Fri.Sep 22, 2023

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Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. | Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer.

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Three years after an FDA rejection, DBV sees a path for its peanut patch

PharmaVoice

Despite lower-than-expected demand for a competing treatment, DBV’s chief medical officer says the company’s topical skin patch could be a game-changing option for patients.

FDA 122
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Look out, AZ. Lilly and Boehringer's Jardiance is ready to roll in chronic kidney disease after FDA nod

Fierce Pharma

Fast on the heels of winning a European approval to treat chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim's versatile SGLT2 inhibitor Jardiance is expanding its reach in the U.S., | After AstraZeneca's Farxiga won a class-first chronic kidney disease approval back in 2021, Eli Lilly and Boehringer are entering the fray with their SGLT2 drug Jardiance.

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21Grams, Area 23, and IPG Health Dominate The Creative Floor Awards 2023

PM360

The Creative Floor Healthcare Awards , celebrated the world’s best health and wellness creative work, agency talent, and clients yesterday at its 10 th -year anniversary party. Area 23 won the Most Awarded Agency and IPG Health won the Most Awarded Network. 21Grams took home Best Communications Agency. Bravest Client Awards went to Uyum Evcin from CSL Vifor and Peter Zenobi from Sanofi.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bristol Myers joins AstraZeneca, Merck in touting positive lung cancer drug use around surgery

Fierce Pharma

It’s not a proper market showdown without all the players. | It’s not a proper market showdown without all the players. In the perioperative treatment of early-stage non-small cell lung cancer with a PD-1/L1 inhibitor, Bristol Myers Squibb is touting a new trial win. The results follow positive readouts from AstraZeneca and Merck.

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Hospitals Should Take A Page Out of Amazon’s Digital Engagement Playbook, Argues Providence Digital Chief

MedCity News

In order for health systems to “not be commoditized fully,” they need to collect data to know their patients’ behaviors better and build stronger relationships with them, argued Sara Vaezy, Providence’s chief strategy and digital officer. Consumer brands like Amazon have been doing this for years so they can deliver personalized experiences to their users, and it’s time hospitals take a page out of their playbook, she said.

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Study Highlights PBMs’ Role in Drug Prices

Pharmaceutical Commerce

An analysis by 3 Axis Advisors has found that there is a large variability in pharmacy reimbursement of prescription drugs depending on PBM contracts with insurers. This creates a system with huge inconsistencies on the prices of both generics and branded products.

Insurance 105
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Retraction notice

Fierce Pharma

A story this week about an FDA Form 483 filing for an Ajinomoto site in San Diego was reported in error. While the site did receive FDA observations in early 2023, the inspection has since closed. | A story published Sept. 19 about an Ajinomoto site in San Diego has been retracted.

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Senior Living Braces for a New Era of Search

MedCity News

The next generation of senior living searchers are markedly different from their predecessors, and they will challenge us to work together to reshape their search experience.

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NICE recommends Eli Lilly ulcerative colitis biologic

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) have for the first time, recommended a IL-23p19 targeted biologic for adults with moderate to severe active ulcerative colitis in Great Britain. Eli Lilly’s mirikizumab (OMVOH ® ▼) is indicated for these patients when conventional or biological treatment cannot be tolerated, or the condition has not responded well enough or lost response to treatment.

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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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Equip Expands Care to Adults, Banks Investment From General Catalyst

MedCity News

San Diego-based Equip, which was founded in 2019, previously focused on those ages 6 to 24. The startup is now expanding to serve people of all ages, it announced Tuesday.

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Aseptic packaging market to value $35bn by 2033

European Pharmaceutical Review

According to a report by Research Nester, the global aseptic packaging market is projected to reach a revenue of $35 billion by 2033 and is estimated to reach a compound annual growth rate (CAGR) of 10 percent between 2023 and 2033. Aseptic packaging eliminates the necessity for preservatives and refrigeration which is especially advantageous for medications and vaccines that are sensitive to temperature changes.

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How Genome Sequencing Can Broaden the Scope of Newborn Screening

MedCity News

Standard newborn screening can detect dozens of inherited diseases, but genomics technology enables testing for hundreds of them. A North Carolina program evaluating the feasibility of bringing genomics to newborn screening is expanding with an initial goal of testing 5,000 babies in the next year.

