Bio Pharma Dive
MARCH 9, 2022
Patients with severe hemophilia A who were given the drug had, on average, less than one bleeding event over a year, results that Sanofi and partner Sobi believe will pass muster with regulators.
pharmaphorum
MARCH 9, 2022
Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. New phase 3 data on efanesoctocog alfa (also known as BIVV001) has met its objectives in a phase 3 study, providing protection from bleeding episodes in patients with haemophilia A with once-weekly dosing.
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Bio Pharma Dive
MARCH 9, 2022
A settlement will allow the Iceland-based drugmaker to launch its Humira copycat, currently under FDA review, in the U.S. beginning next July.
Scienmag
MARCH 9, 2022
Danish and Swedish researchers have dated the enormous Hiawatha impact crater, a 31 km-wide meteorite crater buried under a kilometer of Greenlandic ice. The dating ends speculation that the meteorite impacted after the appearance of humans and opens up a new understanding of Earth’s evolution in the post-dinosaur era. Credit: University of Copenhagen Danish and […].
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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 9, 2022
Supplies of the drug, called Paxlovid, have become more available for adults in the U.S., which recently began rolling out a "test-to-treat" initiative likely to make use of Pfizer's pill.
Pharma Times
MARCH 9, 2022
Trodelvy is accepted for use in mTNBC patients who have already received two or more systemic therapies
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
MARCH 9, 2022
Results showed a clinically meaningful prevention of bleeds in people with severe haemophilia A
Scienmag
MARCH 9, 2022
CHAMPAIGN, Ill. — California is a national leader in renewable energy development. But energy systems development is driven more by financial considerations than environmental ones, leaving customers more vulnerable to the effects of climate change, a University of Illinois Urbana-Champaign researcher determined. Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — California is a national […].
pharmaphorum
MARCH 9, 2022
There isn’t enough evidence to support the use of Merck & Co/MSD’s Keytruda in combination with chemotherapy as a first-line treatment for advanced triple negative breast cancer, according to the UK cost effectiveness watchdog NICE. In draft guidance, the agency has said that while Keytruda (pembrolizumab) added to chemotherapy is more effective than chemo alone.
Scienmag
MARCH 9, 2022
When you look at ponds, you might see birds and fish, but you probably don’t think about carbon. In fact, Florida’s 76,000 ponds store plenty of carbon, and a lot of it escapes into the atmosphere. Credit: Audrey Goeckner, UF/IFAS When you look at ponds, you might see birds and fish, but you probably don’t […].
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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
Clairnes
MARCH 9, 2022
The post Interview with Dr. Laura Blauth about her work in music therapy trials for dementia appeared first on Clinical Trial Recruitment & Management Services.
Scienmag
MARCH 9, 2022
New method pinpoints how dogs move, and could use information about their gait to find them the right harness Credit: Pálya et al., 2022, PLOS ONE, CC-BY 4.0 ([link] New method pinpoints how dogs move, and could use information about their gait to find them the right harness ### Article URL: [link] Article Title: […].
Roots Analysis
MARCH 9, 2022
Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical products are currently under clinical investigation worldwide. .
Scienmag
MARCH 9, 2022
Berkeley — When Google unveiled its first autonomous cars in 2010, the spinning cylinder mounted on the roofs really stood out. It was the vehicle’s light detection and ranging (LiDAR) system, which worked like light-based radar. Together with cameras and radar, LiDAR mapped the environment to help these cars avoid obstacles and drive safely. Credit: […].
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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.
The Pharma Data
MARCH 9, 2022
Novartis today announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets. A leader in gene therapy with a strong commitment to developing treatments for diseases of the central nervous system, Novartis seeks to apply its expertise and recent learnings to neurological
Scienmag
MARCH 9, 2022
The soils and vegetation of Patagonia’s fjord regions form a unique and highly sensitive ecosystem that is closely linked to marine ecosystems, sediment deposition and carbon storage in the ocean. A research team, including the University of Göttingen, has been working on reconstructing the climate history of this region in this extremely wet, rainy and […].
The Pharma Data
MARCH 9, 2022
Once-weekly efanesoctocog alfa met primary endpoint in phase 3 study, resulting in a clinically meaningful prevention of bleeding episodes (bleed protection) In the key secondary endpoint, efanesoctocog alfa demonstrated superiority in prevention of bleeding episodes, showing a statistically significant and clinically meaningful reduction in annualized bleeding rate compared to prior factor VIII prophylaxis therapy Efanesoctocog alfa is a novel and investigational factor VIII therapy designed to
Scienmag
MARCH 9, 2022
RIVERSIDE, Calif. — Each simple RNA virus has a genome, its “native RNA.” This genome dictates how the virus replicates in cells to eventually cause disease. The genome also has the code for making a capsid, the protein shell of a virus that encapsulates the genome and protects it like a nanocontainer. Credit: Zandi lab, […].
