Fri.Feb 12, 2021

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A gene therapy pipeline takes shape for a cluster of rare diseases

Bio Pharma Dive

Lysosomal storage disorders, diseases of cellular metabolism gone wrong, are the focus of a fast-expanding lineup of experimental genetic medicines, a research boom that recalls biotech's roots.

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MOVIANTO -DENNIS SPAMER, new Board Member of Movianto GERMANY

Pharma Mirror

The Walden Group is pleased to announce the appointment of Dennis Spamer (38) as member of the Board authorized to sign as statutory director of the company. Together with Thomas Creuzberger, who has been managing Movianto Germany since more than 20 years and Stéphane Baudry, founder and CEO of the Walden Group, Spamer shall push on the further development of the logistics specialist.

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FDA approves Regeneron drug for rare, genetic form of high cholesterol

Bio Pharma Dive

The biotech set an average annual price of $450,000 for the first-of-its-kind drug, which treats a condition that affects about 1,300 people in the U.S.

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Ireland is open: The biologics boom boosting the Irish economy

pharmaphorum

The life sciences industry has an important role in the Irish economy, with sectors such as biologics booming across the country. Rory Mullen, head of biopharma at Ireland’s economic development agency IDA Ireland tells pharmaphorum why business is blossoming in the Emerald Isle. With an attractive corporate tax rate and the youngest workforce in the EU, Ireland continues to be a popular destination for life science companies to settle.

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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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US secures 200 million more vaccine doses from Pfizer, Moderna

Bio Pharma Dive

With the orders now finalized, President Biden said the U.S. would have enough doses to vaccinate 300 million Americans by the end of the July.

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Novartis antibiotic retreat doesn’t stop Sandoz buying GSK drugs

pharmaphorum

Novartis exited novel antibiotics R&D three years ago, but is clearly still interested in the category – its Sandoz unit has just spent $350 million buying GlaxoSmithKline’s cephalosporin franchise. . The deal covers global rights to three brands – Zinnat (cefuroxime axetil), Zinacef (cefuroxime) and Fortum (ceftazidime) – which are sold in more than 100 markets around the world and had sales of around $140 million last year.

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Ipsen’s John Chaddock on making neurotoxins a priority for healthcare systems

pharmaphorum

Injected neurotoxins can be incredibly potent in treating spasticity from neurological diseases, but the field doesn’t always get the attention it needs. Ipsen’s John Chaddock tells us why the company is investing heavily in neurotoxin research and how he hopes to raise awareness among young scientists and the NHS. When the COVID-19 pandemic first hit, countries were forced to make difficult decisions about which healthcare services to continue and which to halt as systems came under immense st

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Green tea compound aids p53, ‘guardian of the genome’ and tumor suppressor

Scienmag

Research offers new lead for cancer drug discovery Credit: Rensselaer Polytechnic Institute TROY, N.Y. — An antioxidant found in green tea may increase levels of p53, a natural anti-cancer protein, known as the “guardian of the genome” for its ability to repair DNA damage or destroy cancerous cells. Published today in Nature Communications, a study […].

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Roche’s vision loss therapy faricimab extends time between treatments by up to four months

Pharma Times

Results from four Phase III studies demonstrated non-inferior vision gains with extended dosing schedule

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Study reveals mutations that drive therapy-related myeloid neoplasms in children

Scienmag

Research from scientists at St. Jude Children’s Research Hospital found mutations up to two years before cancer developed, showing an opportunity for early interventions Credit: St. Jude Children’s Research Hospital Children treated for cancer with approaches such as chemotherapy can develop therapy-related myeloid neoplasms (a second type of cancer) with a dismal prognosis.

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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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Valentine’s Day Sparks Product Innovation Among Big Food Brands

XTalks

The COVID-19 pandemic has undoubtedly changed consumer buying habits when it comes to food and almost all other commodities. But one thing it hasn’t changed is the desire for chocolate, candy and other confections on Valentine’s Day. The National Confectioners Association found that 87 percent of Americans plan to celebrate the holiday by sharing a gift of chocolate or candy — business as usual.

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Limited transmission of Covid-19 from open schools but teachers were affected

Scienmag

Credit: Mikael Wallerstedt Most countries introduced school closures during the spring of 2020 despite substantial uncertainty regarding the effectiveness in containing SARS-CoV-2. In Sweden, upper-secondary schools moved online while lower-secondary schools remained open. A comparison of parents with children in the final year of lower-secondary and first year of upper-secondary school shows that keeping the […].

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bluebird bio’s beta-thalassaemia gene therapy rejected by NICE

Pharma Times

NICE determined that there were uncertainties around the cost-effectiveness of the therapy

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Lemurs show there’s no single formula for lasting love

Scienmag

Brain imaging reveals that not all monogamous mammals are ‘wired for love’ in the same way Credit: David Haring, Duke Lemur Center DURHAM, N.C. — Humans aren’t the only mammals that form long-term bonds with a single, special mate — some bats, wolves, beavers, foxes and other animals do, too. But new research suggests the […].

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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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AbbVie and Caribou partner on CAR-T cell therapy development

BioPharma Reporter

AbbVie and Caribou Biosciences have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics.

