Thu.Jun 16, 2022

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Pharma under the microscope as FTC considers new ways to review acquisitions

Bio Pharma Dive

At a two-day meeting, experts argued drug divestitures may not be enough to prevent market concentration. Economists and regulators also appeared worried by the effect of buyouts on innovation.

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Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial

pharmaphorum

The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to slow cognitive decline in patients with an inherited form of the disease. The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyses found it would be futile to continue – but is another blow to the

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Roche Alzheimer's study fails in another setback to a long-tested hypothesis

Bio Pharma Dive

The failure is an upset not only to Roche, but also a blow to the wider Alzheimer’s research field, which has for years kept focus on a protein called beta amyloid.

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Valneva reaches COVID-19 vaccine settlement with UK government, while EU deal remains uncertain

BioPharma Reporter

Valneva has reached a settlement with the UK government over an abandoned COVID-19 vaccine contract. Meanwhile, the future of its COVID-19 vaccine in the EU could become clearer next week after an EMA committee vote.

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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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Boehringer extends cancer dealmaking with right to buy biotech partner

Bio Pharma Dive

The German pharma company has secured an option to acquire Trutino Biosciences, two years after inking a research collaboration with the San Diego drug developer.

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Data-Led Digital KOL Engagement

pharmaphorum

When creating engagement plans for individual Digital Key Opinion Leaders (DOLs), it’s best to look at a range of data-led metrics about each DOL to fine tune the engagement and maximise benefit for all parties. The simplest, and often easiest metrics to obtain, relate to the activity characteristics of the Digital KOL. In Twitter for example, this may equate to the DOL’s activity levels, follower numbers, and so on.

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Why diverse clinical trials matter: the pharmaphorum podcast

pharmaphorum

In this episode of the pharmaphorum podcast, editor in chief Jonah Comstock welcomes Dr. Jennifer Jones-McMeans, divisional vice president for global affairs for Abbott’s vascular business to discuss diversity and equity in clinical trials. They discuss the nitty-gritty of clinical trial diversity – why it’s been so hard to achieve, why it’s important, and how to overcome the specific barriers to inclusion for different underrepresented communities.

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Colorful urban environments, even if just in virtual reality, promote wellbeing

Scienmag

Drab urban environments tend to increase our stress, whereas nature can soothe the soul, but how do you get the best of both? One option is to increase color and vegetation in cities, but finding the best approach can be tricky. A new study in Frontiers in Virtual Reality tested the effects of vegetation and […].

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MorphoSys slims down, narrowing its focus to cancer

pharmaphorum

MorphoSys seemingly inexorable shift into an oncology pure-play has continued with an out-licensing deal for two programmes in the kidney disease and immunology categories to China’s HIBio. The German biotech is handing over rights to CD38-targeted antibody felzartamab for two forms of glomerulonephritis and MOR210, an anti-C5aR1 antibody for autoimmune disorders and some forms of cancer, which are both currently in early-stage clinical testing.

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‘Networking and relationship building key to finding answers to CGT challenges’

BioPharma Reporter

Measuring potency for gene and cell therapies is not so clear-cut, and some companies have hit roadblocks in their submissions to regulatory agencies as a result.

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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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Moderna Plans Trial Testing COVID-19 Vaccine in Youngest Babies

BioSpace

Moderna's study, dubbed BabyCove, is expected to begin recruiting in September and will include up to 700 babies three to six months of age.

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Lilly partners with Sidekick in digital health alliance

pharmaphorum

A personalised, treatment plan for patients with breast cancer is the first digital health product to emerge from a newly-announced partnership between digital health specialist Sidekick and pharma group Eli Lilly. The two companies say the integrated digital therapeutic (DTx) for breast cancer will aim to promote behaviour modifications to improve the wellbeing of breast cancer patients as well as adherence to drug treatment, foe example by managing side effects.

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Researchers Identify Molecule Produced During Exercise that Reduces Obesity

BioSpace

Researchers from the Baylor College of Medicine, part of the Stanford School of Medicine, discovered a molecule produced during exercise in mice that suppresses feeding and obesity.

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Largest study of domestic cat DNA identifies disease-causing variants in new breeds

Scienmag

Thirteen genetic variants associated with disease in cats are present in more pedigreed breeds than previously thought, according to the largest ever DNA-based study of domestic cats, led by Heidi Anderson from Wisdom Panel in the United States and colleagues from the University of Helsinki in Finland. However, these variants are declining in frequency in […].

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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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Report: Merck Looks into Possible Buyout of Seagen

BioSpace

Pharmaceutical giant Merck is exploring a possible purchase of biotech company Seagen, according to The Wall Street Journal.

