Bio Pharma Dive
APRIL 19, 2021
If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies.
World of DTC Marketing
APRIL 19, 2021
QUICK READ: At times, the public health response to coronavirus (COVID-19) has been scary, characterized by antimask behavior, antivaccine beliefs, conspiracy theories around the development of the vaccine, and a general belief that even COVID numbers are false. These people are doing more harm to others than they know, and they are generally making themselves irrelevant.
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Bio Pharma Dive
APRIL 19, 2021
Adagio Therapeutics, a well-financed spinout of antibody developer Adimab, could challenge Regeneron and Eli Lilly if its drug candidate proves protective in clinical tests.
pharmaphorum
APRIL 19, 2021
The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in the country at a plant owned by FUJIFILM Diosynth Biotechnologies in Stockton-on-Tees.
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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
APRIL 19, 2021
Real World Data provides increasingly significant value throughout all stages of a product's lifecycle. The time to embrace it is now. Here's why.
XTalks
APRIL 19, 2021
In 2018 , Coke tested their Coca-Cola Stevia No Sugar product in New Zealand to see how this beverage would succeed in the market before launching it in other countries. But where is the beverage now? Is Coke Stevia Still Available? Coke with stevia was distributed worldwide until it slowly started losing sales and has now been discontinued and removed from The Coca-Cola Company’s product portfolio.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 19, 2021
French genomic medicines firm SparingVision has agreed to buy GAMUT Therapeutics, a biotech specialising in gene therapies for inherited eye diseases such as retinitis pigmentosa (RP) that could compete against Roche/Spark’s Luxturna in a wider patient group. . GAMUT’s lead product, now SPVN20, is a novel, mutation-agnostic gene therapy, which aims at restoring the function of dormant cone cells in the retina.
Outsourcing Pharma
APRIL 19, 2021
One Healthâs FidoCure is using genomics and AI technology to develop precision oncological treatments, and the work is benefiting human cancer research.
pharmaphorum
APRIL 19, 2021
The EMA has started reviewing the emergency use application for GlaxoSmithKline and Vir Biotech’s COVID-19 antibody VIR-7831, which could become the fourth drug of its type cleared for early use in the EU. . The monoclonal antibody – also known as GSK4182136 – is being evaluated for the treatment of people with mild or moderate COVID-19 who are aged over 12 and don’t need oxygen supplementation, but are considered to be at risk of developing more severe symptoms.
Drug Patent Watch
APRIL 19, 2021
Annual Drug Patent Expirations for HETLIOZ Hetlioz is a drug marketed by Vanda Pharms Inc and is included in two NDAs. It is available from one supplier. There are fifteen…. The post New patent for Vanda Pharms drug HETLIOZ appeared first on DrugPatentWatch - Make Better Decisions.
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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
APRIL 19, 2021
US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.
Drug Patent Watch
APRIL 19, 2021
Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are thirty-nine patents…. The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
APRIL 19, 2021
Technique creates color on metal that can be changed, erased and rewritten Credit: Yaroslava Andreeva WASHINGTON — Researchers are blurring the lines between science and art by showing how a laser can be used to create artistic masterpieces in a way that mirrors classical paints and brushes. The new technique not only creates paint-like strokes […].
BioPharma Reporter
APRIL 19, 2021
The UKâs Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
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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.
Scienmag
APRIL 19, 2021
Researchers from Aarhus University and Aarhus University Hospital replace sick intestinal bacteria with intestinal bacteria from healthy donors in a treatment intended to help patients with cirrhosis of the liver. The Novo Nordisk Foundation supports the Credit: Simon Mark Dahl Baumwall. Can cirrhosis of the liver be treated with faeces transplantation?
