Biogen comes out ahead in investor lawsuit over Aduhelm disclosures
Fierce Pharma
MARCH 31, 2023
Biogen comes out ahead in investor lawsuit over Aduhelm disclosures zbecker Fri, 03/31/2023 - 11:06
Fri.Mar 31, 2023
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Cytokinetics Stops ALS Program After Analysis Finds No Evidence of Effect
MedCity News
MARCH 31, 2023
Cytokinetics drug reldesemtiv has failed a pivotal clinical trial in amyotrophic lateral sclerosis. The small molecule had previously failed in Phase 2, but the biotech believed adjustments could lead to better results in Phase 3.
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Seeking full approval in Alzheimer's, Eisai dives into prominent Leqembi side effect
Fierce Pharma
MARCH 31, 2023
Seeking full approval in Alzheimer's, Eisai dives into prominent Leqembi side effect fkansteiner Fri, 03/31/2023 - 11:30
Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape
Pharmaceutical Technology
MARCH 31, 2023
The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.
After Amarin's clash with Sarissa, CEO Mikhail hits the exit
Fierce Pharma
MARCH 31, 2023
After Amarin's clash with Sarissa, CEO Mikhail hits the exit esagonowsky Fri, 03/31/2023 - 10:52
Current Health CEO: At-Home Care Models Could Lead to Better Staff Retention
MedCity News
MARCH 31, 2023
Many healthcare workers prefer providing at-home care because it allows them to provide more personal, less hectic care than they can on the hospital floor, said Current Health CEO Chris McGhee. He thinks health systems should realize that switching more healthcare workers to at-home care could help alleviate the burnout crisis and improve staff retention levels.
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Data Governance: Addressing Data Defense and Offense
MedCity News
MARCH 31, 2023
Proper data governance is essential to ensure the efficient and accurate operation of an organization. It involves creating static rules, dynamic management processes and a comprehensive set of business objectives which must be met to protect the integrity of data within the system.
Moderna to set up new mRNA manufacturing facility in Kenya
Pharmaceutical Technology
MARCH 31, 2023
Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company will construct the new advanced mRNA facility, which is claimed to be Moderna’s first mRNA manufacturing facility in Africa and is expected to have the capacity to produce up to 500 million vaccine doses annually.
Generic manufacturers sign sublicences to produce long-acting HIV medicine
European Pharmaceutical Review
MARCH 31, 2023
The Medicines Patent Pool (MPP) has signed sublicence agreements with three generics manufacturers to produce generic versions of cabotegravir long-acting (LA) injectable for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). First sublicence agreement signed by MPP for a long-acting medicine Through the sublicences, the selected generic manufacturers will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to requir
In Teva vs. GSK skinny label feud, Biden admin urges Supreme Court to weigh in
Fierce Pharma
MARCH 31, 2023
In Teva vs.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Biopharma could reap benefits from SVB UK acquisition
European Pharmaceutical Review
MARCH 31, 2023
“The access to increased capital… could allow for the potential for biopharmaceutical companies to improve investment in the development of therapies.” Following the collapse of Silicon Valley Bank (SVB), HSBC’s acquisition of Silicon Valley Bank (SVP) UK may offer new opportunities for biopharmaceutical companies, according to data and analytics firm, GlobalData.
There’s a Need for PBMs, but also a Need for Change
PharmExec
MARCH 31, 2023
Rohit Gupta, vice president of analytics strategy and transformation at Beghou Consulting, addresses the controversial middlemen of the drug pricing world, the pharmacy benefit managers (PBMs). Can increased competition and other innovative solutions loosen their grip and prevent further consolidation?
Common Mistakes In Medical Device Labeling And How To Avoid Them
MedCity News
MARCH 31, 2023
Labels may be small and simple items, but they have a huge part to play in patient health, and any hospital or healthcare institution that wants to keep patients safe should absolutely invest in adequate labeling methods moving forward.
Swift, Emphatic Decision in Internet Archive Infringement Case
Copyright Clearance Center
MARCH 31, 2023
The post Swift, Emphatic Decision in Internet Archive Infringement Case appeared first on Copyright Clearance Center.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Tackling Misconceptions of Influencer Marketing with Patients Can Benefit Healthcare Industry
MedCity News
MARCH 31, 2023
Over the past decade, influencer marketing has become a popular tool for brands looking to […]
Drug discovery link-up for Galapagos and NovAliX
PharmaTimes
MARCH 31, 2023
Collaboration comes after renewed focus on key therapeutic areas of immunology and oncology
StartUPDATES: New Developments from Healthcare Startups
MedCity News
MARCH 31, 2023
Check out news from VenoVision, Cora Therapeutics, Zorro, and Validic.
