Tue.Jun 14, 2022

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FDA approves Lilly, Incyte drug for alopecia, but includes safety warning

Bio Pharma Dive

The partners’ JAK inhibitor Olumiant is the first systemic treatment for an autoimmune disease that causes hair loss. But known risks of heart attacks and cancer could complicate its launch.

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US life expectancy continues historical decline.

World of DTC Marketing

According to a new report , life expectancy in the United States took another hit in 2021, furthering a dramatic decline from 2020 that was the largest since World War II. US life expectancy decreased from 78.86 years in 2019 to 76.99 years in 2020 and 76.60 years in 2021, a net loss of 2.26 years. In contrast, peer countries averaged a smaller decrease in life expectancy between 2019 and 2020 (0.57 years) and a 0.28-year increase between 2020 and 2021, widening the gap in life expectancy betw

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Watchdog group cautious on Amylyx's ALS drug benefits, potential cost

Bio Pharma Dive

ICER, an influential nonprofit, suggested in a draft report that Amylyx’s closely watched ALS treatment would not be cost effective if priced on par with a currently available treatment.

Drugs 197
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Lilly’s Olumiant okayed in alopecia, with Pfizer, Concert in hot pursuit

pharmaphorum

Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair loss that affects more than 700,000 people in the US. The JAK1/2 inhibitor has been cleared for adults who are severely affected with the condition at a dose of 2mg once-daily, which can be stepped up to 4mg/day if needed, and according to the FDA will “help fulfil a significant unmet need for patients.” It is estimated tha

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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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Alnylam wins FDA approval of rare disease drug in step toward profitability

Bio Pharma Dive

Amvuttra, a transthyretin amyloidosis medicine previously known as vutrisiran, is viewed by biotech analysts as important to the company’s goal of ending years of financial losses.

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Pandemic highlights need for supply chain visibility, partnerships

Outsourcing Pharma

During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.

More Trending

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Spirea raises £2.4m to develop antibody drug conjugates in cancer

Pharma Times

Funding will enable the development of Spirea’s pipeline of antibody drug conjugate therapeutics for the treatment of solid tumours

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Lehigh University PhD student receives Fulbright research award to continue work on owl-inspired aero-acoustics

Scienmag

He was surprised. And also not surprised. Credit: Christa Neu/Lehigh University He was surprised. And also not surprised. John Kershner, a PhD candidate in the Department of Mechanical Engineering and Mechanics, was in the middle of an internship a month ago when he went online and saw that his application for a Fulbright research award […].

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Merck and Mulliken Center collaborate for machine learning project

Pharma Times

The three-year project will focus on molecular representations and computational tools

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A weird star produced the fastest nova on record

Scienmag

Astronomers are buzzing after observing the fastest nova ever recorded. The unusual event drew scientists’ attention to an even more unusual star. As they study it, they may find answers to not only the nova’s many baffling traits, but to larger questions about the chemistry of our solar system, the death of stars and the […].

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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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In Tough Biotech Market, Third Rock Raises New $1.1B Fund

BioSpace

Third Rock Ventures Fund VI, providing the company with $1.1 billion to invest in new life science companies. This brings Third Rock to a total of $3.8 billion across its venture funds.

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Real-time imaging of dynamic atom-atom interactions

Scienmag

Chemistry is the study of bond formation (or dissociation) between atoms. The knowledge of how chemical bonds form is, in fact, fundamental to not just all of chemistry but also fields like materials science. However, traditional chemistry has been largely limited to the study of stable compounds. The study of dynamic assembly between atoms during […].

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A New JAMA Study Misleads About Drug Prices—And Launches a New Attack on Patients with Ultra-Rare Diseases

Drug Channels

Last week, the authors of a new JAMA study claimed that “prices for new drugs are skyrocketing.” Their research, along with a simultaneously released New York Times op-ed, received widespread media coverage. Links below. But as I explain, the study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations.

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Native bee key to social evolution

Scienmag

Studying the unusual social behaviour of an Australian native bee has enabled Flinders University researchers to obtain a clear understanding about the earliest stages of social evolution. Credit: Photo James Dorey Photography Studying the unusual social behaviour of an Australian native bee has enabled Flinders University researchers to obtain a clear understanding about the earliest […].

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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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WHO to Rename Monkeypox Due to Stigma, Discrimination

BioSpace

The World Health Organization is giving the monkeypox virus a new name soon in an attempt to quell the stigma and discrimination that might go with it.

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Moth wing-inspired sound absorbing wallpaper in sight after breakthrough

Scienmag

Experts at the University of Bristol have discovered that the scales on moth wings act as excellent sound absorbers even when placed on an artificial surface. Credit: University of Bristol Experts at the University of Bristol have discovered that the scales on moth wings act as excellent sound absorbers even when placed on an artificial […].

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Meet the Scientific Review Officer: Leaders of Peer Review

BioSpace

Peer review is integral to the scientific process, and one group plays a bigger role than you might think: Scientific Review Officers.

