Bio Pharma Dive
SEPTEMBER 13, 2021
Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed.
BioSpace
SEPTEMBER 13, 2021
This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics.
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Bio Pharma Dive
SEPTEMBER 13, 2021
The company has agreed to pay $370 million, and possibly north of $1 billion more, to gain access to a Regenxbio treatment targeting wet AMD and other eye conditions.
BioSpace
SEPTEMBER 13, 2021
Takeda announced that the company plans to grow its vaccines business. CEO Christophe Weber discussed this today in an interview at Reuters Events’ Pharma Japan 2021 conference.
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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
SEPTEMBER 13, 2021
Pharmaceutical companies are increasingly attracted to the idea of replacing the current multichannel marketing focus with an omnichannel marketing approach. But the industry is struggling to break out of its own silos.
XTalks
SEPTEMBER 13, 2021
Hershey’s is expanding its better-for-you segment by catering to the consumer group that looks for organic, plant-based and fair-trade products. Hershey’s is currently exploring and developing new products in this segment because they see that plant-based products are the fastest growing in the better-for-you category. Hershey’s Oat Made Chocolate bars, with ingredients like extra-creamy almond, sea salt and classic dark chocolate, is the company’s newest oat milk-based i
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
SEPTEMBER 13, 2021
Freezing is a relatively safe and cost-effective way to preserve food, but it also requires a considerable amount of energy and produces carbon emissions. But a new approach called isochoric freezing could be the more sustainable alternative to traditional freezing methods. So, how does it work and does it have the potential to be widely adopted in the food and beverage industry?
BioSpace
SEPTEMBER 13, 2021
?Lightstone Ventures recently announced the closing of Lightstone Ventures III, securing $375 million to invest in early-stage firms that develop high-impact technologies that can change lives.
pharmaphorum
SEPTEMBER 13, 2021
AbbVie has expanded its ophthalmology pipeline via a licensing deal with Regenxbio, paying $370 million upfront to get its hands on a gene therapy for wet age-related macular degeneration (AMD) and other eye diseases. The partnership centres on RGX314, which delivers a gene coding for an antibody against VEGF – a well-established approach to treating wet AMD and the target of current blockbuster drugs like Bayer’s Eylea (aflibercept) and Novartis/Roche’s Lucentis (ranibizumab).
Outsourcing Pharma
SEPTEMBER 13, 2021
The two companies are collaborating on development of Myfembree, a combination therapy to treat the painful condition affecting millions of women worldwide.
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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
BioSpace
SEPTEMBER 13, 2021
Centessa Pharmaceuticals and genomics testing firm Sophia Genetics have both announced plans to expand their real estate footprints in Boston.
pharmaphorum
SEPTEMBER 13, 2021
Apellis Pharma has reported mixed results with its lead drug pegcetacoplan in geographic atrophy (GA) – a major cause of blindness – with one hit and one miss in its phase 3 programme. Shares in the company were hit hard after the news was announced, although Apellis insisted that the totality of the data would still be strong enough to file for FDA approval, saying it plans to do so in the first half of next year.
BioSpace
SEPTEMBER 13, 2021
Recently, the National Institutes of Health (NIH)'s removal of genetic data about the COVID-19 virus from its archive was brought into the spotlight.
BioPharma Reporter
SEPTEMBER 13, 2021
AbbVie is aligning with Regenxbio to develop and commercialize a potential one-time gene therapy for the treatment of chronic retinal diseases.
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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
SEPTEMBER 13, 2021
CureVac NV is downsizing its European mRNA production network due to decreased demand for vaccines after the first wave of vaccinations.
Pharma Times
SEPTEMBER 13, 2021
AZ’s combo treatment reduced the risk of disease progression or death by 28% compared to chemotherapy alone
BioSpace
SEPTEMBER 13, 2021
?NovoCure and Roche aim to explore the combined efficacy of TTFields with atezolizumab as a potential treatment for pancreatic cancer.
Outsourcing Pharma
SEPTEMBER 13, 2021
The advocacy organization's PIE4CNS initiative is aimed at targeting and reducing gaps in diagnosis, research, and trials for rare neurological conditions.
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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.
Pharma Times
SEPTEMBER 13, 2021
The Galleri test is able to identify the ‘earliest’ signs of cancer in the blood
pharmaphorum
SEPTEMBER 13, 2021
A blood test called Galleri that could detect dozens of different forms of cancer before symptoms appear will start trials by the NHS in England involving around 140,000 subjects. Volunteers aged between 50 and 77 are being sought to trial the diagnostic developed by California biotech Grail, which spun out of Illumina in 2016 and agreed to be reacquired by the lab technology giant last month.
BioSpace
SEPTEMBER 13, 2021
A patient treated with Astellas Pharma’s experimental gene therapy for patients with X-linked Myotubular Myopathy (XLMTM) has died after a serious adverse event following treatment.
Delveinsight
SEPTEMBER 13, 2021
Anemia is a serious cause of global health loss with over 80% of the total cases diagnosed in developing countries, according to several studies. Anemia is characterized by reduced quality of red blood cells, diminished hemoglobin levels and even altered morphology of red blood cells. The symptoms of the condition vary from weakness, fatigue, difficulty concentrating, or poor work productivity and are a result of impaired tissue oxygen delivery.
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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.
BioSpace
SEPTEMBER 13, 2021
?Zabdeno, a two-dose heterologous vaccine, was well-tolerated and induced antibody responses to the Zaire ebolavirus species 21 days after the second dose in 98% of all participants.
Scienmag
SEPTEMBER 13, 2021
DNA is the instruction manual for every living organism, guiding the development and functioning of all biological processes. In essence, it is a molecule with a double helix structure with each unit of a helix containing what are known as “DNA bases”. Credit: Gwangju Institute of Science and Technology DNA is the instruction manual for […].
BioSpace
SEPTEMBER 13, 2021
Several biopharma companies announced Series B financing rounds or additional investment raises. Here’s a look.
pharmaphorum
SEPTEMBER 13, 2021
The UK has terminated its order for up to 190 million doses of a COVID-19 vaccine developed by French biotech company Valneva, accusing it of breaching their supply agreement. Valneva said it “strenuously denies” that allegation, but added that the €1.4 billion ($1.65 billion) contract does provide the UK government with the right to exit the agreement to purchase VLA2001, a purified inactivated SARS-CoV-2 vaccine.
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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.
Pharma Times
SEPTEMBER 13, 2021
The awards were presented on Thursday 9 September
BioPharma Reporter
SEPTEMBER 13, 2021
The UK government accuses Valneva of being in breach of its supply agreement obligations - something the company 'strenuously denies' - as it cancels its COVID-19 vaccine contract.
Scienmag
SEPTEMBER 13, 2021
AUGUSTA, Ga. (Sept. 14, 2021) – Whether consuming cocoa, known to be packed with powerful antioxidants that protect our cells from damage, helps us age better, is a question scientists want to definitively answer. Credit: Mike Holahan, Augusta Chronicle AUGUSTA, Ga. (Sept. 14, 2021) – Whether consuming cocoa, known to be packed with powerful antioxidants that protect […].
Drug Patent Watch
SEPTEMBER 13, 2021
Annual Drug Patent Expirations for JEVTANA+KIT Jevtana Kit is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are…. The post New patent for Sanofi Aventis drug JEVTANA KIT appeared first on DrugPatentWatch - Make Better Decisions.
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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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