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Red meat consumption may remain high in Finland despite consumer support for plant-based diets

Scienmag

Meat production is a significant source of greenhouse gasses and widespread adoption of a plant-based diet is key to achieving the United Nations 2030 Sustainable Development Goals. A study publishing June 16th in PLOS Sustainability and Transformation by Maijaliisa Erkkola at the University of Helsinki, Finland, and colleagues suggests that while consumers may have an […].

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FDA Authorizes Pfizer-BioNTech, Moderna COVID Vaccines for Children 6 Months to 4 Years

BioSpace

Friday morning, the FDA granted Emergency Use Authorization to both Moderna's and Pfizer-BioNTech's COVID-19 vaccines for use in children ages 6 months to 4 years old.

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Language matters when describing weight loss goals

Scienmag

Obesity affects millions of individuals worldwide and is associated with a significantly increased risk for cardiovascular and metabolic diseases. A study publishing June 16th in the open access journal PLOS Digital Health by Annabell Ho at Noom, Inc. New York, United States, suggests that while setting a weight-loss goal, analytical language was associated with greater […].

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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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Remote Workers More Productive in Short-Term Than Long-Term, Study Shows

BioSpace

Researchers surveyed 60,000 Microsoft employees and found that remote workers are more productive than their in-office counterparts in the short-term, but less productive long term.

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Study: Humans responsible for over 90% of world’s oil slicks

Scienmag

TALLAHASSEE, Fla. — A team of U.S. and Chinese scientists mapping oil pollution across the Earth’s oceans has found that more than 90% of chronic oil slicks come from human sources, a much higher proportion than previously estimated. Credit: Courtesy of Ian MacDonald TALLAHASSEE, Fla. — A team of U.S. and Chinese scientists mapping oil […].

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FDA Grants Orphan Drug Designations to VBI, Hepion Cancer Drugs

BioSpace

VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.

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Sharks may be closer to the city than you think, new study finds

Scienmag

MIAMI— The world’s coastlines are rapidly urbanizing, but how this increased human presence may impact species living in the ocean is not fully understood. In a new study led by scientists at the University of Miami (UM) Rosenstiel School of Marine and Atmospheric Science, researchers tracked the movements of three shark species, bull, nurse and […].

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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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With Positive Data, Checkpoint Looks to Add Second Indication to BLA

BioSpace

Checkpoint Therapeutics announced that its checkpoint inhibitor cosibelimab is showing positive objective response rate data in patients with locally advanced cutaneous squamous cell carcinoma.

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Undergrads begin summer quantum research with support from Moore Foundation, Chicago region universities, national labs

Scienmag

More than a dozen college students from underrepresented backgrounds will be spending the summer conducting quantum information science and engineering research in labs across the Midwest thanks to the Open Quantum Initiative Undergraduate Fellowship, a new program that seeks to make the burgeoning quantum workforce a more diverse and inclusive community from the start.

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Bavarian Nordic Takes on Pfizer-BioNTech with COVID-19 Booster Candidate

BioSpace

???????Bavarian Nordic announced that the upcoming Phase III trial for its COVID-19 booster candidate has been redesigned to compete against licensed mRNA-based vaccines.

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Bringing daylight back into view: Scientists transplant human photoreceptors to successfully recover daylight perception in mice

Scienmag

Transplantation of photoreceptor cells is a promising intervention that in the future could help recover vision in people with blinding diseases. A team of researchers led by Prof. Marius Ader from the Center for Regenerative Therapies Dresden (CRTD) at TU Dresden has just reported another pre-clinical advance in a new study published in the Journal […].

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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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Nordic Bioscience and Roche strengthen collaboration

Pharma Times

The companies will focus on the development of biomarkers for chronic diseases

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Genes & Cancer | Now on PubMed: Volume 12

Scienmag

BUFFALO, NY- June 16, 2022 – Oncology-focused research papers published in Volume 12 of Genes & Cancer are now on PubMed. Read short previews below about some of the groundbreaking studies published in 2021 by Genes & Cancer. Visit YouTube to watch video previews of studies published by Genes & Cancer. Credit: Impact Journals BUFFALO, […].

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WTO Approves Patent Waivers to Increase Worldwide Access to COVID-19 Vaccines

BioSpace

The World Trade Organization approved vaccine patent waivers to increase the availability of COVID-19 vaccines to lower-income countries.

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New global biodiversity framework falls short on chemicals

Scienmag

TORONTO, ON (JUNE 16, 2022) – Environmental scientists, ecologists, and policy experts argue in a letter published today in Science that the proposed Post-2020 Global Biodiversity Framework – a new international agreement to protect biodiversity – fails to account for the totality of chemical pollutants that threaten the health of ecosystems worldwide.

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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.