Fierce Pharma
APRIL 21, 2023
In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35
MedCity News
APRIL 21, 2023
By combining in-home and virtual care, we can meet patients literally where they are. More importantly, we can improve outcomes, reduce costs and help patients get back to a normal life while giving therapists the flexibility and opportunity to provide more customized care for their patients.
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Fierce Pharma
APRIL 21, 2023
As Bayer's CEO switch nears, activist investor pushes harder for breakup, board changes fkansteiner Fri, 04/21/2023 - 10:25
MedCity News
APRIL 21, 2023
About 70% of hospital IT pilots fail or face major challenges, yet it’s rare for hospitals to discuss these setbacks. At HIMSS23, two nursing informatics leaders argued that project failure is nothing to be ashamed of because it can teach hospitals valuable lessons about what they need for technology initiatives to thrive in the future.
Fierce Pharma
APRIL 21, 2023
United Nations agency PAHO in early negotiations with Takeda over dengue vaccine pricing: director zbecker Fri, 04/21/2023 - 11:01
MedCity News
APRIL 21, 2023
A cell phone is one of the best tools to have when caring for those experiencing homelessness, two experts said during a Tuesday panel at the HIMSS 2023 conference in Chicago.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
APRIL 21, 2023
Image recognition ML models are being widely used in radiology with excellent results, sometimes catching things missed by even the most highly trained human eye. This doesn’t mean ML is ready to replace clinicians’ judgment or take their jobs, but results so far offer compelling evidence that ML may have value as a tool to augment their clinical judgment.
Fierce Pharma
APRIL 21, 2023
In Zetia antitrust case, Merck and Glenmark ink deals with 2 plaintiff groups as retailers hold out fkansteiner Fri, 04/21/2023 - 08:53
Pharmaceutical Technology
APRIL 21, 2023
Moderna has signed an agreement with IBM to explore quantum computing and generative artificial intelligence (AI) for advancing and expediting its mRNA research. Moderna will gain access to IBM’s quantum computing systems, an emerging technology that harnesses quantum mechanics for solving complex problems that cannot be handled efficiently by classical computers.
Fierce Pharma
APRIL 21, 2023
Inside Abbott’s beating heart of electrophysiology innovation jpiatt Fri, 04/21/2023 - 12:03
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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.
Pharmaceutical Technology
APRIL 21, 2023
Incyte has received marketing authorisation from the European Commission for Opzelura (ruxolitinib) cream 15mg/g to treat non-segmental vitiligo with facial involvement in adults and in adolescents aged 12 years and above. Opzelura is the first and only approved treatment across the European Union (EU) aimed at achieving repigmentation in the targeted patients.
MedCity News
APRIL 21, 2023
The new DEA ruling is doing a disservice not only to people with OUD, but to the entire medical care system—exacerbating a condition that will most likely lead to death.
Pharmaceutical Technology
APRIL 21, 2023
The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.
European Pharmaceutical Review
APRIL 21, 2023
We have 27 years left to transform the EU into a climate-neutral continent in order to keep the ecological catastrophes that the climate crisis brings at a manageable level – to find solutions for every flight taken, every car driven and every medical treatment undergone in the EU. Other sectors are already on the way to reducing their emissions and have received much public and political attention.
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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
Copyright Clearance Center
APRIL 21, 2023
The post CCC Celebrates World Book and Copyright Day 2023 appeared first on Copyright Clearance Center.
PharmaVoice
APRIL 21, 2023
Peter Kirk’s marathon story of inspiration and perseverance.
Copyright Clearance Center
APRIL 21, 2023
The post In London, Publishing Confronts AI appeared first on Copyright Clearance Center.
PharmaTimes
APRIL 21, 2023
Companies will collaborate to boost novel treatments for individuals with geographic atrophy
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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
APRIL 21, 2023
China’s National Medical Products Administration (NMPA) has cleared CARsgen Therapeutics’ CT041 investigational new drug (IND) for postoperative adjuvant therapy to treat CLDN18.2 positive pancreatic cancer (PC). CT041 is an autologous CAR T-cell product currently under development for use against the CLDN18.2 protein. It targets CLDN18.2 positive solid tumours by focusing primarily on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and PC.