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Aiming to improve joint connection technologies for light-weight and high-strength structures

Scienmag

Overview Credit: COPYRIGHT (C) TOYOHASHI UNIVERSITY OF TECHNOLOGY. ALL RIGHTS RESERVED. Overview The research team (led by Professor Yukihiro Matsumoto) formed by Department of Architecture and Civil Engineering of Toyohashi University of Technology and Electronics-Inspired Interdisciplinary Research Institute (EIIRIS) proposed and demonstrated a method for improving the dynamic behavior of bolted connections by using Glass […].

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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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Oxford University Researchers Identify Gene Linked to Chronic Pain

BioSpace

Researchers at Oxford University have identified a gene linked to pain. The discovery opens possibilities to develop drugs or gene therapies to help treat patients who suffer from chronic pain.

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SNNMI Abstract of the Year: Targeted radionuclide treatment achieves high response rate, minimal toxicities for advanced-stage neuroendocrine tumors

Scienmag

Vancouver, British Columbia, Canada—A targeted radionuclide alpha therapy, 225Ac-DOTATATE, has been shown to have long-term anti-tumor effects in patients with advanced-stage gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Results from the Phase II study showed promising survival rates, high response rates and an acceptable toxicity profile, making 225Ac-DOTATATE a potential treatment option for patients who have exhausted other […].

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Almirall-backed psoriasis support app Claro launches in Europe

pharmaphorum

An alliance between Spanish drugmaker Almirall and digital health company Happify has yielded its first fruit, with the launch of their Claro app designed to reduce anxiety and improve wellbeing in people with psoriasis. The web-based app is rolling out first in the UK, Spain and Italy and is aimed at the 20% to 30% of patients with moderate to severe psoriasis who also suffer from mental health issues, according to the partners.

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Seagrass meadows are reliable fishing grounds for food

Scienmag

A new study shows that seagrass fisheries provide a reliable safety-net for poor, since fishermen perceive those habitats to maintain large fish catches over time. Surprisingly, even more so than coral reef fisheries, which people normally associate with small-scale fishery. Credit: Susantha Udagedara A new study shows that seagrass fisheries provide a reliable safety-net for […].

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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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COVID-19 Research: Paxlovid Disappoints in Standard-Risk Setting, Nasal Spray Offers New Hope

BioSpace

???????Biopharma has been stepping up research and drug development against COVID-19 -though results haven't always been encouraging.

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Scientists on the hunt for planetary formation fossils reveal unexpected eccentricities in nearby debris disk

Scienmag

Using the Atacama Large Millimeter/submillimeter Array (ALMA), astronomers have imaged the debris disk of the nearby star HD 53143 at millimeter wavelengths for the first time, and it looks nothing like they expected. Based on early coronagraphic data, scientists expected ALMA to confirm the debris disk as a face-on ring peppered with clumps of dust. […].

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Immunic Touts Favorable Phase II Results for MS Treatment

BioSpace

Immunic released favorable updated results for the Phase II EMPhASIS clinical trial investigating the safety and efficacy of vidofludimus calcium to treat relapsing-remitting multiple sclerosis.

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Near-sun comet roasted to death

Scienmag

Astronomers using a fleet of world leading telescopes on the ground and in space have captured images of a periodic rocky near-Sun comet breaking apart. This is the first time such a comet has been caught in the act of disintegrating and could help explain the scarcity of such periodic near-Sun comets. Credit: Subaru Telescope/CFHT/Man-To […].

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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 Shows Biotech Job Growth Outpaces Other Sectors

BioSpace

Since 2020, the life sciences industry has worked to rebound from the COVID-19 pandemic. But one sector's growth has far outpaced the others–the biotech industry.

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Kabuki Syndrome Foundation awards $125,000 to fund research at Kennedy Krieger Institute

Scienmag

Dr. Jacqueline Harris, a pediatric neurologist and director of Kennedy Krieger’s Epigenetics Clinic, received a $125,000 grant from the Kabuki Syndrome Foundation (KSF) for her research efforts into the cause and treatment of Kabuki syndrome, a rare neurological disorder. The two-year grant supports Dr. Harris’ work to develop and test a neurocognitive and neurobehavioral […].

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Study: FDA Approves Cancer Drugs Eight Months Earlier than European Regulators

BioSpace

A recent study found that over a span of ten years, the FDA approved cancer drugs approximately eight months earlier than the same drugs were greenlit by the European Commission (EC).

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Undergraduate researcher captures young galaxy’s “coming of age” and finds evidence that early galaxies may be bigger and more complex than we thought

Scienmag

Scientists using the Atacama Large Millimeter/submillimeter Array (ALMA)— an international observatory co-operated by the US National Science Foundation’s National Radio Astronomy Observatory (NRAO)—have observed a significant amount of cold, neutral gas in the outer regions of the young galaxy A1689-zD1, as well as outflows of hot gas coming from the galaxy’s center.

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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.