Fierce Pharma
AUGUST 23, 2024
Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.
MedCity News
AUGUST 23, 2024
AI startup Paige launched an AI-powered biomarker module that the company says can evaluate more than 505 genes and identify 1,228 molecular biomarkers from standard pathology slides. The post Paige Launches AI Tool that Screens 505 Genes for Improved Cancer Diagnosis appeared first on MedCity News.
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Fierce Pharma
AUGUST 23, 2024
The FDA has authorized the use of | The FDA has authorized the use of new vaccines from Pfizer/BioNTech and Moderna which have been designed to defend against the Omicron KP.2 variant of SARS-CoV-2. The nod comes as word of a new omicron variant, KP.3.1.1, is beginning to eclipse KP.2 as the dominant strain of the virus in the United States.
MedCity News
AUGUST 23, 2024
Healthcare is a highly regulated industry, and any use of AI within it is dealing with the most sensitive data. In order to ensure you’re not putting you, your company or patients at risk, consider an evaluation framework for any AI tool that considers these three things. The post From FOMO to FOMU: A Framework for Getting AI Right appeared first on MedCity News.
Fierce Pharma
AUGUST 23, 2024
While some analysts figure Jazz Pharmaceuticals’ Epidiolex—sold as Epidyolex abroad—could surpass the blockbuster sales threshold by the end of the decade, the cannabidiol-based seizure drug has st | On Friday, Jazz revealed that its Epidiolex oral solution failed to mass muster in a late-stage study when used as an adjunct treatment for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in young Japanese patients.
MedCity News
AUGUST 23, 2024
Celeste Health Solutions launched on Wednesday. The company works with employers and offers a range of point solutions and provides administrative support. The post How One Company Is Easing Employers’ Administrative Headaches appeared first on MedCity News.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
AUGUST 23, 2024
The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in recent months.Both new mRNA-based vaccines have been approved for use in people aged 12 and over – and been granted emergency use authorisation for younger people aged 6 months to 11 years – and will be available within the next few days, said the drugmakers.
Fierce Pharma
AUGUST 23, 2024
Yuhan's Lazcluze, licensed by Johnson & Johnson, has made history as the first Korea-developed novel cancer drug to be approved by the FDA. | As part of a J&J combo, Yuhan's Lazcluze has become the first Korea-developed novel cancer drug to be approved by the FDA. Merck has optioned in on one Kelun Biotech ADC but returned another.
Scott Burrows
AUGUST 23, 2024
Keynote Speaking C.W. Driver Annual Meeting at the Discovery Cube in Santa Ana, CA As I’ve talked to many, many leaders through the years, I’ve noticed many similar traits in work styles, life experiences, and mindsets. There was a time when I would have never labeled myself as a leader in any capacity. It wasn’t until I was forced to lead myself to success, that I saw traits of leadership in myself.
MedCity News
AUGUST 23, 2024
Digital tools are producing a more efficient patient-centered system. Practices tuned in to the new digital world operate more smoothly, deliver higher-quality care, and allow payers to manage costs and risks more effectively. The post Time to Get Digital in Your Practice: Improving and Making Healthcare Easier for Patients, Practices, Providers and Payors appeared first on MedCity News.
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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.
pharmaphorum
AUGUST 23, 2024
Novartis and VC Versant set up a new biotech, Borealis Biosciences, using a similar model to an earlier alliance to create Chinook Therapeutics
Pharmaceutical Technology
AUGUST 23, 2024
Novartis has partnered with Versant Ventures to establish Borealis Biosciences, a Canada based independent, discovery-stage biotech company.
pharmaphorum
AUGUST 23, 2024
AstraZeneca says rumours that it will relocate a planned vaccines facility from the UK to the US "do not seem to be based on facts"
Pharmaceutical Technology
AUGUST 23, 2024
The two companies have expanded their agreement first inked in 2023, with a second ‘high-value target’ now in the crosshairs.
pharmaphorum
AUGUST 23, 2024
Zenas BioPharma has filed an initial public offering in the US seeking $100m+ for obexelimab, a therapy for rare disease IgG4-RD in phase 3
PharmaTimes
AUGUST 23, 2024
Most cases go undetected until an advanced stage, as the disease rarely causes early symptoms
pharmaphorum
AUGUST 23, 2024
ICER says Geron's new drug Rytelo for myelodysplastic syndromes (MDS) is priced three to four times higher than it should be
Pharmaceutical Commerce
AUGUST 23, 2024
The latest news for pharma industry insiders.
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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
AUGUST 23, 2024
The conference will be held in Basel, Switzerland from 26-28 August
PharmExec
AUGUST 23, 2024
In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of access and advancement of myeloma therapies.
Pharmatutor
AUGUST 23, 2024
The New Penal Provisions in the Drugs and Cosmetics Act admin Sat, 08/24/2024 - 11:28 In a bid to decriminalise and rationalise offences to further enhance trust-based governance for ease of living and doing business, the Jan Vishwas (Amendment of Provisions) Act, 2023 was published in the Gazette of India, Extraordinary, Part II – Section 1, No. 21 on the 11th August, 2023.
European Pharmaceutical Review
AUGUST 23, 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first treatment for Alzheimer’s in Great Britain that has shown some efficacy in slowing disease progression. Lecanemab is authorised to treat adults with early Alzheimer’s. It is therefore indicated for individuals with either one or no copies of the apolipoprotein E4 gene (ApoE4).
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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
ALULA
AUGUST 23, 2024
What would happen if you applied some of the best and most modern practices for improving leadership performance in a sector that has traditionally shunned this kind of investment? That was the question being asked by executives at TD Bank’s Retail Card Services, who oversee the call centers through their Merchant Solutions and Customer Service operation.
PharmExec
AUGUST 23, 2024
64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says.
Scott Burrows
AUGUST 23, 2024
In the dynamic world of franchising, where both challenges and opportunities abound, Scott Burrows stands out as a truly inspirational speaker. His remarkable journey from personal adversity to achieving success across various industries provides invaluable insights for franchisees and franchisors. With a proven track record of engaging with top franchises, Scott delivers impactful messages that resonate deeply within the franchise community.
Pharmaceutical Commerce
AUGUST 23, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, outlines the various types of available digital solutions when delivering patient services, while also sharing ways to drive efficiencies.
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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
Scott Burrows
AUGUST 23, 2024
In a rapidly evolving world where the demands for innovation and resilience are ever-increasing, national associations are continually seeking keynote speakers who can inspire and drive transformative change. Scott Burrows stands out as a premier choice for delivering impactful and motivational speeches that resonate with diverse audiences and stimulate meaningful action.
European Pharmaceutical Review
AUGUST 23, 2024
EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.1 It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few.
Scott Burrows
AUGUST 23, 2024
When it comes to after-dinner speakers who leave a lasting impact, Scott Burrows stands out as a beacon of inspiration. His story, marked by resilience and an unbreakable spirit, transforms a typical dinner event into an unforgettable experience. A Journey Beyond Adversity Scott Burrows’ journey is nothing short of extraordinary. Diagnosed as a quadriplegic, Scott faced challenges that most people would find insurmountable.
Pharmaceutical Technology
AUGUST 23, 2024
The US FDA has approved and granted EUA for Moderna and Pfizer-BioNTech’s updated mRNA Covid-19 vaccines, Comirnaty and Spikevax.
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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.
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