Spotio
APRIL 21, 2023
Do you sell POS systems? Then you have a lot to look forward to. Recent research shows that the hardware as a service market (HaaS) should reach $300+ billion in 2026. Other studies predict the POS space, specifically, to grow by 6.9% over the next five years or so—especially those sold via subscription. In other words, there’s tons of potential.
Pharmaceutical Technology
APRIL 21, 2023
Biotechnology company Enveda Biosciences has raised $51m in equity financing in a Series B1 round to advance several drug candidates to clinical development. The Series B1 financing comes after the company raised equity and debt financing worth $68m in a Series B round in December 2022. It brings the total capital raised by the company to $175m. Led by new investor Kinnevik, the Series B1 financing round has also seen participation from another new investor, Henry R Kravis, co-founder of private
PharmaTech
APRIL 21, 2023
Rafael Antunes, vice-president of Business Development Europe at Aurisco, speaks about his company's recent efforts in the field of oligonucleotides, its partnership with Cytiva, and its broader sustainability efforts.
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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.
Pharmaceutical Commerce
APRIL 21, 2023
In this latest Harvard Business School Healthcare Alumni Association Q&A, Dr. Peter Cappelli, Professor of Management at The Wharton School and Director of Wharton’s Center for Human Resources, explains how biopharma C-suites can lead their teams through 2023’s turbulent times.
PharmaTech
APRIL 21, 2023
Experts in solid dosage technology, offering electrostatic spray dryers, fluid bed systems, and other process solutions used daily to help the pharmaceutical, nutraceutical, food, fine chemical, and biopharmaceutical industries.
Pharmaceutical Technology
APRIL 21, 2023
In a statement emailed to Endpoints News , AstraZeneca (AZ) disclosed intentions to terminate its clinical program for its daily glucagon-like peptide-1 receptor glucagon co-agonist (GLP-1RA/GCGR) cotadutide, in favour of focusing on the development of AZD9550, its once-weekly injectable GLP-1RA/GCGR. In parallel, the company will also shift its focus from the non-alcoholic steatohepatitis (NASH) market to the ever-growing diabetes and obesity market in lieu of the increase in the utilisation of
PharmaTech
APRIL 21, 2023
At Interpack 2023, Steriline (Hall 16, Booth 16B15) will welcome visitors and showcase a Robotic Vial Filling Machine and two innovative systems developed internally by the company’s R&D team.
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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
Pharmaceutical Technology
APRIL 21, 2023
On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine.
Pharma Leaders
APRIL 21, 2023
Digital technology company BullFrog AI and Sage Group have entered into a strategic partnership to develop oncology assets. This partnership will focus on exploring joint venture (JV) opportunities for advancing a Phase II ready asset and the preclinical prodrug asset of BullFrog AI. The Phase II ready asset targets glioblastoma, which is an aggressive form of brain cancer.
Pharmaceutical Technology
APRIL 21, 2023
US-based biopharmaceutical company Blue Water Vaccines has signed an asset purchase agreement with Veru to buy its Entadfi (finasteride and tadalafil) capsules business, for a total consideration of $100m. The company will make a $20m upfront payment, which includes $6m paid at closing and an additional $4m payment in the fiscal year 2023. It will pay another $10m in instalments through to September 2024.
Legacy MEDSearch
APRIL 21, 2023
Bay Area-based BlackSwan Vascular, Inc., a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval (PMA) of its Lava® Liquid Embolic System (Lava® LES) for treatment of peripheral arterial hemorrhage. Lava LES, a nonadhesive injectable, is the first liquid embolic product approved by the FDA for use in the peripheral vasculature and is specifically indicated for embolization of peripheral arterial
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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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