Fri.Apr 19, 2024

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Roche snags postsurgery FDA nod for Alecensa, eyes even broader lung cancer use

Fierce Pharma

Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.

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Confronting the Digital Dilemma in Healthcare’s Quest for Innovation

MedCity News

The imperative to modernize healthcare communication methods extends beyond mere technological upgrades. Rather, it’s a fundamental necessity to enhance patient care, streamline healthcare delivery, and unlock the full potential of medical innovation. The post Confronting the Digital Dilemma in Healthcare’s Quest for Innovation appeared first on MedCity News.

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'The Top Line': Winning formulas for the best biotech and drug names

Fierce Pharma

This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. | This week on "The Top Line," we are joined by Annalee Armstrong, Senior Editor at Fierce Biotech, and Ben Adams, Senior Editor of Fierce Pharma Marketing, to discuss Fierce's take on March Madness.

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Ilant Health Raises Extended Seed Round of $5.5M for Obesity Management Platform

MedCity News

Ilant Health extended its seed round from $3 million to $5.5 million. The company garnered interest from LifeX Ventures, Celtic House Asia Partners and Cornucopian Capital. The post Ilant Health Raises Extended Seed Round of $5.5M for Obesity Management Platform appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FibroGen settles with former employees who it claimed stole trade secrets

Fierce Pharma

Nearly a year and a half after FibroGen slapped a pair of former employees with a lawsuit alleging trade secrets theft, both the plaintiffs and the defendants are walking away from the case little | Nearly a year and a half after FibroGen slapped a pair of former employees with a lawsuit alleging trade secrets theft, both the plaintiffs and the defendants are walking away from the case little worse for wear.

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Roche Drug Scores Label Expansion for Earlier Use in Lung Cancer

MedCity News

The FDA expanded the approval of Roche’s Alecensa to include adjuvant treatment of non-small cell lung cancer. The targeted therapy addresses cancers driven by the ALK genetic mutation. The post Roche Drug Scores Label Expansion for Earlier Use in Lung Cancer appeared first on MedCity News.

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More Trending

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Personalization In Sales Leads To Increased Loyalty and Repeat Business

Integrity Solutions

Mastering the human side of selling is key to sales success, but what does phrase that mean exactly? At its essence, humanizing the sales experience is really about personalization. It’s about asking questions from a place of genuine curiosity, listening, fully absorbing what you’re hearing and then being willing and able to pivot in whatever direction the customer’s answers take us.

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Fierce Pharma Asia—Leqembi's cost to Medicare; Takeda's $1.2B-plus Kumquat deal; Fujifilm Diosynth's reorg

Fierce Pharma

Medicare's spending projection on the Alzheimer's drug Leqembi is way higher than Eisai's own estimates. Takeda signed an immuno-oncology deal potentially worth more than $1.2 billion. | Medicare's spending projection on the Alzheimer's drug Leqembi is way higher than Eisai's own estimates. Takeda signed an immuno-oncology deal potentially worth more than $1.2 billion.

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LogiPharma Europe 2024: Niklas Adamsson Discusses Ways to Improve Visibility and Risk Management for Cold Chain Shipping

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.

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Protecting Health Data Without Harming Patients: Overcoming the Barriers That Limit Our Access to Our Personal Health Information

MedCity News

The availability of innovative technologies affords us the opportunity to chart a more patient-centric, efficient, and secure path to managing and leveraging PHI. The post Protecting Health Data Without Harming Patients: Overcoming the Barriers That Limit Our Access to Our Personal Health Information appeared first on MedCity News.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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AskBio’s AB-1002 gene therapy receives FDA fast-track status

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

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Behind the ‘encouraging’ new results for Amylyx’s beleaguered drug

PharmaVoice

Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.

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How Are You Guiding Employers on Virtual Care Solutions Within Their Benefits Plan?

MedCity News

Attenton, healthcare benefit consultants: Take part in our survey and share some of the trends you are seeing among your clients. A full report of the findings will be available later this year. The post How Are You Guiding Employers on Virtual Care Solutions Within Their Benefits Plan? appeared first on MedCity News.

