Fierce Pharma
JUNE 5, 2023
After a postmarketing study of AstraZeneca's bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.< | The phase 4 study ended ahead of schedule after it quickly established the benefits of Andexxa. AZ now plans to seek full approvals for the drug.
MedCity News
JUNE 5, 2023
The ED boarding crisis is not one that’s going to be solved overnight. But left to continue unchecked, it will only engender wider discontent, decrease patient satisfaction, and ultimately lead to worse outcomes.
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Fierce Pharma
JUNE 5, 2023
Six months after filing for bankruptcy, Clovis Oncology was hoping for a last gasp | Six months after filing for bankruptcy, Clovis was hoping for a last gasp win for fading cancer drug Rubraca. But the FDA has rejected the company’s bid for approval of the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients who have responded to a round of chemotherapy.
Pharmaceutical Technology
JUNE 5, 2023
Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.
Fierce Pharma
JUNE 5, 2023
Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene | Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.
MedCity News
JUNE 5, 2023
If a drug’s FDA approval could be overturned by any judge, anywhere, anytime the pharmaceutical industry would be severely impacted. While mifepristone is no blockbuster, a legal precedent allowing courts to overturn the FDA’s approval could be applied to other drugs like blockbuster drugs like Viagra, Humira, or the new diabetes, weight-loss drugs Ozempic or Wegovy.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JUNE 5, 2023
A group of healthcare researchers and health system leaders recently proposed a new framework to evaluate evidence for digital health products. The framework seeks to provide hospitals, payers and trade organizations with a clear set of steps they can use to determine whether or not a digital health product is evidence-based and therefore suitable for their company to adopt.
Fierce Pharma
JUNE 5, 2023
Amgen and Horizon extended a prior September restraining order to Halloween as they work through the FTC litigation. Up next, the parties are set for a court hearing on September 11.
PharmaVoice
JUNE 5, 2023
Rachel King took the reins at BIO during a rocky time. Now, after steadying the ship, she’s brought the trade association’s focus back to the industry’s most pressing priorities.
Fierce Pharma
JUNE 5, 2023
One of the hottest topics shaping the world of pharmaceuticals and medicine is patient centricity. How can the industry better engage with the people who rely on its products and services? | Victoria Summers, principal at ZS Associates, discusses one of the most pressing challenges facing the pharma industry today: patient centricity.
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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.
MedCity News
JUNE 5, 2023
Prana Thoracic, a startup focused on earlier detection and intervention for lung cancer, recently won the medical devices track of the MedCity News INVEST Pitch Perfect contest. The company is developing a minimally invasive electrosurgical device to help thoracic surgeons better excise smaller and intermediate-size lung nodules.
European Pharmaceutical Review
JUNE 5, 2023
Based on an in silico analysis of over 12,000 small molecule drugs and drug impurities , a recent paper has reported that the presence of nitrosamines in pharmaceuticals is likely more prevalent than originally expected. In total, 40.4 percent of the analysed active pharmaceutical ingredients (APIs) and 29.6 percent of the API impurities were revealed as potential nitrosamine precursors.
MedCity News
JUNE 5, 2023
OmniLIfe Health, based in Lexington, Kentucky, won the MedCity News INVEST Pitch Perfect contest on May 23, beating five other payer/provider startups. The company works to streamline workflows for organ transplants.
European Pharmaceutical Review
JUNE 5, 2023
A two-year study monitoring microbial contamination of adipose tissue-derived stem cells (ADSC)-based advanced therapy medicinal products (ATMP) during manufacture , showed over 40 percent of lipoaspirate samples were contaminated with thirteen different microorganisms. over 40 percent of lipoaspirate samples [from ADSC-based ATMPs] were contaminated with thirteen different microorganisms” This is the first study to show this observation, according to the authors of the paper.
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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
MedCity News
JUNE 5, 2023
Doulas — who provide physical, emotional and informational support to expectant mothers — have shown to improve maternal health outcomes, but there’s little insurance coverage of their services. That’s starting to change, however, particularly in Medicaid programs.
PharmExec
JUNE 5, 2023
Indicates that reimbursement for new slate of Alzheimer’s treatments will occur only with the completion of studies to support full approval.
