Thu.Oct 28, 2021

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Merck sees up to $7B in coming sales of coronavirus pill

Bio Pharma Dive

Executives based their projections on contracts already in place for the drug, known as molnupiravir. But sales could climb even higher if it works as a preventive treatment too.

Sales 306
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CPhI Annual Report 2021: Short term reshoring the catalyst for longer term manufacturing innovations by 2030

Pharma Mirror

Amsterdam, The second part of the 2021 CPhI Annual Report looks ahead to predict the pharma manufacturing, therapeutic and technology environment in 2030. The analysis foresees the use of automated cobots, AI, real-time release and rapid growth in new areas like mRNA vaccines, alongside the personalization of therapeutics (delivered at far larger scale).

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John Maraganore, pioneering RNAi executive, to step down as Alnylam CEO

Bio Pharma Dive

In a move that surprised Wall Street analysts, the executive, who has overseen Alnylam's journey from startup to one of biotech's top companies, will leave by the end of the year for an unspecified role "helping other entrepreneurs.

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Industry welcomes boost to health research in UK budget

pharmaphorum

Groups representing the biopharma industry have welcomed an increase in health-specific R&D to £5 billion in the UK autumn budget, despite a longer timeline for reaching the target of £22 billion in overall R&D spending. The Association of the British Pharmaceutical Industry (ABPI) and BioIndustry Association (BIA) both said that the increase acknowledges the enormous contribution made by the life sciences sector in helping to limit the impact of the pandemic through the rapid developmen

Research 111
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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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NIH, FDA spearhead broad partnership to speed gene therapy research

Bio Pharma Dive

The two institutions will work with drugmakers and non-profit groups on a wide-ranging initiative meant to make the complex treatments easier and less costly produce.

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Jaguar Gene Therapy, UCSF and Others Expand Innovation Capacity

BioSpace

?The 174,000 square-foot location will house a fully-equipped production plant to create its initial programs for Type 1 diabetes, a specific genetic cause of autism, galactosemia, and more.

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BioNTech to Build First mRNA Vaccine Production Plant in Africa

XTalks

BioNTech has announced plans to build a manufacturing facility in Africa to help ramp up production of COVID-19 mRNA vaccines for countries in the continent. On Tuesday, the German biotech company inked a deal with Rwanda’s government and Institut Pasteur de Dakar in Senegal to begin construction of the facility in mid-2022. With less than ten percent of its population vaccinated, Africa continues to be deeply affected by global vaccine inequities.

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Takeda buys GammaDelta to boost cancer cell therapy credentials

pharmaphorum

Japanese drugmaker Takeda has said it will exercise its option to buy UK-based GammaDelta Therapeutics, a specialist in ‘off-the-shelf’ cell therapies for solid tumours and blood cancers. The two companies have been working together since 2017, with Takeda pledging $100 million to help GammaDelta advance its cell therapy platform as part of a “build-to-buy” arrangement.

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Here’s How These Four Companies are Celebrating Halloween This Year

XTalks

The National Confectioners Association (NCA) reported that Halloween candy sales have increased in 2021 compared to 2020. Retailers have 27 percent more seasonal items this year than last year, and 93 percent of consumers are looking forward to ways they are going to celebrate this day. In fact, sales of chocolate and candy are up 48 percent compared to 2020, and nearly 60 percent since 2019. “Chocolate and candy sales have come roaring back during the 2021 Halloween season as excitement

Sales 98
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Are COVID-19 Vaccine Mandates Legal? Are there exceptions?

Triage Cancer

As more employers require their employees to get vaccinated, the federal government’s requirement for larger employers to have vaccine mandates moves forward, and schools are considering vaccine requirements for students, you might be wondering: are COVID-19 vaccine mandates legal? The Centers for Disease Control & Prevention (CDC) has indicated that COVID-19 vaccines are safe and effective.

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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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Brave Robot Launches Plant-Based, Climate-Friendly Cake Mix

XTalks

California-based The Urgent Company recently unveiled a plant-based, climate-friendly cake mix under the company’s Brave Robot brand. Packaged in a compostable bag, the Climate Hero Super Cake is a versatile, shelf-stable yellow cake mix that requires adding only oil and water. So, how does Brave Robot’s new cake mix differ from the rest? First, while most cake mixes require eggs for structure, color and flavor, the Climate Hero Super Cake mix replaces approximately three eggs with the use of fo

Protein 98
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Cerner Enviza aims to accelerate therapies and improve patient outcomes

pharmaphorum

Combining decades of healthcare, life sciences and collaborative research to transform the way care is delivered. Kansas City, Mo. — Oct. 26, 2021 — Cerner Corporation (NASDAQ: CERN), a global healthcare technology company, announces the launch of a new operating unit, Cerner Enviza SM , that offers data-driven solutions and research services to help bring clarity to multi-dimensional data through real-world evidence and insights.

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COVID Update: Deaths Rising in Europe, Moderna vs. Pfizer and Vaccine Mandates

BioSpace

In the face of Delta, the actual efficacy of the vaccines has come into question, while global cases and deaths from COVID-19 increased for the first time in two months, primarily in Europe.

