May, 2023

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Research reveals cancer-killing benefits of popular obesity treatment

Medical Xpress

Maynooth University's Kathleen Londsdale Institute for Human Health Research has just published research into the benefits of the popular obesity treatment drug, GLP-1.

Research 143
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Serial biotech founder Tim Springer on investing in startups and democratizing antibody research

Bio Pharma Dive

Springer, who became a billionaire after an early investment in Moderna, spoke with BioPharma Dive after gifting $210 million to his nonprofit institute in Boston.

Antibody 298
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BioNTech’s RNA vaccine sparks potential in pancreatic cancer

Pharmaceutical Technology

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

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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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It’s Official: Artificial Sweeteners Don’t Work For Weight Loss, WHO Says

AuroBlog - Aurous Healthcare Clinical Trials blog

This week, the World Health Organization (WHO) advised that “non-sugar sweeteners should not be used as a means of achieving weight control or reducing the risk of noncommunicable diseases” such as diabetes and heart disease.

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May 31, 2023: PROACT Xa Pragmatic Trial to Be Featured in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. John Alexander In this Friday’s PCT Grand Rounds, John Alexander of Duke University will present “PROACT Xa and the Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial.” The Grand Rounds session will be held on Friday, June 2, 2023, at 1:00 pm eastern. PROACT Xa was a prospective, randomized clinical trial conducted to determine whether apixaban was noninferior to warfarin in preventing valve thrombosis or valve-related thromboembolism in patients w

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Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

Bio Pharma Dive

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth prospects.

Drugs 360
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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.

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Johnson & Johnson cites rebates and discounts for drug price increases

Fierce Pharma

Johnson & Johnson cites rebates and discounts for drug price increases kdunleavy Fri, 05/26/2023 - 07:36

Drugs 145
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Experimental MS Treatment Reverses Paralysis in Mice, Scientists Report

AuroBlog - Aurous Healthcare Clinical Trials blog

Microscopic backpacks full of drugs designed to stick to troublesome immune cells have been shown to improve the health of mice with a condition similar to multiple sclerosis in humans.

Scientist 246
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Meeting Global Demands for Viral Vector-based Vaccines

Pharma Mirror

In the face of increasing global health challenges, the development and production of vaccines have become paramount. One critical aspect is the ability to scale up manufacturing processes to meet the growing demand for viral vector-based vaccines. In this article, we will explore the efforts being made by innovative biotechnology companies to develop scalable and cost-effective manufacturing methods.

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Evidence of consciousness-like activity in the dying brain

Medical Xpress

Reports of near-death experiences—with tales of white light, visits from departed loved ones, hearing voices, among other attributes—capture our imagination and are deeply engrained in our cultural landscape.

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J&J antibody drug combination shows promise in multiple myeloma

Bio Pharma Dive

A pair of dual-acting antibodies displayed early potential to become a new type of drug regimen for the blood cancer, but led to a high rate of side effects as well.

Antibody 357
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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

Vaccine 298
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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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Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

Fierce Pharma

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

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Mouse Study Reveals An Immune Cell That May Cause Fibromyalgia

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have caught a type of immune cell invading nerve cells, discovering a possible cause of fibromyalgia in an animal model of the disease. Fibromyalgia is characterized by chronic, widespread, and debilitating pain, thought to be triggered by a process known as central sensitization.

Scientist 245
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FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

Bio Pharma Dive

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

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Sanofi strikes a $150M deal for Maze’s Pompe disease drug

Bio Pharma Dive

The cash influx extends Maze’s financial runway into 2025, giving the South San Francisco company time to advance other drug candidates into testing.

Drugs 351
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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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Cancer vaccine from BioNTech, Roche shows potential in small study

Bio Pharma Dive

The companies’ personalized shot generated tumor-specific T cells that researchers hope could help prevent pancreatic cancer from returning after surgery.

Vaccine 348
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FDA panel narrowly backs approval of Sarepta’s Duchenne gene therapy

Bio Pharma Dive

Advisers voted 8-6 in favor of an accelerated approval despite uncertainty around the treatment’s benefit. The agency is set to make a final decision by May 29.

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J&J, building on CAR-T success, strikes another cell therapy deal

Bio Pharma Dive

Fresh off its success with the multiple myeloma treatment Carvykti, J&J is paying Cellular Biomedicine Group $245 million upfront for rights to two experimental cell therapies for blood cancer.

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Pfizer turns focus to new drugs as COVID vaccine revenue falls

Bio Pharma Dive

The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

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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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Ovid partners with Waksal startup to develop drugs for rare brain disorders

Bio Pharma Dive

Founded by Sam Waksal, Graviton Biosciences is developing drugs that block an enzyme called ROCK2, which drew the interest of neurology-focused Ovid.

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Biotech startup Ray raises $100M for vision-restoring gene therapies

Bio Pharma Dive

Founded in early 2021, the company is using optogenetics to design treatments that could work across disease genotypes and in the later stages of vision loss.

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Lilly drug slows Alzheimer’s decline in large study

Bio Pharma Dive

The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.

Drugs 328
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Biohaven sends latest drug to FDA, despite past trial setback

Bio Pharma Dive

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

Trials 325
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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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ASCO puts spotlight on advancing antibody-drug conjugate pipeline

Bio Pharma Dive

Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

Antibody 324
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Pfizer’s RSV vaccine wins FDA approval in older adults

Bio Pharma Dive

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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Bristol Myers data make case for earlier use of bone marrow disease drug

Bio Pharma Dive

Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

Drugs 321
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Convergent raises $90M to develop its radiopharmaceutical for prostate cancer

Bio Pharma Dive

The biotech is the latest startup to capitalize on rising investor interest in targeted drugs that use radioisotopes to destroy tumors.

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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