Bio Pharma Dive
MARCH 2, 2021
Since December, three drugmakers have withdrawn immunotherapies from indications previously granted fast-tracked approvals, suggestive of broader FDA concerns.
World of DTC Marketing
MARCH 2, 2021
SUMMARY: Almost every pharma company seems to be posting open digital marketing positions on LinkedIn but are they really hiring? A quick check of three open positions found that they “were on hold” due to budget constraints. Pharma acknowledges the need to get better in digital marketing, which starts with hiring the right people. The open positions for emarketing people seem to be everywhere, but almost every industry is adding more digital marketing people as people shift to buyin
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Bio Pharma Dive
MARCH 2, 2021
Though a mid-stage study read out negative, Neurocrine still sees a path forward for the drug, which it licensed from Takeda last summer.
Pharma Mirror
MARCH 2, 2021
Eisai Co., Ltd. announced that its Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. has obtained approval for the in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. This approval is the first approval for DAYVIGO in Asia outside of Japan.
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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
MARCH 2, 2021
The biotech expected the FDA to rule on approval of its anemia drug by March 20. But a newly announced advisory committee meeting seems to make a decision by then unlikely.
Pharma Mirror
MARCH 2, 2021
I Holland, leaders in the manufacture of tablet tooling for the pharmaceutical and nutraceutical markets, has announced a series of appointments to form a new senior management team to lead the company moving forward. The new Board of Directors consists of six highly-experienced team members many of which remain from the previous management team. David Hinds has handed over the baton of Managing Director to Javier Raposo but will continue to serve on the Board as Non-Executive Director.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
MARCH 2, 2021
Recent research suggests that it may be possible to categorize GBM into different subtypes based on the underlying biological mechanisms driving tumor development and growth.
BioPharma Reporter
MARCH 2, 2021
This week France has raised the age limit for the AstraZeneca COVID-19 vaccine; but Canada, conversely, has put a 65-year-old limit into its recommendations.
BioSpace
MARCH 2, 2021
Across the Pharm Country Hotbed, the agency has provided hundreds of millions of dollars to universities, research institutes and pharmaceutical companies.
Scienmag
MARCH 2, 2021
Elder suns with low-mass companions Credit: Andrzej Romanski/NCU An international team led by Prof. dr habil. Andrzej Niedzielski, an astronomer from the Nicolaus Copernicus University in Torun (Poland), has discovered yet another three extrasolar planets. These planets revolve around the stars that can be called elder sisters of our Sun. You can read about the […].
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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
MARCH 2, 2021
Bionauts™, a novel treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, or small molecule therapies to precise areas of the brain, has the potential to go where no therapy has gone before, opening up new pathways in the fight against devastating CN.
pharmaphorum
MARCH 2, 2021
With COVID-19 forcing a shift towards decentralised trials, two digital health firms – Medable and Seqster – have teamed up to offer ways to also incorporate real-world data into remote study designs. . Decentralised studies reduce or eliminate the need to travel to clinical sites, and the two partners want to go even further by harnessing technologies that can provide additional data in real-time to generate “a more holistic view of patient health,” according to Medable CEO Dr Michelle Longmire
BioSpace
MARCH 2, 2021
GE Research selected DNA Script to join a collaboration working on a rapid response, mobile platform to develop on-demand production of nucleic acid-based vaccines and therapies related to biological threats.
Scienmag
MARCH 2, 2021
Credit: FSU Photography Services A team of international researchers led by a Florida State University assistant professor has analyzed reams of data from the Neolithic to Late Roman period looking at migration patterns across the Mediterranean and found that despite evidence of cultural connections, there’s little evidence of massive migration across the region. “Because of […].
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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
MARCH 2, 2021
The topline data from the BRAVE-AA2 study in 546 adults showed both 2 mg and 4 mg doses of Olumiant regrew hair in adult patients with more than 50% scalp hair loss, compared with placebo.
