Tue.Apr 26, 2022

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Undeterred by gene therapy's struggles, a startup launches into a downturn

Bio Pharma Dive

Apertura Gene Therapy, a new company formed by Deerfield, is hoping a suite of next-generation tools will help it stand out at a time when this area of research has fallen out of favor with some public investors.

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Valneva and Pfizer report positive Phase 2 data for Lyme disease vaccine in children

BioPharma Reporter

Valneva and Pfizer report positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15: and now plan to include this population in an upcoming Phase 3 trial.

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Nektar begins sweeping layoffs after $2B Bristol Myers deal falls apart

Bio Pharma Dive

Loss of the lucrative partnership has triggered a wide-ranging restructuring that will pare down Nektar’s workforce by about 70%.

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Understanding the microbiome as an ‘overlooked critical organ’

pharmaphorum

Compared to a ‘critical organ’ that had been largely ignored, companies working to develop microbiome-based therapies believe there is untapped potential in the area. Ben Hargreaves speaks to companies that are developing therapies not just in gastrointestinal conditions but also in broader areas, such an immuno-oncology. The interest in how the human microbiome influences health has grown substantially in the last decade.

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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 names longtime analyst as top dealmaker amid organizational shakeup

Bio Pharma Dive

Novartis said in an earnings presentation Tuesday that it hired biotech analyst Ronny Gal as chief strategy and growth officer and revealed more details about planned layoffs as the company restructures.

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Living near fast food restaurants in South Asia may increase risk of Type 2 diabetes

Scienmag

Globally, the prevalence of type 2 diabetes mellitus (T2DM) is increasing. A study publishing April 26th in the open access journal PLOS Medicine by Marisa Miraldo at Imperial College Business School, London, United Kingdom, and colleagues suggests that living near fast food restaurants increases the risk of developing Type 2 diabetes. Credit: Yalinda De Almeida […].

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Solar beats nuclear at many potential settlement sites on Mars

Scienmag

The high efficiency, light weight and flexibility of the latest solar cell technology means photovoltaics could provide all the power needed for an extended mission to Mars, or even a permanent settlement there, according to a new analysis by scientists at the University of California, Berkeley. Most scientists and engineers who’ve thought about the logistics […].

Scientist 101
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Achieving diversity, equity and inclusion in clinical trials

pharmaphorum

Making sure clinical trials are diverse and representative of the populations they’re studying isn’t just the right thing to do to promote inclusivity and equity; it’s also just good science/clinical scientific practice. But despite growing efforts to improve, many organisers still fall short when it comes to reaching, recruiting and retaining diverse patient populations in clinical trials.

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Intouch Wins “Best Rare Disease” Manny Award

Intouch Solutions

Intouch was awarded the “Best Rare Disease Campaign” at the 33rd annual Med Ad News Manny Awards on April 22, a recognition for the “Kind to Each Other – Fierce Against MD” campaign for Kindness Over Muscular Dystrophy. The goal of the campaign was to increase awareness about Duchenne muscular dystrophy (DMD). DMD is an incurable and fatal genetic disorder that gradually weakens the body’s muscles, and affects one in 5,000 newborn babies, primarily boys.

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ViGeneron and Daiichi Sankyo to develop therapy for eye diseases

Pharma Times

Follow-on collaboration between ViGeneron and Daiichi Sankyo allows the companies to create and validate vgAAV-based therapeutic candidates

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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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New patent for Janssen Pharms drug INVEGA TRINZA

Drug Patent Watch

Annual Drug Patent Expirations for INVEGA+TRINZA Invega Trinza is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Janssen Pharms drug INVEGA TRINZA appeared first on DrugPatentWatch - Make Better Decisions.

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Sanofi revs up manufacturing with help from McLaren

pharmaphorum

French drugmaker wants the efficiency of its manufacturing operations to go up a gear, and has joined forces with Formula One racing team McLaren to make it happen. The multi-year partnership will see McLaren work with Sanofi’s industrial affairs team, using its digital and analytics expertise to look at the pharma company’s manufacturing operations and find ways to improve efficiency.

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The Steve Morgan Foundation donates £50m to diabetes research

Pharma Times

The Foundation also launched a new collaboration with Diabetes UK and the Juvenile Diabetes Research Foundation UK

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Air Protein: The Alt Meat Startup Making Plant-Based Protein Out of Thin Air

XTalks

California-based startup Air Protein developed an alt meat called Air Meat, which is made using microbes that turn recycled carbon dioxide (CO2) into protein. Described by the company as “the meat of tomorrow,” Air Meat was designed to replicate the flavor and texture of real meat products like chicken, pork, steak and seafood. So, how does the company make alt protein out of thin air?

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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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Shrinking gap in surgical safety outcomes benefits older black patients in South Carolina

Scienmag

Preparing for surgery can be a scary, momentous occasion in any person’s life, but a greater chance of danger because of skin color should not be part of the equation. The South Carolina Surgical Quality Collaborative (SQC) was created in 2015 to level the playing field for surgical patients, and a recent study conducted at […].

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Impel Pharmaceuticals upper-nasal delivery offers hope for migraine patients

Outsourcing Pharma

The companyâs Precision Olfactory Delivery technology, currently combined with its Trudhesa migraine treatment, reportedly facilitates high absorption rates.

