Bio Pharma Dive
AUGUST 7, 2020
Development of EDIT-101, the first CRISPR-based therapy to be used in a company-led trial to alter genes within a person's body, will now move forward under Editas' sole ownership.
Pharma Times
AUGUST 7, 2020
Scientists from the University of Oxford say the drug is being ‘discarded prematurely’
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Bio Pharma Dive
AUGUST 7, 2020
Approval of Evrysdi, from Roche and PTC Therapeutics, adds a third option for treating the neuromuscular disease, joining Spinraza and Zolgensma.
BioSpace
AUGUST 7, 2020
Aerovate Therapeutics secured $72.6 million in Series A funding to advance trials of AV-101, an inhaled, dry powder aerosol version of Novartis’ cancer drug Gleevec (imatinib) in a repurposed effort to treat pulmonary arterial hypertension (PAH).
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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
AUGUST 7, 2020
The agency's decision kicks off a historic and dramatic regulatory review, as significant lingering questions surround aducanumab's approval chances.
BioSpace
AUGUST 7, 2020
Intravenous immunoglobulin (IVIG) could be a key to combating seriously ill COVID-19 patients who have been hospitalized due to complications from the disease, and Octapharma AG aims to find out as it assesses the plasma-based treatment in a Phase III study.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
AUGUST 7, 2020
Pfizer has signed a multi-year agreement with Gilead to manufacture and supply the COVID-19 antiviral remdesivir, which is also being tested in combination with other drugs in an effort to fight the pandemic. Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease.
Scienmag
AUGUST 7, 2020
Credit: NOAA OER A new publication on the impacts of deep-seabed mining by 13 prominent deep-sea biologists, led by University of Hawai’i at M?noa oceanography professor Craig Smith, seeks to dispel scientific misconceptions that have led to miscalculations of the likely effects of commercial operations to extract minerals from the seabed. The deep sea, ocean […].
pharmaphorum
AUGUST 7, 2020
Pharma’s reputation has soared due to the COVID-19 pandemic – but coronavirus is starting to bite companies’ sales. Find out more in our roundup of the biggest R&D, market access and digital stories from the past week. The perception of pharma and medical companies has surged upward since the start of the COVID-19 pandemic, but they still lie mostly outside the top-rated firms in the FutureBrand Index.
BioSpace
AUGUST 7, 2020
Vigeo Therapeutics is expanding indications for its tumor microenvironment (TME)-targeting oncology platform, which inhibits tumor growth by reprogramming normal cells that were recruited and coopted by a tumor.
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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
Scienmag
AUGUST 7, 2020
Credit: WSU Public plant breeding programs are declining across the United States. A team of scientists led by Kate Evans, a Washington State University horticulture professor who leads WSU’s pome fruit (apples and pears) breeding program, found that public plant breeding programs are seeing decreases in funding and personnel. The study was published in the […].
BioSpace
AUGUST 7, 2020
Genentech’s checkpoint inhibitor Tecentriq combined with chemotherapy failed to hit the mark in a Phase III metastatic triple-negative breast cancer study.
Scienmag
AUGUST 7, 2020
Credit: Pavel Odinev / Skoltech Nowadays, agriculture is going to become AI-native: Skoltech researchers have used the Zhores supercomputer to perform a very precise sensitivity analysis to reveal crucial parameters for different crop yields in the chernozem region. Their paper was published in the proceedings of the International Conference on Computational Science 2020.
The Pharma Data
AUGUST 7, 2020
AstraZeneca has signed its first deal in China to produce and deliver its vaccine candidate against COVID-19 in the country, partnering up with manufacturing firm Shenzhen Kangtai Biological Products. The deal is for 100 million doses of the candidate by the end of this year, known as AZD1222, which AZ is working on in partnership with the University of Oxford.
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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
AUGUST 7, 2020
UNC School of Medicine researchers describe in detail the different weaponry bacteria use to establish infection in the lungs of people with cystic fibrosis, depending on their age Credit: Cotter lab, UNC School of Medicine Several different kinds of bacteria can cause lung infections in people with cystic fibrosis (CF). Pseudomonas aeruginosa, which can cause […].
