Tue.Apr 13, 2021

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US calls for pause in J&J coronavirus vaccine rollout after rare blood clotting cases

Bio Pharma Dive

The FDA and CDC recommended halting vaccinations while they investigate six cases of unusual blood clots in women given the company's shot.

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Reaching HCPs online

World of DTC Marketing

QUICK READ: Recent research from Zoom Rx saying that digital interactions with HCPs are myopic and don’t apply to the heavily segmented HCP audience. The future of reaching HCPS is both on and off-line depending on the product, health condition, and specialty. Zoom Rx recently polled HCPs and found 78% of physicians want to maintain some contact with pharma reps.

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Lilly, Arch join Deerfield in backing new gene therapy biotech Jaguar

Bio Pharma Dive

Just two months after launching, Jaguar Gene Therapy has raised another $139 million for a preclinical pipeline aimed at gene-linked autism and diabetes.

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Dr. August Wolff and Cantabria Labs enter into an exclusive commercialization agreement for Southern Europe for hyperhidrosis product

Pharma Mirror

The German pharmaceutical company Dr. August Wolff GmbH & Co. KG Arzneimittel Arzneimittel (“Dr. Wolff”) and the Spanish pharmaceutical company Cantabria Labs (“Cantabria Labs”) concluded a strategic partnership on March 12th 2021 by entering into an exclusive licensing agreement for a newly developed medicinal product for the treatment of hyperhidrosis.

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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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Gilead stops Veklury study, citing enrollment challenges, changing treatment

Bio Pharma Dive

The company said a multi-day infusion treatment that must be administered in healthcare settings no longer addresses an unmet need of non-hospitalized COVID-19 patients.

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Changing the paradigm: Microbiome modulation may become the next ‘pillar’ in cancer treatment

BioPharma Reporter

Insights have been gained into the role of the microbiome in disease states such as cancer, and strategies to manipulate the microbiome are quickly emerging, though optimal approaches are not yet known, said experts during an AACR 2021 event this week.

More Trending

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Cytisinicline – the solution to stop smoking?

pharmaphorum

Whether present in electronic or combustible cigarettes, nicotine is a highly addictive substance. Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . Although e-cigarettes are considered a less dangerous alternative to combustible cigarettes, they can still result in, or sustain, nicotine addiction, for which the long-term safety issues and associated health risks are unknown.

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Parkinson’s and Melanoma Share an Amyloid Link, Says New Research

XTalks

A new study has uncovered a mechanistic link between Parkinson’s and melanoma. While it has been known for about five decades now that patients with Parkinson’s disease have a higher likelihood of developing melanoma than the general population, the exact reasons for this were unknown. Now, thanks to a study funded by the National Institutes of Health Intramural Research Program, scientists have discovered that ?

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Regeneron’s COVID-19 antibody cocktail protects against infection, says Phase 3 study

BioPharma Reporter

REGEN-COV (casirivimab with imdevimab) has been shown to reduce the risk of symptomatic SARS-CoV-2 infections by 81%, in a Phase 3 study among household contacts of infected individuals.

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Retail Sales of Plant-Based Foods Surged to $7 Billion in 2020

XTalks

New data from the Plant Based Foods Association (PBFA) and The Good Food Institute (GFI) shows that the retail sales of plant-based foods in the US grew by 27 percent in 2020, bringing its total market value to $7 billion. The plant-based food market grew nearly twice as fast as the total US food retail market, and the sales increase was consistent across the country.

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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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Combining mask wearing, social distancing suppresses COVID-19 virus spread

Scienmag

Network model findings could shape public health policy for airborne viruses Credit: Anna Sawulska and Maurizio Porfiri WASHINGTON, April 13, 2021 — Studies show wearing masks and social distancing can contain the spread of the COVID-19 virus, but their combined effectiveness is not precisely known. In Chaos, by AIP Publishing, researchers at New York University […].

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Protected: Health Psychology – the Solution to First Fill Abandonment?

Pharma Marketing Network

This content is password protected. To view it please enter your password below: Password: The post Protected: Health Psychology – the Solution to First Fill Abandonment? appeared first on Pharma Marketing Network.

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Superbug killer: New nanotech destroys bacteria and fungal cells

Scienmag

Nanothin antimicrobial coating could prevent and treat potentially deadly infections Credit: RMIT University Researchers have developed a new superbug-destroying coating that could be used on wound dressings and implants to prevent and treat potentially deadly bacterial and fungal infections. The material is one of the thinnest antimicrobial coatings developed to date and is effective against […].

