Tue.Mar 22, 2022

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Argenx boosted by positive trial results for new shot

Bio Pharma Dive

An easier-to-take version of Vyvgart could help Argenx expand the drug's use in autoimmune disease, potentially adding to the biotech's appeal as an acquisition target.

Trials 284
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SmiLe Inject invests 2 MSEK in eHealth company developing a voice robot for the elderly

Pharma Mirror

SmiLe Incubator’s angel investment company, SmiLe Inject Capital, invests 2 MSEK in Call Knut, an incubator company that is developing a voice robot- based service using AI and ordinary phone calls as a complement in communicating with and caring for elderly people living on their own. The investment will be used to complete the development of the product and enable a commercial launch during the year.

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Al Sandrock takes on CEO role at gene therapy developer

Bio Pharma Dive

The well-known researcher and Biogen alumnus has agreed to take the top spot at Voyager Therapeutics, which, last spring, underwent a "strategic shift" that saw its then-CEO and research head depart.

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metaMe Health partners with Indegene to launch Regulora(R), an FDA-cleared Prescription Digital Therapeutic for adults with Irritable Bowel Syndrome

Pharma Mirror

PRINCETON, N.J. and CHICAGO. Indegene, a technology-led global healthcare solutions provider, and metaMe Health, Inc. (metaMe), a Prescription Digital Therapeutics (PDT) company and developer of Regulora®, today announced a partnership to bring Regulora to market for the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). IBS is a chronic condition that affects 10-15% of adults in the United States.

Marketing 130
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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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Vertex plans path to FDA for top drug prospect

Bio Pharma Dive

After observing promising results in a small study, Vertex is moving ahead with a pivotal trial for a kidney disease drug that's become a key part of the company's efforts to grow beyond cystic fibrosis.

Drugs 169
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Virtual and augmented reality: Bringing the future to pharma manufacturing

pharmaphorum

Virtual and augmented reality tools have reached a level of maturity to be utilised across various industries. In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. Virtual reality (VR) and augmented reality (AR) have spent a lot of time in the headlines recently.

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eBook: 10 Ways Xtalks Simplifies the Webinar Process

XTalks

If you’ve never hosted a webinar before, you might not know where to start. For those of you who haven’t yet hosted a webinar through Xtalks, you’re likely unaware of the ways that our team optimizes the webinar process. We’re involved in planning, scheduling, marketing, production, reporting and everything in between — we do it all.

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2 Strategies to Grow Your Excipient Business by Tracking Drug Patents

Drug Patent Watch

Drugs contain ingredients with therapeutic activity, so-called “active ingredients” as well as inactive ingredients. These inactive ingredients, called excipients, are included in oral products for various reasons, such as to…. The post 2 Strategies to Grow Your Excipient Business by Tracking Drug Patents appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 115
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Ex-Biogen R&D head Sandrock takes the top job at Voyager

pharmaphorum

Voyager Therapeutics has lost little time in elevating Al Sandrock to the chief executive position, with the appointment coming just a few weeks after he joined the biotech’s board. Sandrock announced he was ending a 23-year career at Biogen last November, in the wake of the company’s controversial approval and disastrous rollout of Alzheimer’s therapy Aduhelm (aducanumab).

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Celebrating Women’s History Month: Most recent female station crew members

Scienmag

For Women’s History Month, NASA and the International Space Station celebrate the women who conduct science aboard the orbiting lab. Credit: NASA For Women’s History Month, NASA and the International Space Station celebrate the women who conduct science aboard the orbiting lab. Women have participated in scientific research on the space station since 2001 and become an integral part […].

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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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AstraZeneca, Merck breast cancer treatment lands FDA approval

Outsourcing Pharma

The agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

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Self-monitoring blood oxygen at home can help COVID patients spot early warning signs, study finds

Scienmag

Measuring blood oxygen levels at home is a safe way for people with COVID-19 to spot signs that their health could be deteriorating, and they may need emergency and hospital care, new research led by Imperial College London has found. Credit: Imperial College London / Thomas Angus Measuring blood oxygen levels at home is a […].

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Takeda’s Exkivity receives MHRA conditional marketing authorisation

Pharma Times

Approval of Exkivity could mean NHS access to ground-breaking treatment for patients with rare lung cancer

Marketing 117
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Stress hormone reduces altruistic behavior in empathetic people

Scienmag

The stress hormone cortisol reduces altruistic behavior and alters activity in brain regions linked to social decision making — but only in people who are better at imagining others’ mental states, according to new research published in JNeurosci. Credit: Schulreich et al., JNeurosci 2022. The stress hormone cortisol reduces altruistic behavior and alters activity in […].

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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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Fujifilm to acquire Shenandoah Biotechnology

BioPharma Reporter

Fujifilm Irvine Scientific, Inc, has announced the acquisition of Shenandoah Biotechnology, a company supplying recombinant proteins to the drug discovery, life science research, and cell and gene therapy markets.

