Mon.Oct 12, 2020

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Mallinckrodt, beset by opioid drug suits, files for bankruptcy

Bio Pharma Dive

The drugmaker aims to resolve billions of dollars in opioid-related claims and a federal lawsuit over Medicaid rebates, liabilities it says would be "otherwise unmanageable.

Drugs 158
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Gossamer Bio’s GB001 Shows Minimal Impact in Asthma and Chronic Rhinosinusitis

BioSpace

Gossamer Bio announced today that its two studies examining GB001 – the Phase IIb LEDA trial in eosinophilic asthma and Phase II TITAN trial in chronic rhinosinusitis – failed to meet their primary endpoints.

Trials 119
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Alkermes' comeback bid boosted by FDA panel backing for schizophrenia drug

Bio Pharma Dive

While the committee's votes in favor of ALKS 3831 make an approval more likely, the drug's effects on patients also taking opioids could limit its use.

Drugs 150
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A Dose of Optimism, as the Pandemic Rages On

NY Times

The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do.

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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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CPhI: Dramatic changes ahead for the generics market

Outsourcing Pharma

Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report.

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The future of vaccine development: 5 legacies from COVID-19

BioPharma Reporter

The progress in the race for a COVID-19 vaccine to date has been nothing short of phenomenal. But what can the industry learn from these achievements to inform vaccine development in the future?

More Trending

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UK joins global trial to test BCG vaccine against COVID-19

BioPharma Reporter

A global trial, designed to test the theory that the BCG vaccine could help protect against COVID-19, will soon start recruitment in the UK.

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Exploding Biopharma Industry Going the Distance for Specialized Talent

BioSpace

The urgency of 2020 has shone a spotlight on the investment and advances in the U.S. biotech industry over the past decade – and overall, it is looking strong.

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Ancient tiny teeth reveal first mammals lived more like reptiles

Scienmag

Credit: Graphics: Nuria Melisa Morales Garcia. Morganucodon based on Bob Nicholls/ Palaeocreations 2018 model Pioneering analysis of 200 million-year-old teeth belonging to the earliest mammals suggests they functioned like their cold-blooded counterparts – reptiles, leading less active but much longer lives. The research, led by the University of Bristol, UK and University of Helsinki, Finland, […].

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Mallinckrodt Files for Chapter 11 Amid Growing Legal Battles in Opioid Crisis

BioSpace

Mallinckrodt has filed for Chapter 11 bankruptcy amid growing lawsuits that allege the company has participated in fueling the opioid epidemic in the United States.

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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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Scientists develop new precise therapeutic leukemia vaccine

Scienmag

Credit: WEI Wei Exploration of new leukemia antigens and construction of appropriate delivery systems using FDA-approved material are important strategies for developing leukemia vaccines for clinic use. Researchers from the Institute of Process Engineering (IPE) of Chinese Academy of Sciences and Zhujiang Hospital of Southern Medical University have developed a new type of precise therapeutic […].

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AZ’s long-acting COVID-19 antibody moves into phase III

Pharma Times

Two trials will involve over 6,000 participants at sites in and outside the US

Antibody 132
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Sapphires show their true colors: Not water-loving

Scienmag

Credit: ©Science China Press In 1805, Thomas Young took the mechanical equilibrium at the solid/liquid/gas three-phase contact line into consideration (the balance of forces acting on the contact line formed by the intersection of the liquid-gas interface and the solid surface), and introduced the macroscopic concept of “contact angle” and Young’s equation.

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The Race for a Super-Antibody Against the Coronavirus

NY Times

A network of scientists is chasing the pandemic’s holy grail: an antibody that protects against not just the virus, but also related pathogens that may threaten humans.

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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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Oncotarget: miR-708-5p targets oncogenic prostaglandin E2 production in lung cancer cell

Scienmag

Volume 11, Issue 26 of Oncotarget reported that Lung cancer is of particular importance, as it is the deadliest cancer worldwide. Credit: Correspondence to – Carol S. Lutz – lutzcs@njms.rutgers.edu Volume 11, Issue 26 of Oncotarget reported that Lung cancer is of particular importance, as it is the deadliest cancer worldwide. In this study, the […].

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BMS’ Zeposia hits the mark in ulcerative colitis

Pharma Times

Oral S1P receptor modulator hit both primary endpoints in a phase III trial

Trials 132
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IPK scientists discover gene that ensures slim inflorescence shape of barley

Scienmag

Credit: Photo: Nadja Sonntag The “spikelet meristem” (SM) plays a central role during the development of the grass inflorescence. Meristems are plant cells or tissues that have the capacity to produce new organs – in this case spikelets. To do this, however, cells destined to become SM must first attain the SM identity. This is […].

