Pharmaceutical Technology

JULY 7, 2022

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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MedCity News

JULY 7, 2022

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.

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Medgadget

JULY 7, 2022

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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MedCity News

JULY 7, 2022

Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Distribution

Medgadget

JULY 7, 2022

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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European Pharmaceutical Review

JULY 7, 2022

Inadequate investigations and failure to follow standard operating procedures (SOPs) are some of the most common causes for regulatory warning letters in companies, according to Jeanne Moldenhauer, Vice President of Excellent Pharma Consulting. However, she notes that useful information for assessing risks in your facility and preparing for upcoming inspections can be gleaned from other’s warning letters and regulatory inspection observation reports, such as FDA 483.

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Pharmaceutical Technology

JULY 7, 2022

Genetic mutations, both germline and acquired, are behind a large proportion of the most debilitating and sometimes life-threatening human diseases. But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. For many decades, investigators have been working on innovative therapeutic modalities known as cell and gene therapies, which use modified versions of the body’s own cellular and genetic material to treat and potentially cure the

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MedCity News

JULY 7, 2022

Seniors’ demand for Medicare Advantage plans shows no signs of slowing down any time soon, and that means CMS is likely to continue accelerating its FWA audits of MA plans, particularly given the prevalence of Covid-19-related fraud.

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European Pharmaceutical Review

JULY 7, 2022

Dr Eric Hughes joins Teva with experience in all phases of drug development at global pharmaceutical companies, most recently Boston-based Vertex Pharmaceuticals, which he joined last year. He will be based out of Teva’s US headquarters in Parsippany, New Jersey. . “Eric brings nearly 20 years of leadership roles with a proven track record in a variety of R&D functions for global pharmaceutical companies, and has a successful record of accomplishment fostering productive collaborations with

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MedCity News

JULY 7, 2022

The rising levels of both type 1 and type 2 diabetes in American youth is quickly becoming a major public health concern. To help address this problem, Mount Sinai partnered with mPulse Mobile, a company that offers a AI-based mobile patient messaging platform. Together with a group of teenage community members, they created a text message-based youth diabetes prevention program focused on integrating healthy behaviors into teens’ lives.

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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.

Safety

European Pharmaceutical Review

JULY 7, 2022

The WuXi Biologics MFG14 facility has been performing Chemistry, Manufacturing and Controls (CMC) projects since early 2022, and has now started current good manufacturing practice (cGMP) manufacturing of microbial products. It is part of WuXi Biologics’ Integrated Innovation Centre, which was launched in November 2020 to offer products based on microbial fermentation technologies.

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MedCity News

JULY 7, 2022

The Supreme Court’s majority opinion in Dobbs will create a big mess around what data will be revealed and the repercussions that will come when data are obtained. Individuals will bear the brunt of the burden while it all gets figured out.

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pharmaphorum

JULY 7, 2022

In the second of a three-part series, Ben Hargreaves looks at the importance of early-stage research into various emerging infectious disease threats and how it saved precious time in the work to develop a working vaccine during the current pandemic. When COVID-19 first emerged, scientists cautioned that developing an effective and safe vaccine could take longer than the commonly estimated figure of a year.

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Government 85

MedCity News

JULY 7, 2022

From 2001 to 2017, the fatal overdose rate in Cabell County increased from 16.6 to 213.9 per 100,000. Judge finds no evidence of causation.

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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.

Specialization

PharmaVoice

JULY 7, 2022

Precision BioSciences’ CEO discusses the company’s potentially groundbreaking cancer treatment.

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MedCity News

JULY 7, 2022

The U.S. government agencies warned that Maui ransomware has been used by North Korean state-sponsored cyber actors since at least May 2021.

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PharmaVoice

JULY 7, 2022

Marc Kikuchi weighs in on the company’s plans to pump up its pipeline and sales in the coming years.

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MedCity News

JULY 7, 2022

Exo recently partnered with Henry Ford Health to validate its software platform for point-of-care ultrasounds. The health system’s physicians will work with the company to increase the platform’s ease of use, as well as commercialize the mobile ultrasound device Exo is developing.

