Comprehensive & Concise News

Teneobio’s Lead Candidate, TNB-383B, Receives Orphan Drug Designation from the FDA for the Treatment of Multiple Myeloma

Nov. 06, 2019: Teneobio, Inc. announced that it has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.

“New and better treatment options are needed for multiple myeloma. While there are a number of BCMA-targeting agents currently in clinical development, TNB-383B, an anti-BCMAxCD3 currently in Phase I, is a bispecific comprised of a unique T-cell engager designed to maximize the therapeutic window for this class of drugs,” said Roland Buelow, CEO of Teneobio.

“TNB-383B, an anti-BCMAxCD3 currently in Phase I, is a bispecific comprised of a unique T-cell engager designed to maximize the therapeutic window for this class of drugs,”. https://fda.einnews.com/pr_news/501361475/teneobio-s-lead-candidate-tnb-383b-receives-orphan-drug-designation-from-the-fda-for-the-treatment-of-multiple-myeloma

Calquence data to show improved progression-free survival in Phase III front-line chronic lymphocytic leukaemia trial at ASH 2019 Annual Meeting

Nov. 06, 2019: AstraZeneca will present the first data from the Phase III ELEVATE-TN trial assessing Calquence (acalabrutinib), a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor, in patients with previously untreated chronic lymphocytic leukaemia (CLL), as well as data from novel-combination trials across multiple blood cancers at the 2019 American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, USA, December 7-10.First-time data on roxadustat as a potential new treatment for anaemia in patients with primary myelodysplastic syndrome (MDS)

 “AstraZeneca continues to demonstrate its strength in haematology, presenting new research at ASH that spans targeted therapies across eight blood cancers. ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone vs. chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-data-to-show-improved-progression-free-survival-in-phase-iii-front-line-chronic-lymphocytic-leukaemia-trial-at-ash-2019-annual-meeting.html

 American Gene Technologies  Submits Its First IND (For HIV) To The Food and Drug Administration (FDA)

Nov. 06, 2019: American Gene Technologies (AGT) announced a red carpet event  to celebrate a significant milestone in the company’s 11-year history of scientific research in cell and gene therapy: AGT successfully submitted its Investigational New Drug (IND) application to the Food & Drug Administration (FDA) to begin a Phase 1 clinical trial for its genetically modified autologous cell therapy for HIV. This milestone was announced on October 18th. https://fda.einnews.com/pr_news/501399533/american-gene-technologies-hosts-celebration-event-for-its-first-ind-submission-for-hiv-to-the-food-and-drug-administration-fda

Abbott announces discovery of new strain of HIV, keeping global health community a step ahead of the virus

Nov. 06, 2019: Abbott announced that a team of its scientists identified a new subtype of the human immunodeficiency virus (HIV), called HIV-1 Group M, subtype L. This shows the role next-generation genome sequencing is playing in helping researchers stay one step ahead of mutating viruses and avoiding new pandemics.

This research marks the first time a new subtype of "Group M" HIV virus has been identified since guidelines for classifying new strains of HIV were established in 2000. Group M viruses are responsible for the global pandemic, which can be traced back to the Democratic Republic of Congo (DRC) in Sub-Saharan Africa. https://abbott.mediaroom.com/2019-11-06-Abbott-Announces-Discovery-of-New-Strain-of-HIV-Keeping-Global-Health-Community-a-Step-Ahead-of-the-Virus

Aptar’s Activ-Blister Packaging Solution Approved By U.S. FDA For Oral Solid Dose HIV Prevention Medicine

Nov. 06, 2019:The US Food and Drug Administration (FDA) has approved the sealing and packaging solutions provider Aptar’s Activ-Blister packaging solution for oral solid dose drug delivery in the HIV treatment and prevention space.

Aptar designed the 3-Phase Activ-Polymer solution to be completely incorporated into the blister package for drug protection, including moisture adsorption, as well as oxygen and odour scavenging.The technology can also be used for specific drug protection. It can be modified in line with the drug developer’s long-term and in-use stability requirements.The solution can also scavenge volatile organic compounds (VOCs) and emit aromas. https://fda.einnews.com/article__detail/501354680-aptar-s-activ-blister-packaging-solution-approved-by-u-s-fda-for-oral-solid-dose-hiv-prevention-medicine?vcode=XIbw

Meridian submits Curian? analyzer and the Curian? HpSA assay to the FDA

Nov. 06, 2019: Meridian Bioscience, Inc. announced that it has submitted Curian? and the Curian? HpSA assay to the FDA for review. This platform and assay are designed to specifically detect Helicobacter pylori antigens in human stool using fluorescent lateral flow technology. Curian? HpSA is intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. The addition of this new platform and assay continues to strengthen Meridian’s strategic positioning in the gastrointestinal disease testing market.

 “The submission of Curian and the Curian HpSA assay is yet another strategic move to maintain our leadership and expertise in gastrointestinal diagnostics testing. Curian is an analyzer that will advance rapid GI disease testing, with HpSA being the first of several tests in development.” https://fda.einnews.com/pr_news/501359201/meridian-submits-curian-analyzer-and-the-curian-hpsa-assay-to-the-fda

NHS reveals online training for speedier hospital dismissal

Nov. 06, 2019: NHS England has revealed a new “tool” designed to help patients get home from hospital quicker.The new online training, called ActNow, has been developed for health service and care staff to help them reduce hospital delays for patients.The initiative has been launched off the back of the news that nearly 350,000 patients currently spend over three weeks in acute hospitals each year - many of those are older people who are often frail, and while a short period of treatment in hospital is sometimes necessary, staying too long can leave them vulnerable to infections or deconditioning.

The NHS has implemented the system as they want to “ensure that all patients benefit from the shortest possible stay on a ward, getting home as soon as they are fit to leave with the support they need.”“This new ActNow resource will help nursing and care teams in the vital role they play throughout a patient’s journey, and are ideal to include as part of team training or for professional development plans for nurses at every level, including our non-registered colleagues.”                                                                                                     https://www.nationalhealthexecutive.com/Health-Service-Focus/nhs-online-training-to-reduce-time-spent-in-hospital-

AZ launch new medicine research, development centres in China

Nov. 06, 2019: AstraZeneca has announced plans to launch three “large-scale” initiatives, in order to help advance global research and development (R&D) for innovative new medicines.The news, which was unveiled at the 2nd annual China International Import Expo (CIIE) in Shanghai, includes the creation of a new Global R&D Centre and an artificial intelligence (AI) Innovation Centre, as well as a first-of-its-kind Healthcare Industrial Fund with China International Capital Corporation Limited (CICC).

The new AI Innovation Centre is set to be established to “capitalise on the latest digital technology in R&D, manufacturing, operations and commercialisation in order to accelerate the delivery of medicines to patients in China and globally.                                      https://www.astrazeneca.com/media-centre/press-releases/2019/astrazeneca-announces-three-large-scale-initiatives-in-china-to-advance-global-medicine-research-and-development-061120119.html