Fierce Pharma
AUGUST 21, 2023
Regeneron pulled off a rare double play on Friday afternoon as it scored two FDA approvals—one under the radar and the other highly anticipated. | With the FDA signing off on Regeneron and Bayer’s high-dose Eylea, the companies are set to take on Roche’s Vabysmo in a high-stakes battle for the massive eye disease market.
MedCity News
AUGUST 21, 2023
As the U.S. healthcare system works to focus on the move to preventive, personalized care for patients, it’s time to turn the tide on diabetes by addressing the three Cs of chronic disease care: compassion, coordination, and community.
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Fierce Pharma
AUGUST 21, 2023
First came doubts about the combinability of Amgen’s Lumakras with a standard PD-1 inhibitor. | The FDA will hold an advisory committee meeting to discuss confirmatory trial data for Amgen's Lumakras in KRAS-mutated lung cancer. This comes after a bumpy stretch for the medicine since its debut in 2021.
MedCity News
AUGUST 21, 2023
Healthcare M&A deals are expected to pick up over the next few months, and one expert is predicting that the biopharma sector in particular will see especially robust activity. M&A lawyer Matt Gardella said there are three sets of market circumstances that will lead to an influx of biopharma deals: a looming patent cliff, shrinking valuations and a weak IPO market.
Fierce Pharma
AUGUST 21, 2023
After a losing streak in the clinic, Roche and Exelixis’ combo of Tecentriq and Cabometyx has delivered a trial win in tough-to-treat prostate cancer. | Roche’s immuno-oncology star Tecentriq plus Exelixis and Ipsen’s tyrosine kinase inhibitor Cabometyx helped patients with pretreated metastatic castration-resistant prostate cancer live longer without their disease getting worse, the partners said Monday.
PharmExec
AUGUST 21, 2023
In this exclusive Q&A with Pharmaceutical Executive, Janice Chang, CEO of TransCelerate BioPharma, provides an inside look into her career journey, her work at the company, how the industry has changed in the last 10 years, as well as her thoughts on where the industry should put its efforts in clinical trials.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
AUGUST 21, 2023
Do some people simply think the A in AI stands for Automation? Most likely the confusion is due to a lack of understanding of what AI truly is, combined with a strong desire to use the term for marketing purposes.
Fierce Pharma
AUGUST 21, 2023
After Johnson & Johnson initiated a share-exchange offer to significantly reduce its holdings in Kenvue, the company says it's keeping about a 9.5% stake in the consumer health spinoff. | J&J sought to offload most of its stake in the consumer health spinout through an exchange offer. The company's offer ended on August 18 and ended up being oversubscribed.
MedCity News
AUGUST 21, 2023
Spring Health launched Sage, a platform that offers asynchronous video lessons to help employees manage their own mental health and support managers in creating a healthy work environment.
European Pharmaceutical Review
AUGUST 21, 2023
According to a market report , the global RNA therapy clinical trials market is anticipated to reach $3.5 billion by 2030 and grow at a CAGR of 3.84 percent from 2023 to 2030. The data stated that expansion of the market in emerging countries is due to factors such as the rising success rate of RNA-based COVID-19 vaccines, regulatory approval, as well as demand for personalised medicines.
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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
AUGUST 21, 2023
The current imaging interpretation model undoubtedly has reached its breaking point due to increasing volumes and fewer radiologists. The time is now to solve this systemic imaging interpretation issue.
Pharmaceutical Technology
AUGUST 21, 2023
The EC approved Janssen's Type II variation application for reduced dosing frequency of bispecific antibody TECVAYLI for multiple myeloma.
MedCity News
AUGUST 21, 2023
Genesis Therapeutics recently joined the growing list of AI-powered drug discovery startups receiving venture funding this year. The company closed a $200 million Series B financing round, taking its total funding to date to more than $280 million.
