Fierce Pharma
OCTOBER 20, 2023
Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers. | Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers.
MedCity News
OCTOBER 20, 2023
Access to oncology-specific interdisciplinary care delivered digitally by a team of nurses, mental health therapists, nutritionists, advanced practice providers, and oncologists is the best option for combatting pain points related to both cost and access.
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Fierce Pharma
OCTOBER 20, 2023
In the race to secure U.S. approval for the first five-pronged meningitis vaccine, Pfizer has eked out a regulatory win well ahead of its immunization rival GSK. | The U.S. FDA gave a thumbs-up to Penbraya, the commercial moniker for Pfizer’s pentavalent vaccine defending against the most common serogroups behind meningococcal disease. The shot is approved for adolescents and adults between the ages of 10 and 25.
Impetus Digital
OCTOBER 20, 2023
Register for one of Impetus’ upcoming webinars between November 20-24: Digital Learning Programs with a Twist About the webinar Last year, we hosted a series of webinars on virtual learning programs. By popular demand, we are bringing them back in November, featuring all the new best practices, tips, and tricks that we’ve picked up in the last 12 months.
Fierce Pharma
OCTOBER 20, 2023
In September, Eli Lilly filed lawsuits against eight com | Eli Lilly is going after 11 online pharmacies—including several overseas—that are allegedly importing, selling or distributing unauthorized versions of its diabetes drug Mounjaro. In a complaint filed with the U.S. International Trade Commission, Lilly has named three companies in China, three in Europe and five in the U.S. that it claims are selling “low-grade” versions of the drug.
MedCity News
OCTOBER 20, 2023
We must prioritize early screening and diagnosis to facilitate timely interventions, prevent the progression to advanced liver disease and, ultimately, help save the lives of 1 in 10 Americans.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
OCTOBER 20, 2023
Cedars-Sinai published research in JAMA Cardiology this week on a algorithm it developed to detect atrial fibrillation in people not yet showing symptoms. The study found that the AI model does a good job of identifying hidden signals in common medical diagnostic testing and could help physicians better prevent strokes and other heart-related complications in people with atrial fibrillation.
Fierce Pharma
OCTOBER 20, 2023
With a new chief operating officer and an ongoing generics hit to its longtime stalwart Xyrem, Jazz Pharma has been going through some changes this year. | The company is in talks with advisors to field interest in a potential sale, people with knowledge of the matter told Bloomberg. Other options include breaking up the business and divesting some key assets.
European Pharmaceutical Review
OCTOBER 20, 2023
A paper by Tim Sandle, Head of Microbiology, Risk Management and Sterility Assurance at Bio Products Laboratory Ltd has underlined the importance of proper cleanroom disinfection practices by elucidating on the robust survival mechanism of the bacterium Micrococcus luteus (M. luteus). As “one of the most abundant organisms on the outer layer of human skin” M. luteus is a common contaminant recovered from cleanrooms, according to Sandle.
Fierce Pharma
OCTOBER 20, 2023
In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi a | In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's pa
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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
OCTOBER 20, 2023
After paying $4 billion up front, Merck will share in the development and commercialization of three Daiichi Sankyo cancer drugs in the red-hot field of antibody drug conjugates, or ADCs. The most advanced of them is on track for an FDA submission in 2024.
Fierce Pharma
OCTOBER 20, 2023
On the verge of a $43 billion powerhouse merger with Pfizer, Seagen has two Presidential Symposium presentations at the European Society of Medical Oncology (ESMO) Congress in Madrid, further evide | Seagen and Genmab's Tivdak produced a 30% reduction in the risk of death compared to chemotherapy for cervical cancer patients following disease progression on or after first-line therapy.
MedCity News
OCTOBER 20, 2023
FOLX Health is now in-network with insurers, including Blue Shield of California. The company serves the LGBTQIA+ community and offers virtual primary care, one-on-one therapy, mental health medication management, hormone replacement therapy, pre-exposure prophylaxis and care navigation.
