June, 2023

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WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

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J&J sees trial data supporting earlier CAR-T use in multiple myeloma

Bio Pharma Dive

The results, which partially leaked in April, show Carvykti’s potential to be used after a drug called Revlimid fails, rather than reserved for only after several treatments do.

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Invasive Bacteria May Trigger Endometriosis, Study Suggests

AuroBlog - Aurous Healthcare Clinical Trials blog

A type of bacteria commonly found in human oral and gut flora could play a major role in the development of endometriosis, scientists have discovered – potentially giving us crucial insight into the development of the painful condition, and opening up new ways to treat it.

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Eisai, Biogen's Alzheimer's disease drug Leqembi passes muster at FDA adcomm

Fierce Pharma

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing. | After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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FDA Braces for Looming Boom in Cell and Gene Therapy Submissions

BioSpace

The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.

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Avacta announces AVA6000 dose escalation results

Pharma Times

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes

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BioMarin finally secures FDA approval of hemophilia gene therapy

Bio Pharma Dive

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

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What is Going on in Billing Compliance for Clinical Trials?

ACRP blog

Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. Incorrect billing can result in federal and state violations as well as financial penalties. “To ensure billing compliance, research professionals should inspect their program, measure risks, and assemble the team members who can make billing compliance better,” said Kelly Willenber

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BioNTech to defend itself against COVID-19 vaccine injury claim in Germany

Fierce Pharma

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.

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Discontinuation of Universal Admission Testing for SARS-CoV-2 and Hospital-Onset SARS-CoV-2 Infections in England and Scotland

JAMA Internal Medicine

This quality improvement study examines the association between the discontinuation of universal admission testing for SARS-CoV-2 infections and hospital-onset SARS-CoV-2 infections in England and Scotland.

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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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Invizius’ ‘angry blood’ research recruits 300th patient

Pharma Times

525-patient trial intends to assess ‘complement activation’ during HD in patients with end stage renal failure - News - PharmaTimes

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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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First Duchenne gene therapy approved by FDA for young children

Bio Pharma Dive

The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.

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17th Edition Project Portfolio and Resource Management Excellence for Pharma

Drug Patent Watch

17th Edition Project Portfolio and Resource Management Excellence for Pharma July 11-13, 2023 | Sheraton Philadelphia University City Hotel | Philadelphia, PA Mastering Resource and Project Prioritization, Operational Excellence, and People Development… The post 17th Edition Project Portfolio and Resource Management Excellence for Pharma appeared first on DrugPatentWatch - Make Better Decisions.

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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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BioMarin's hemophilia gene therapy Roctavian lands FDA nod with 'glimmers' of enthusiasm among doctors

Fierce Pharma

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

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Roctavian Becomes First Gene Therapy for Severe Hemophilia A to Get FDA Nod

XTalks

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The US Food and Drug Administration (FDA) approved BioMarin’s Roctavian, an adeno-associated virus (AAV) vector-based gene therapy, for the treatment of adults with severe hemophilia A.

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Alchemab Therapeutics reveals Alzheimer’s candidate

Pharma Times

ATLX-1088 is regarded as a possible first-in-class human antibody targeting CD33 – a cell surface protein - News - PharmaTimes

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China grants EUA to Covid-19 vaccine against XBB descendent lineages

Pharmaceutical Technology

WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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After years of disappointment, cancer vaccines show new promise

Bio Pharma Dive

Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.

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DrugChatter Featured Questions

Drug Patent Watch

DrugChatter recently launched as an experimental AI chat-based business intelligence tool. Here’s some of the more interesting questions it’s been asked: Cost savings for bulk lipitor Who Invented Advil? What… The post DrugChatter Featured Questions appeared first on DrugPatentWatch - Make Better Decisions.

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Bayer needs 'midsize acquisition' to reach $10B oncology sales goal, exec says

Fierce Pharma

Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.

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What is celiac disease?

Antidote

Celiac disease is a common autoimmune disorder that causes a reaction to gluten within the small intestine. It is often underdiagnosed, but it is estimated to impact around 2 million people in the United States.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Janssen reveals data from erdafitinib study

Pharma Times

Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma - News - PharmaTimes

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Health Canada approves Endo’s anti-seizure pills

Pharmaceutical Technology

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

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FDA sets decision dates for Vertex, CRISPR gene editing drug

Bio Pharma Dive

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

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Busting common myths about lab automation 

Drug Discovery World

Ernesto Staroswiecki, Senior Manager, R&D, at Beckman Coulter Life Sciences takes readers through common lab automation myths. Many clinical and research laboratories today are having to do more with less: faced with ongoing staffing shortages, increased workloads, and budgetary constraints, many laboratory managers are feeling the stress, which is where the benefits of automation can be truly realised for labs in both academia and industry.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection

Fierce Pharma

Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.

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What motivates patients to participate in clinical trials?

Antidote

In order to connect people with medical research opportunities, it is important to understand what motivates patients to participate in clinical trials. We asked 4,000 volunteers and caregivers to gain insight into their motivation for clinical trial participation. Here’s what we learned.

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Cardiff University begins study of schizophrenia therapy

Pharma Times

The treatment candidate, known as MDI-26478, is a positive allosteric modulator of the AMPA receptor - News - PharmaTimes

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NASH drugs race to cross the finish line

Pharmaceutical Technology

After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.