Bio Pharma Dive
AUGUST 24, 2020
Vertex pioneered a more precise way of developing drugs. Relay, which has raised nearly $1 billion since its founding five years ago, thinks it can go one step further.
BioSpace
AUGUST 24, 2020
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
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Bio Pharma Dive
AUGUST 24, 2020
The biotech's plans to challenge Vertex Pharmaceuticals have fallen short, leading to a merger with a neuroscience-focused startup.
pharmaphorum
AUGUST 24, 2020
Could collecting, understanding, and disseminating patient-reported outcomes during trials be the key to advancing oncology treatments and improving cancer outcomes? . With our understanding of cancer accelerating at an unprecedented rate, and personalised medicines on the cusp of becoming mainstream, regulatory bodies need new ways to assess products. .
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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 24, 2020
The deal would designate up to 160 million doses of Moderna's shot for the European Union, which has worked aggressively of late to bolster its supply.
NY Times
AUGUST 24, 2020
Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where a key statistic came from.
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Outsourcing Pharma
AUGUST 24, 2020
Led by the Spaulding Rehabilitation Hospital, a study by a 60-person task force shows ways mobile health tech can help mitigate the pandemicâs effects.
BioSpace
AUGUST 24, 2020
The genetic sequences of the two samples were markedly different, which strengthened the theory that the patient had been infected a second time.
Pharma Times
AUGUST 24, 2020
The study assessed investigational immunotherapy spartalizumab (PDR001) in combination with targeted therapies Tafinlar and Mekinist
BioSpace
AUGUST 24, 2020
The Hadean Platform, a distributed computing platform, streamlines running applications via cloud by removing excessive middleware and helping scale the process – a journey that has taken them from the world of gaming to the modeling a pandemic.
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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
AUGUST 24, 2020
European Commission lines up deal to buy 405 million COVID-19 vaccines from CureVac, swelling stockpile to 1.5 billion doses.
BioSpace
AUGUST 24, 2020
ATAI Life Sciences announced on Monday that it has launched EmpathBio, a wholly-owned subsidiary focused on developing derivatives of 3,4-methylenedioxy-methamphetamine (MDMA) for the treatment of post-traumatic stress disorder.
Pharma Times
AUGUST 24, 2020
A 33-year-old man was infected twice with slightly different strains of coronavirus more than four months apart
NY Times
AUGUST 24, 2020
Sowing doubt about the safety of treatments will imperil the fight against coronavirus in the months and years to come.
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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.
Pharma Times
AUGUST 24, 2020
Parties to adopt multi-phase approach to develop precision medicine strategies to optimize treatment of cardiovascular, renal and metabolic disease
Scienmag
AUGUST 24, 2020
New findings may provide new therapeutic target and help explain why IBD and other autoimmune diseases are often chronic and life-long Credit: NIAID Inflammatory bowel disease (IBD) is a group of intestinal disorders affecting an estimated six to eight million people worldwide. Although there are many treatments for IBD, a number of patients fail to […].
Pharma Times
AUGUST 24, 2020
Clearance was based on two global Phase III studies showing statistically significant improvements in lung function
Scienmag
AUGUST 24, 2020
An in-depth Garvan study of how the immune system generates effective antibodies provides new insights for vaccine design. Credit: Dr Ofir Shein-Lumbroso, Garvan Institute of Medical Research An in-depth Garvan study of how the immune system generates effective antibodies provides new insights for vaccine design. Researchers at the Garvan Institute of Medical Research have uncovered […].
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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.
pharmaphorum
AUGUST 24, 2020
Takeda has joined the ranks of big pharma companies jettisoning consumer health businesses in order to concentrate on higher-margin prescription drugs. The drugmaker is divesting Takeda Consumer Healthcare, which operates mainly in Japan, to private equity group Blackstone for 242 billion yen ($2.3 billion), with the deal expected to close in March of next year.
Scienmag
AUGUST 24, 2020
The research took place within UK’s Sanders-Brown Center on Aging Credit: Photo by Mark Cornelison | UKphoto LEXINGTON, Ky. – Research looking at a possible new therapeutic approach for Alzheimer’s disease was recently published in the Journal of Neuroinflammation. The paper out of the University of Kentucky’s Sanders-Brown Center on Aging (SBCoA) is titled “Therapeutic […].
Pharma Times
AUGUST 24, 2020
The monoclonal antibody combination is being tested for prevention and treatment of coronavirus
BioSpace
AUGUST 24, 2020
BMS announced that the Phase III IDHENTIFY trial of Idhifa (enasidenib) plus best supportive care (BSC) compared to conventional care, did not meet the primary endpoint of overall survival in relapsed or refractory acute myeloid leukemia (r/r AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.
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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 24, 2020
Credit: Kazuya Ono Ice is melting at a surprisingly fast rate underneath Shirase Glacier Tongue in East Antarctica due to the continuing influx of warm seawater into the Lützow-Holm Bay. Hokkaido University scientists have identified an atypical hotspot of sub-glacier melting in East Antarctica. Their findings, published in the journal Nature Communications, could further understandings and […].
pharmaphorum
AUGUST 24, 2020
With the ink barely dry on a deal to develop Dragonfly’s lead cancer immunotherapy, Bristol-Myers Squibb’s business development team has agreed to buy Canadian biotech Forbius and its pipeline of drugs for cancer and fibrotic diseases. Since its foundation in 2011, privately-held Forbius has been working on drugs that inhibit TGF beta 1 and 3, two targets thought to play a role in protecting cancers from attack by the immune system and the development of fibrosis (scarring).
Pharma Times
AUGUST 24, 2020
The £588-million fund can be used to provide up to six weeks of care and support following hospital discharge
Outsourcing Pharma
AUGUST 24, 2020
The pharmaceutical technology investment fund is partnering with and financing Atomwise, a company that provides AI solutions for drug discovery.
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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 24, 2020
New research suggests that Black patients may have less pain and anxiety when treated by a physician of their own race When doctors are the same race as their patients, it can sometimes forge a sense of comfort that helps to reduce anxiety and pain, particularly for Black patients, new research from the University of […].
The Pharma Data
AUGUST 24, 2020
U.S. Army photo by Jason W. Edwards. The FDA could expand its Emergency Use Authorization (EUA) for Gilead’s remdesivir for treating coronavirus patients, according to Gilead. Currently, the FDA guidelines state that the treatment can be given to patients experiencing severe symptoms from coronavirus. Recent studies by Gilead show that a five-day course of intravenous remsdesivir modestly helped less severe cases of COVID-19, but a 10-day course did not show much benefit.
Scienmag
AUGUST 24, 2020
New fossil species belongs to a group of extant starfish-like creatures living in the deep sea today Credit: Dr Ben Thuy Palaeontologists from the Natural History Museums in Luxembourg and Maastricht have discovered a previously unknown species of brittle star that lived in the shallow, warm sea which covered parts of the present-day Netherlands at […].
The Pharma Data
AUGUST 24, 2020
Image copyright. Getty Images. While mums-to-be and women trying for a baby should limit their caffeine intake, a couple of cups of tea or coffee a day is fine, say experts. Their comments come as a new research paper in a medical journal suggests there is no safe level in pregnancy. But the experts say that is alarmist. The NHS and many other organisations say consuming 200mg or less a day should not pose any significant risk in terms of miscarriage or growth of the baby while in the womb.
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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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