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Protecting species for the good of global climate

Scienmag

When the global community is expected to meet for the second part of the UN Biodiversity Conference in Kunming, China, in autumn, it must also adopt the next generation of UN biodiversity targets. These will then replace the Aichi Targets that were aimed for until 2020 – and have hardly been achieved. 21 “Post-2020 Action […].

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Drug Channels News Roundup, April 2022: 340Boom, 340B Profits for Pharmacies & PBMs, Fixing Insulin, Walgreens’ Robots, and Doctors’ Day

Drug Channels

Baseball season is in full swing! Oil up your glove, lace up your cleats, and let's run the bases around this month's news stories. Remember: Sometimes you win, sometimes you lose, and sometimes it rains. In this issue: Green Monster : The 340B market hits new highs in 2021 Not-Free Agents : Big 340B profits for CVS, Walgreens, Express Scripts, et al Batter Up : Fixing the insulin market Pinch Hitters : Walgreens bets on robots Plus, Dr.

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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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Threatened South American coati found roaming in a large city

Scienmag

You may assume that metropolitan areas are devoid of wildlife, but that is very far from the truth. The remaining green spaces within the urban matrices of large cities can serve as corridors or stepping stones for wild animals. Sometimes, even threatened mammal species end up using them. Credit: Diego Floriano da Rocha, Thaís Brauner […].

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Readout sets up phase 3 for Valneva/Pfizer’s Lyme disease jab

pharmaphorum

There’s only one vaccine candidate for tick-borne infection Lyme disease in clinical development – Valneva and Pfizer’s VLA15 – and it has just moved another step closer to being available. The two partners have reported positive results in a phase 2 trial in paediatric patients aged five to 17, backing up earlier results in adults and setting up the start of a pivotal phase 3 trial in the third quarter of this year.

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A blood test allows to differentiate severe COVID-19 from preeclampsia in pregnant women

Scienmag

Pregnancy brings deep changes in women’s physiology, especially regarding her blood system. The placenta is the organ which ensures an efficient communication between the mother and the baby. This organ grows quickly and links a significant quantity of mother’s blood supply to the fetus’. Thus, placenta has a relevant impact on blood pressure and it […].

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How To Prepare A Successful PCD Pharma Business Plan?

Fossil Remedies

PCD Pharma Business Plan. In a pharmaceutical business, you need a link between the pharma marketing company and the end-user, i.e., doctors, pharmacists, or others who can prescribe the medicine. This connecting link is the PCD Pharma Business. The full form of PCD is Propaganda Cum Distribution. Are you a person who wants to know about the details of preparing a successful PCD pharma business plan?

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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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It’s a dirty job, but some catalyst has got to do it

Scienmag

Catalysts are tricky things, but without them, our world would be a lot dirtier. Credit: Tom Cogill/University of Virginia School of Engineering and Applied Science Catalysts are tricky things, but without them, our world would be a lot dirtier. Catalysts – materials that accelerate chemical reactions – are used to save energy, reduce waste and […].

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Vaccines for young children are being delayed by incomplete applications, a top F.D.A. official suggests.

NY Times

Moderna and the Pfizer-BioNTech partnership are developing versions of their coronavirus vaccines for children under 5, with emergency-use filings expected in the next several weeks.

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Parental type 1 diabetes can affect children’s cognitive development

Scienmag

Cognitive development in children could be affected regardless of which biological parent has type 1 diabetes, according to research publishing April 19th in the open access journal PLOS Medicine. The research shows for the first time that having a parent with a chronic disease like type 1 diabetes may be associated with lower school performance […].

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Scorpion Biological Services to create new Kansas biomanufacturing facility

BioPharma Reporter

CDMO Scorpion Biological Services will build a new biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas.

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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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UTA computer scientist training next generation of digital fabrication researchers

Scienmag

A University of Texas at Arlington computer scientist is exploring how to integrate materials like clay, silicone, glass, biomaterials and textiles with 3D-printing technologies. Credit: UT Arlington A University of Texas at Arlington computer scientist is exploring how to integrate materials like clay, silicone, glass, biomaterials and textiles with 3D-printing technologies.

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Intouch Wins “Best Rare Disease” Manny Award

Intouch Solutions

Intouch was awarded the “Best Rare Disease Campaign” at the 33rd annual Med Ad News Manny Awards on April 22, a recognition for the “Kind to Each Other – Fierce Against MD” campaign for Kindness Over Muscular Dystrophy. The goal of the campaign was to increase awareness about Duchenne muscular dystrophy (DMD). DMD is an incurable and fatal genetic disorder that gradually weakens the body’s muscles, and affects one in 5,000 newborn babies, primarily boys.

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Pathogens can hitch a ride on plastic to reach the sea

Scienmag

Microplastics are a pathway for pathogens on land to reach the ocean, with likely consequences for human and wildlife health, according to a study from the University of California, Davis. Credit: Karen Shapiro, UC Davis Microplastics are a pathway for pathogens on land to reach the ocean, with likely consequences for human and wildlife health, […].

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Sanofi teams up with McLaren Racing to accelerate industrial excellence

The Pharma Data

Sanofi announces today that it is partnering with McLaren Racing to accelerate manufacturing efficiency and performance in support of the company’s ambition to attain world-class standards of manufacturing excellence. Following a successful pilot in 2021 with McLaren Racing, both companies have decided to extend their collaboration across multiple sites in seven countries, covering more than 100 production lines, across all technologies.

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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.