Fierce Pharma
JULY 26, 2023
As with Novo Nordisk’s popular offering for obesity, Wegovy, demand for Eli Lilly’s dual GIP/GLP-1 agonist Mounjaro appears to be outpacing supply once again. | The U.S. Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. The agency also expects supply issues with three other doses to persist longer than previously thought.
PM360
JULY 26, 2023
As biosimilars make inroads across various disease states, oncology especially appears to have embraced the new breed of therapies. Biosimilar adoption, however, is not as simple as picking the lowest-cost option, according to one expert. Deciding which biosimilars to use requires a complex set of considerations for oncology clinics, notes Andre Harvin, PharmD, Executive Director of Pharmacy and Oncology Services at Cone Health.
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Fierce Pharma
JULY 26, 2023
With a European approval for chronic kidney disease nod in hand, Boeringer Ingelheim and Eli Lilly's Jardiance is looking to catch up to AstraZeneca's Farxiga in this use and continue growing its r | After recent label expansions in the U.S. and Europe paid off with a sizable sales increase for Jardiance, the drug has added a third use to its European label.
PM360
JULY 26, 2023
Today, the U.S. is facing an aging population, a mounting physician shortage, and increasing demands for a more equitable healthcare system. 1 According to the U.S. Surgeon General, burnout among healthcare workers has reached crisis levels. 2 It’s no wonder physicians across the country are limiting time with the industry and prioritizing their limited time with their patients.
Fierce Pharma
JULY 26, 2023
Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter. | Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter.
PM360
JULY 26, 2023
Digital fireworks were launched just hours after the July 4 th holiday in the U.S. with the official launch of Threads by Meta, a new platform that is a direct competitor of Twitter. It should be of no surprise to anyone that a flurry of Twitter competitors is now entering the marketplace. Ever since Elon Musk’s purchase of Twitter, a target has been on the back of one of the original and most polarizing social platforms.
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MedCity News
JULY 26, 2023
More than 600 rural U.S. hospitals — which is more than 30% of the country’s rural hospitals — are at risk of closing due to their financial instability, according to a new report. The report argued that the dire financial situation among the nation’s rural hospitals stems from two main issues: low financial reserves and inadequate payments from private health plans.
Fierce Pharma
JULY 26, 2023
More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. | The FDA signed off on Octapharma's blood coagulant Balfaxar as a treatment to counter the effects of commonly used blood thinner warfarin.
PM360
JULY 26, 2023
Since passage of the Inflation Reduction Act (IRA) in August 2022, the focus of many industry analysts and pharmaceutical companies has been on two important first order concerns: identifying products to be negotiated by the Centers for Medicare & Medicaid Services (CMS) and assessing the direct impact on prices. Most companies have now completed the critical analyses associated with these direct effects.
Fierce Pharma
JULY 26, 2023
Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. | In a quarter fueled by sales of Shingrix and its HIV medicines, GSK topped revenue expectations and bumped up its sales projection for the year. While the company anxiously awaits the launch this fall of RSV vaccine Arexvy, it is tamping down expectations of an immediate boom in sales for the potential blockbuster.
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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.
PM360
JULY 26, 2023
Would it surprise you to know that the COVID-19 pandemic turned pharmacy priorities on its head, which could have the potential of morphing pharmacies into full-fledge healthcare centers over the long term? Pharmacy technicians (aka “techs”) and pharmacists alike were affected by COVID-19. Adding responsibilities of testing for COVID-19 and administering the vaccine in mass volumes when it became available, pharmacists and techs had to shuffle workload and priorities in a way that supported this
Fierce Pharma
JULY 26, 2023
After triumphing over Novartis’ Cosentyx in a 2020 psoriasis study, Skyrizi has dished out another serving of competitor-busting data. | AbbVie's Skyrizi has dished out another serving of competitor-busting data, this time going head-to-head against Amgen’s Otezla.
Pharma Marketing Network
JULY 26, 2023
The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. One of the FDA’s enforcement mechanisms is the issuance of marketing violation letters to pharmaceutical companies found in violation of advertising and promotion regulations.