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Inhaled asthma drug accelerates recovery from COVID-19

Pharma Times

Self-reported recovery was three days shorter for patients receiving inhaled budesonide

Drugs 127
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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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Giant electronic conductivity change driven by artificial switch of crystal dimensionality

Scienmag

Credit: Tokyo Tech The electronic properties of solid materials are highly dependent on crystal structures and their dimensionalities (i.e., whether the crystals have predominantly 2D or 3D structures). As Professor Takayoshi Katase of Tokyo Institute of Technology notes, this fact has an important corollary: “If the crystal structure dimensionality can be switched reversibly in the […].

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Moderna to Showcase Vaccine Programs in RSV, CMV and COVID-19 on Vaccines Day

BioSpace

Following the success of its authorized vaccine against COVID-19, Moderna is boosting its efforts to develop preventative drugs in other viral areas.

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ISSCR launches new podcast

Scienmag

The Stem Cell Report with Martin Pera highlights the stories behind impactful science Credit: Credit: ISSCR Skokie, IL – The International Society for Stem Cell Research (ISSCR) unveils a new podcast today in connection with the Society’s open-access, peer-reviewed scientific journal, Stem Cell Reports. The Stem Cell Report with Martin Pera goes “beyond the paper” […].

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SciNeuro and Eli Lilly Unite on Antibodies to Defeat Neurological Diseases in China

BioSpace

Under the terms of the deal, SciNeuro is paying Lilly cash upfront as well as various milestone payments and royalties. No financial details were disclosed.

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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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NIH trial of anti-CD14 antibody to treat COVID-19 respiratory disease begins

Scienmag

Credit: NIAID A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun. The Phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT), is sponsored and funded […].

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COVID-19 Brief: Theories on the COVID-19 Blood Clotting and More Top Stories

BioSpace

The top COVID-19 story is on the pause of the Johnson & Johnson vaccine in the U.S. over rare blood clots. But it’s not the only news. Here’s a look.

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Basketball Mathematics scores big at inspiring kids to learn

Scienmag

Credit: Photographer: Allan Jørgensen, University of Copenhagen New study with 756 1st through 5th graders demonstrates that a six-week mashup of hoops and math has a positive effect on their desire to learn more, provides them with an experience of increased self-determination and grows math confidence among youth. The Basketball Mathematics study was conducted at […].

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Four medicines accepted for use by NHS Scotland

Pharma Times

Newly accepted medicines include treatments for multiple myeloma and severe migraine

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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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Study warns of ‘oxygen false positives’ in search for signs of life on other planets

Scienmag

Oxygen in the atmosphere may not be an entirely reliable ‘biosignature,’ but there are ways to distinguish false positives from signs of life, scientists say Credit: Illustration by J. Krissansen-Totton In the search for life on other planets, the presence of oxygen in a planet’s atmosphere is one potential sign of biological activity that might […].

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F.D.A. Will Allow Abortion Pills By Mail During the Pandemic

NY Times

The agency said it would stop enforcing a rule requiring women to get the first of two pills in person at a medical clinic or hospital.

Drugs 98
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Almond production remains stable in the long term, despite deficit irrigation

Scienmag

Credit: University of Cordoba Spain boasts the largest cultivated area of almond trees in the world, with more than 700,000 ha (MAPA, 2018), but ranks third in terms of production. How can this be? Actually it’s easy to explain: most of the country’s cultivated area of almond trees is comprised of traditional rainfed orchards and […].

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F.D.A. Will Allow Abortion Pills By Mail During the Pandemic

NY Times

The agency said it would stop enforcing a rule requiring women to get the first of two pills in person at a medical clinic or hospital.

Drugs 96
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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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Airborne laser scanning of gaps in Amazon rainforest helps explain tree mortality

Scienmag

The researchers concluded that water stress, soil fertility and human-induced forest degradation cause gaps in the world’s largest tropical forest Credit: Ricardo Dal’Agnol/INPE A group of researchers led by Brazilians has used an innovative model to map gaps in the Amazon rainforest and identify factors that contribute to tree mortality.

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PPD, Clinical Ink join on lupus assessment and endpoint data

Outsourcing Pharma

The two companies have partnered to develop a systemic erythematosus assessment review to streamline clinical trials centered on the autoimmune disease.

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World’s protected areas need more than a ‘do not disturb’ sign

Scienmag

Credit: Sue Nichols, Michigan State University Center for Systems Integration and Sustainability Lessons learned from the world’s protected forests: Just declaring a plot of land protected isn’t enough – conservation needs thoughtful selection and enforcement. A group of scientists, many tied to Michigan State University, examined nearly 55,000 protected areas across the world to understand […].

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Akston Biosciences takes second-generation COVID-19 vaccine into Phase 1/2 clinical trial

BioPharma Reporter

Akston Biosciences Corporation has dosed the first participants in a Phase 1/2 trial for its COVID-19 vaccine candidate.

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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.