BioSpace
OCTOBER 25, 2020
Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.
Scienmag
OCTOBER 25, 2020
Adagrasib (MRTX849) achieves objective responses in nearly half of patients with non-small cell lung cancer; Encouraging early results in patients with colorectal, pancreatic, and endometrial cancer Credit: Dana-Farber Cancer Institute A novel agent that targets a mutated form of the KRAS gene – the most commonly altered oncogene in human cancers and one long considered […].
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Drug Patent Watch
OCTOBER 25, 2020
Annual Drug Patent Expirations for CIALIS Cialis is a drug marketed by Lilly and is included in one NDA. It is available from seven suppliers. There is one patent protecting…. The post New patent expiration for LILLY drug CIALIS appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
OCTOBER 25, 2020
Little-known but common form of product placement boosts children’s exposure to unhealthy food, warrants stronger regulations Kids with wildly popular YouTube channels are frequently promoting unhealthy food and drinks in their videos, warn researchers at NYU School of Global Public Health and NYU Grossman School of Medicine in a new study published in the journal […].
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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
JAMA Internal Medicine
OCTOBER 25, 2020
This study examines the frequency of hospitalization for all non–COVID-19-related conditions in a health system at the epicenter of the COVID-19 pandemic.
BioSpace
OCTOBER 25, 2020
It was another busy week for clinical trial updates and news. Here’s a look.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
The Pharma Data
OCTOBER 25, 2020
It was another busy week for clinical trial updates and news. Here’s a look. COVID-19-Related. The U.S. Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The vaccine candidate is called “spike ferritin nanoparticle” (SpFN) and uses ferritin—“attaching a certain type of spike protein to a polymerized version of ferritin,” according to the organization.
Scienmag
OCTOBER 25, 2020
An analysis of information from a large U.S. cancer database indicates that patients with liver cancer from rural regions and lower income households often have more advanced cancer at the time of diagnosis and face a higher risk of death compared with other patients. The findings are published early online in CANCER, a peer-reviewed journal […].
The Pharma Data
OCTOBER 25, 2020
. SOUTH PLAINFIELD, N.J. , Oct. 26, 2020 /PRNewswire/ — PTC Therapeutics , Inc. (NASDAQ: PTCT), today announced the initiation of a registration-directed Phase 2/3 clinical trial to evaluate vatiquinone (PTC743) in patients with mitochondrial epilepsy, the highly morbid condition of refractory seizures in children with inherited mitochondrial disease.
Scienmag
OCTOBER 25, 2020
The majority of parents support teen’s involvement with demonstrations; Black parents more likely to discuss racism and police brutality in-depth with teens, new national poll suggests. Credit: C.S. Mott Children’s Hospital National Poll on Children’s Health at Michigan Medicine ANN ARBOR, Mich. — A growing number of demonstrators taking to the streets to protest police […].
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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
The Pharma Data
OCTOBER 25, 2020
. EMERYVILLE, Calif. , Oct. 26, 2020 /PRNewswire/ — Santen, Inc. the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on ophthalmology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18.
Scienmag
OCTOBER 25, 2020
Construction costs reduced by 40%, while improving fire resistance Credit: Korea Institute of Civil Engineering and Building Technology (KICT) The Korea Institute of Civil Engineering and Building Technology (KICT) has announced the development of an effective structural strengthening method using a noncombustible carbon textile grid and cement mortar, which can double the load-bearing capacities of […].
The Pharma Data
OCTOBER 25, 2020
Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization. TORONTO , Oct. 26, 2020 /PRNewswire/ – SQI Diagnostics Inc. (the “Company” or “SQI”) (TSX-V: SQD) (OTCQB: SQIDF), a precision medicine company that discovers, develops, manufactures and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, today update
Scienmag
OCTOBER 25, 2020
The cover for issue 32 of Oncotarget features Figure 2, ‘This figure depicts overall survival and local in-brain recurrence-free survival in the study’s subgroups,’ by Hussein, et al. Credit: Correspondence to – Bawarjan Schatlo – bawarjan.schatlo@med.uni-goettingen.de The cover for issue 32 of Oncotarget features Figure 2, “This figure depicts overall survival and local in-brain recurrence-free […].
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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
OCTOBER 25, 2020
Oct. 26, 2020 11:55 UTC. DANVERS, Mass.–( BUSINESS WIRE )– The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System. This press release features multimedia. View the full release here: [link].
Pharma in Brief
OCTOBER 25, 2020
On Friday, October 23, the Patented Medicine Prices Review Board ( PMPRB ) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments ). According to the PMPRB: The Guidelines provide information on the PMPRB’s general approach to the price review process and investigations.