Pharma Times
AUGUST 7, 2020
Study co-led by UCL and the London School of Hygiene & Tropical Medicine
Scienmag
AUGUST 7, 2020
Credit: UTHSC Neil Hayes, MD, MS, MPH, division chief of Hematology and Oncology at the University of Tennessee Health Science Center, is among recipients of the 2020 Team Science Awards from the American Association for Cancer Research (AACR) for his contributions to developing The Cancer Genome Atlas (TCGA), a groundbreaking multisite project to understand cancer […].
BioSpace
AUGUST 7, 2020
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
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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.
Scienmag
AUGUST 7, 2020
Credit: NASA Helium is the second most abundant element in the universe after hydrogen. But scientists aren’t sure just how much there actually is in the Sun’s atmosphere, where it is hard to measure. Knowing the amount of helium in the solar atmosphere is important to understanding the origin and acceleration of the solar wind […].
Pharma Times
AUGUST 7, 2020
Allergy drug approved for severe chronic rhinosinusitis with nasal polyps
Scienmag
AUGUST 7, 2020
Credit: Photo provided by Jun Nishioka A group of researchers from three Japanese universities has discovered why the western subarctic Pacific Ocean, which accounts for only 6 percent of the world’s oceans, produces an estimated 26 percent of the world’s marine resources. Japan neighbors this ocean area, known for rich marine resources including salmon and […].
pharmaphorum
AUGUST 7, 2020
Biogen has bought a licence to co-develop and co-market potential Parkinson’s disease drugs with US biotech Denali, in a deal worth more than $2.1 billion. Denali has been working on small-molecule compounds capable of crossing the blood-brain barrier and Biogen has bought a licence to co-develop and co-market compounds known as LRRK2 inhibitors in Parkinson’s disease.
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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.
Scienmag
AUGUST 7, 2020
Wayne State University professor to lead efforts Credit: Wayne State University College of Engineering DETROIT – Shifting the current energy landscape away from fossil fuels is a major challenge that will require the development of sustainable and clean energy conversion and storage technologies including fuel cells, electrolyzers and batteries.
Pharmacy Checkers
AUGUST 7, 2020
Congress is on my mind this week. There’s a lot of talk on PharmacyCheckerBlog about Big Pharma doing this and Big Pharma doing that to keep drug prices high in America. Most often, I aim to expose them for outright lying or exaggerating about the risks of buying cheaper meds from foreign countries using online pharmacies. Criticism of the FDA follows a close second, and in large part due to Big Pharma’s outsized influence on the agency.
Scienmag
AUGUST 7, 2020
Credit: Gabriele Villarini, University of Iowa With a new Atlantic hurricane season in full swing, scientists may have found a new influence on how tropical cyclones develop. Researchers led by the University of Iowa have identified a connection between a climate system in East Asia and the frequency of tropical storms that develop in the […].
Pharma Times
AUGUST 7, 2020
First anti-BCMA therapy to be approved anywhere in the world
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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.
Scienmag
AUGUST 7, 2020
American Heart Association Scientific Statement DALLAS, Aug. 7, 2020 — The time has come for routine health care visits to include some form of dietary assessment and counseling, according to a new scientific statement from the American Heart Association published today in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.
BioSpace
AUGUST 7, 2020
Biopharma and life sciences companies strengthen their leadership teams and board with these Movers and Shakers.
Scienmag
AUGUST 7, 2020
AUSTIN, Texas — The “invisible” words that shaped Dickens classics also lead audiences through Spielberg dramas. And according to new research, these small words can be found in a similar pattern across most storylines, no matter the length or format. When telling a story, common but invisible words — a, the, it — are used […].
pharmaphorum
AUGUST 7, 2020
Health technology firms Cerner and LRVHealth have invested $6 million in Xealth to scale up its business offering digital health tools to patients and clinicians. The companies said the new relationship aims to give patients control over their own digital data so they can be more engaged in their treatment plans. Cerner and LRVHealth join Xealth’s other investors Atrium Health, Cleveland Clinic, Froedtert and the Medical College of Wisconsin, MemorialCare Innovation Fund, Providence Ventures 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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