Fierce Pharma
JULY 11, 2023
Caught in a litigation crossfire, Moderna has reportedly opened two new fronts in its COVID-19 vaccine patent war with Pfizer and BioNTech. | Moderna has lodged two new lawsuits at the High Court in Dublin, Ireland, and the Brussels Commercial Court in Belgium, Juve Patent first reported. This adds to a complex web of ongoing mRNA patent litigation.
MedCity News
JULY 11, 2023
There are three key areas of the healthcare sector where generative AI is booming the most — in terms of both venture capital funding and the development of innovative technology — according to Anjalika Komatireddy, an analyst at CB Insights. During a recent webinar, she discussed the generative AI activity occurring in these three areas: care delivery and navigation, digital therapeutics and drug discovery.
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Fierce Pharma
JULY 11, 2023
After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead. | After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead.
Pharmaceutical Commerce
JULY 11, 2023
The National Alliance of Healthcare Purchaser Coalitions releases resources for employers/health plan purchasers to offer insights on PBMs role in high prescription drug costs.
Fierce Pharma
JULY 11, 2023
U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. | U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. After an ominous delay, Takeda has decided to withdraw the FDA application for its dengue vaccine candidate after the agency raised concerns about data collection.
MedCity News
JULY 11, 2023
HCA Healthcare recently suffered a data breach affecting 1,038 hospitals and physician clinics across 20 states. The health system said hackers stole data from an external data storage location “exclusively used to automate the formatting of email messages.” It also said that the incident has not caused any disruption to HCA’s daily operations or the services it provides to patients.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JULY 11, 2023
The average income of a traditional Medicare enrollee is $85,085, versus $76,720 for a Medicare Advantage enrollee, according to a whitepaper done in partnership between Harvard Medical School and software solutions company Inovalon.
Fierce Pharma
JULY 11, 2023
Right after Leqembi's full approval from the U.S. FDA, Eisai’s global Alzheimer’s disease officer is getting ready to hang up his hat. | Ivan Cheung, Eisai's American CEO and global Alzheimer's disease officer, will retire at the end of the month. With Cheung headed for the exit, Keisuke Naito—the 34-year-old son of Eisai’s CEO Haruo Naito—has taken up the lead Alzheimer’s mantle, the company said Tuesday.
MedCity News
JULY 11, 2023
From stock transparency and supplier diversification to AI shipping and cart negotiations, novel solutions are emerging to revolutionize procurement and logistics of medical supplies at healthcare organizations.
Fierce Pharma
JULY 11, 2023
With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. | With Xspray Pharma and Eversana’s cancer med hitting a regulatory setback, a launch in the second half of 2023 now looks unlikely. That’s good news for Bristol Myers Squibb, which has secured a few more competition-free months for its aging leukemia blockbuster Sprycel.
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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
JULY 11, 2023
Novartis and BeiGene ended their partnership on a cancer immunotherapy for a target called TIGIT. Though BeiGene describes the termination as mutual, it comes before Novartis would need to pump more money into the alliance even as questions linger about TIGIT as a cancer target.
Fierce Pharma
JULY 11, 2023
ADC Therapeutics has slammed the brakes on enrollment in a phase 2 combination trial for Zynlonta as it investigates seven patient deaths and five other severe respiratory events among patients who | A total of 12 severe adverse events were reported among the 40 patients enrolled in the phase 2 trial, 11 of which ADC says were not related to the treatment.
MedCity News
JULY 11, 2023
Health Connect America, a mental health company, improperly billed Virginia Medicaid for three different behavioral health services for children, according to the U.S. Attorney’s Office of Western District of Virginia.
Copyright Clearance Center
JULY 11, 2023
Science publications are typically written by scientists and for scientists, yet the audience for science is far wider, especially any reporting on medical breakthroughs in treatments of serious diseases.