Pharma Times
APRIL 19, 2021
JCVI advises pregnant women in the UK be offered COVID-19 vaccination at the same time as the rest of the population
BioSpace
APRIL 19, 2021
One month after snapping up Five Prime Therapeutics and its Phase III ready anti-FGFR2b antibody bemarituzumab for $1.9 billion, Amgen announced the U.S. FDA awarded Breakthrough Therapy Designation to the asset as a first-line treatment for certain types of gastric cancer.
pharmaphorum
APRIL 19, 2021
NICE has included proposals to speed up evaluations and focus on new technology such as digital health in a new strategy to provide faster access to new medical treatments and innovations. . The cost-effectiveness body has produced a new vision for the next five years, after reflecting on lessons learned during the COVID-19 pandemic. NICE said the pandemic showed the importance of swiftness and flexibility and embracing new forms of innovation in healthcare technology.
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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
APRIL 19, 2021
Under the terms of the expanded deal, Vertex will be responsible for 60% of the costs of developing, manufacturing and commercializing CTX001 with support from CRISPR Therapeutics, and will receive 60% of profits from global sales.
Pharma Times
APRIL 19, 2021
Five-year strategy will seek to transform key elements of organisation's approach to latest treatments
BioSpace
APRIL 19, 2021
Humanigen reported positive data from its Phase Ib ZUMA-19 trial of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL).
Scienmag
APRIL 19, 2021
UMD engineering research team demonstrates overscreening, flow reversal in nanosystems Credit: T. H. Pial et al., ACS Nano, 2021, DOI: 10.1021/acsnano.0c09248 Nanochannels have important applications in biomedicine, sensing, and many other fields. Though engineers working in the field of nanotechnology have been fabricating these tiny, tube-like structures for years, much remains unknown about their properties […].
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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.
pharmaphorum
APRIL 19, 2021
After announcing plans to go public, prescription digital therapeutics (DTx) firm Better Therapeutics has begun a “real world” study to test whether its BT-001 prescription cognitive behavioural therapy tool could change behaviours that are the root cause of type 2 diabetes. . The company has begun the open-label, non-randomised, controlled study to test whether the durability of treatment effect and total cost of care impact of the treatment.
Scienmag
APRIL 19, 2021
A joint research project with UK using Giga mobile backhaul network; AR demonstration held on Seoul Subway Line No. 8 with 1.9 Gbps, up to 30 times faster Credit: Electronics and Telecommunications Research Institute(ETRI) A team of Korean and British researchers have successfully performed a demonstration test of AR1) services on the subway by using […].
BioSpace
APRIL 19, 2021
An optimistic trend reported from the experimental drug lecanemab (BAN2401) clinical trials broaches the question of when the joint asset of Eisai Co., Ltd. and Biogen Inc. will hit the market.
Scienmag
APRIL 19, 2021
Researchers used nanophotonic technology to develop a brain-implantable tool that can aid in the optical imaging of brain activity Credit: Sacher et al., doi 10.1117/1.NPh.8.2.025003. Tools that allow neuroscientists to record and quantify functional activity within the living brain are in great demand. Traditionally, researchers have used techniques such as functional magnetic resonance imaging, but […].
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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.
BioSpace
APRIL 19, 2021
BioSpace caught up Foghorn Therapeutics’ Steven Bellon, Ph.D., SVP, drug discovery, shortly before he chaired a panel on new epigenetic developments at the AACR Annual Meeting 2021.
Scienmag
APRIL 19, 2021
Credit: Michelle Pedrazas/UT Jackson School of Geosciences A first-of-its-kind study led by The University of Texas at Austin has found that rock weathering and water storage appear to follow a similar pattern across undulating landscapes where hills rise and fall for miles. The findings are important because they suggest that these patterns could improve predictions […].
BioSpace
APRIL 19, 2021
Several prominent investors are urging shareholders to reject the compensation package because it shields the executive from billions of dollars in opioid-related litigation costs to the company.
Scienmag
APRIL 19, 2021
A study of immune cells circulating in the blood hints the gut’s immune response to COVID-19 infection may not provide sufficient whole-body immunity from the virus Our guts may not provide long-lasting systemic immunity from COVID-19, which is where immune cells circulate through the body to provide protection to other organs, finds a new study […].
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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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