Clinical Trials & Research

NEW YORK, Oct. 12, 2020 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced it has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for IV

Reviewed by Emily Henderson, B.Sc.Oct 12 2020 As the return of college students to campuses has fueled as many as 3,000 COVID-19 cases a day, keeping track of them is a logistical nightmare for local health departments and colleges. Some students are putting down their home addresses instead of their college ones on their COVID

NEW YORK and MAINZ, GERMANY, October 6, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19. The EMA’s decision to start a rolling review follows the encouraging preliminary

Reviewed by Emily Henderson, B.Sc.Oct 9 2020 Rotavirus (RV) is an extremely contagious viral infection and the most common cause of diarrhea in infants and children worldwide. The World Health Organization reports that more than 215,000 children under the age of 5 die of a vaccine-preventable rotavirus infection each year. An RV vaccine, introduced in

NEW YORK & BRISBANE, Calif.–(BUSINESS WIRE) October 07, 2020 — Pfizer Inc. (NYSE: PFE) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today announced that the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients. AFFINE is a global

Reviewed by Emily Henderson, B.Sc.Oct 8 2020 Since the end of July, the number of new infections with the coronavirus has been on the rise again in Germany. Because of falling temperatures and group activities being relocated indoors, the pandemic’s development is at risk of becoming difficult to control again. In its ad-hoc statement “Coronavirus

SAN DIEGO–(BUSINESS WIRE)–Oct. 6, 2020– Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for TK216, an investigational potentially first-in-class targeted small-molecule inhibitor of the E26 transformation-specific (ETS) family of oncoproteins, for treatment of Ewing

Reviewed by Emily Henderson, B.Sc.Oct 6 2020 With a $500,000 Research Grant from Alliance for Cancer Gene Therapy (ACGT), Sidi Chen, PhD, assistant professor in the Department of Genetics and Systems Biology Institute at Yale School of Medicine and member of Yale Cancer Center, will advance a versatile and highly scalable strategy he’s been developing

Print this page PLYMOUTH MEETING, Pa., Sept. 28, 2020 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company’s

Oct 2 2020 A recent study1 undertaken at Rovira i Virgili University in Tarragona, Spain, reveals that biolabeling through luminescence thermometry has the potential to detect cancer cells at an early stage of development, just by monitoring the temperature rise in the body, due to accelerated metabolic activities in abnormal cells. The Linkam THMS600 stage

Print this page CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sep. 29, 2020– 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 the publication of the second interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The New

Oct 2 2020 Global glass primary packaging supplier SGD Pharma has expanded its ready-to-use (RTU) molded glass vial range to introduce a market-first 50ml volume option in tray developed at industrial scale by a molded glass manufacturer. The Sterinity platform, which includes both ISO and EasyLyo injectable vials, offers high-quality sterile Type I molded glass

Print this page SEATTLE, Sept. 29, 2020 /PRNewswire/ – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a recent Pre-NDA meeting with the U.S. Food and Drug Administration (“FDA” or “the Agency”), the Company has reached an agreement to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet count

Reviewed by Emily Henderson, B.Sc.Sep 30 2020 The federal government did a quick pivot on the threat of the coronavirus spreading through the air, changing a key piece of guidance over the weekend. On Sept. 18, the Centers for Disease Control and Prevention warned that tiny airborne particles, not just the bigger water droplets from

News Clinical Trials Khondrion Receives Rare Pediatric Disease Designation for Sonlicromanol from US FDA Print this page September 28, 2020 — Khondrion, a clinical-stage biopharmaceutical company discovering and developing therapies targeting mitochondrial disease, today announces that it received a rare pediatric disease (RPD) designation from the United States (US) Food and Drug Administration (FDA) for

Reviewed by Emily Henderson, B.Sc.Sep 28 2020 The research by the UPV/EHU-University of the Basque Country, in collaboration with Harvard University, has yielded highly encouraging results, and studies in animal models have already begun. The UPV/EHU’s NanoBioCel research group has for many years been developing systems enabling cells to be used as drugs. Cell therapy

Print this page NEW BRUNSWICK, N.J., September 23, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a

Reviewed by Emily Henderson, B.Sc.Sep 26 2020 A novel mobile health program created in early 2018 by the Kraft Center for Community Health at Massachusetts General Hospital (MGH) has proven to be an effective model for bringing opioid addiction treatment services directly to marginalized individuals, particularly the homeless, a population that faces the highest risk

Print this page TOKYO — September 23, 2020 FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada; hereinafter “FUJIFILM Toyama Chemical”) has announced today that primary endpoint has been met in phase III clinical trial of “Avigan Tablet” (generic name: favipiravir, “Avigan”) conducted in Japan for patients with novel coronavirus infections (hereinafter “COVID-19”). The efficacy primary

Sep 24 2020 The importance of cleanrooms is currently in the spotlight as the global community awaits a vaccine for Covid-19. Laboratories need controlled environments that are contamination free in order to carry out development and testing that produces reliable test results. Image Credit: ZwickRoell A cleanroom is classified according to the level of cleanliness

Print this page THOUSAND OAKS, Calif., Sept. 20, 2020 /PRNewswire/ – Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). Data from 59 patients with

Reviewed by Emily Henderson, B.Sc.Sep 22 2020 In a new University of California, Irvine-led study, researchers have discovered how regulatory T cells (Treg) are instrumental in limiting the damage caused to the spinal cord in diseases like multiple sclerosis (MS). Published in the Proceedings of the National Academy of Sciences, the results of the study

Print this page Tokyo, Basking Ridge, N.J. and Munich – (September 14, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that the first patient has been dosed in a phase 2 study evaluating patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), in patients with advanced or metastatic colorectal cancer who

Reviewed by Emily Henderson, B.Sc.Sep 19 2020 Researchers from the Singapore University of Technology and Design (SUTD) developed a method to perform direct ink writing (DIW) 3D printing of milk-based products at room temperature, while maintaining its temperature sensitive nutrients. 3D printing of food has been achieved by different printing methods, including the widely used

Print this page HAMILTON, Bermuda, Sept. 15, 2020 (GLOBE NEWSWIRE) – Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to mavrilimumab for the treatment of giant cell arteritis (GCA). Mavrilimumab

Sep 18 2020 Scientists and researchers at the U.S. Naval Research Laboratory and National Center for Advancing Translational Sciences (NCATS), submitted their findings to ACS Nano, a monthly peer-reviewed scientific journal, on their collaboration to develop SARS-CoV-2 nanoparticle probes that are used to study fundamental interactions between SARS-CoV-2 Spike proteins and human cells. Here we

Print this page INDIANAPOLIS, Sept. 16, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555, a SARS-CoV-2 neutralizing antibody, for the treatment

Reviewed by Emily Henderson, B.Sc.Sep 16 2020 The patients walk into Dr. Melissa Marshall’s community clinics in Northern California with the telltale symptoms. They’re having trouble breathing. It may even hurt to inhale. They’ve got a cough, and the sore throat is definitely there. A straight case of COVID-19? Not so fast. This is wildfire