Fierce Pharma
OCTOBER 20, 2023
Moving drugs into early-stage cancers is in vogue these days. | Moving drugs into early-stage cancers is in vogue these days. Roche has just posted a trial win for its targeted lung cancer therapy Alecensa that should enable earlier use, while eliciting a sense of déjà vu from a study of AstraZeneca’s Tagrisso.
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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
European Pharmaceutical Review
OCTOBER 20, 2023
In a long-term extension study, Eli Lilly and Company’s biologic lebrikizumab enabled almost 80 percent of patients with moderate-to-severe atopic dermatitis (eczema), who continued monthly maintenance dosing for up to two years, to maintain fully or almost complete skin clearance for this period. According to research highlighted by Eli Lilly, lebrikizumab is an interleukin-13 (IL-13) inhibitor that blocks signalling of IL-13.
Fierce Pharma
OCTOBER 20, 2023
Late this week, the FDA dished up a pair of manufacturing write-ups, with one going to high-flying Samsung Biologics and the other to India’s Nectar Lifesciences. | After inspecting Samsung Biologics' Incheon, South Korea, manufacturing site in August and September, the FDA chided the company for problems related to data and production controls, machine validation shortfalls, poor facility maintenance and lackluster quality control.
Pharmaceutical Technology
OCTOBER 20, 2023
NVIDIA’s vice-president of healthcare, Kimberly Powell, discussed GenAI in pharma and the importance of partnerships.
Fierce Pharma
OCTOBER 20, 2023
Rater qualification and training play a crucial role in the success of clinical trials. | Embracing standardized training methodologies and leveraging technology solutions can lead to more consistent, efficient, and inclusive 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.
PharmaTimes
OCTOBER 20, 2023
The new technology was safely trialled on 20 healthy volunteers for the first time ever - News - PharmaTimes
Impetus Digital
OCTOBER 20, 2023
In the early lead-up to our client’s multi-center Rare Disease Phase 3 Clinical Trial, they first conducted an internal engagement planning LEEP to conduct an informal needs assessment, map out all required external stakeholder engagements, and identify suitable investigators. The ultimate goal of all (completed and planned) projects is to ensure that the needs and preferences of the broader patient population are taken into consideration and that the clinical trial protocol is inclusive, patien
PharmaTimes
OCTOBER 20, 2023
Global innovators can apply to PACE to receive up to £1m per project - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 20, 2023
Health Canada has granted a Notice of Compliance (NOC) to Sumitomo Pharma Canada and Pfizer Canada’s MYFEMBREE.
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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.
Copyright Clearance Center
OCTOBER 20, 2023
Scholastic has found itself on the defensive over an optional collection of diverse titles at its book fairs.
Pharmaceutical Commerce
OCTOBER 20, 2023
Partnership intends to indirectly boost patient medication adherence rates in the process.
pharmaphorum
OCTOBER 20, 2023
Amwell, Leidos win $180m US military digital health contract Phil.
Clarify Health
OCTOBER 20, 2023
Clarify Health was honored to speak with physician liaisons in the Midwest who recently came together for the American Association of Physician Liaisons (AAPL) regional networking meeting. Clarify led a session titled “ Best Practices for Applying Data to Drive More Effective Outreach,” designed to help liaisons and business development team members build a greater understanding of the datasets they have available to them and how to best leverage them in their day-to-day.
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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
OCTOBER 20, 2023
Intelivation Technologies, a medical device company with a cutting-edge orthopedic and spine portfolio announced today that it is expanding into new markets with its Golden Isles Pedicle Screw System. The comprehensive system features multiple options for surgical preferences. The Golden Isles system encompasses open, MIS, and cannulated applications, as well as a novel solution for spondylolisthesis reduction.
pharmaphorum
OCTOBER 20, 2023
Young hit hardest by England’s ‘community health crisis’ Phil.
Pharmaceutical Technology
OCTOBER 20, 2023
Daiichi Sankyo will receive an upfront payment of $4bn and will be eligible for additional milestone payments of up to $22bn.
pharmaphorum
OCTOBER 20, 2023
MSD sinks $4bn upfront into ADC pact with Daiichi Sankyo Phil.
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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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