Bio Pharma Dive
SEPTEMBER 8, 2020
A participant in a clinical trial of the experimental shot suffered from an unexplained illness, triggering an investigation and a pause in vaccinations.
BioSpace
SEPTEMBER 8, 2020
Preclinical data for Pfizer and BioNTech’s Phase II/III COVID-19 mRNA vaccine candidate generated BNT162b2 strong anti-viral effects against an infectious SARS-CoV-2 challenge.
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Bio Pharma Dive
SEPTEMBER 8, 2020
In an unusual letter, the heads of nine top vaccine developers pledged to "stand with science" and only move forward with approval applications if warranted by clinical results.
BioSpace
SEPTEMBER 8, 2020
In people with diabetes, periods of high blood sugar can negatively impact their health years later, even if they get their blood sugar under control. While this ‘metabolic memory’ phenomenon has been known for years, why it happens is poorly understood.
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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 8, 2020
Gavreto is cleared to treat certain lung cancer patients who have so-called RET mutations. Partners Blueprint and Roche will now compete with Eli Lilly and its rival drug Retevmo.
pharmaphorum
SEPTEMBER 8, 2020
An EU consumer body has urged the European Commission to keep compensation measures in place for people who might be harmed in COVID-19 vaccine trials, responding to reports that the drug industry is lobbying to reduce liability. In a letter to the Commissioner for Health and Food Safety Stella Kyriakides, the BEUC says that even though the need for a coronavirus vaccine is urgent, access “must go hand in hand with adequate consumer compensation in case of harm.”.
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BioSpace
SEPTEMBER 8, 2020
A study published in Nature Communications on August 27 shows that a feline antiviral drug was effective at inhibiting the replication of human coronaviruses in cell cultures infected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Outsourcing Pharma
SEPTEMBER 8, 2020
The company has submitted an investigational new drug application for FSD201, a possible therapy for patients with severe cases of the virus.
BioSpace
SEPTEMBER 8, 2020
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
BioPharma Reporter
SEPTEMBER 8, 2020
AbbVie has boosted its immunotherapy pipeline in a global licensing deal with Chinese biotech, I-Mab, for its anti-CD47 monoclonal antibody, lemzoparlimab.
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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
Outsourcing Pharma
SEPTEMBER 8, 2020
The collaboration combines two solutions to help pharma and healthcare providers deal with myriad challenges associated with limited drug supplies.
BioSpace
SEPTEMBER 8, 2020
This morning, Dublin-based Amryt said the primary endpoint of the late-stage study was met.
XTalks
SEPTEMBER 8, 2020
Albany Molecular Research Inc (AMRI), a global provider of advanced drug development and manufacturing solutions, announced that they have signed a supply agreement with AstraZeneca. The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus. AZD1222 is now in Phase III clinical trials which will enroll approximately 30,000 adult volunteers in 80 states in the US, to determine whether the vaccine c
NY Times
SEPTEMBER 8, 2020
The company halted late-stage trials of its coronavirus vaccine because of a serious suspected adverse reaction in a participant.
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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 8, 2020
Rockville, Maryland-based OncoImmune closed on a Series B round worth $56 million.
pharmaphorum
SEPTEMBER 8, 2020
Sandoz’s Pierre Bourdage looks at the unexpected secondary impacts of COVID-19 on countries and healthcare systems, and asks how pharma can help improve sustainability to tackle them. It is undeniable that the COVID-19 pandemic has had a tremendous impact on all aspects of our lives, with ripple effects continuing to evolve. Faced with constant and overwhelming information about the pandemic, including rapidly changing policy responses, there is also an alarming acceleration of a healthcare sust
BioSpace
SEPTEMBER 8, 2020
Like almost all conferences this year, Citi’s 15th Annual BioPharma Conference 2020 is being held virtually.
BioPharma Reporter
SEPTEMBER 8, 2020
The chief executives of nine leading biopharma companies have moved to reassure the public over the development and testing procedures for Covid-19 vaccines.
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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
SEPTEMBER 8, 2020
Strength of the average prescription is at levels linked to an increased risk of overdose death Credit: Texas A&M University Health Science Center New research from Texas A&M University and the University of Pennsylvania on opioid prescribing practices across the country after outpatient knee surgeries found that prescription strength and number of tablets is prescribed […].
Pharma Times
SEPTEMBER 8, 2020
The decisions bring a raft of new treatment options for conditions including epilepsy, depression and cancer
Scienmag
SEPTEMBER 8, 2020
Credit: Zachary Randall/Florida Museum GAINESVILLE, Fla. — An international team of scientists has identified at least 11 species of fish suspected to have land-walking abilities. The findings are based on CT scans and a new evolutionary map of the hillstream loach family, which includes the only living fish species caught in the act of walking: […].
Pharma Times
SEPTEMBER 8, 2020
Preliminary guidelines reject NHS funding for the drug for BRAF V600E mutation-positive metastatic colorectal cancer
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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
SEPTEMBER 8, 2020
Key patterns of brain function are more pronounced with more severe symptoms Credit: UCLA Health A new UCLA study shows partially overlapping patterns of brain function in people with anorexia nervosa and those with body dysmorphic disorder, a related psychiatric condition characterized by misperception that particular physical characteristics are defective.
The Pharma Data
SEPTEMBER 8, 2020
Image copyright. Getty Images. Social gatherings of more than six people will be illegal in England from Monday – with some exemptions – amid a steep rise in coronavirus cases. A new legal limit will ban larger groups meeting anywhere socially indoors or outdoors, No 10 said. But it will not apply to schools, workplaces or Covid-secure weddings, funerals and organised team sports.
Scienmag
SEPTEMBER 8, 2020
Credit: Charlie Ehlert Racial disparities among essential workers could be a key reason that Black Americans are more likely than whites to contract and die of COVID-19, according to researchers at the University of Utah. They found that Blacks disproportionately worked in nine vital occupations that increase their exposure to SARs-CoV-2, the virus that causes […].
Drug Patent Watch
SEPTEMBER 8, 2020
Annual Drug Patent Expirations for BYDUREON+PEN Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are twenty-nine…. The post Patent delisted for Astrazeneca Ab drug BYDUREON PEN 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
SEPTEMBER 8, 2020
Astrocytic GABA fine-tunes tactile sensory acuity Credit: IBS Parents might be familiar with their toddlers gotten messy with flour. Feeling the soft texture of flour, kids can spend the whole time and create, explore and learn through the messy play. Such tactile sensory play is an effective stimulus for children’s senses as the tactile system […].
Drug Patent Watch
SEPTEMBER 8, 2020
Annual Drug Patent Expirations for AMPYRA Ampyra is a drug marketed by Acorda and is included in one NDA. It is available from two suppliers. Drug patent litigation for AMPYRA.…. The post Patent delisted for Acorda drug AMPYRA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
SEPTEMBER 8, 2020
Credit: Avalos Lab/Princeton University Researchers at Princeton University have created a new and improved way to more precisely control genetically engineered bacteria: by simply switching the lights on and off. Working in E. coli, the workhorse organism for scientists to engineer metabolism, researchers developed a system for controlling one of the key genetic circuits needed […].
Drug Patent Watch
SEPTEMBER 8, 2020
Annual Drug Patent Expirations for OXYCONTIN Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from eight suppliers. There are twenty-three…. The post Patent delisted for Purdue Pharma drug OXYCONTIN 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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