News

The AMA believes physicians should still be the main prescribers, while advocates for provider status for pharmacists say it’s a win for health equity and will expand treatment access.

FDA 117
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Brii Bio acquires Vir’s antibody rights for Hepatitis B in Greater China

Pharmaceutical Technology

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio.

Safety 111
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Partners come on board GSK’s plan for Stevenage life science hub

pharmaphorum

GSK’s recently-unveiled plan to develop a bioscience cluster close to its main R&D site in Stevenage, UK, has moved closer to fruition, now that the first partners have joined the initiative. The asset management arm of Swiss back UBS has formed a joint venture with property developer Reef Group that will develop the 33-acre campus in Stevenage, Hertfordshire.

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Soft Bioresorbable Implant Controls Pain by Cooling Nerves

Medgadget

A team of engineers at Northwestern University led by John Rogers, the person responsible for many advances in flexible electronics, created a drug-free implant that can control pain by cooling nerves. The soft implant is intended to be wrapped around a nerve during surgical procedures that would typically involve opioid-based analgesia afterwards. As a drug-free technology, the implant could help to avoid the addiction and side-effects that opioids frequently cause.

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How Pfizer won the pandemic, reaping outsize profit and influence

MedCity News

Because the virus keeps mutating and will be around for a long time, the market for Pfizer’s products won’t go away. In wealthier countries, the public is likely to keep coming back for more, like diners at an all-you-can-eat restaurant, sated but never entirely satisfied.

Marketing 114
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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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Brii Bio introduces Covid-19 combination therapy in China

Pharmaceutical Technology

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.

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FDA backs pharmacist prescribing of Paxlovid for COVID

pharmaphorum

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug. The regulator has revised the emergency use authorisation (EUA) for Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to patients, providing they can provide recent health records and a list of current medicines they are taking.

FDA 111
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Carbon Monoxide-Loaded Foam as Inflammatory Disease Treatment

Medgadget

Researchers at MIT have created a carbon monoxide-loaded foam intended for therapeutic use against inflammatory disease. While the gas is toxic if inhaled in large quantities, in small doses it has potent anti-inflammatory effects. However, delivering it to the gastrointestinal tract to treat inflammatory diseases, such as colitis, is a challenge. In response, these researchers emulated the edible foams available at high-end restaurants and loaded them with small amounts of carbon monoxide.

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With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

MedCity News

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

Safety 114
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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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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in

Safety 105
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Medical Informatics and Rare Disease: a bridge between two worlds

pharmaphorum

Today’s rare disease landscape comprises of around 7,000 different diseases. With a broad and diverse range of symptoms and severities impacting patients around the world, connecting these individuals with the information and expertise needed to achieve the correct diagnosis can be extremely lengthy and pose a significant barrier to treatment. “As the severity, progress, and treatment potential of rare diseases varies from patient to patient, each condition is going to need to be addressed diffe

Medical 104
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Scott Burrows, Insurance and Financial Speaker

Scott Burrows

Are You Prepared to Reinvent Yourself? As an insurance and financial speaker with strong ties to the industry, I have not seen such interesting—and positive—developments in years. For example, according to Statista the sales of electric vehicles are on the verge of explosion.

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Amgen joins Kernal Bio’s $25M financing as the startup brings mRNA 2.0 to cancer

MedCity News

Kernal Biologics has technology that enables the delivery of messenger RNA therapies to a wider range of destinations in the body. The Series A financing comes as the startup works to advance its lead immuno-oncology program toward its first clinical test.

Leads 114
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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.

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Europe is seeing a hiring boom in pharmaceutical industry data analytics roles

Pharmaceutical Technology

Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.

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StartUp Health takes a multidisciplinary approach to fight type 1 diabetes

pharmaphorum

David Weingard, chief impact officer of T1D Moonshot and founder of Cecelia Health, tells us how T1D Moonshot aims to break silos and advance type 1 diabetes prevention and treatment options by utilising numerous partners’ expertise. In the US alone, 37.3 million Americans live with diabetes, with 1.6 million having type 1 diabetes (T1D). Still, a scarcity of T1D treatments exists.

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Application of RSD Charts for Content Uniformity Data in Continued Process Verification

PharmaTech

This article is focused on introducing a control chart technique using relative standard deviation (RSD) statistics (i.e., RSD chart); in other words, a coefficient of variation chart for continued process verification.

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OSF Ventures’ new leader will focus investments on alternative care modalities, workforce retention

MedCity News

OSF Ventures — the investment arm of Peoria, Illinois-based OSF HealthCare — gained a new leader last week when Mayank Taneja took the helm. In the role, Taneja oversees $250 million in assets across three funds. The venture capital arm is currently focused on investing in solutions to take care outside the four walls of a hospital and increase workforce retention, he said.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.