Bio Pharma Dive
NOVEMBER 19, 2020
The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market.
World of DTC Marketing
NOVEMBER 19, 2020
People who stay with a company just because of their salary and benefits are not the kind of people that are needed to make the leap from good to great. This week a friend and colleague I have known for over ten years decided to leave her current position where she was a top performer for a position where her expertise would be more valued. No one tried to stop her from leaving or asked if there was anything they could do to keep her.
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Bio Pharma Dive
NOVEMBER 19, 2020
The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels.
NY Times
NOVEMBER 19, 2020
In a review of several trials, the World Health Organization found that Gilead’s drug did not improve survival rates for patients nor did it help them recover.
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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
Bio Pharma Dive
NOVEMBER 19, 2020
Facilities are preparing ultra-cold storage capabilities and reviewing secruity plans as they brace for their role in distributing potentially multiple shots.
BioSpace
NOVEMBER 19, 2020
Parker H. “Pete” Petit, the former chief executive officer of wound care company MiMedx was convicted of fraud and making false statements to the U.S. Securities and Exchange Commission, following a months-long investigation into the company’s financial records. William Taylor, the company’s form.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
NOVEMBER 19, 2020
How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds.
pharmaphorum
NOVEMBER 19, 2020
The FDA has agreed to expedite development of two rare disease drugs from Sanofi. The most significant of the two announcements is the Priority Review for avalglucosidase alfa, a potential new therapy for Pompe disease. The review period will be shortened from the standard ten months to six months or less, and the French pharma said the FDA will make the regulatory decision before May 18th.
BioPharma Reporter
NOVEMBER 19, 2020
Itâs been a big week for mRNA-based COVID-19 vaccines: with both Pfizer/BioNTech and Moderna reporting impressive efficacy for their COVID-19 vaccine candidates. Here's five key takeaways from this week's developments.
pharmaphorum
NOVEMBER 19, 2020
The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found. The phase 2/3 trial results published in The Lancet about the UK-developed shot follow more detailed findings from Pfizer/BioNTech showing that their vaccine protected 94% of adults over 65 years old.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioPharma Reporter
NOVEMBER 19, 2020
The European Commission has granted a marketing authorization for Sanofiâs Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union.
Scienmag
NOVEMBER 19, 2020
The microbial composition of art pieces can reveal interesting facts about their past and the journey they made Credit: The authors The work of Leonardo Da Vinci is an invaluable heritage of the 15th century. From engineering to anatomy, the master paved the way for many scientific disciplines. But what else could the drawings of […].
BioSpace
NOVEMBER 19, 2020
Novartis inked an exclusive worldwide license and collaboration deal with Australia-based Mesoblast to develop, commercialize and manufacture remestemcel-L for acute respiratory distress syndrome (ARDS), including when it is linked to COVID-19.
Scienmag
NOVEMBER 19, 2020
New study shows impacts of increased levels of evaporative demand as climate grows warmer and drier Credit: Meghan Collins/DRI Reno, Nev. (Nov. 19, 2020) – Climate change and a “thirsty atmosphere” will bring more extreme wildfire danger and multi-year droughts to Nevada and California by the end of this century, according to new research from […].
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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.
BioSpace
NOVEMBER 19, 2020
Researchers out of the University of Arizona led by Dr. Rajesh Khanna have published interesting experimental evidence that may help explain why some people contract COVID-19 without falling ill.
Scienmag
NOVEMBER 19, 2020
Scientists at Osaka University create seaweed-shaped sodium titanate mats made of nanofibers that can remove cobalt ions from water, which may help provide a source of safe, recycled drinking water by removal of heavy metals and radionuclides Credit: Osaka University Osaka, Japan – A team of researchers at Osaka University has developed a nanopowder shaped […].
XTalks
NOVEMBER 19, 2020
As the COVID-19 pandemic progresses, emphasis on food safety in all sectors of the food and beverage industry is escalating. Gone are the days of foodservice workers handling food with their bare hands, or food processing employees working together in close quarters at bustling assembly lines. So how can food and beverage companies effectively create a food safety culture within their organization and communicate that message to consumers?
