Bio Pharma Dive
SEPTEMBER 27, 2021
The hold, which was put in place by the FDA during the fourth quarter last year, came after five patients in an early trial experienced muscle weakness following treatment.
Pharma Mirror
SEPTEMBER 27, 2021
With the COVID-19 coronavirus outbreak, emergency preparedness has become an increasing concern. In extreme pandemics, overburdened healthcare systems can delay critical medical services or a shortage of essential supplies, but these supplies serve an important purpose. Our list of essentials for a survival medical kit is vital for every home, so we have compiled it for you.
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Bio Pharma Dive
SEPTEMBER 27, 2021
The discovery and development of next generation therapeutics will drive the availability and use of Biologics to meet the unmet medical needs, never imagined before.
Pharma Mirror
SEPTEMBER 27, 2021
New York/USA, At Interphex 2021 in New York, Syntegon (formerly Bosch Packaging Technology) presents new solutions for lab-scale and small batch filling of solid and liquid pharmaceuticals. “The need for smaller quantities of highly potent drugs is rising continuously. We have put these solutions in the focus of our current development activities and are proud to offer our customers a number of exciting new technologies”, says Thomas Mauritzen, General Manager at Syntegon Minneapolis.
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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 27, 2021
Phase 3 results showed Merck's drug improved overall survival versus placebo, which should lessen pressure for a market withdrawal in the indication.
Pharma Mirror
SEPTEMBER 27, 2021
SHANGHAI, Hua Medicine (“Hua Medicine”; SEHK: 2552) today announced that at the 6th China BioMed Innovation and Investment Conference held September 25-27 in Suzhou, China (the “CBIIC”), Professor Jianhua MA, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, as one of the principal researchers, presented the results from a clinical study called DREAM, which showed that dorzagliatin, a glucokinase activato
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 27, 2021
As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most. This already significant industry is growing – it is estimated to be worth $1.27 trillion by end of 2020.
BioPharma Reporter
SEPTEMBER 27, 2021
CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., have enrolled the first participant in a Phase 1 clinical trial of their intranasal COVID-19 vaccine in Rochester, NY.
BioSpace
SEPTEMBER 27, 2021
Pfizer and BioNTech share data with FDA on COVID-19 vaccines for younger children as Sanofi pivot on its mRNA COVID-19 vaccine, shifting focus toward other infectious diseases instead.
BioPharma Reporter
SEPTEMBER 27, 2021
Takeda has received approval from Japanâs ministry of health to manufacture and market its stem cell therapy, Alofisel, for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohnâs disease (CD).
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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
XTalks
SEPTEMBER 27, 2021
Although the US Food and Drug Administration (FDA) doesn’t vet pharma ads, it has a “Bad Ad” program that now has an interactive quiz to help in the reporting of misleading information in pharmaceutical promotions. The FDA’s Bad Ad Program is an outreach program designed to help healthcare providers (HCP) report potentially false or misleading prescription drug promotion and report it to the FDA for review.
BioSpace
SEPTEMBER 27, 2021
The Phase II trial, VLA150202, evaluated the safety and immunogenicity of VLA15 on 246 healthy adults aged 18 to 65 years old across the United States.
XTalks
SEPTEMBER 27, 2021
SquarEat , a Miami-based company, is breaking the internet with its latest food innovation. The company is reinventing meal kits by revolutionizing the way we eat them. The concept behind SquarEat is that any food can be shaped into a 50 g square that provides consumers with nutrients in a flavorful, affordable and ready-to-eat way. The square-shaped food is made from natural ingredients prepared and created in low temperatures that preserve all the nutrients and extends the foods’ shelf l
BioPharma Reporter
SEPTEMBER 27, 2021
The biopharma industry continues to seek technologies that enable process control, while improving process development times and quality, says a Gamma Biosciences executive.
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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.
pharmaphorum
SEPTEMBER 27, 2021
Capricor Therapeutics’ bid to find a partner for its Duchenne muscular dystrophy (DMD) cell therapy CAP-1002 could get a boost after final phase 2 data showed a strong effect on disease progression. Initial results from the 20-patient HOPE-2 trial reported last year showed signs of activity in older boys and young men with advanced DMD , prompting Capricor to ask the FDA about the possibility of filing for approval based on the mid-stage trial.
Outsourcing Pharma
SEPTEMBER 27, 2021
The protease inhibitor PF-07321332 (co-administered with ritonavir) is designed for patients exposed to (or showing the first signs of) the COVID-19 virus.
NY Times
SEPTEMBER 27, 2021
A growing number of cancer patients, especially those with breast and lung cancers, are being spared the dreaded treatment in favor of other options.
BioSpace
SEPTEMBER 27, 2021
Peter Marks will serve as acting director of the Office of Vaccines Research and Review at the U.S. FDA following the resignation of two top officials at the agency.
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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 27, 2021
The Korea Institute of Machinery and Materials (KIMM), an institute under the jurisdiction of the Ministry of Science and ICT, has developed a flexible, stretchable battery that bends and stretches like a snake. This new battery is expected to have a wide range of uses, such as in energy storage technology and disaster situations, by […].
BioSpace
SEPTEMBER 27, 2021
Kytopen has seen an influx of cash of the past few months. Most recently, the biotech raised a large chunk of money in its Series A funding round, which was announced on Tuesday.
Delveinsight
SEPTEMBER 27, 2021
West syndrome is a rare form of neurological disorder, an age-related specific Epileptic Encephalopathy that displays an umbrella of symptoms such as seizures known as epileptic (infantile) spasms, gross EEG abnormalities of hypsarrhythmia and intellectual disability. There are many different causes of epileptic spasms. It can be due to the previous existence of brain damage signs (psychomotor retardation, neurologic signs, radiologic signs, or other types of seizures) or on the basis of etiolog
BioSpace
SEPTEMBER 27, 2021
Avanir is developing its future leadership from within through a program it calls “Leading at Avanir,” which focuses on emotional intelligence and situational leadership components.
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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 27, 2021
As early as 18,000 years ago, humans in New Guinea may have collected cassowary eggs near maturity and then raised the birds to adulthood, according to an international team of scientists, who used eggshells to determine the developmental stage of the ancient embryos/chicks when the eggs cracked. Credit: Andy Mack As early as 18,000 years […].
BioSpace
SEPTEMBER 27, 2021
?Nucleate, the non-profit organization seeking to support future leaders in the life sciences industry, announced its official launch and immediately opened applications to its Activator program.
Outsourcing Pharma
SEPTEMBER 27, 2021
A leader from Firma Clinical Research advises that while using RWD can be daunting, putting the data to use can lead to a number of notable advantages.
BioSpace
SEPTEMBER 27, 2021
FDA approved ViiV Healthcare’s Cabenuva as the very first once-a-month injection for HIV patients. But the Research Triangle pharma isn’t satisfied yet.
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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.
ECRG Media's Clinical Research Podcast
SEPTEMBER 27, 2021
How ClinEssentials Helps Clinical Research Professionals (Part 8) Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for s
BioSpace
SEPTEMBER 27, 2021
Sputnik V’s 91.6% efficacy against the original COVID-19 strain has stood up to peer review in The Lancet. However, the vaccine is not recognized as a means to enter the United States.
ECRG Media's Clinical Research Podcast
SEPTEMBER 27, 2021
How ClinEssentials Helps Clinical Research Professionals (Part 8). Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.
BioSpace
SEPTEMBER 27, 2021
Eriksson said that HMNC Brain Health is a pioneer in developing precision medicine for the psychiatric space.
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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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