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.

Trials 350
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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.

Drugs 133
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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June 29, 2023: Workshop Materials and Videocast Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’

Rethinking Clinical Trials

Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster. ” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

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Why Should I Seek an Emergency Dentist?

Pharma Mirror

A bright smile is said to be the best compliment one can hear from others, and the heart of preserving and sweetening those smiles lies in a dentist’s hand. Dentistry, the art, and science of oral health, confines a diverse range of practices and professionals committed to maintaining the well-being of your teeth, gums, and overall oral health.

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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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Dr K Sujith Kumar appointed as new drug controller-in-charge in Kerala

AuroBlog - Aurous Healthcare Clinical Trials blog

Dr K Sujith Kumar, the senior deputy drugs controller (DDC) at the department of drugs control administration (DCA) in Kerala has been appointed as the drug controller-in-charge of the state from Thursday, June, 1. A Ph D holder in Pharmaceutical Regulatory Affairs (PRA) from the JSS University in Mysore, Dr.

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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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June 29, 2023: Grand Rounds Podcast with Dr. Joshua Denny on All of Us Research Program is Available

Rethinking Clinical Trials

In the latest episode of the NIH Collaboratory Grand Rounds podcast , Dr. Joshua Denny continues his discussion about All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine. The full May 5 Grand Rounds webinar with Dr. Denny is also available. The post June 29, 2023: Grand Rounds Podcast with Dr.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Transforming Digital Experiences: Viseven and SpotMe Form Strategic Partnership

Pharma Mirror

LAUSANNE, Switzerland – Viseven, a leading global MarTech services provider for the Pharma and Life Sciences industries, is thrilled to announce its partnership with SpotMe, an enterprise event platform tailored to high-touch industries. This collaboration marks a significant milestone in digital communication within the healthcare industry. Driving Success in Pharma Communication The partnership between Viseven and SpotMe creates a unique point of view on the HCP engagement and B2B event organi

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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.

Drugs 321
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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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Scientists Just Figured Out How This Deadly Superbug Hides Inside Us

AuroBlog - Aurous Healthcare Clinical Trials blog

Golden staph are ubiquitous bacteria, living harmlessly on the skin or inside the nose of nearly one in three people worldwide. Yet they are duplicitous, too. In some situations, golden staph (Staphylococcus aureus) can become monsters, causing dangerous infections in the skin, blood, bones, or elsewhere.

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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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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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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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Verve partners with Lilly on gene editing therapy for heart disease

Bio Pharma Dive

Lilly will pay the genetic medicine specialist $60 million upfront to work together on a treatment targeting a risk factor known as Lp(a).

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FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug

Bio Pharma Dive

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

Drugs 309
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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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Psylo signs research deal with Daiichi Sankyo for psychiatric therapies

Pharmaceutical Technology

Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.

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UniQure stock tumbles on ‘confusing’ results for Huntington’s gene therapy

Bio Pharma Dive

While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.

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Coherus sets steep discount for Humira copycat, plans direct sales

Bio Pharma Dive

The biotech will price its biosimilar Yusimry at 85% below Humira’s list price when it launches next month, and charge even less if bought through Mark Cuban’s pharmacy.

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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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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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Sarepta prices Duchenne gene therapy at $3.2M

Bio Pharma Dive

The cost makes Sarepta’s treatment, called Elevidys, among the most expensive medicines in the world. But company executives said they don’t expect significant insurer pushback.

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Novartis drug helps stop breast cancer’s return in large study

Bio Pharma Dive

Treatment with Kisqali reduced the risk of disease recurrence when used after surgery, potentially positioning Novartis to win a similar adjuvant approval as Lilly’s rival therapy Verzenio.

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Medicare sets next tranche of drugs to face price hike penalties

Bio Pharma Dive

CMS named 43 Part B drugs for which prices rose more than inflation, and which will have lower coinsurance rates next quarter as a result.

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Acadia gives once-rejected Prader-Willi drug a second chance

Bio Pharma Dive

The FDA last year turned back an approval request from the drug’s former developer, Levo Therapeutics. That biotech is now owned by Acadia, which will run a new study designed to boost its odds of success.

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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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10 clinical trials to watch in the second half of 2023

Bio Pharma Dive

A Duchenne gene therapy faces a crucial test, while highly anticipated study results are expected in lung cancer, obesity and heart disease.

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Flagship’s latest startup aims to take the guesswork out of small molecule drugs

Bio Pharma Dive

Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.

Drugs 280
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Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

Alkeus Pharmaceuticals has raised $150m in Series B financing to support the registration and launch of gildeuretinol (ALK-001) to treat Stargardt disease, a genetic cause of blindness in children and young adults. Led by Bain Capital Life Sciences, the financing round has also seen participation from Sofinnova Investments, TCGX and Wellington Management.

Genetics 279
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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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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