CDE

Lefamulin NDA Filed in Mainland China for Treatment of Community Acquired Pneumonia

Monday, November 29, 2021 - 2:00pm

This filing brings Nabriva and Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. one step closer to their goal of offering lefamulin to patients with CAP in China.

Key Points: 
  • This filing brings Nabriva and Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. one step closer to their goal of offering lefamulin to patients with CAP in China.
  • To date there have been 4 approvals and two applications pending review, said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics.
  • Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections.
  • Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP).

Fovia Ai to Showcase AI Visualization Integrations at IAIP Exhibit, RSNA 2021

Sunday, November 28, 2021 - 3:00pm

RSNA attendees visiting the IAIP exhibit will be able to explore meaningful AI integrations from 22 exhibitors based on real-world clinical scenarios and will see live demonstrations of Fovia Ai software integrated with vendors including Siemens Healthineers, 3M M*Modal, Ambra Health, Bayer AI, Lunit, Smart Reporting and VUNO.

Key Points: 
  • RSNA attendees visiting the IAIP exhibit will be able to explore meaningful AI integrations from 22 exhibitors based on real-world clinical scenarios and will see live demonstrations of Fovia Ai software integrated with vendors including Siemens Healthineers, 3M M*Modal, Ambra Health, Bayer AI, Lunit, Smart Reporting and VUNO.
  • This demo will show the future of interconnected AI workflows within the radiology ecosystem," stated Fovia Ai's Chief Technology Officer, Kevin Kreeger, Ph.D.
  • Adjacent to the IAIP demonstration, in the Fovia Ai booth (#4535), attendees can:
    Explore AI-driven advanced visualization via XStream aiCockpit and XStream aiPlatform, and see how Fovia Ai technology enables radiologists and clinicians to efficiently access, interact with and modify AI results directly within their existing workflows.
  • Join Fovia Ai at the AI Showcase Theater to watch industry veteran Kevin Kreeger, Ph.D. overcome barriers to the clinical adoption of AI as he demonstrates how users seamlessly interact with algorithm-augmented radiology data using Fovia Ai's intuitive tools.

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Monday, November 22, 2021 - 1:40am

"AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.

Key Points: 
  • "AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.
  • This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML."
  • The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
  • The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia.

Apollomics Inc. Doses First Patient in Phase 3 Clinical Trial with APL-106 (Uproleselan Injection) in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

Monday, November 22, 2021 - 12:10pm

AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.

Key Points: 
  • AML is a highly aggressive hematological cancer, and the prognosis of patients with relapsed or refractory disease is extremely poor.
  • This combined treatment approach could have a meaningful impact on the lives of patients living with relapsed or refractory AML.
  • The Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study.
  • The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for the treatment of adults with relapsed or refractory acute myeloid leukemia.

Brii Bio Receives the BioCentury-BayHelix R&D Achievement of the Year Award at the 2021 BioCentury China Healthcare Summit

Wednesday, November 17, 2021 - 9:03am

The recognition is for the R&D achievements of Brii Bio's investigational monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198 ("combination BRII-196/BRII-198"), for the treatment of COVID-19.

Key Points: 
  • The recognition is for the R&D achievements of Brii Bio's investigational monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198 ("combination BRII-196/BRII-198"), for the treatment of COVID-19.
  • In parallel, the company has submitted the Phase 3 interim data to China Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA).
  • The BioCentury-Bayhelix China Healthcare Awards celebrate outstanding individuals and companies for their achievement and contribution to the local healthcare ecosystem.
  • R&D Achievement of the Year recognizes one company for a scientific discovery in China with direct impact to drug R&D or a significant achievement in pharmaceutical development milestones.

Oracle Aconex Achieves British Standards Institution Certification for Building Information Modeling Software

Tuesday, November 16, 2021 - 6:35pm

AUSTIN, Texas, Nov. 16, 2021 /PRNewswire/ -- Oracle Aconex is the first project management solution to achieve British Standards Institution (BSI) Kitemark certification of the ISO standard and DIN specification for Building Information Modeling (BIM) software.

