Fierce Pharma
OCTOBER 17, 2023
Editor's note: This is an evolving story. Please check back on Oct. 23 when the full data of MARIPOSA are presented at ESMO 2023. | A drug combination from Johnson & Johnson outperformed AstraZeneca’s Tagrisso in slowing the worsening of newly diagnosed lung cancer. But it’ll take more than a tumor progression win to dethrone the EGFR king.
PharmaVoice
OCTOBER 17, 2023
Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.
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Fierce Pharma
OCTOBER 17, 2023
If there’s one thing a wide swath of industry players can agree on, it’s that the FDA’s drug approval process represents the gold standard for drug regulation. | Influential trade group PhRMA—plus hundreds of drugmakers, leaders and investors—are urging the Supreme Court to overturn a restrictive ruling on the abortion pill mifepristone. In SCOTUS filings, the industry representatives said the ruling undermines the FDA's authority.
MedCity News
OCTOBER 17, 2023
Thermo Fisher Scientific is acquiring Olink, a company that provides proteomics analysis tools and services used in drug discovery research. Olink’s growing revenue will help shore up a Thermo Fisher business segment whose sales have fallen due to declining Covid-19 testing demand.
Fierce Pharma
OCTOBER 17, 2023
The third time’s the charm for Ardelyx and its chronic kidney disease med Xphozah (tenapanor). | After the FDA requested more data in 2021, Ardelyx instead defended its drug's profile through two appeals and an advisory committee meeting. Now, the company can celebrate a long-awaited win.
MedCity News
OCTOBER 17, 2023
Mass General Brigham launched a program this month in collaboration with behavioral health medical group Concert Health. Under the program, more than 400 Mass General primary care providers can refer their patients to Concert. The health system’s goal is to increase patients’ access to diagnoses and treatment for mild to moderate behavioral health issues — particularly for Medicaid patients, who are the most underserved.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
OCTOBER 17, 2023
Psychedelic-assisted therapy is currently used to treat severe mental health conditions. But there is evidence it could help with prevention as well, and more research needs to be done on this, said Sherry Rais, CEO and co-founder of Enthea.
Fierce Pharma
OCTOBER 17, 2023
Even as pharma giants try to get a handle on the Inflation Reduction Act in the U.S., drug pricing tensions continue to flare overseas. | With the U.K. working to tweak the Statutory Scheme for branded medicines, the Association of the British Pharmaceutical Industry is making its discontent known—and it’s managed to rally more than 20 major drugmakers to its cause.
Pharmaceutical Technology
OCTOBER 17, 2023
In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.
MedCity News
OCTOBER 17, 2023
At HLTH, Shaun Miller — Cedars-Sinai’s chief medical information officer — pointed out one thing he thinks healthcare AI companies haven’t quite gotten right yet. He said he would “really like there to be a lot more recognition around the personalization of AI and the ability for technology to understand that not every clinician is the same.
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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.
European Pharmaceutical Review
OCTOBER 17, 2023
In final guidance , the National Institute for Health and Care Excellence (NICE) has recommended glofitamab as a new treatment option for advanced lymphoma. NICE’s recommendation coincides with the Medicines and Healthcare Products Regulatory Agency (MHRA) granting a licence for glofitamab” The bispecific monoclonal antibody (BsAb) treatment is indicated for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic treatments.
MedCity News
OCTOBER 17, 2023
Roche is paying $50 million up front to begin a drug R&D alliance with Monte Rosa Therapeutics, a biotech whose molecular glue technology could address targets previously deemed undruggable. It’s Roche’s second such deal in the past month.
European Pharmaceutical Review
OCTOBER 17, 2023
The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. For example, the applications are New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), or a Biologics License Applications (BLAs).
MedCity News
OCTOBER 17, 2023
Ilant Health launched out of stealth Tuesday. The company serves employers and payers and helps identify patients in need of obesity treatment and matches them to the care best for them.
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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
Pharmaceutical Technology
OCTOBER 17, 2023
As AI applications in drug manufacturing widen, Leucine’s digital twin of the shop floor helps automate compliance and improve safety.
PharmaTech
OCTOBER 17, 2023
Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expre
PharmaTimes
OCTOBER 17, 2023
The two projects will investigate the potential causes of Parkinson’s disease - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 17, 2023
SpliceBio will license Spark Therapeutics’ propriety protein splicing platform to develop a gene therapy for renal disease.
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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.
Medgadget
OCTOBER 17, 2023
Arsenal Medical , a medtech company based in Massachusetts, has developed Neocast , an embolic biomaterial designed for catheter-mediated embolization procedures. Conventional materials for embolization can have several limitations, including a lack of radiopacity, catheter clogging, catheter entrapment at the delivery site, solvent-mediated pain at the delivery site, and they can even cause sparking of electrocautery tools.
PharmExec
OCTOBER 17, 2023
Morton discusses his transition from working as a urologist to the C-suite.
PharmaTimes
OCTOBER 17, 2023
The condition is responsible for 2,200 annual deaths in the UK - News - PharmaTimes
Evolve Your Success
OCTOBER 17, 2023
Pharmaceutical sales isn’t just about selling pills; it’s about crafting a winning plan, staying coachable, and asking for help when you need it. A pharmaceutical sales professional with over six years of experience, Zach Caskey joins host Samuel Adeyinka in this episode to discuss how to elevate your performance in pharmaceutical sales.
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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.
PharmaVoice
OCTOBER 17, 2023
A pharma with a massive collection of rainforest-derived plants needs a regulatory win to overcome last year’s financial decline.
Clarify Health
OCTOBER 17, 2023
In today’s healthcare landscape, outcomes data has emerged as an essential instrument in assessing the quality and effectiveness of healthcare services. It empowers decision-makers to craft strategies for coverage, pricing, and provider partnerships that better serve both patients and profitability. Outcomes data is crucial for payers, as it serves as a critical tool in evaluating the quality and effectiveness of healthcare services.
pharmaphorum
OCTOBER 17, 2023
Roche builds gene therapy portfolio with SpliceBio deal Phil.
Pharmaceutical Technology
OCTOBER 17, 2023
The extended agreement will focus on developing checkpoint inhibitors in cancer, with two anti-PD1 antibodies in preclinical development.
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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
pharmaphorum
OCTOBER 17, 2023
Owkin signs up another pharma partner for its AI platform Phil.
PharmaTech
OCTOBER 17, 2023
Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the important components of nitrosamine impurities from a manufacturing point of view as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View.
Pharma Marketing Network
OCTOBER 17, 2023
Data-driven decisions are increasingly becoming the norm in the pharmaceutical industry. By leveraging data analytics, marketers can make informed decisions about their campaigns and optimize their resources for greater success. This article will discuss the benefits and challenges of data-driven decisions in pharma campaigns, as well as how to make them.
pharmaphorum
OCTOBER 17, 2023
VR-based navigation test may detect Alzheimer’s 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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