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Generic pill could be alternative to oral antivirals in COVID-19

pharmaphorum

A generic pill has been shown to reduce hospitalisation rates in high-risk patients with early COVID-19, potentially offering a low-cost alternative to oral antivirals from Merck & Co and others, according to researchers in Brazil. The antidepressant fluvoxamine given as a twice-daily regimen for 10 days to acutely symptomatic patients with COVID-19 who also had at least one risk factor such as diabetes, cardiovascular disease, underlying respiratory conditions such as chronic asthma and obe

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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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Alnylam and AbbVie Each Reveal Influential Phase III Results

BioSpace

After first reporting that its investigational RNAi drug vutrisiran hit its 9-month Phase III endpoints, Alnylam announced it continues to demonstrate positive results at the 18-month mark.

Drugs 98
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Researcher: American industrial revolution helped shape gothic literature

Scienmag

Growing up in Pennsylvania as the daughter of a casket salesman, UMass Lowell’s Bridget Marshall, associate professor of English, became more familiar with death than most children. Credit: Katharine Webster Growing up in Pennsylvania as the daughter of a casket salesman, UMass Lowell’s Bridget Marshall, associate professor of English, became more familiar with death than […].

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Potentially Predictive Genetic Link Could Help Identify ICB Responsive Patients

BioSpace

Digital interdisciplinary journal Science Translational Medicine published a new study this week that proposed a potential new biomarker for predetermining patient responsiveness to ICB therapies.

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Oregon State receives $7.65 million grant to study impact of smoke on grapes and wine

Scienmag

CORVALLIS, Ore. – Oregon State University researchers and a team of West Coast university collaborators have received a $7.65 million grant to study the impact of smoke exposure on grapes, a project that will provide critical knowledge to grape growers and winery owners severely impacted by widespread wildfire smoke in recent years. Credit: Sean Nealon […].

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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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Kymera Study Validates IRAK4 as Viable Protein Degradation Target

BioSpace

Kymera was able to demonstrate for the first time proof-of-biology ex vivo using whole blood from one of their KT-474 treated patient cohorts.

Protein 108
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Wireless communication devices without batteries? Research and sustainability, united through light

Scienmag

A team of researchers, led by Domenico Giustiniano, Research Associate Professor at IMDEA Networks Institute, Madrid, has presented important advances in the creation of sustainable wireless communication systems. This represents a new step towards making battery-free devices a reality, through the convergence of two emerging technologies: LiFi and radio frequency (RF) backscatter.

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Patients Maintain Disease Suppression After One Year on Gilead HIV Drug

BioSpace

Gilead Sciences has one of the most robust HIV pipelines in the world. New real-world data from the ongoing BICSTaR study demonstrates benefits of HIV drug Biktarvy.

Drugs 98
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Oxidation-tolerant solid electrolyte provides high energy capacity for Li2S cathode

Scienmag

Recent advances on materials in development since the 1980’s at Osaka Prefecture University (OPU) bring all-solid-state batteries (ASSBs) a step closer towards reality. Credit: A. Sakuda, OSAKA PREFECTURE UNIVERSITY Recent advances on materials in development since the 1980’s at Osaka Prefecture University (OPU) bring all-solid-state batteries (ASSBs) a step closer towards reality.

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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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Pfizer’s Bourla on Drug Pricing: “We Have a Problem Here”

BioSpace

Albert Bourla, chief executive officer of Pfizer, argued this week that politicians were approaching the problem of drug pricing the wrong way — as usual.

Drugs 98
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In dry years, rivers become birds’ crowded corridors

Scienmag

In a dry year in the West, when the world turns crispy and cracked, rivers and streams with their green, lush banks become a lifesaving yet limited resource. Credit: Monte Neate-Clegg In a dry year in the West, when the world turns crispy and cracked, rivers and streams with their green, lush banks become a […].

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FDA Signs Off on Pfizer-BioNTech Vaccine for Kids 5 to 11

BioSpace

The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for children ages 5 to 11.

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Stopping the spread of stony coral tissue loss disease

Scienmag

From the Florida Keys to the Caribbean Sea, coral reefs, the complex ecosystems that house 25% of marine species, are dying from a novel infection known as stony coral tissue loss disease (SCTLD). Credit: Randy Gentry/UTA From the Florida Keys to the Caribbean Sea, coral reefs, the complex ecosystems that house 25% of marine species, […].

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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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Research Roundup: Amino Acids Might Fend Off Dementia and Alzheimer’s and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

Research 106
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Plant from plastics: Bio-based polymers can be transformed into fertilizer

Scienmag

Plastics have taken the world by storm over the last century, finding applications in virtually every aspect of our lives. However, the rise of these synthetic polymers, which form the basis of plastics, has contributed to many serious environmental issues. The worst of these is the excessive use of petrochemical compounds and the disposal of […].

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FDA panel OK’s Pfizer/BioNTech jab for children aged five to 11

Pharma Times

The FDA will likely make a formal decision on the use of the vaccine in this age group in the coming days

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Dos Santos’ award-winning research focuses on neural networks

Scienmag

Rodrigo Augusto Dos Santos, a doctoral candidate in the Computer Science and Engineering Department at The University of Texas at Arlington, is one of 10 students nationwide to win a Computing Alliance of Hispanic-Serving Institutions (CAHSI) Google Dissertation Award. Credit: UT Arlington Rodrigo Augusto Dos Santos, a doctoral candidate in the Computer Science and Engineering […].

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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.