The Pharma Data
OCTOBER 25, 2020
Oct. 26, 2020 11:00 UTC. CAMBRIDGE, Mass.–( BUSINESS WIRE )– Moderna, Inc. , (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support the Ministry’s ongoing efforts to secure early access to a safe and effective COVID-19 vaccine
Druggist
OCTOBER 25, 2020
Calamine lotion for chickenpox is usually considered the first choice in the management of itchiness caused by varicella-zoster virus infection. Calamine lotion is cheap and widely available. In this post, I will review the use of calamine lotion for chickenpox. Summary of this post: What is calamine lotion? Is calamine lotion effective for chickenpox rush?
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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
OCTOBER 25, 2020
An Indian trial evaluating convalescent plasma as a COVID-19 treatment has found that the therapy failed to reduce progression to severe COVID-19 or death, leaving the Indian government skeptical about its viability, though medical experts say the treatment may still hold promise. Source link.
Scienmag
OCTOBER 25, 2020
New study findings show that people with type 2 diabetes can better maintain overnight glycemic control when high Glycemic Index (GI) potatoes are included in an evening meal versus low GI basmati rice People with type 2 Diabetes (T2D) are frequently told to avoid eating potatoes, and other high Glycemic Index (GI) foods, because of […].
The Pharma Data
OCTOBER 25, 2020
German drugmaker CureVac said preclinical studies of its COVID-19 vaccine candidate, CVnCoV, showed the vaccination prompted a successful immune response. The messenger RNA-based vaccine, which is designed to block replication of the coronavirus, was shown to induce neutralizing antibodies and activate T-cells in hamsters and mice. The data show that the vaccine candidate “has the potential to induce an efficacious and balanced immune response, mimicking the natural immune defense and providing
Scienmag
OCTOBER 25, 2020
Highlights Social determinants of health are associated with patient-reported outcomes in adults who are eligible to undergo kidney transplantation evaluations. Results from the study will be presented online during ASN Kidney Week 2020 Reimagined October 19-October 25. Washington, DC (October 25, 2020) — Certain social determinants of health predict patient-reported outcomes in potential kidney transplant […].
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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.
The Pharma Data
OCTOBER 25, 2020
News. Consumer News. Skip Costume Contact Lenses This Halloween. SUNDAY, Oct. 25, 2020 — Halloween is risky enough this year with the coronavirus pandemic, so don’t risk your vision as well by wearing costume contact lenses, the American Academy of Ophthalmology (AAO) says. Costume contact lens packaging that claims “one-size-fits-all” or “no need to see an eye doctor” is false, the academy said.
Scienmag
OCTOBER 25, 2020
Culturally relevant strategies are necessary to improve preventive health care in this rapidly growing population, Rutgers researchers say Indian and Pakistani women are diagnosed with breast cancer, including more aggressive forms of the disease, at a younger age, according to Rutgers researchers. South Asians are the fastest-growing major ethnic group in the United States with […].
The Pharma Data
OCTOBER 25, 2020
Oct. 26, 2020 12:00 UTC. SALT LAKE CITY–( BUSINESS WIRE )– Foldax® , Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval to expand the U.S. clinical study of the Tria surgical aortic heart valve. This next stage of enrollment is expected to begin within the next month. “We are excited to expand enrollment in this U.S. clinical study to gain additional clinical experience with the Tria valve,” stated Frank Shannon, MD, Chief of Cardiovascular Sur
Scienmag
OCTOBER 25, 2020
A new drug designed to work on cancers with an altered BRAF gene has shown promise in an early patient trial presented at the 32nd EORTC-NCI-AACR [1] Symposium on Molecular Targets and Cancer Therapeutics, which is taking place online. The BRAF gene is involved in telling healthy cells when to grow and form new cells, […].
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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.
The Pharma Data
OCTOBER 25, 2020
LUND, Sweden , Oct. 26, 2020 /PRNewswire/ — RhoVac AB (“RhoVac”) announces today that the publication of the article on RhoVac’s Phase I/II study is set to be published in November. As previously disclosed, the article elaborating on the results of RhoVac’s Phase I/II study in prostate cancer including the 12-month follow-up period, has been accepted for publication in the Journal for ImmunoTherapy of Cancer (JITC).
Scienmag
OCTOBER 25, 2020
The first large-scale study of the risks that countries face from dependence on water, energy and land resources has found that globalisation may be decreasing, rather than increasing, the security of global supply chains. Countries meet their needs for goods and services through domestic production and international trade. As a result, countries place pressures on […].
The Pharma Data
OCTOBER 25, 2020
Oct. 26, 2020 10:55 UTC. RESEARCH TRIANGLE PARK, N.C.–( BUSINESS WIRE )– TransEnterix, Inc. (NYSE American: TRXC) announced today that it plans to release third quarter financial and operating results after the market closes on Thursday, November 5, 2020. The Company will host a conference call to discuss these results starting at 4:30 p.m.
BioTech 365
OCTOBER 25, 2020
NEW YORK–(BUSINESS WIRE)–New Mountain Capital announced that it has reached a definitive agreement with Aurobindo Pharma to acquire Natrol and combine it with Jarrow Formulas, another New Mountain Capital portfolio company.
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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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