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A Look at the Impact of Industry Trends on Sensor Technologies (INTERPHEX 2024)

PharmaTech

Jay Rajagopalan, senior director—Engineering & Product Management for Malema at PSG Biotech, shared insights at on how current industry trends are shaping the development and advancement of sensor technologies.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Emerging Mental Health Care Options for EDs in Crisis

MedCity News

Optimizing care journeys based on patient needs and using collaborative resources outside of the ED can result in effective and efficient behavioral care, regardless of volume. The post Emerging Mental Health Care Options for EDs in Crisis appeared first on MedCity News.

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Microbial burden assessment of solid pharmaceutical products

European Pharmaceutical Review

The “accurate, precise, and robust” data obtained via the dew point chilled mirror method, means it is an “outstanding” approach for quantifying water activity status in tablets and capsules, according to a paper published in RPS Pharmacy and Pharmacology Reports. It has value for direct assessment to determine microbiological bioburden , stated Prada-Ramírez et al.

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Q&A: Cell and gene therapy value assessments need a rework to allow access

Pharmaceutical Technology

Paolo Morgese, vice president of European public affairs at the Alliance for Regenerative Medicine, discusses the barriers affecting access to gene therapies.

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Cerevel Parkinson’s data adds lustre to AbbVie acquisition

pharmaphorum

Cerevel's first phase 3 trial of Parkinson's drug tavapadon is positive - good news for AbbVie which is trying to buy the biotech for $8.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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How New Regulations Are Impacting Pharmaceutical Manufacturing Facility Design

PharmaTech

New regulations, including those put forth by Annex 1, require many pharmaceutical manufacturers to rethink their facility designs to promote compliance.

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Hyundai Bio plans trials of antiviral for dengue fever

pharmaphorum

Hyundai Bioscience is preparing to start clinical trials of what it hopes could become the first antiviral treatment for dengue fever

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CureVac and MD Anderson Cancer Center partner to develop new cancer vaccines

PharmaTimes

Both will develop cancer vaccine candidates in selected haematological and solid tumour indications

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FDA clears Roche’s Alecensa for adjuvant use in NSCLC

pharmaphorum

Roche's Alecenesa has become the first ALK inhibitor to be approved by the FDA for adjuvant use in early-stage, ALK+ NSCLC

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Roles and Responsibilities of Specialized Clinical Supply Experts

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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FDA approves Takeda’s ENTYVIO SC for Crohn’s disease

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

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Experimental AI predicts whether cancer drugs will work

pharmaphorum

Researchers in the US have developed an artificial intelligence tool that can predict how a patient will respond to cancer treatment

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NIH team develops AI tool to predict cancer drug response

Pharmaceutical Technology

Researchers at the National Cancer Institute, a unit of the National Institutes of Health (NIH) in the US, have developed an AI tool that can predict drug responses in cancer treatment.

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Medical imaging modalities: A spotlight on the liver

Clarivate

Liver disease is responsible for 2 million deaths annually. [1] This week marks World Liver Day (April 19th), an initiative to raise awareness of liver health that is supported by major liver associations, such as the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD). [2] [3] Medical imaging plays a key role in detecting liver diseases, supporting informed diagnosis, guiding treatment selection, and continued monitoring. [

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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New clinical trial aims to investigate skin patches to spot lung transplant rejection

PharmaTimes

Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%

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Pharma Pulse 4/19/24: The Real Cost of State Drug Importation Programs, Millions in Africa Will Miss HPV Shots After Merck Production Problem & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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The next phase for mRNA: Looking beyond COVID-19

Pharmaceutical Technology

Following the success of the COVID-19 vaccines, there has been an increasing focus on mRNA’s potential to address a wide range of diseases, including cancer.

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LogiPharma Europe 2024: Envirotainer COO Discusses Reshaping Cold Chain Logistics and Adapting to Disruptions

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Envirotainer, offers his thoughts on how changing customer needs are affecting cold chain logistics.

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Accelerating Clinical Supply Through Integrated Drug Development

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.