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First, a Vaccine Approval. Then ‘Chaos and Confusion.’

NY Times

Come spring, Americans may have their choice of several so-so coronavirus vaccines — with no way of knowing which one is best.

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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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J&J Taps the Brakes on COVID-19 Vaccine Trial After “Unexplained Illness"

BioSpace

J&J did not disclose much information about the unexplained illness, stating, “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.

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MHz, multi-beams coherent XUV source by intracavity high-order harmonic generation

Scienmag

Credit: by Natsuki Kanda, Tomohiro Imahoko, Koji Yoshida, Akihiro Tanabashi, A. Amani Eilanlou, Yasuo Nabekawa, Tetsumi Sumiyoshi, Makoto Kuwata-Gonokami, and Katsumi Midorikawa Coherent extreme ultraviolet (XUV) and soft x-ray radiation are very powerful in studying various material properties in biology, chemistry, and physics. Synchrotron radiation (SR) and X-ray free electron laser (XFEL), which are based […].

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Professor Charged in Chinese Funds Coverup Case Wants Harvard to Foot His Legal Bill

BioSpace

Charles M. Lieber is currently on paid leave from Harvard’s chemistry department after his arrest in January on charges of lying to the U.S. government about funds received from China.

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When reproductive rights are less restrictive, babies are born healthier

Scienmag

Women, particularly US-born Black women, in states with restrictive reproductive rights policies deliver more low birth weight babies and experience greater health inequities, according to the American Journal of Preventive Medicine Credit: Elsevier Ann Arbor, October 13, 2020 – American women living in states with less restrictive reproductive rights policies are less likely to give […].

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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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Dupixent Posts Positive Results in Phase III Pediatric Asthma Study

BioSpace

In a Phase III study, the biologic met primary and all key secondary endpoints in children ages 6 to 11 who have uncontrolled moderate-to-severe asthma.

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HIV epidemic: Successful use of self-tests in rural Africa

Scienmag

Credit: University of Basel / Swiss TPH, Alain Amstutz Despite significant progress in prevention and therapy, millions of people still get infected with HIV every year. The main burden of HIV/AIDS falls on Africa. To contain the epidemic, innovative methods are needed to enable early diagnosis of all those affected. A Basel research group has […].

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UK biotech sector sets new record with more than £1bn investment in Q3

pharmaphorum

There has been a well-publicised boom in biotech investment during the pandemic, and the UK is no exception, with a record £1 billion raised in the third quarter. Latest figures from the BioIndustry Association representing the UK’s biotech and life sciences sector, showed it raised more than £1 billion in equity finance between June and August, the highest in the sector on record.

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Voyager Takes a Hit After FDA Places Hold on Gene Therapy for Huntington's Disease

BioSpace

The FDA placed the hold onto the program hold pending the resolution of certain chemistry, manufacturing and controls (CMC) matters, Voyager said.

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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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Total deaths recorded during the pandemic far exceed those attributed to COVID-19

Scienmag

States that reopened sooner, such as Texas, Arizona and Florida, experienced summer surges, report says. Credit: Courtesy of JAMA Network RICHMOND, Va. (Oct. 12, 2020) — For every two deaths attributed to COVID-19 in the U.S., a third American dies as a result of the pandemic, according to new data publishing Oct. 12 in the […].

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Glitches in the COVID-19 Race: Less than 24 Hours After J&J Pauses Vaccine Trial, Eli Lilly Pause.

BioSpace

Eli Lilly announced that it is pausing its clinical trial of a combination antibody against COVID-19 over safety concerns. Typically, this would be because a patient or volunteer showed a serious side effect or became sick, but the company did not clarify what the reason for the pause is.

Trials 78
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Crayfish ‘trapping’ fails to control invasive species

Scienmag

Credit: Eleri Pritchard Despite being championed by a host of celebrity chefs, crayfish ‘trapping’ is not helping to control invasive American signal crayfish, according to new research by UCL and King’s College London. There have been grave concerns within the science community and amongst conservationists that American signal crayfish are wiping out other species of […].

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Femtech Trailblazers Talk Innovation and Capitalization to Meet Women’s Underserved Needs

BioSpace

Femtech represents significant growth opportunities for biotech companies, but is still under the radar for most investors. None-the-less, pioneering companies are emerging to address this sector’s many underserved needs.

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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.