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Space-grown lettuce could help astronauts avoid bone loss

Scienmag

SAN DIEGO, March 22, 2022 — NASA is preparing to send humans to Mars sometime in the 2030s. The 3-year mission will expose astronauts to a long period of microgravity, which will cause them to lose bone mass. But now, scientists report transgenic lettuce that produces a bone-stimulating hormone. Someday, astronauts could grow the lettuce […].

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NICE recommends Biomarin’s Vimizim for patients with rare life-limiting metabolic disorder

Pharma Times

Patients with a life-limiting skeletal condition welcome availability of elosulfase alfa on the NHS

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NASA finds 2022 Arctic winter sea ice 10th-lowest on record

Scienmag

Arctic sea ice appeared to have hit its annual maximum extent on Feb. 25 after growing through the fall and winter. This year’s wintertime extent is the 10th-lowest in the satellite record maintained by the National Snow and Ice Data Center, one of NASA’s Distributed Active Archive Centers. Credit: Credits: Joshua Stevens/NASA Earth Observatory Arctic sea […].

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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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'Rising and sustained’ commercial investment in advanced therapy trials in UK

BioPharma Reporter

There were 168 Advanced Therapy Medicinal Product (ATMP) trials ongoing in the UK in 2021, compared to the 154 studies reported the previous year, a 9% increase, finds a new report.

Trials 84
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Treating TB: uOttawa scientists collaborate to identify new drug for unique therapeutic approach

Scienmag

A Faculty of Medicine team from the University of Ottawa and their international collaborators have shown proof of concept for an entirely new therapeutic approach in treating tuberculosis (TB), an enduring and recently accelerating scourge that is the leading cause of death worldwide by a bacterial infection. The disease is caused by a bacterium, Mycobacterium […].

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Indegene backs launch of metaMe’s DTx for irritable bowel syndrome in US

pharmaphorum

metaMe Health has enlisted the aid of health tech company Indegene to launch its recently-approved prescription digital therapeutic (DTx) Regulora for irritable bowel syndrome in the US. The digital health company got a green light from the FDA last November for Regulora – which delivers hypnotherapy through an Apple or Android smartphone – as a therapy for abdominal pain associated with all forms of IBS.

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Lettuce could protect astronauts’ bones on Mars trip

Scienmag

Astronauts might one day grow and eat genetically modified plants to ward off disease associated with long spaceflights. Researchers at the University of California, Davis College of Engineering have developed a transgenic, or genetically modified, lettuce producing a drug to protect against bone density loss in microgravity. The work will be presented March 22 at […].

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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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Catalent completes $30m expansion to biologics network

BioPharma Reporter

Catalent completes expansion of its biologics manufacturing network by upgrading its Limoges, France, location with additional capacity and the ability to produce large molecules.

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Changing beliefs is critical to sustaining high levels of vaccination

Scienmag

The rise of the BA.2 Omicron variant — first in Europe and East Asia and now in the U.S. — makes it clear that the pandemic isn’t done with us, and it isn’t likely to be anytime soon — unless we achieve very high vaccination levels with recurring boosters. But so far, too few people […].

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New patent for Genentech Inc drug COTELLIC

Drug Patent Watch

Annual Drug Patent Expirations for COTELLIC Cotellic is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Genentech Inc drug COTELLIC appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Correcting night blindness in dogs

Scienmag

People with congenital stationary night blindness (CSNB) are unable to distinguish objects in dim-light conditions. This impairment presents challenges, especially where artificial lighting is unavailable or when driving at night. Credit: Courtesy of Keiko Miyadera People with congenital stationary night blindness (CSNB) are unable to distinguish objects in dim-light conditions.

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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.

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New patent expiration for Plx Pharma drug VAZALORE

Drug Patent Watch

Annual Drug Patent Expirations for VAZALORE Vazalore is a drug marketed by Plx Pharma and is included in one NDA. There are four patents protecting this drug. This drug has…. The post New patent expiration for Plx Pharma drug VAZALORE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Tracking real-time atomic movement between crystal grains in metals

Scienmag

Metallic materials used in engineering must be strong and ductile – capable of carrying high mechanical loads while able to withstand deformation without breaking. Whether a material is weak or strong, ductile or brittle, however, is not determined simply by the crystal grains that make up the material, but rather by what happens in the […].

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Boehringer Ingelheim and the World Association for Buiatrics support outstanding research on ruminant animal health and well-being

The Pharma Data

Boehringer Ingelheim supports young scientists and veterinarians dedicated to ruminant health research Submissions for Ruminant Well-Being Awards and Gustav Rosenberger Memorial Fund grant open now. Boehringer Ingelheim, a global leader in animal health supports farmers and veterinarians worldwide in their work and promotes better farming practices to achieve long-term, positive impact not only in terms of animal health, but also in terms of well-being.

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Nanoparticle-based COVID-19 vaccine could target future infectious diseases

Scienmag

Just one dose of a new nanoparticle-based COVID-19 vaccine was enough to produce an immune response in animals on track with vaccines currently in clinical use. And with minor changes, Northwestern University researchers hope the same vaccine platform could target other infectious diseases. Credit: Credit image to Mirkin lab / Northwestern University Just one dose […].

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.