Sat.Nov 19, 2022 - Fri.Nov 25, 2022

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A unified, connected foundation is transforming the future of digital trials

Bio Pharma Dive

A holistic approach allows stakeholders to adapt to the ever-increasing number of clinical trials and data points.

Trials 286
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AI will continue to attract investment in near future in the healthcare industry

Pharmaceutical Technology

Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl

Big Data 363
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The Cause of Alzheimer’s Could Be Coming From Inside Your Mouth

AuroBlog - Aurous Healthcare Clinical Trials blog

In recent years, a growing number of scientific studies have backed an alarming hypothesis: Alzheimer’s disease isn’t just a disease, it’s an infection. While the exact mechanisms of this infection are something researchers are still trying to isolate, numerous studies suggest the deadly spread of Alzheimer’s goes way beyond what we used to think.

Research 202
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Bacteria that break down nicotine found in the guts of mice

Medical Xpress

A team of researchers affiliated with multiple institutions in China, working with a colleague in the U.S., has isolated a type of bacteria in the guts of mice that break down nicotine. In their paper published in the journal Nature, the group describes how they isolated the bacteria and why their finding could reduce incidences of fatty liver disease in humans.

Bacteria 145
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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 approves first gene therapy for hemophilia B

Bio Pharma Dive

The treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million.

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Ozempic compensating for Wegovy’s supply shortage due to high demand

Pharmaceutical Technology

In recent months, Wegovy (semaglutide), indicated for obesity, has been subjected to widespread supply shortages due to high demand, in addition to manufacturer production problems, with Novo Nordisk intending to relaunch Wegovy by the end of 2022. In the meantime, however, Novo Nordisk’s Ozempic, another version of semaglutide indicated particularly for patients with type 2 diabetes, has picked up the slack by being used off-label for obesity patients.

Marketing 279

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Opinion: A tripledemic hurricane is making landfall. We need masks, not just tent hospitals

STAT News

A viral hurricane is making landfall on health care systems battered by three pandemic years. With the official start of winter still weeks away, pediatric hospitals are facing crushing caseloads of children sick with RSV and other viral illnesses. Schools that promised a “return to normal” now report widespread absences and even closures from RSV and flu in many parts of the country , contributing to parents missing work in record numbers.

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Cancer drugmaker Plexxikon gets new life as Opna Bio

Bio Pharma Dive

Eight months after Daiichi Sankyo shuttered the San Francisco Bay Area subsidiary, Plexxikon’s former CEO is resuscitating its drug research under a new name.

Drugs 317
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NICE questions value and efficacy of five Covid-19 drugs with rejection

Pharmaceutical Technology

The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK.

Drugs 279
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Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial

BioPharma Reporter

A Phase 3 trial for Northwest Biotherapeuticsâs DCVax-L vaccine extended survival in patients with gliobastoma for many months, or in some cases, years: according to new data.

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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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Hidden audits reveal millions in overcharges by Medicare Advantage plans

NPR Health - Shots

Taxpayers footed the bill for care that should have cost far less, according to records released under the Freedom of Information Act. The U.S. government may charge insurers $650 million as a result.

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GSK to pull blood cancer drug from US market after study failure

Bio Pharma Dive

The British drugmaker has begun the process of withdrawing its multiple myeloma treatment Blenrep following a request from the FDA.

Marketing 312
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Umoja and IASO partner to develop therapies for haematological malignancies

Pharmaceutical Technology

Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. Under the alliance, the companies will assess the induced cytotoxic innate lymphocytes (iCIL) platform of Umoja with chimeric antigen receptors (CARs) of IASO to develop the next generation of widely accessible, easily available cell therapies.

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Long-COVID personalized medicine enters Phase 2 trial

BioPharma Reporter

GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.

Trials 144
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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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Experts are concerned Thanksgiving gatherings could accelerate a 'tripledemic'

NPR Health - Shots

As the holiday approaches, infectious disease specialists are bracing for the possibility that big family get-togethers and travel will propel the spread of RSV, flu and COVID-19.

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Teva taps Sandoz veteran to take over CEO post from Schultz

Bio Pharma Dive

Richard Francis will take over for the retiring Kåre Schultz on Jan. 1. He’ll face major challenges at Teva, including opioid settlements, biosimilar launches and reducing the company’s debt.