European Pharmaceutical Review
AUGUST 21, 2023
For 20 of the leading biopharmaceutical companies, the second quarter (Q2) of 2023 has brought an aggregate market capitalisation growth of 2.3 percent. Data and analytics company GlobalData has reported a rise from $3.49 trillion in the Q1 of 2023 to $3.56 trillion in Q2 2023. Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1 percent over Q2 2023, moving up to first position in the list and displacing Johnson & Jo
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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
PharmaVoice
AUGUST 21, 2023
The depression space recently got a stinging FDA rebuke — but Brii thinks it can break through with improved formulations.
MedCity News
AUGUST 21, 2023
Viome Life Sciences’ Series C funding round included participation from Khosla Ventures, Bold Capital and WRG Ventures. In total, Viome has raised $175 million.
Pharmaceutical Technology
AUGUST 21, 2023
The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ EYLEA HD injection 8 mg.
PharmaVoice
AUGUST 21, 2023
Using real-time data, patient centricity and personalized medicine to accelerate clinical trials.
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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.
Pharmaceutical Technology
AUGUST 21, 2023
The company’s generative and predictive AI-powered drug discovery platform is already being used by Eli Lilly.
Medgadget
AUGUST 21, 2023
Researchers at the University of Leeds in the UK have developed a magnetic tentacle robot that is intended for use in minimally invasive medical procedures, such as the treatment of tumors in the lungs. The soft tentacles are made from silicone. They are unlikely to cause tissue damage, and contain a series of magnets that can be influenced by external magnetic robots.
PharmaTimes
AUGUST 21, 2023
Mitazalimab is a monoclonal antibody that has been created to sensitize tumours to chemotherapy - News - PharmaTimes
PharmExec
AUGUST 21, 2023
Biopharma companies and contract research organizations (CROs) adopted decentralized or digital clinical trials (DCTs) to reduce contact, improve the patient experience and keep studies on track during the pandemic. It’s already clear that the virtual approach of DCTs are benefiting life science organizations. From improvements in clinical trial operations such as enhanced patient engagement and site experience to cost savings and better data integration, the clinical trial dynamic has shifted a
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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.
PharmaTech
AUGUST 21, 2023
The lab of the future is about the whole enterprise. It generates business value by using advanced digital tools and techniques to make contextualized, actionable scientific data available at the bench, in the executive boardroom, and wherever that data can help generate revenue, accelerate innovation, and drive meaningful business decisions. This paper will help you keep up—and even get ahead—in a future that’s rapidly approaching.
Clarify Health
AUGUST 21, 2023
When it comes to healthcare data analytics, both quantity and quality play a critical role. While large and varied datasets (quantity) allow for big-data innovations like machine learning and AI, data quality is paramount to ensure our analyses lead us to fair, accurate, and transparent insights. Data quality is a measure of the condition of data based on factors such as accuracy, completeness, consistency, timeliness, and reliability is crucial to enabling both payers and providers to measu
LEVO Health
AUGUST 21, 2023
With the rise of digital platforms and tools, healthcare providers (HCPs) have transformed into digitally savvy professionals, seeking information and resources at their fingertips. For businesses in the healthcare sector, this presents both a challenge and an opportunity. The challenge? To effectively engage these HCPs in a cluttered digital landscape.
Legacy MEDSearch
AUGUST 21, 2023
Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced 510(k) clearance from the U.S. Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. “After years of research and development in polyethylene, Activit-E represents a breakthrough achievement for Exactech,” said Adam Hayden, CMO and SVP, Large Joints Business Unit at Exactech.
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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
PharmaTimes
AUGUST 21, 2023
The treatment is indicated for adults with moderate-to-severe chronic hand eczema - News - PharmaTimes
PharmaTech
AUGUST 21, 2023
FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.
Pharmaceutical Technology
AUGUST 21, 2023
AstraZeneca received China’s NMPA approval for Forxiga to cut the risk of cardiovascular mortality and hospital admission for heart failure.
PharmaTech
AUGUST 21, 2023
The expanded operations will also support the start of proline/alanine/serine (PAS)-nomacopan clinical trials in geographic atrophy (GA).
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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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