Bio Pharma Dive
SEPTEMBER 7, 2021
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.
Pharma Mirror
SEPTEMBER 7, 2021
The Hague, Pharmacists must be allowed to do more to manage respiratory conditions in communities if the urgent need to address the harmful effects of air pollution on health is to be met, the International Pharmaceutical Federation (FIP) said today. The expansion of pharmacists’ roles in mitigating the health threats of air pollution is among several actions described in a call to action issued by FIP, marking the United Nations International Day of Clean Air for Blue Skies.
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Bio Pharma Dive
SEPTEMBER 7, 2021
Wall Street analysts expect little impact on biotech developers after an inconclusive discussion last week. Yet the FDA still appears wary, as shown by a new hold on a BioMarin rare disease treatment.
Pharma Mirror
SEPTEMBER 7, 2021
Increasing burden of chronic diseases and rising awareness about necessity of early warning signs are fuelling the demand of remote patient monitors With the COVID-19 pandemic, health systems or hospitals rapidly adopted remote patient monitoring technology to maintain social distancing and thereby control viral spread. Patients suffering from COVID – 19 need to monitor blood oxygen level and heart rate regularly.
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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 7, 2021
Long a bystander in the race to develop so-called allogeneic treatments, the cancer drugmaking giant has joined the fray with a wide-ranging alliance that could be worth up to $3 billion.
World of DTC Marketing
SEPTEMBER 7, 2021
SUMMARY: John F. Kennedy said, “Change is the law of life, and those who look only to the past and present are certain to miss the future”. Change is coming for one simple reason; our country can’t sustain the current costs of healthcare. Today’s pharma CEOs should prepare their organizations for the future, not wasting money with lobbying costs.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
SEPTEMBER 7, 2021
Singapore, Local family cord blood bank Cryoviva Singapore ([link] is continuing with its rapid geographic growth plans with an entry into the Bahrain market. This latest new market entry closely follows Cryoviva establishing a footprint in Dubai to serve couples in the UAE that are on the family way. “It fills the entire Cryoviva team with a great sense of pride and satisfaction to help customers in Bahrain and add another nation to the list of countries we serve from Singapore.
BioPharma Reporter
SEPTEMBER 7, 2021
Moderna and the nonprofit Institute for Life Changing Medicines (ILCM) are collaborating to develop a new messenger RNA (mRNA) therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare disease.
BioSpace
SEPTEMBER 7, 2021
Adaptimmune will be responsible for developing clinical T-cell candidates for the two companies through its induced pluripotent stem cell (iPSC) derived allogeneic platform.
NY Times
SEPTEMBER 7, 2021
An intubated patient was prescribed the deworming drug by his doctor. Federal health officials have said that it has not been shown to be effective against the coronavirus and that it can be toxic in humans.
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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 7, 2021
After a two-month long halt, federal officials have given the go-ahead to resume nationwide distribution of Eli Lilly’s COVID-19 monoclonal antibodies bamlanivimab and etesevimab. The pause on the antibody combo was made over concerns of the drugs not being effective against new SARS-CoV-2 variants, back when they were first identified in Brazil and South Africa.
Scienmag
SEPTEMBER 7, 2021
Researchers at the Max Planck Institute of Animal Behavior and University of Konstanz in Germany have identified how large land birds fly nonstop for hundreds of kilometers over the open ocean—without taking a break for food or rest. Using GPS tracking technology, the team monitored the global migration of five species of large land birds […].
BioPharma Reporter
SEPTEMBER 7, 2021
Vaccitech has signed a lease for 31,000 sq. ft at Harwell Science and Innovation Campus, fitting out the facility with a state-of-the art wet laboratory and offices.
BioSpace
SEPTEMBER 7, 2021
Concerns about Mu and Lambda are growing, but data suggests that Delta is still the biggest problem. The U.S. is also struggling with infections this year. Here’s the latest news.
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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 7, 2021
Servier and Neurochlore have been forced to admit defeat in their bid to bring the first drug to market for people with autism spectrum disorder (ASD), after a comprehensive fail for their bumetanide candidate in two phase 3 trials. The French partners said today that there was “no sign of effectiveness” for bumetanide compared to placebo in 422 children and adolescents with ASD enrolled in the two studies, which have now been halted.
BioSpace
SEPTEMBER 7, 2021
Elizabeth Holmes heads to court today to face multiple criminal fraud charges that could land the Theranos founder and CEO in prison for more than a decade.
pharmaphorum
SEPTEMBER 7, 2021
French biopharma company Hybrigenics has made another bid to merge with Belgium’s Bone Therapeutics, a specialist in regenerative medicine that is still recovering from a setback in its lead development programme. Hybrigenics said in a press release today that it had started discussions with Bone Therapeutics, but the Belgian company was quick to come out with its own statement downplaying the significance of what it described as “very preliminary contacts” between the compani
BioSpace
SEPTEMBER 7, 2021
The new bacterial enzyme has the ability to cut and modify RNA with the exquisite precision that has only been possible so far for DNA editing.
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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.
Pharma Times
SEPTEMBER 7, 2021
New analysis from the Health Foundation's REAL Centre warns extra support and investment needed
BioSpace
SEPTEMBER 7, 2021
French biotech Diaccurate bolstered its oncology and immunology pipeline with the acquisition of a Phase II-ready dual PAM inhibitor from Merck KGaA, Darmstadt, Germany.
BioPharma Reporter
SEPTEMBER 7, 2021
A leader from the home trial services provder says patientsâ increasing awareness of clinical research has how trial teams should consider their approach.
BioSpace
SEPTEMBER 7, 2021
Replicate focuses on using self-replicating RNA (srRNA) to develop therapies for autoimmune and inflammatory diseases and prevent drug resistance in 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.
Pharma Times
SEPTEMBER 7, 2021
Funds will be used over the next six months to tackle waiting lists and manage ‘immediate pressures’
BioSpace
SEPTEMBER 7, 2021
The oncogenicity and neurotoxicity risks of AAVs and possible mitigation strategies were the primary focus on Thursday.
pharmaphorum
SEPTEMBER 7, 2021
A study has shown that people with anxiety or depression who used a digital therapeutic (DTx) for insomnia alongside psychological therapy, had better improvement in their mental health than those receiving therapy on its own. The study – published in the journal Behaviour Research and Therapy – tested the Sleepio app developed by digital health specialist Big Health as an add-on to standard NHS care for anxiety and depression under the improving access to psychological therapies (IAPT) policy.
BioSpace
SEPTEMBER 7, 2021
Chin, 57, and Humad, 36, along with the company, were indicted on charges of paying surgeons to use their spinal implants in surgeries.
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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.
Pharma Times
SEPTEMBER 7, 2021
Funds will be used for the development of hybrid interferon Alfacyte
BioSpace
SEPTEMBER 7, 2021
Life sciences funding rounds were quieter this week with the Labor Day holiday. Here’s the short list.
Outsourcing Pharma
SEPTEMBER 7, 2021
The trial tech firm says analysis of trials in low- and middle-income regions reveals that innovative statistical methods could make a huge difference.
BioSpace
SEPTEMBER 7, 2021
?The acquisition expands Sanofi's General Medicines core assets and highlights the addition of Rezurock (belumosudil) to its transplant portfolio.
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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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