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JURA Bio and Syena partner to develop TCR-based therapies

Pharmaceutical Technology

JURA Bio has entered into a research collaboration with Replay cell therapy product company Syena for the development of TCR based therapies.

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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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Correcting Provider Biases About Transgender and Gender Non-Conforming Patients Can Protect Their Health and Safety

MedCity News

Providers, administrators, health insurers and other healthcare-access gatekeepers can learn, train, change policies and remove barriers facing vulnerable groups so they can receive the long-overdue opportunity to pursue their best health and well-being.

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Evaxion and Afrigen Biologics to develop mRNA vaccine for gonorrhoea

PharmaTimes

The collaboration will utilise Evaxion’s EDEN-discovered antigen targets - News - PharmaTimes

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FDA clears Krystal Biotech’s IND for Type 1 AATD treatment KB408

Pharmaceutical Technology

A Phase I trial exploring the gene therapy in patients with alpha-1 antitrypsin deficiency is expected to start in Q1 2024.

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UK government launches pathway for innovative technologies

PharmaTimes

IDAP aims to address unmet clinical needs for patients and healthcare professionals - News - PharmaTimes

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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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Vial2Bag Advanced® 20mm Admixture Device Special Report #2

Progressive Medical

Vial2Bag Advanced® 20mm Admixture Device: Waste Reduction in IV Distribution Large-scale drug waste is an ongoing problem in health care […] The post Vial2Bag Advanced® 20mm Admixture Device Special Report #2 appeared first on Progressive Medical, Inc.

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Organized Groups Try For Library Book Bans

Copyright Clearance Center

“The rise in unique titles challenged is indicative of the rise in organized political groups creating and sharing lists of objectionable books,” Andrew Albanese explains.

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FDA Approves Empagliflozin for Adults With Chronic Kidney Disease at Risk of Progression

Pharmacy Times

Empagliflozin (Jardiance) demonstrated a 28% relative risk reduction, with an absolute risk reduction of 3.6% per patient-year at risk in the treatment of chronic kidney disease.

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Alvotech’s AVT05 in phase III rheumatoid arthritis study, as the sole candidate

Pharmaceutical Technology

According to GlobalData, the number of individuals affected by rheumatoid arthritis is anticipated to rise to 6,980,823 cases by 2029.

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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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Community Pharmacy Can Help Solve National Health Equity Challenges Facing Clinical Research

Pharmacy Times

The people who come to the community pharmacy represent the surrounding population at large, making the pharmacy an ideal place to identify and recruit underrepresented patients.

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Yale and Transcend wins US DoD grant for PTSD therapy

Pharmaceutical Technology

The US Department of Defense grant is to study methylone for the rapid and long-lasting treatment of PTSD.

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Survey: 72% of Pharmacy Technicians’ Workflow Affected by Drug Shortages

Pharmacy Times

Chemotherapy, medication for attention deficit/hyperactivity disorder, glucagon-like peptide-1 agonists for weight loss and diabetes, and local anesthetics were among the drugs most affected by shortages.

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Jazz Pharma’s Enrylaze wins European approval for AML and LBL

Pharmaceutical Technology

The European Commission has approved Enrylaze for treating acute lymphoblastic leukaemia and lymphoblastic lymphoma.

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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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Pharmacist Role in Breast Cancer Treatment

Pharmacy Times

Heather Moore, CPP, PharmD, highlights key contributions from pharmacists in breast cancer treatment and identifies current unmet needs in the treatment landscape.

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Debiopharm, SunRock sign agreement for cancer ADCs

Pharmaceutical Technology

Debiopharm and SunRock Biopharma have signed an agreement to advance the development of specifically targeted ADCs for hard-to-treat cancers.

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Pharmacy Focus: AAPT Hosts Fall Seminar for Pharmacy Technicians

Pharmacy Times

Tune in to this episode of Pharmacy Focus to gain a deeper understanding of the AAPT Fall Seminar, the evolving landscape of pharmacy practice, and the crucial roles played by pharmacy technicians.

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Over half of world’s population not covered by essential healthcare services

Pharmaceutical Technology

The WHO and the World Bank have published the 2023 UHC Global Monitoring Report, detailing global health spending and service coverage rate.

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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.