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More trees do not always create a cooler planet, Clark University geographer finds

Scienmag

Clark researchers discover some US forests add to global warming Credit: n/a WORCESTER, Mass. — New research by Christopher A. Williams, an environmental scientist and professor in Clark University’s Graduate School of Geography, reveals that deforestation in the U.S. does not always cause planetary warming, as is commonly assumed; instead, in some places, it actually […].

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F.D.A. Agrees Moderna Can Increase Vaccine Supply in Each Vial

NY Times

Federal regulators are in favor of a simple, potentially quick fix to bolster coronavirus vaccine supplies: more doses per bottle.

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Scientists awarded Fulbright scholarships to study climate and the environment

Scienmag

Lora Harris and Christina Goethel to begin research exchange in Finland and Iceland Credit: University of Maryland Center for Environmental Science University of Maryland Center for Environmental Science (UMCES) Associate Professor Lora Harris and Ph.D. candidate Christina Goethel have been named Fulbright Scholars for 2021-2022. Harris will use her award to work in Finland on […].

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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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CureVac starts rolling review in Europe for COVID-19 vaccine

BioPharma Reporter

CureVac has initiated a rolling review with the European Medicines Agency, working towards authorization for its mRNA COVID-19 vaccine in the European Union.

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Promising new approach to stop growth of brain cancer cells

Scienmag

Credit: The Princess Margaret Cancer Foundation (Friday, February 12, 2021 – Toronto) — Inhibiting a key enzyme that controls a large network of proteins important in cell division and growth paves the way for a new class of drugs that could stop glioblastoma, a deadly brain cancer, from growing. Researchers at Princess Margaret Cancer Centre, […].

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State Drug Importation Bills Just Got More Personal in California

Pharmacy Checkers

With lies and deception, Big Pharma has used the threat posed by rogue websites and counterfeit drugs to push back against U.S. state legislation to gain access to lower drug prices in Canada. Regardless, several states have passed laws toward creating importation programs: Colorado, Florida, Maine, New Hampshire, New Mexico, and Vermont. Simple summary: Canada’s brand drugs are priced much lower and states want access to them.

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Applying quantum computing to a particle process

Scienmag

Berkeley Lab team models parton showers using a quantum algorithm Credit: ATLAS Collaboration A team of researchers at Lawrence Berkeley National Laboratory (Berkeley Lab) used a quantum computer to successfully simulate an aspect of particle collisions that is typically neglected in high-energy physics experiments, such as those that occur at CERN’s Large Hadron Collider.

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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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NHS to roll-out tocilizumab treatment for COVID-19

Pharma Times

In the RECOVERY trial, tocilizumab treatment significantly reduced deaths caused by COVID-19

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Researchers find parallels in spread of brain cancer in mammals, zebrafish

Scienmag

Fralin Biomedical Research Institute at VTC scientists say zebrafish suitable models for human glioblastoma research Credit: Robyn Umans/Virginia Tech Scientists at the Fralin Biomedical Research Institute at VTC have identified a new zebrafish model that could help advance glioblastoma multiforme research. Glioblastoma is an aggressive form of primary brain tumor – fewer than one in […].

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The Year Of Virtual Co(Creation)

pharmaphorum

If 2020 was the year that cemented the role of virtual advisory boards and virtual engagement in many forms, then we believe that 2021 will be the year of ‘virtual co-creation’. The benefits of virtual advisory boards (VABs) in replacing face-to-face advisory discussion with KOLs and HCPs are now clear and established. But there are many other ways in which a VAB platform can enhance digital interactions and engagements with KOLs and HCPs.

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Mexico’s poor have little luck obtaining opioids intended for palliative care

Scienmag

If you’re poor and terminally ill in southern Mexico, there’s far less chance you’ll get the painkillers you need for palliative care than your cousins in more prosperous regions, particularly those pharmacy-rich areas along Mexico-U.S. border, say UCLA researchers and colleagues who studied opioid dispensing levels across the country.

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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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Orexo eyes real-world testing of its modia opioid use disorder app

pharmaphorum

Orexo will start a new study of its modia app – used to treat people with opioid use disorder – to test how it performs in real-world settings. The Swedish drugmaker has teamed up with consultancy ApexB.io and pharmacy group Magellan Rx Management on the study of the digital therapeutic, which provides tailored cognitive behavioural therapy (CBT) via a mobile device or PC.

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UTIA professor earns SAEA Lifetime Achievement Award

Scienmag

Burton C. English recognized for outstanding contributions to agricultural economics Credit: Photo courtesy UTIA. KNOXVILLE, Tenn. — Burton C. English, professor at the University of Tennessee Institute of Agriculture (UTIA), has received the 2021 Lifetime Achievement Award from the Southern Agricultural Economics Association (SAEA). The award is given in recognition of his significant and enduring […].

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Entry deadline extended for INTCR 2021

Pharma Times

The entry deadline for the 2021 International Clinical Researcher of the Year has been extended to the 16th of April.

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Chemotherapy and hearing loss: Until now, an unquantified risk

Scienmag

Children’s Hospital Los Angeles leads largest ever multi-center study to characterize side effects of a common chemotherapy agent Cisplatin is one of the most effective chemotherapy agents, used in just under half of pediatric cancer cases. Permanent hearing loss is a common side effect of this medication, but until now, studies have been too small […].

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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.