MedCity News
JUNE 5, 2023
A recent CDC report found that many Americans are not taking their prescription medications as directed to reduce costs. There are significant differences in Americans doing so based on gender, race and coverage.
European Pharmaceutical Review
JUNE 5, 2023
Ninety-four percent of advanced stage (3 or 4) classic Hodgkin lymphoma patients treated with nivolumab, a PD-1 checkpoint inhibitor plus AVD chemotherapy (N-AVD) had one-year progression-free survival (PFS), according to Phase III trial results. This was compared with 86 percent of patients given brentuximab vedotin, a monoclonal antibody (mAb), and AVD (BV-AVD).
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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.
MedCity News
JUNE 5, 2023
In a confirmatory Phase 3 test of ImmunoGen’s Elahere, the ovarian cancer drug handily beat chemotherapy with results that clinicians say could make the treatment the new standard of care for certain patients. The data were presented during the annual meeting of the American Society of Clinical Oncology.
PharmaTimes
JUNE 5, 2023
New division aims to provide laboratories with the equipment and support to uphold analytical data - News - PharmaTimes
MedCity News
JUNE 5, 2023
The HER2 protein targeted by the approved cancer drug Enhertu is found on a wide range of tumors. Interim Phase 2 data reported at the annual meeting of the American Society of Clinical Oncology suggest the AstraZeneca and Daiichi Sankyo drug has potential to treat many of these cancers.
MedReps
JUNE 5, 2023
Even medical sales reps working for small businesses can end up with impressive sales commissions. Not only do these salespeople get paid a base salary, but they also receive commissions and bonuses for making sales, increasing the incentives. If you want to see the size of your sales commissions go up exponentially, then consider following these five steps.
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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.
PharmaTimes
JUNE 5, 2023
Company’s phase 3 study showed treatment with Tagrisso reduced risk of death by over half - News - PharmaTimes
Pharmaceutical Technology
JUNE 5, 2023
ITM (Isotope Technologies Munich) has announced a €255 million ($273.16 million) equity investment funding raise. According to ITM’s CEO Steffen Schuster, the raise is one of the largest private biotechnology financing rounds to date in the company’s home market, per the 5 June announcement. The funding will be used to fuel the company’s pipeline of targeted radionuclide therapies alongside manufacturing capacities.
Clarivate
JUNE 5, 2023
Research administrators provide real-world recommendations on optimizing limited submission opportunities in the U.S. The number of new U.S. government limited submissions has nearly doubled over the last three years and now make up between 16% and 20% of all U.S. government funding opportunities, according to data from Pivot-RP ®. These limited submission opportunities, which restrict the number of submissions a single institution can submit, are also becoming more complex and are often confine
Pharmacy Times
JUNE 5, 2023
It’s imperative to redefine the future of pharmacy to help ensure a robust pipeline of future pharmacists and create a culture that helps ensure pharmacists live their purpose and passion.
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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
The Marketing Advantage
JUNE 5, 2023
June 5, 2023 The methodology under which physician targets are segmented and selected is a critical component of optimizing the productivity and efficiency of the sales force. The right sales force calling on the wrong targets dramatically hinders the sales force’s selling efforts and ultimately leaves sales on the table. So how do you know if your targets are as good as they could be?
Pharmaceutical Technology
JUNE 5, 2023
Kid EDV is under clinical development by ImmunityBio and currently in Phase I for Pediatric Diffuse Intrinsic Pontine Glioma. According to GlobalData, Phase I drugs for Pediatric Diffuse Intrinsic Pontine Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Kid EDV LoA Report.
Pharma Leaders
JUNE 5, 2023
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to Innovent Biologics’ olverembatinib for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumour (GIST). The designation was granted based on the results from an ongoing Phase Ib/II study of olverembatinib carried out in China.
Legacy MEDSearch
JUNE 5, 2023
American Society for Mass Spectrometry (ASMS) — Waters Corporation (NYSE: WAT ) today launched the industry’s first targeted imaging mass spectrometer based on its Xevo TQ Absolute tandem quadrupole mass spectrometer, the most sensitive and compact mass spectrometer in its class. The new instrument combines the Waters DESI XS source with the Xevo TQ Absolute system and is five times more sensitive and five times faster than discovery-based imaging systems at precisely determin
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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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