Janssen’s Rybrevant yields positive data
PharmaTimes
MARCH 31, 2023
Results from trial showed a long-term response among specific lung cancer population
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
Oncology is Increasingly Competitive – Here’s How to Stand Out
Eversana Intouch
MARCH 31, 2023
It’s an exciting era in oncology: many new drugs with increasing benefits and more tolerable profiles are being developed and released, and that means that nearly all tumor type spaces are becoming more competitive. For example, about 20 drugs are now FDA-approved to treat multiple myeloma, and these drugs have provided advances in care that have more than tripled the median survival rate in the last two decades.
4 Best Factors That Affect Customer Satisfaction In MedTech
Cesare Ferrari
MARCH 31, 2023
In this article, I’m going to analyze the factors affecting customer satisfaction. And in the previous posts, I covered customer satisfaction , dissatisfaction , and their impact–you can refer back to them. Several factors determine customer satisfaction, and the importance of a single determinant might vary depending on the sub-segment of the medical device market.
MedTechVets Winter 2023 Networking Conference
MedTechVets
MARCH 31, 2023
MARCH 31 – On February 15th, MedTechVets held its Winter Networking Conference to mark the end of a successful Winter MTV Academy. This conference, we were honored to be joined by our two Keynote Speakers, Michael Minogue and Gregory Gadson. We also had 40 attendees from our Veteran Graduates, Mentors, Alumni, and representatives from18 different companies.
Pediatric Medicine: Challenges Abound
Pharmaceutical Commerce
MARCH 31, 2023
Innovation and investment in advancing lifesaving therapies for pediatric patients to the commercial stage remains a daunting task, but rapid advances today in modeling and simulation are reducing the hurdles for drugmakers.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Talem, Xyphos sign agreement for potential cancer therapeutic candidates
Pharma Leaders
MARCH 31, 2023
ImmunoPrecise Antibodies (IPA) subsidiary, Talem Therapeutics has entered into a research collaboration and licence option agreement with Astellas Pharma’s wholly-owned subsidiary, Xyphos Biosciences. As part of the deal, both the entities will be involved in research activities to detect and improve LENS ai in silico-generated antibodies. These antibodies are being developed as potential therapeutic candidates for an undisclosed target in the tumour microenvironment (TME).
GSK signs licence deal with Scynexis for fungal infection treatment
Pharmaceutical Technology
MARCH 31, 2023
GSK has signed an exclusive licence agreement with Scynexis to commercialise and further develop Brexafemme (ibrexafungerp tablets) to treat fungal infection. Brexafemme has a wide spectrum of activity, including against emerging resistant threats. GSK will obtain the rights to commercialise the new oral glucan synthase inhibitor for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC).
Q&A: Why Dynamic Data Feeds are Critical for Successful Commercial Machine Learning Models
PharmExec
MARCH 31, 2023
Indegene's Jitesh Sah, Vice President, Analytics and Vikas Mahajan, Sr. Director, Data & Analytics chat with senior editor Fran Pollaro about the challenge of data drift.
Pharmaceutical Commerce - April 2023 Issue (PDF)
Pharmaceutical Commerce
MARCH 31, 2023
Click the title above for a link to open the Pharmaceutical Commerce April 2023 issue in an interactive PDF format.
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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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
FDA Approves Evkeeza for Young Children with Ultra-Rare Form of High Cholesterol
PharmaTech
MARCH 31, 2023
FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.
Keeping Up with the Action
Pharmaceutical Commerce
MARCH 31, 2023
DSCSA, 340B among the headliners at the Healthcare Distribution Alliance's Distribution Management Conference.
Leaders wave a magic wand at pharma’s thorniest issues
PharmaVoice
MARCH 31, 2023
The major challenges pharma leaders would solve with a quick flick of an imaginary wand.
Assessing Drug Pricing in Europe
Pharmaceutical Commerce
MARCH 31, 2023
How various factors are affecting the amount of funds allocated to healthcare.
Accelerating Clinical Supply Through Integrated Drug Development
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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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