Thu.Jun 03, 2021

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An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

Bio Pharma Dive

Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it.

Genetics 356
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The Future of Health Care

World of DTC Marketing

IN SHORT : Out-of-control health care spending exact an enormous and growing toll on Americans. The scale of the broken US health care system reveals itself in tragic ways. Fraud accounts for about $300 billion of annual US health care spending. Many employers no longer try to contain health care spending, but many more are fighting back. The Future of Health Care is Local, Open, and Independent.

Pharmacy 198
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Bayer buys a biotech and its offshoot in bet on radiopharmaceuticals

Bio Pharma Dive

The German drugmaker will add an experimental prostate cancer medicine to its pipeline through the deal, which reflects growing industry interest in the field.

Medicine 332
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Opdivo, Yervoy combination approved to treat malignant pleural mesothelioma

Pharma Times

Combination immunotherapy treatment approved in the EU for first-line treatment of adults with unresectable MPM

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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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Novartis prostate cancer drug extends survival in key test of radiopharmaceutical therapy

Bio Pharma Dive

Results from the Phase 3 trial, which Novartis plans to use to ask for approval, help validate the pharma's bet on the therapy's original developer, Endocyte.

Drugs 321
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Bayer Acquires Noria, PSMA Therapeutics to Expand Place in Prostate Cancer Space

BioSpace

Bayer will nab exclusive rights to a differentiated alpha radionuclide, actinium-225 investigational compound, and a small molecule targeting prostate-specific membrane antigen.

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Nanobiotix’s Radiotherapy Enhancer for Tumors Also Primes the Immune System

BioSpace

Nanobiotix is developing a way for its locally-injected radioenhancer for solid tumors to treat metastasized cancers, in combination with checkpoint inhibitors, and also deliver results distally.

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Orchard abandons promising gene therapy for rare immune disorder

Bio Pharma Dive

The U.K. biotech deprioritized the therapy last year, despite positive results in clinical testing that were recently published in a top medical journal.

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Bayer at ASCO: Vitrakvi Effective in TRK Fusion Cancers Regardless of Tumor Type

BioSpace

Bayer, like many biopharma companies, is presenting study results at the 2021 American Society of Clinical Oncology (ASCO) Annual meeting being held online June 4-8, 2021.

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Former FDA official Abernethy joins Google health spinoff

Bio Pharma Dive

The agency's former acting CIO pushed development of real world evidence as well as improved data sharing. At Verily, she'll head up the unit's clinical research business.

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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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70-year-old coffee-killing fungus brought back to life to fight the disease

Scienmag

Credit: CABI Researchers have re-animated specimens of a fungus that causes coffee wilt to discover how the disease evolved and how its spread can be prevented. Coffee Wilt Disease is caused by a fungus that has led to devastating outbreaks since the 1920s in sub-Saharan Africa, and currently affects two of Africa’s most popular coffee […].

Research 101
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Frutta Bowls is Bringing Consumers an Endless Summer

XTalks

Superfoods café, Frutta Bowls, is known for its açaí bowls, is introducing four new limited-time menu items to launch their new campaign called Endless Summer. . The campaign started on June 1 st and will run through August 31 st. Endless Summer will feature three summer-themed smoothies and a new protein bite that will offer nostalgic and retro flavors intended to remind consumers of their favorite childhood summer memories.

Protein 98
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Skin-patch COVID-19 vaccine could offer enhanced antibody responses, according to preclinical data

BioPharma Reporter

COVID-19 vaccination via Vaxxasâ novel high-density microarray patch showed 'significantly enhanced' T-cell and spike-specific antibody responses compared to needle delivery, according to a pre-print preclinical study published this week.

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Lessons from the last pandemic point the way toward universal flu vaccines

Scienmag

Strong immune responses to unchanging, conserved parts of the 2009 H1N1 pandemic flu virus suggest strategies for effective universal vaccines Credit: Guthmiller et al. A new study from the University of Chicago and Scripps Research Institute shows that during the last great pandemic–2009’s H1N1 influenza pandemic–people developed strong, effective immune responses to stable, conserved parts […].

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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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CVR Holders Slap BMS with Lawsuit After Missed Liso-Cel Deadline

BioSpace

It didn’t take too long before a lawsuit was filed over Bristol Myers Squibb’s failure to meet a deadline for a $9 Contingent Value Rights agreement tied to the company’s merger with Celgene.