Scienmag
MARCH 2, 2021
Credit: American Astronomical Society (AAS) WASHINGTON — About 17 years ago, J. Martin Laming, an astrophysicist at the U.S. Naval Research Laboratory, theorized why the chemical composition of the Sun’s tenuous outermost layer differs from that lower down. His theory has recently been validated by combined observations of the Sun’s magnetic waves from the Earth […].
BioSpace
MARCH 2, 2021
The study of VIR-7831, which is a dual-action SARS-CoV-2 monoclonal antibody, was recommended to be closed to enrollment by an independent data monitoring board, stating that "there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of.
Scienmag
MARCH 2, 2021
Human gum cells as a test system for investigating interactions between resveratrol, bitter receptors and the release of inflammatory markers Credit: Photographer: Joseph Krpelan, Copyright: Prof. Dr. Veronika Somoza Resveratrol is a plant compound found primarily in red grapes and Japanese knotweed. Its synthetic variant has been approved as a food ingredient in the EU […].
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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.
BioPharma Reporter
MARCH 2, 2021
AstraZeneca, through its partnership with the Serum Institute of India, says it is the biggest initial COVID-19 vaccine supplier to COVAX.
Scienmag
MARCH 2, 2021
Study challenges classic notion of mammal spine evolution Credit: Ken Angielczyk When it comes to the evolution of the mammal spine — think of animals whose backbone allows them to gallop, hop, swim, run, or walk upright — a key part of the tale is quite simple. Because nonmammalian synapsids, the extinct forerunners to mammals, […].
Outsourcing Pharma
MARCH 2, 2021
According to Noxopharm, a recent study shows combining its Veyonda drug and a radiopharmaceutical yields favorable results against prostate cancer.
BioSpace
MARCH 2, 2021
STI-2099 is a formulation of its antibody against COVID-19 that can be taken in a nasal spray. It is also evaluating the antibody in an intravenous form (STI-2020) in a Phase I trial.
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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
MARCH 2, 2021
Syneos Health Communications has made several senior hires to strengthen its Europe-based team. A portfolio of Syneos Health agencies, Syneos Health Communications, offers expertise spanning advertising and branding, public relations and medical communications. Orrin Pollard. Among the most notable hires is Orrin Pollard, who joins as director of European creative expression.
BioSpace
MARCH 2, 2021
With the overflow of investments into life sciences, who has time to keep up? Find your weekly snapshot of where the cash is headed in this week's Money on the Move.
Scienmag
MARCH 2, 2021
Credit: Copyright Diamond Light Source Ltd In June 2019, an international team brought the complete skull of the 3.67-million-year-old Little Foot Australopithecus skeleton, from South Africa to the UK and achieved unprecedented imaging resolution of its bony structures and dentition in an X-ray synchrotron-based investigation at the UK’s national synchrotron, Diamond Light Source.
BioSpace
MARCH 2, 2021
Takeda will develop soticlestat, a first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), as a potential treatment for developmental and epileptic encephalopathies.
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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
MARCH 2, 2021
Credit: Sarah Atkinson/Michigan Tech Imagine you’re driving up a hill toward a traffic light. The light is still green so you’re tempted to accelerate to make it through the intersection before the light changes. Then, a device in your car receives a signal from the controller mounted on the intersection alerting you that the light […].
BioSpace
MARCH 2, 2021
Century Therapeutics received a $160 million infusion of cash to advance the company’s pipeline of induced pluripotent stem cell (iPSC)-derived cell therapies for cancer.
Scienmag
MARCH 2, 2021
UNC-Chapel Hill scientists Charles Carter, Qi Zhang, and Abigail Knight were awarded $1 million from the W.M. Keck Foundation to answer the age-old question: How did life on Earth begin? Credit: UNC-Chapel Hill CHAPEL HILL, NC – About four billion years ago, life arose from a primordial soup of chemicals. Somehow, amino acids linked together […].
Pharma Times
MARCH 2, 2021
Focus of the agreement is a first-in-class small molecule adenosine A2B receptor antagonist
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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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