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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.
The Pharma Data
MARCH 9, 2022
Access to safe abortion critical for health of women and girls: WHO. The World Health Organization (WHO) is releasing new guidelines on abortion care today, in a bid to protect the health of women and girls and help prevent over 25 million unsafe abortions that currently occur each year. “Being able to obtain safe abortion is a crucial part of health care,” said Craig Lissner, acting Director for Sexual and Reproductive Health and Research at WHO.
Scienmag
MARCH 9, 2022
COLUMBIA, Mo. — After a stroke, patients may lose feeling in an arm or experience weakness and reduced movement that limits their ability to complete basic daily activities. Traditional rehabilitation therapy is very intensive, time-consuming and can be both expensive and inconvenient, especially for rural patients travelling long distances to in-person therapy appointments.
The Pharma Data
MARCH 9, 2022
Investigators at Cedars-Sinai have identified a potential new therapy for COVID-19: a biologic substance created by reengineered human skin cells. Scientists found the substance stopped SARS-CoV-2, the virus that causes COVID-19, from reproducing itself and also protected infected cells when tested in human lung cells. Although still in the early stages, the findings open the possibility of having a new therapy for COVID-19 patients.
Scienmag
MARCH 9, 2022
Currently, there is little research focused on understanding mechanisms and drug discovery of lymphatic vascular diseases. However, conditions such as lymphedema, a buildup of fluid in the body when the lymph system is damaged, impact more than 200,000 people every year in the United States alone. Credit: Dr. Abhishek Jain/Texas A&M Engineering Currently, there is […].
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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.
Drug Patent Watch
MARCH 9, 2022
Annual Drug Patent Expirations for SYNDROS Syndros is a drug marketed by Benuvia and is included in one NDA. There are three patents protecting this drug and two Paragraph IV…. The post New patent for Benuvia drug SYNDROS appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MARCH 9, 2022
Pioneering research by the University of Leicester into chronic kidney disease has received a major boost on World Kidney Day (10th March 2022) following a generous £1million donation from long-term supporter and kidney health advocate Jimmy Mayer. Credit: University of Leicester Pioneering research by the University of Leicester into chronic kidney disease has received a […].
Drug Patent Watch
MARCH 9, 2022
Annual Drug Patent Expirations for MAVYRET Mavyret is a drug marketed by Abbvie Inc and is included in two NDAs. It is available from one supplier. There are seven patents…. The post New patent for Abbvie Inc drug MAVYRET appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
MARCH 9, 2022
An early-stage collaboration between a U of T Scarborough researcher and The BRIDGE will work to ensure that Ghanaian cashew farmers receive equitable wages for their valuable export. Credit: Ken Jones An early-stage collaboration between a U of T Scarborough researcher and The BRIDGE will work to ensure that Ghanaian cashew farmers receive equitable wages for their valuable export. […].
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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.
pharmaphorum
MARCH 9, 2022
MIP, the Business School of Politecnico di Milano, the largest technical university, is partnering with Healthware Group, a digital health consultancy (and pharmaphorum’s parent company) to launch a new executive programme aimed at providing digital health literacy and education to life sciences executives, as well as to the startup community. The five-month program will begin in June of this year and is currently accepting applications.
Scienmag
MARCH 9, 2022
A team led by scientists at the University of Birmingham has come a step closer to uncovering the purpose of a distinctive set of modifications found at the beginning of messenger RNA which have long remained a fundamental mystery in molecular biology. Messenger RNAs (mRNAs) are vital for protein production. Their specific structure at the […].
Pharma in Brief
MARCH 9, 2022
The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Court dismissed allegations of anticipation based on prior art, as well as arguments that the asserted claims were invalid due to lack of demonstrated utility, insufficiency of disclosure, and/or overbreadth.
Scienmag
MARCH 9, 2022
CHAMPAIGN, Ill. — For 700 years, Mexico City’s public square, known as the Zócalo, has been the place where many of the nation’s most significant events unfolded. Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — For 700 years, Mexico City’s public square, known as the Zócalo, has been the place where many of the […].
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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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