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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.

Safety

PharmaTimes

JULY 7, 2022

The British Heart Foundation’s project will accelerate the search for better prevention and treatment of diabetes

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Patients 89

Pharmaceutical Technology

JULY 7, 2022

The US Food and Drug Administration (FDA) has granted priority review to Roche’s Biologics License Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). These patients should have received a minimum of two prior systemic therapies. A CD20xCD3 T-cell engaging bispecific antibody, Lunsumio can act on CD20 present on the B-cell surface and CD3 on the T-cell surface.

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Food and Drug Administration FDA Food Patients 64

PharmaTimes

JULY 7, 2022

The therapy is for moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic treatment

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Patients 82

Pharmaceutical Technology

JULY 7, 2022

The health concern over COVID-19 in June 2022 decreased from May 2022. It averaged at 23.9%, declining from 25.3% recorded in May 2022, shows the COVID-19 concern index, which is measured by responses to an ongoing poll Verdict launched in March 2020. The poll has been tracking how the concerns over coronavirus have been changing over time. The poll asked how concerned the respondents were about the spread of coronavirus and included five options to choose from - very concerned, slightly concern

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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.

Management

pharmaphorum

JULY 7, 2022

New data on Sarepta’s gene therapy for Duchenne muscular dystrophy (DMD) has gone a long way towards building confidence in its efficacy – but have introduced a concern about its safety. Updated results from several trials of SRP-9001 (delandistrogene moxeparvovec) revealed a wealth of positives, including functional benefits in patients with the muscle-wasting disease after one to fours years of follow-up, pointing to a durable effect of the gene therapy.

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PharmaTech

JULY 7, 2022

In this exclusive Drug Digest video, experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development.

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Clarify Health

JULY 7, 2022

By: Stephanie Finch, Executive Director, Transformation & Performance, Clarify Health At the recent AHIP conference in Las Vegas, I joined thousands of payer executives, insurance industry experts, policymakers and thought leaders for three days of thought-provoking discussion around the issues and trends facing our industry. I always come back from conferences feeling energized (especially since so many are back to being in-person!

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Scott’s Directories

JULY 7, 2022

The healthcare industry, as a result of immense interest and competition, has undergone a massive digital transformation in recent years. From curating an online Winnipeg doctors list to formulating digital marketing strategies, everything in the industry has moved online. If you are a part of the healthcare industry, using the following marketing trends will significantly help you win the race against your competitors.

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Leads

Spotio

JULY 7, 2022

Success in sales is all about process. Develop a winning process and optimize it to perfection and your team will close more deals, drive more revenue, and exceed all expectations. Easier said than done, we know, which is why we want to take a few minutes to talk about sales management software. Keep reading to learn what this software does, why it’s beneficial, specific features to look for, and the best sales management software available.

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Legacy MEDSearch

JULY 7, 2022

If you ever studied English literature, it’s almost certain that you’ve heard of a Six Word Story; A contributing method to Ernest Hemingway’s Iceberg theory in which the writer uses only six words to tell an entire story. You may have even written a few. According to legend, Hemingway constructed the six-word story at lunch with a table full of fellow writers.

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Clarify Health

JULY 7, 2022

By: Stephanie Finch, Executive Director, Transformation & Performance, Clarify Health. At the recent AHIP conference in Las Vegas, I joined thousands of payer executives, insurance industry experts, policymakers and thought leaders for three days of thought-provoking discussion around the issues and trends facing our industry. I always come back from conferences feeling energized (especially since so many are back to being in-person!

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Insurance Transportation Medicine Government 52

Storyvine

JULY 7, 2022

The Storyvine team celebrated our win as one of 2022’s Colorado Companies to Watch at the 14th Annual Gala Wards Dinner on June 17, 2022. The statewide awards program recognizes growing companies that fuel the economic fire of the state. Winners are considered to be Colorado’s most innovative, visionary, job-creating, impactful, and successful 2nd Stage entrepreneurs, so after several years as a finalist, we are thrilled to be a winner in 2022.

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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.

Patients