Bio Pharma Dive
JUNE 30, 2021
A pill from Atea Pharmaceuticals rapidly reduced the amount of virus in the blood of patients with COVID-19, a step forward in drugmaker efforts to develop easier-to-take treatments for the disease.
World of DTC Marketing
JUNE 30, 2021
SUMMARY: The pharmaceutical trade publications, except STAT News and Endpoints, have remained silent on the sham approval of Biogen’s Alzheimer’s drug. Pharma trade magazines have become irrelevant, and most could care less what they print, although they try to suck up with phony awards. It’s up to people within the industry to push back and try to be the change we want and need to see.
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Bio Pharma Dive
JUNE 30, 2021
The companies aim to develop therapies for complement-driven diseases, a specialty of Apellis and relatively new research ground for gene editing.
XTalks
JUNE 30, 2021
Blood health and research organization Versiti Inc. is offering a comprehensive diagnostic for COVID-19 vaccine-induced blood clot testing to help in the accurate and prompt diagnosis of the rare but serious blood clots being seen after some individuals are vaccinated with viral vector COVID-19 vaccines such as those from AstraZeneca and Johnson & Johnson.
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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
JUNE 30, 2021
Biotech initial public offerings could break records set just last year. But their average size and performance are declining, which some in the industry say might reflect an overdue correction.
BioPharma Reporter
JUNE 30, 2021
Cobra Biologics, the gene therapy division of the Charles River owned Cognate BioServices, and Sweden's CombiGene recently announced the successful production and quality assurance of the plasmids to be used in the GMP production of the gene therapy, CG01.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 30, 2021
bluebird bio’s sickle cell disease (CD) gene therapy LentiGlobin is the latest recipient of an ‘innovation passport’ introduced in the UK earlier this year to speed up NHS access to promising new medicines. The designation means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced last December.
Pharma Times
JUNE 30, 2021
Innovation passport designation scheme aims to reduce the time to market for promising treatments
pharmaphorum
JUNE 30, 2021
Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . It’s a big disappointment for Altimmune, which said back in February that it was hoping to find a more convenient alternative to injected COVID-19 vaccines – and one which would be stable at room temperature, making distribution and delivery easier.
Scienmag
JUNE 30, 2021
Researchers determine suitable amplitude for electrically stimulating nerves in the mouth Credit: Dr. Hangue Park, Texas A&M Engineering Even the mundane act of swallowing requires a well-coordinated dance of more than 30 muscles of the mouth. The loss of function of even one of these, due to disease or injury, can be extremely debilitating. For […].
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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
pharmaphorum
JUNE 30, 2021
Pharma has both an opportunity and a responsibility to do its part in tackling climate change – and the time to act is now, according to speakers at a recent event. Amanda Barrell reports. The pharma industry has clearly stated its commitment to a net zero future, but where are we on that journey, what else can be done, and could organisations achieve more if they worked together?
Pharma Times
JUNE 30, 2021
Lenacapavir is designed to inhibit HIV-1 replication by interfering with a number of ‘essential’ steps in the viral lifecycle
Scienmag
JUNE 30, 2021
Loss of function of the C9orf72 gene may affect communication between neurons and muscles Credit: Christian Fleury Amyotrophic lateral sclerosis, or ALS, attacks nerve cells known as motor neurons in the brain and spinal cord, gradually leading to paralysis. The loss of function of an important gene, C9orf72, may affect communication between motor neurons and […].
pharmaphorum
JUNE 30, 2021
The University of Manchester has formed a joint venture with Morningside to carry out clinical trials of various digital health technologies developed by the investment group’s portfolio companies. . Health Innovation Manchester and its Academic Health Science Centre are also participating in the JV, which will focus on digital diagnostics and interventions that could play a role in prevention and early detection of disease and helping more patients to receive treatment outside the hospita
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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
JUNE 30, 2021
Credit: NTU Singapore Nanyang Technological University, Singapore (NTU Singapore) is collaborating with the Institute for Human Resource Professionals (IHRP) to launch two new MiniMasters™ programmes to develop talent in human resources (HR). The MiniMasters in HR Thought Leadership aims to strengthen HR practitioners’ business, digital, and financial acumen, while the MiniMasters in Strategic HR Performance […].
