Tue.Jul 20, 2021

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Amylyx, faced with longer FDA path for promising ALS drug, gets major cash infusion

Bio Pharma Dive

A $135 million investment will help the small biotech potentially prepare to launch the treatment in Canada and Europe as well as fund another trial requested by U.S. regulators.

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Koselugo: The First Non-Surgical Alternative for Rare Plexiform Neurofibroma

BioSpace

Notably, Koselugo was studied in pediatric populations first, a reversal of the typical development path taken by the majority of drugs.

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Ardelyx latest biotech surprised by unexpected FDA criticism of drug application

Bio Pharma Dive

The FDA cited problems with Ardelyx's case for its kidney disease drug just weeks before an approval deadline — feedback one analyst described as "troubling" evidence of FDA inconsistency.

Drugs 286
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NuVasive Resumes Shipping of Spinal Implant, Continues to Address FDA Safety Warnings

XTalks

NuVasive , a medical device company focused on developing devices and procedures for minimally invasive spine surgery, has recommenced shipping of the newest version of its MAGEC line of spinal curve-correcting magnetic rod systems. The previous version of the MAGEC spinal implant was flagged by the US Food and Drug Administration (FDA) for potential mechanical risks.

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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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Celltrion says its COVID-19 antibody shows ‘strong neutralising activity’ against Delta variant

Pharma Times

A therapeutic dose of regdanvimab also reduced the viral load of the SARS-CoV-2 virus and inflammation in the lungs

Antibody 129
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Bougie Bakes Enters the Pet Treat Market with Their New Bougie Barks

XTalks

Bougie Bakes, a Los Angeles-based healthy snack alternative company, has now released dog cookies under the “Bougie Barks” brand. The brand introduces Bougie Barks Peanut Butter Carob Dog Cookies, which are made of five main ingredients: almond flour, peanut butter, carob powder, collagen powder and ground flaxseed. The human version of this cookie was introduced in 2018 by Ryan and Meghan, who struggled to find better-for-you baked goods that satisfied their cravings.

Marketing 105

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What America’s Food Monopolies Mean for Producers and Small Businesses

XTalks

McDonald’s is bringing back its Monopoly promotion for a chance to win a plethora of prizes, but unfortunately, it’s not the only monopoly reigning over the food industry. A recent investigation by The Guardian about America’s food monopolies dismisses the concept that consumers truly have a choice in the brands they purchase. So, what does this look like and what does it mean for smaller producers and businesses?

Branding 105
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Roche reveals new safety data for haemophilia treatment Hemlibra

Pharma Times

No new safety signals identified with longer-term Hemlibra treatment in adult and adolescent patients

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Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor

pharmaphorum

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. The US regulator had extended its review of the drug by three months – setting back its action date from April to 29 July – but now says that deficiencies in the marketing application “preclude discussion” of labelling and post-ma

Drugs 98
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Machine learning models to help photovoltaic systems find their place in the sun

Scienmag

Scientists develop algorithms that predict the output of solar cells, easing their integration into existing power grids Credit: [link] With the looming threat of climate change, it is high time we embrace renewable energy sources on a larger scale. Photovoltaic systems, which generate electricity from the nearly limitless supply of sunlight energy, are one of […].

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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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EMA starts review of latecomer GSK/Sanofi COVID-19 vaccine

pharmaphorum

The EMA has kicked off a rolling review of a COVID-19 vaccine from Sanofi and GlaxoSmithKline, which started a 35,000-patient phase 3 trial in May. The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK that aims to boost its efficacy.

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Researchers develop novel method for glucagon delivery

Scienmag

Credit: University of Notre Dame For children with Type 1 diabetes, the risk of experiencing a severe hypoglycemic episode is especially common — and for parents, the threat of that happening in the middle of the night is especially frightening. Sudden and critical drops in blood sugar can go undetected overnight when the child is […].

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FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy

pharmaphorum

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently in early-stage clinical testing. The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time.

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FDA Grants Breakthrough Device Designations to Endologix and NeuroMetrix

BioSpace

The U.S. Food and Drug Administration has recently granted Breakthrough Device Designation to two medical device companies, with California-based healthcare tech company Endologix leading the mix.

Drugs 98
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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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Deep-sea research bolstered with $2 million grant

Scienmag

Credit: Photo courtesy of Woods Hole Oceanographic Institution. Bigelow Laboratory for Ocean Sciences has been awarded $2 million by the National Science Foundation to lead an international effort to accelerate scientific understanding of the environmental impacts of emerging industries in the deep sea – one of the most mysterious, and potentially lucrative, areas of the […].