Fierce Pharma
JULY 26, 2023
Following in EU regulators' footsteps, the U.K. has reportedly launched a probe into potential suicide risks for popular diabetes and weight-loss drugs. | Following in EU regulators' footsteps, the U.K. has reportedly launched a probe into potential suicide risks for popular diabetes and weight-loss drugs.
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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
PharmExec
JULY 26, 2023
As we approach the one-year anniversary of the IRA being signed into law, questions remain about how the new law will reverberate changes across the biopharma industry.
Fierce Pharma
JULY 26, 2023
After quitting FDA adcomm in protest of Aduhelm decision, Harvard's Aaron Kesselheim finds agency has an approval bias kdunleavy Wed, 07/26/2023 - 05:39
MedCity News
JULY 26, 2023
UnitedHealthcare awarded grants to 66 nonprofits across 12 states. The grants will support those struggling with social isolation, behavioral health, food insecurity and other social determinants of health.
PM360
JULY 26, 2023
An initial and discernible benefit to adopting decentralized clinical trial (DCT) models is alleviating patient burden by mitigating unnecessary travel through the utilization of eClinical platforms, mobile phlebotomy/nursing services, local clinics, and other technologies. For example, oncology patients with end-stage cancers participating in traditional clinical trials would be required to travel, often substantial distances several times a week, to a research/academic site for something as si
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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.
European Pharmaceutical Review
JULY 26, 2023
The European Commission (EC) has approved Jardiance ® (empagliflozin) for adults with chronic kidney disease (CKD). The oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor is the first type 2 diabetes medicine to include cardiovascular death risk reduction data for patients with type 2 diabetes and cardiovascular disease in its label in several countries.
PM360
JULY 26, 2023
As interest in artificial intelligence (AI) has swelled since the release of ChatGPT and other generative AI at the end of last year, so have concerns around its use. Even top AI developers from Google and OpenAI co-signed a statement at the end of May from non-profit the Center for AI Safety that said, “Mitigating the risk of extinction from AI should be a global priority alongside other societal-scale risks such as pandemics and nuclear war.
MedCity News
JULY 26, 2023
While Octapharma drug Balfaxar met the goal of its pivotal clinical trial, more deaths and blood clot problems were reported in the study drug arm versus the comparator group. The FDA is requiring a post-marketing study to further assess the drug’s risks.
Pharmaceutical Technology
JULY 26, 2023
Eli Lilly has extended the tender offer expiration date for the acquisition of all Dice Therapeutics in a deal valued at $2.4bn.
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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.
MedCity News
JULY 26, 2023
Spring Health’s Family Care solution now serves kids of all ages and their parents. It connects each family with a care navigator and offers a dashboard that allows parents and caregivers to track their child’s care.
European Pharmaceutical Review
JULY 26, 2023
A Finnish contract development and manufacturing organisation (CDMO) specialising in biopharmaceuticals, has announced it is investing over €50 million to expand its manufacturing facility in Turku, Finland. Biovian’s financing will help to meet the growing demand for innovative biologics and gene therapies. Antti Nieminen, CEO of Biovian, stated that the new manufacturing facility will “contribute to the growth of the biopharmaceutical industry in Finland”.
MedCity News
JULY 26, 2023
Rich multimedia content, chatbots and human interaction all play important roles in helping new health technologies become part of a patient’s lifestyle.
Pharmaceutical Commerce
JULY 26, 2023
Updated deal will cover exclusive US commercialization for several of Alvotech’s biosimilars.
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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
MedCity News
JULY 26, 2023
The webinar, sponsored by Intelligent Medical Objects, will explore the impact of poor data quality and methods to improve patient data quality. It will also highlight healthcare industry employee burnout and how to improve retention.
PharmExec
JULY 26, 2023
Common advice for OA sufferers is joint replacement, but there should be other options.
MedCity News
JULY 26, 2023
Octave Bioscience, based in Menlo Park, California, just closed a $30 million extension to its Series B funding round.
PharmaTimes
JULY 26, 2023
The new company’s core mission is to boost patient access to disease-modifying treatments - News - PharmaTimes
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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.
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