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Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Pharmaceutical Technology

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive unresectable or recurrent breast cancer in adults. The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane. The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy a

Antibody 263
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Wireless smart bandage provides new insights on healing chronic wounds

Medical Xpress

Some wounds just won't heal. Infections, diseases like diabetes, and suppressed immune systems often stack up to slow healing. Chronic wounds can last months and lead to anxiety and depression. In the worst cases, they are life threatening. Cost of treatment has soared to $25 billion each year.

Research 143
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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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How monoclonal antibodies lost the fight with new COVID variants

NPR Health - Shots

The treatments were highly popular earlier in the pandemic. One by one, they got knocked out by more convenient, less expensive treatment options, and new COVID variants.

Antibody 145
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Merck to buy blood cancer biotech Imago for $1.35B

Bio Pharma Dive

The deal is Merck’s second notable acquisition of a cancer drugmaker in the past year and a half, part of a strategy to diversify its pipeline beyond top-selling immunotherapy Keytruda.

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XtalPi and CK Life Sciences to develop AI-driven tumour vaccine R&D platform

Pharmaceutical Technology

XtalPi has entered a strategic partnership with CK Life Sciences for artificial intelligence (AI)-driven tumour vaccine research and development (R&D). Under the collaboration, the companies will utilise their capabilities to co-develop a new AI tumour vaccine R&D platform. Such a platform will aid in boosting tumour vaccine discovery and design expertise as well as expedite the development of other kinds of vaccines.

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New male contraceptive does not involve hormones

Medical Xpress

A team of researchers at a company called Contraline has developed a new kind of male contraceptive. Instead of using hormones to disrupt sperm production, the new technique involves placing a hydrogel called ADAM into the vas deferens to prevent sperm from making its way to the urethra. The new technique is not yet available for men seeking an alternative way to prevent pregnancy, however—it is currently undergoing a clinical trial in Australia.

Hormones 143
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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.

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Real-world data show updated Covid-19 boosters increase protection against infection

STAT News

The updated Covid-19 boosters increase people’s protection against symptomatic infection from the coronavirus, according to some of the first estimates of how the shot is performing in the real world and in people, not just in lab experiments. What’s more, that protection was even stronger when people waited a longer period of time since their last dose of the original shot.

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The next era of Greater Boston’s biotech boom

Bio Pharma Dive

Over the past two decades, the Cambridge area has become a nerve center for biotech in the U.S. But to stay relevant and accessible, the hub is expanding to the suburbs.

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Japan grants emergency regulatory approval for Shionogi’s Covid-19 drug

Pharmaceutical Technology

The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted emergency regulatory approval for Shionogi ’s new anti-SARS-CoV-2 drug, Xocova (ensitrelvir fumaric acid, S-217622), for Covid-19. This approval under the emergency regulatory approval system is granted under the Article 14-2-2 of the Pharmaceuticals and Medical Devices Act, the company noted.

Drugs 246
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Doctors who want to defy abortion laws say it's too risky

NPR Health - Shots

In states with abortion bans, doctors may hesitate to provide abortion care in a medical emergency. Some ethicists argue doctors should practice civil disobedience and put patients' lives first.

Doctors 138
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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.

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STAT+: FDA approves a gene therapy for the inherited bleeding disorder hemophilia B

STAT News

The Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder. The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company.

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How brands can tap into wellness – lessons from influencers

Bio Pharma Dive

Our latest research uncovers new insights on how brands can truly close the wellness gap and grow within their industry sectors.

Branding 269
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Merck agrees to acquire Imago for $1.35bn

Pharmaceutical Technology

Merck (MSD outside North America) has signed a definitive agreement for the acquisition of all outstanding shares of Imago BioSciences, through a subsidiary, for $36.00 per each share in cash or for a total equity price of nearly $1.35bn. A clinical-stage biopharmaceutical firm, Imago focuses on the development of new therapies to treat myeloproliferative neoplasms (MPNs) and other bone marrow ailments.

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'Sunny Makes Money': India installs a record volume of solar power in 2022

NPR Health - Shots

India, on track to become the world's most populous country, gets about 70% of its electricity from coal. But the government is aggressively investing in renewable energy — particularly solar.

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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.