XTalks
JUNE 30, 2021
In this episode, Ayesha talks about a peripheral nerve stimulation system for chronic pain developed by biotech company NeuraLace that received 510(k) FDA clearance last week. The device uses electromagnetic induction technology to directly target nerves damaged from injuries like accidents, surgery and burns among others. The goal is to stimulate damaged nerves involved in the body’s natural pain-relief pathways, helping alleviate pain at the source rather than trying to mask it as most other n
Scienmag
JUNE 30, 2021
Credit: Copyright Joslin Diabetes Center Elevated levels of three specific circulating proteins are associated with protection against kidney failure in diabetes, according to research from the Joslin Diabetes Center that will be published 30th June in Science Translational Medicine. “As well as acting as biomarkers for advancing kidney disease risk in diabetes, the proteins may […].
Pharma Times
JUNE 30, 2021
The approval of Byfavo is based on data from a US-based Phase III clinical trial programme in procedural sedation
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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
JUNE 30, 2021
Wine grapes are particularly finicky when it comes to their environment. For instance, heatwaves and droughts lead to earlier berry ripening and lackluster wine. And these types of episodes are expected to intensify as Earth’s climate changes. Now, researchers reporting in ACS’ Journal of Agricultural and Food Chemistry have tweaked growing conditions for Cabernet Sauvignon […].
Pharma Times
JUNE 30, 2021
Immunotherapy regimen approved to treat metastatic colorectal cancer after prior chemotherapy
Scienmag
JUNE 30, 2021
The University of South Australia will lead a world-first study, using artificial intelligence, to map the risks of the most fatal reproductive cancer in women worldwide so it can be detected and treated earlier. Internationally-renowned nutritional epidemiologist Professor Elina Hypponen and a team from UniSA’s Australian Centre for Precision Health have been awarded $1.2 million […].
Clinical Trial Podcast
JUNE 30, 2021
This podcast episode highlights the top reasons for patient recruitment failure in clinical trials from an investigator perspective. The podcast episode will help you understand how Sponsor and CRO personnel including software vendors can best support investigators meet or exceed their patient recruitment. . The goal is to bring more awareness on how to prevent patient recruitment failure and complete enrollment as planned.
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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
JUNE 30, 2021
Small subsets of high-risk patients produce few or no antibodies, however SAN ANTONIO (June 30, 2021) — In a U.S. and Swiss study, nearly all patients with cancer developed good immune response to the COVID-19 mRNA vaccines three to four weeks after receiving their second dose, but the fact that a small group of the […].
pharmaphorum
JUNE 30, 2021
Shares in Pfizer spinout Cerevel Therapeutics have more than doubled after it reported positive early-stage results with CVL-231, a drug for schizophrenia that it thinks could have a clear side-effect profile than current therapies. The drug – a selective muscarinic M4 receptor positive allosteric modulator (PAM) – is designed to have limited effect on dopamine neurotransmission, a mechanism thought to contribute to tolerability issues with the current generation of antipsychotic drugs.
Scienmag
JUNE 30, 2021
Individuals who contract COVID-19 even after vaccination are likely to have a lower viral load, experience a shorter infection time and have milder symptoms than people who are unvaccinated, according to research that includes data from ongoing University of Arizona Health Sciences studies. “If you get vaccinated, about 90% of the time you’re not going […].
Drug Patent Watch
JUNE 30, 2021
Annual Drug Patent Expirations for LEXETTE Lexette is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for Mayne Pharma drug LEXETTE appeared first on DrugPatentWatch - Make Better Decisions.
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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
JUNE 30, 2021
A recent University of Arizona College of Pharmacy study suggests that Objective Structured Clinical Examinations (OSCEs) may be a valuable means of assesing clinical skills while providing learning experiences for pharmacy students in community pharmacy settings. While the OSCEs were designed to assess health care professionals in a clinical setting, there was limited data on […].
Drug Patent Watch
JUNE 30, 2021
Annual Drug Patent Expirations for RHOPRESSA Rhopressa is a drug marketed by Aerie Pharms Inc and is included in one NDA. It is available from one supplier. There are ten…. The post New patent for Aerie Pharms drug RHOPRESSA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 30, 2021
Credit: U.S. Army ADELPHI, Md. — Army and industry researchers are working to deliver new technology so Soldiers can protect themselves and their assets on the battlefield using enhanced communication methods. Through the U.S. Army’s xTech program, researchers from the U.S. Army Combat Capabilities Development Command, known as DEVCOM, Army Research Laboratory and Syncopated Engineering […].
Drug Patent Watch
JUNE 30, 2021
Annual Drug Patent Expirations for ROCKLATAN Rocklatan is a drug marketed by Aerie Pharms Inc and is included in one NDA. It is available from one supplier. There are eleven…. The post New patent for Aerie Pharms drug ROCKLATAN 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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