Fri.Jul 23, 2021

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Caribou raises $304M in one of gene editing's most lucrative IPOs

Bio Pharma Dive

The IPO is several times larger than what CRISPR Therapeutics, Intellia and Editas raised several years ago, and ranks well ahead of a more recent offering from gene editing startup Beam.

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FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Endometrial Carcinoma

Pharma Mirror

Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma Study Results Demonstrated Statistically Significant Improvements in Overall Survival, Progression-Free Survival and Overall Response Rate, Helping to Address a Significant Unmet Need in Advanced Endometrial Carcinoma TOKYO and KENILWORTH, N.J. – (JCN Newswire) – Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A.

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A biotech's eye gene therapy faces longer odds as serious side effects pile up

Bio Pharma Dive

Five trial participants with diabetic macular edema who received Adverum Biotechnologies' treatment experienced side effects never before reported for an eye gene therapy.

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CPhI Awards 2021 Open for Entries in Incredible Year for Pharma Innovation

Pharma Mirror

On 9 November 2021, the 18th Annual CPhI Pharma Awards will take place in Milan, Italy at the Stella Polare Convention Centre. The CPhI Pharma Awards celebrate innovators and thought leaders breaking new ground in the pharma and biopharma industries, and their commitment to advancing new approaches, processes and technologies. Held as part of CPhI Worldwide (9-11 November 2021), the world’s largest pharma exhibition, these prestigious awards recognise the individuals, teams and companies who tur

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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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Virtual reality therapy: The future of chronic pain management?

pharmaphorum

Could virtual reality tools be effective in helping patients ‘unlearn’ their chronic pain? p harmaphorum speaks to Professor Christopher Eccleston from the University of Bath’s Centre of Pain Research to find out how digital therapeutics are shaping the future of pain management. A digital software developed by Finnish drugmaker Orion is aiming to address chronic pain conditions using virtual reality (VR) devices that provide an immersive gamified therapeutic treatment program.

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AZ says its COVID-19 vaccine protects against severe disease caused by variants

Pharma Times

Real-world data shows jab is effective after one dose against hospitalisation/death caused by Beta and Delta variants

More Trending

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New plans to improve patient access to mental health services unveiled in England

Pharma Times

NHS England has set out new plans to introduce five new waiting time guarantees for mental health services

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Is Macadamia Nut Oil the New Olive Oil for Cooking?

XTalks

For years, consumers have been using olive oil on food and in cooking. Still, Strength Genesis believes it is time for a change and a move towards a more versatile cooking oil option — macadamia oil, otherwise known as “liquid gold” to some. Olive oil is known for its healthy omega-3 fats and is used to aid in body repair and improve health in general.

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Seres’ ulcerative colitis candidate misses primary endpoint in mid-stage study

Pharma Times

Microbiome-based therapeutic failed to improve clinical remission rates among mild-to-moderate ulcerative colitis patients

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UTA researcher explores 3D printing of multilayered materials for smart helmets

Scienmag

A better helmet to protect soldiers in combat Credit: UT Arlington A mechanical and aerospace engineering professor at The University of Texas at Arlington is developing advanced helmets to ensure that members of the military are as protected as possible from blasts and other types of attacks. Ashfaq Adnan received a three-year, $1.5 million Distinguished […].

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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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NICE, PHE publish new antimicrobial prescribing guideline on C. difficile infection

Pharma Times

New recommendations outlined include advice for managing C.

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New organ-on-a-chip finds crucial interaction between blood, ovarian cancer tumors

Scienmag

Team identifies crucial interaction between platelets and tumors for the first time Credit: Texas A&M Engineering In the evolving field of cancer biology and treatment, innovations in organ-on-a-chip microdevices allow researchers to discover more about the disease outside the human body. These organs-on-chips serve as a model of the state an actual cancer patient is […].

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Syneos Health appoints Michael Brooks as Chief Development Officer

pharmaphorum

Syneos Health has appointed Michael Brooks as its new chief development officer. In this newly created role, Brooks will lead the company’s customer engagement and market development portfolio. “COVID-19 has forever changed the way we work with customers and colleagues, and how we effectively engage with patients and health care providers. It’s more important than ever that we drive innovation and find new ways to deliver exceptional customer experiences across the product development lifecycle,

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Advantages of intranasal vaccination against SARS-CoV-2

Scienmag

Intranasal vaccination is needle-free and elicits immunity at the site of infection, the respiratory tract Credit: UAB BIRMINGHAM, Ala. – There are many reasons that an intranasal vaccine against the SARS-CoV-2 virus would be helpful in the fight against COVID-19 infections, University of Alabama at Birmingham immunologists Fran Lund, Ph.D., and Troy Randall, Ph.D., write […].

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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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Headache Research Advances Though Cures Are Elusive

NY Times

Research into these often mysterious and debilitating disorders has languished. That’s changing.

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Cascaded metasurfaces for dynamic control of THz wavefronts

Scienmag

Dynamic control of THz wavefronts demonstrated by rotating layers of cascaded metasurfaces Credit: Shanghai University Electromagnetic (EM) waves in the terahertz (THz) regime contribute to important applications in communications, security imaging, and bio- and chemical sensing. Such wide applicability has resulted in significant technological progress.