Scienmag
NOVEMBER 19, 2020
Credit: Mitsuhiko Yamada MD, PhD., Department of Molecular Pharmacology, Shinshu University School of Medicine, Japan Researchers have identified a new druggable target for heart failure in neonates and infants, a condition for which there has been no specific treatment. Approximately 60 percent of children born with congenital heart abnormalities will develop overt heart failure within […].
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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.
BioSpace
NOVEMBER 19, 2020
As expected after Pfizer and BioNTech announced their COVID-19 vaccine Phase III trial had completed and demonstrated a 95% efficacy rate, the companies plan to apply for an Emergency Use Authorization (EUA) with the FDA.
Scienmag
NOVEMBER 19, 2020
Patients who received the combination therapy had increased cognition and functioning Credit: UCLA Health FINDINGS UCLA scientists and colleagues found the use of long-acting antipsychotic medication combined with the use of cognitive training in group settings led to improved cognition and increased productivity. Researchers say patients using a combination of long-acting antipsychotic medication and a […].
BioSpace
NOVEMBER 19, 2020
Eli Lilly and Company and Precision BioSciences, Inc. announced today that they have entered a research collaboration and exclusive license agreement.
Scienmag
NOVEMBER 19, 2020
In laboratory tests, the material eliminated 79.9% of SARS-CoV-2 particles in three minutes and 99.99% in up to 15 minutes (photo: Alpes) Credit: Alpes Transparent stretchable PVC film for use in packaging meat, fruit, cold cuts, and other foods, and to protect surfaces, can inactivate the novel coronavirus. Marketed by Brazilian plastics manufacturer Alpes, the […].
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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.
Pharma Times
NOVEMBER 19, 2020
New findings from phase 2 study published in The Lancet
Scienmag
NOVEMBER 19, 2020
International development projects that target the education of the world’s very poorest children and marginalized girls also significantly improve other young people’s attainment, new research shows Credit: CAMFED/Eliza Powell International development projects that target the education of the world’s very poorest children and marginalised girls also significantly improve other young people’s attainment, according to new […].
BioSpace
NOVEMBER 19, 2020
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
NOVEMBER 19, 2020
The results of the study reveal that civil society associations are seeking to become more involved in scientific production Researchers at UPF have analysed the relationship between civil society organizations and the Spanish science and technology system. The study has been published in Public Understanding of Science and conducted by Carolina Llorente and Gema Revuelta, […].
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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.
pharmaphorum
NOVEMBER 19, 2020
As the world continues to grapple with the ongoing impact of coronavirus, the healthcare industry has taken centre-stage, working tirelessly and more collaboratively than ever to tackle challenges thrown up by the pandemic. Amid the turmoil and the race to not only find a vaccine but also help to care for those who are battling the long-term effects of COVID-19, healthcare organisations need to sharpen their communication skills.
Scienmag
NOVEMBER 19, 2020
Credit: Meditech Gloves Cranfield University researchers in partnership with Meditech Gloves, one of the leading manufacturers of high-quality examination and surgical gloves, have shown how energy savings can be made with the development of more sustainable, biodegradable, protein-free, natural rubber gloves. More sustainable gloves, with reduced allergens The natural rubber biodegrades 100 times faster than […].
Pharma Times
NOVEMBER 19, 2020
Trial will evaluate whether Mavenclad can slow the rate of upper limb disability progression
Scienmag
NOVEMBER 19, 2020
Credit: Photo by Indiana University BLOOMINGTON, Ind. — An interdisciplinary team led by Indiana University social neuroscientist Anne Krendl was awarded $3.5 million by the National Institutes of Health to navigate a phenomenon with major promise for the treatment of Alzheimer’s disease: that the social connectedness of older adults predicts their vulnerability to Alzheimer’s and […].
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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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