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Most patients confident in personalized medicine: survey

Outsourcing Pharma

A recent survey conducted by dosing technology firm found that the vast majority (85%) of patients think that personalized medicine stands to improve care.

Medicine 105
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Microbially produced fibers: Stronger than steel, tougher than Kevlar

Scienmag

Artificially designed, amyloid-silk hybrid protein developed in Zhang lab even outperforms some spider silks Credit: Washington University in St. Louis/Jingyao Li Spider silk is said to be one of the strongest, toughest materials on the Earth. Now engineers at Washington University in St. Louis have designed amyloid silk hybrid proteins and produced them in engineered […].

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Albireo Breaks New Ground with Approvals for First Drug in PFIC

BioSpace

It will immediately begin to sell Bylvay to treat patients impacted by PFIC, a rare cholestatic liver disease that often leads to cirrhosis and liver failure within the first ten years of life.

Drugs 98
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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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NIH award to study molecule’s role in healthy brain development

Scienmag

Credit: Virginia Tech Raymundo Hernandez was always drawn to psychology – that is, until he took his first neurobiology class as an undergraduate. “Thought, choice, autonomy – I remember being struck by the fact that these concepts we discuss a lot in psychology are fundamentally just brain cells communicating with each other,” said Hernandez, a […].

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One Dose of J.&J. Vaccine Is Ineffective Against Delta, Study Suggests

NY Times

Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.

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SuperBIT: A low-cost balloon-borne telescope to rival Hubble

Scienmag

Credit: SuperBIT team, from Romualdez et al. (2018) SPIE 10702. Durham, Toronto and Princeton Universities have teamed up with NASA and the Canadian Space Agency to build a new kind of astronomical telescope. SuperBIT flies above 99.5% of the Earth’s atmosphere, carried by a helium balloon the size of a football stadium. The telescope will […].

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New advice issued on COVID-19 vaccination of children and young people

Pharma Times

The UK’s JCVI has advised vulnerable children should be offered Pfizer/BioNTech vaccines

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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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Tropical fly study shows that a mother’s age and diet influences offspring health

Scienmag

Credit: Daniel Hargrove The female tsetse fly, which gives birth to adult-sized live young, produce weaker offspring as they get older, and when they feed on poor quality blood. The study, carried out by researchers at the Universities of Bristol, Oxford and the Liverpool School of Tropical Medicine, was designed to measure how tsetse offspring […].

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Novartis inks 10-year pledge to improve equity in research, care

Outsourcing Pharma

The pharma firm's partnership with 26 US Black colleges includes a $13.7m investment in trial and research centers at Morehouse School of Medicine.

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Tiny organisms shed big light on ocean nutrients

Scienmag

Credit: Photo by Debra Lomas As the world warms, sweeping changes in marine nutrients seem like an expected consequence of increased ocean temperatures. However, the reality is more complicated. New research suggests that processes below the ocean surface may be controlling what is happening above. Plankton are some of the most numerous and important organisms […].

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Money on the Move: July 14 – 21

BioSpace

More money means more progress for potentially life-saving therapies. Here's a peek at some biopharma companies adding to their books this week.

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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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Blavatnik National Awards for Young Scientists announce 2021 laureates

Scienmag

Winners of America’s largest unrestricted scientific prize for promising young researchers include a neuroscientist from the Salk Institute for Biological Studies, an inorganic chemist from MIT, and an electrical engineer from CUNY The Blavatnik National Awards for Young Scientists winning laureates include: NEW YORK, July 20, 2021 – The Blavatnik Family Foundation and the New […].

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EU approval for self-administered Crysvita

Pharma Times

Crysvita is used to treat the rare genetic condition X-linked hypophosphataemia

Genetics 123
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COVID-19 shutdowns reveal racial disparities in exposure to air pollution

Scienmag

Disenfranchised, minority neighborhoods still exposed to disproportionately high levels of health harming nitrogen dioxide Credit: GW WASHINGTON (July 20, 2021)–A new study of COVID-19 shutdowns in the United States reveals pronounced disparities in air pollution — with disenfranchised, minority neighborhoods still experiencing more exposure to a harmful air pollutant compared to wealthier, white communities.

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Kineta and Samsung Biologics sign agreement for development and manufacture of anti-VISTA antibody immunotherapy

BioPharma Reporter

Kineta says the partnership with Samsung Biologics will help it advance its novel anti-VISTA antibody as it aims to start clinical trials next year.

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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.