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New organ-on-a-chip finds crucial interaction between blood, ovarian cancer tumors

Bioengineer

Team identifies crucial interaction between platelets and tumors for the first time. Credit: Texas A&M Engineering. In the evolving field of cancer biology and treatment, innovations in organ-on-a-chip microdevices allow researchers to discover more about the disease outside the human body. These organs-on-chips serve as a model of the state an actual cancer patient is in, thus allowing an opportunity to finding the correct treatment before administering it to the patient.

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Using silicone wristbands to measure air quality

Scienmag

A Texas A&M study found that these inexpensive, convenient devices can measure exposure to a class of chemicals that can be harmful during pregnancy Credit: Itza Mendoza-Sanchez A study by researchers at the Texas A&M University School of Public Health shows that inexpensive and convenient devices such as silicone wristbands can be used to yield […].

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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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Intouch Homecoming Events Welcome New Employees

Intouch Solutions

The pandemic … need I say more? It’s kept Intouchers apart for more than a year. It’s been challenging, but it hasn’t stopped us from (virtually) doing great work together, continuing to offer summer internships – stay tuned for a coming-soon post about this year’s internship class — and maintaining the Intouch culture we all value so much. BUT, over the past two weeks, Intouch has hosted return-to-office events we call Homecoming, and there are more to come over the next two months.

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Sharks, lies, and videotape: Scientists document problems with Shark Week

Scienmag

Credit: Marion Kraschl, CC BY 3.0 [link] via Wikimedia Commons MEADVILLE, PA – July 22, 2021 – Shark Week is many things. First and foremost, it’s a week of shark-themed documentary programming on the Discovery Channel. Now in its 33rd year, it’s the longest-running cable event in history. It’s the biggest audience that marine biologists […].

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Commission backs use of Moderna vaccine for children ages 12 and over

BioPharma Reporter

The EU Commission has extended vaccination with Modernaâs COVID-19 vaccine to adolescents, following on from the EMA's recommendation in relation to the use of the shot in children aged between 12 and 17.

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Comprehensive clinical sequencing opens door to the promise of precision medicine

Scienmag

St. Jude Children’s Research Hospital study highlights the power of comprehensive whole genome, whole exome and RNA sequencing to better understand and treat each patient’s cancer Credit: St. Jude Children’s Research Hospital St. Jude Children’s Research Hospital investigators have demonstrated that comprehensive genomic sequencing of all pediatric cancer patients is feasible and essential to capitalize […].

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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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Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of h

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UC San Diego receives $35 million in state funding for new coastal research vessel

Scienmag

First-of-its-kind hydrogen-hybrid vessel will be vital to education and research Credit: Scripps Institution of Oceanography at UC San Diego California legislators have allocated UC San Diego $35 million to design and build a new coastal research vessel with a first-of-its-kind hydrogen-hybrid propulsion system. The new vessel, which will be operated by Scripps Institution of Oceanography […].

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Pfizer and BioNTech to Provide U.S. Government with an Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply in the U.S.

The Pharma Data

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.

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Study shows environmental link to herbicide-resistant horseweed

Scienmag

Credit: Photo by John A. Schramski WESTMINSTER, Colorado – July 23, 2021 – Horseweed is a serious threat to both agricultural crops and natural landscapes around the globe. In the U.S., the weed is prolific and able to emerge at any time of the year. Fall emerging horseweed overwinters as a rosette, while spring emerging […].

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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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Vaxzevria is highly effective after one dose against severe disease or hospitalisation caused by Beta and Delta variants of concern

The Pharma Data

Real-world data from Canada showed 82% and 87% effectiveness after one dose against hospitalisation or death caused by Beta/Gamma and Delta variants respectively. Results from the Canadian Immunization Research Network (CIRN) with support from Public Health Agency of Canada and the Canadian Institutes of Health Research, published as a pre-print , demonstrated one dose of Vaxzevria was 82% effective against hospitalisation or death caused by the Beta/Gamma variants of the SARS-CoV-2 virus.

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Dalian Coherent Light Source reveals strong isotope effects in photodissociation of water isotopolog

Scienmag

Credit: DICP Recently, a research group led by Prof. YUAN Kaijun and Prof. YANG Xueming from the Dalian Institute of Chemical Physics (DICP) of the Chinese Academy of Sciences revealed strong isotope effects in photodissociation of the water isotopologue (HOD) using the Dalian Coherent Light Source. Their findings were published in Science Advances on July […].

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New patent expiration for Allergan drug AVYCAZ

Drug Patent Watch

Annual Drug Patent Expirations for AVYCAZ Avycaz is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are eight patents protecting…. The post New patent expiration for Allergan drug AVYCAZ appeared first on DrugPatentWatch - Make Better Decisions.

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Why do some people get severe COVID-19? The nose may know

Scienmag

People who develop severe COVID-19 have markedly blunted antiviral responses in the nasopharynx Credit: BioRxiv Feb 20, 2021, [link] The body’s first encounter with SARS-CoV-2, the virus behind COVID-19, happens in the nose and throat, or nasopharynx. A new study in the journal Cell suggests that the first responses in this battleground help determine who […].

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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.