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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
JULY 11, 2023
Septerna Therapeutics’ Series B financing will support plans to reach the clinic with a pill for a rare disease whose only approved therapy is a Takeda Pharmaceutical drug that’s leaving the market. Potential rival therapies are all injectables.
European Pharmaceutical Review
JULY 11, 2023
The first CD20xCD3 T-cell-engaging bispecific antibody (BsAb) treatment to be approved in Europe for diffuse large B-cell lymphoma (DLBCL) has been granted conditional marketing authorisation. European approval is based on results from the Phase I/II NP30179 study of Columvi ® (glofitamab). Given as a fixed course, the BsAb treatment induced a complete response (CR) in 35.2 percent of the heavily pre-treated or refractory DLBCL participants.
MedCity News
JULY 11, 2023
Health systems need to turn their attention to technology that can improve staff retention by reducing employee burnout, according to HCA Divisional CIO Andy Draper. Here’s a look at what Parlance is doing to realize ROI with conversational AI.
Pharmaceutical Technology
JULY 11, 2023
Iovance Biotherapeutics completes a preliminary analysis after the US' FDA found the trial design acceptable for accelerated approval.
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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
JULY 11, 2023
To improve public health outcomes, not only at the local and national level, but also globally, we need to invest in hygiene research and those who seek to solve hygiene-related issues.
European Pharmaceutical Review
JULY 11, 2023
Contract research, development, and manufacturing organisation ( CRDMO ) WuXi Biologics has announced a proposed spin-off and separate listing of its subsidiary WuXi XDC Cayman Inc. (WuXi XDC) on the Main Board of the Hong Kong Stock Exchange (HKEX). A biologics CRDMO WuXi XDC is a joint venture between WuXi Biologics and WuXi STA. The organisation provides end-to-end contract R&D and manufacturing services for bioconjugates, including antibody drug conjugates (ADCs).
MedCity News
JULY 11, 2023
Better Therapeutics prescription digital therapeutic, AspyreRx, received De Novo FDA authorization for type 2 diabetes. The mobile app digitizes and personalizes cognitive behavioral therapy.
PharmaVoice
JULY 11, 2023
With a purchase of the pharma giant’s Kenilworth campus, Onyx Equities is looking to make the spot a go-to biotech hub.
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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 11, 2023
As more life-extending medications come on the market, health systems have a responsibility to make meaningful changes in how they screen and reach older adults. Earlier detection could mean millions of individuals enjoy longer lives of good cognitive health.
Pharmaceutical Technology
JULY 11, 2023
Study shows patients taking abatacept, cenicriviroc, or Remicade in addition to SOC do not recover quicker compared to placebo.
PharmExec
JULY 11, 2023
In this insightful Q&A, Aaron Noll, MD, MS, OptimizeRx's senior AI solutions engineer, sheds light on how healthcare professionals leverage various information channels, the type of data they seek, and the role of AI in personalizing and optimizing healthcare communication.
PharmaTech
JULY 11, 2023
FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition
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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
Legacy MEDSearch
JULY 11, 2023
Invictus Medical announced today that the culmination of their De Novo application to the FDA for its Neoasis ® incubator-based active noise control (ANC) device has resulted in a clearance-for-use declaration by the FDA. “With this clearance for use, Invictus has made a huge step towards deploying the Neoasis ® ANC device in neonatal intensive care units.
European Pharmaceutical Review
JULY 11, 2023
A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted the importance of post-approval R&D in advancing oncology treatment options and delivering unprecedented progress over the past ten years. The insight builds off previous research that shows for certain cancer medicines , most of the high-impact clinical research happens after a medicine is initially approved.
PharmaTimes
JULY 11, 2023
Therapy treats patients with chronic graft-versus-host disease who have already received other treatments - News - PharmaTimes
Pharmacy Times
JULY 11, 2023
Pharmaceuticals are a critical and often lifesaving tool for managing disease, but we will never solve our chronic disease crisis through a mindset of mere management.
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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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