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Study finds age doesn’t affect perception of ‘speech-to-song illusion’

Scienmag

Credit: KU LAWRENCE — A strange thing sometimes happens when we listen to a spoken phrase again and again: It begins to sound like a song. This phenomenon, called the “speech-to-song illusion,” can offer a window into how the mind operates and give insight into conditions that affect people’s ability to communicate, like aphasia and […].

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Time for a NICE change

pharmaphorum

The National Institute for Health and Care Excellence (NICE) is world-renowned for their work assessing the clinical and cost-effectiveness of new treatments. In recognition of how the world has changed over its history, NICE is coming to the end of a period of review and consultation on their processes and methods. Leela Barham takes stock. This article appears in our digital magazine Deep Dive: Market Access 2021.

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South Pole and East Antarctica warmer than previously thought during last ice age, two studies show

Scienmag

Credit: Eric Steig/University of Washington The South Pole and the rest of East Antarctica is cold now and was even more frigid during the most recent ice age around 20,000 years ago — but not quite as cold as previously believed. University of Washington glaciologists are co-authors on two papers that analyzed Antarctic ice cores […].

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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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Three Biopharma Companies Raise Millions in Separate Series A Financing Rounds

BioSpace

?The three companies will aim to develop their different programs such as Stablix TPS platform, Stellanova's focused on targeting pro-tumorigenic effects, and Amyl's development of preclinical therapeutic candidates.

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Arctic sea ice thinning faster than expected

Scienmag

Sea ice in the coastal regions of the Arctic may be thinning up to twice as fast as previously thought, according to a new modelling study led by UCL (University College London) researchers Credit: Alfred-Wegener-Institut Sea ice in the coastal regions of the Arctic may be thinning up to twice as fast as previously thought, […].

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Another COVID-19 Win for Regeneron as FDA Okays Lower Dose of Antibody Cocktail

BioSpace

REGEN-COV's 1,200 mg dose is authorized to treat mild-to-moderate COVID-19 in adults and children 12 years and older who weigh 40 kilograms or more.

Antibody 101
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Milk makeover: A great start for a healthy heart

Scienmag

Credit: Unsplash A dash of milk could make all the difference to a healthy heart as new research from the University of South Australia finds that people who regularly consume milk have a lower risk of heart disease. Conducted in partnership with the University of Reading, the world-first study used a genetic-approach to investigate causal […].

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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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FDA grants swift approval to Cognoa’s digital device for autism diagnosis

pharmaphorum

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched “in the coming months” At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence.

Doctors 93
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Scientists make powerful underwater glue inspired by barnacles and mussels

Scienmag

Silk proteins formed fibers, crosslinks, and iron complexes similar to those used by the sea creatures Credit: Marco Lo Presti, Tufts University If you have ever tried to chip a mussel off a seawall or a barnacle off the bottom of a boat, you will understand that we could learn a great deal from nature […].

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ASCO Update: A Theme of Accessibility and Pricing Plus Individual Reporting

BioSpace

With the 2021 American Society of Clinical Oncology Annual Meeting now in high gear, there is plenty of news. Here’s a look at just some of the most recent stories.

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UK is talking to AstraZeneca about beta variant COVID jab

pharmaphorum

The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta variant – also known as B.1.351 – which is estimated to be around 50% more transmissible than earlier strains.

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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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New patent for Radius Health drug TYMLOS

Drug Patent Watch

Annual Drug Patent Expirations for TYMLOS Tymlos is a drug marketed by Radius Health Inc and is included in one NDA. It is available from one supplier. There are three…. The post New patent for Radius Health drug TYMLOS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 90
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J&J’s Tremfya shows significant improvements for post-TNFi psoriatic arthritis patients

Pharma Times

IL-23 inhibitor helped patients achieve complete skin clearance and joint symptom improvement

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HIV Epidemic: 40 Years Later

BioSpace

On June 5, the world marks the 40th anniversary of the HIV epidemic. Biopharma researchers continue to develop safe and effective treatments with an eye to a potential cure.

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Bone marrow stem cell transplants can benefit some Type 2 diabetes patients, study shows

Scienmag

Credit: AlphaMed Press Durham, NC — Type 2 diabetes patients who are not overweight and who have had the disorder for less than a decade can benefit from stromal stem cells transplanted from their own bone marrow, according to a study published today in STEM CELLS Translational Medicine. In a randomized clinical trial at Vinmec […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.