Key Points: 
  • AUSTIN, Texas, Nov. 16, 2021 /PRNewswire/ -- Oracle Aconex is the first project management solution to achieve British Standards Institution (BSI) Kitemark certification of the ISO standard and DIN specification for Building Information Modeling (BIM) software.
  • Oracle Aconex project management solution achieves BSI certification for ISO 19650 and DIN spec 91391 for BIM software.
  • Oracle Aconex is a projectmanagement cloud application that construction and engineering firms use to unite teams and centralize the management of information and processes across projects worldwide.
  • "With a wide range of BIM software available, being the first solution to achieve Kitemark certification for both ISO and DIN standards with Oracle Aconex is a significant milestone," saidMark Webster, senior vice president and general manager, Oracle Construction and Engineering.

Lilly announces winners of inaugural Leonard Award, a global program celebrating 100 years of innovation in diabetes care

Thursday, November 11, 2021 - 1:30pm

The Leonard Award was inspired by the life of Leonard Thompson, the first person with diabetes to be treated with insulin in 1922, and celebrates ongoing achievements in the diabetes community.

Key Points: 
  • The Leonard Award was inspired by the life of Leonard Thompson, the first person with diabetes to be treated with insulin in 1922, and celebrates ongoing achievements in the diabetes community.
  • Diabetes educator/nurse: Vanita Pais, RD, CDE of Toronto, Ontario, Canada, for work on food skills programs and workshops for children with type 1 diabetes.
  • The winners from each category were selected by an external judges' panel comprised of esteemed leaders in diabetes care.
  • Lillyhas been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin.

2021 National Nurse Practitioner Week Celebrated November 7-13, 2021

Friday, November 5, 2021 - 10:00pm

The COVID-19 pandemic has elevated awareness of the essential role APRNs serve in our health care system.

Key Points: 
  • The COVID-19 pandemic has elevated awareness of the essential role APRNs serve in our health care system.
  • To honor the heroic efforts of NPs during the COVID-19 pandemic and recognize National Nurse Practitioner Week (NP WEEK), November 7-13, Governor Eric Holcomb issued an official proclamation recognizing the critical role of NPs.
  • NPs provide a wide range of care to America's patients in more than 1 billion visits annually.
  • NP Week recognizes the contributions made by the nation's more than 325,000 licensed NPs to the health of patients nationwide.

ASH 2021 | Ascentage Pharma to Present Three Studies of Olverembatinib (HQP1351), a Novel Drug Candidate for the Treatment of Drug-Resistant Leukemia, in Abstracts Including One Oral Report at ASH Annual Meeting

Friday, November 5, 2021 - 12:43am

Olverembatinib was orally administered once every other day (QOD)in 28-day cycles and at 11 dose cohorts ranging from 1 to 60 mg.

Key Points: 
  • Olverembatinib was orally administered once every other day (QOD)in 28-day cycles and at 11 dose cohorts ranging from 1 to 60 mg.
  • - From October 26, 2016, through February 2, 2021 (data cut-off date), 101 patients with CML-CP (n=86) or CML-AP (n=15) were enrolled and treated with olverembatinib.
  • In all, 84 (83.2%) patients received 2 prior lines of TKI-therapies, and 63 (62.4%) harbored the T315I mutation.
  • Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases.

Medigate Accelerates Expansion to Meet Growing Demand in Asia-Pacific Region

Thursday, November 4, 2021 - 12:15pm

BROOKLYN, N.Y., Nov. 4, 2021 /PRNewswire/ -- Medigate , Healthcare's Security and Clinical Asset Management leader, today announced its expansion into the Asia-Pacific (APAC) region.

Key Points: 
  • BROOKLYN, N.Y., Nov. 4, 2021 /PRNewswire/ -- Medigate , Healthcare's Security and Clinical Asset Management leader, today announced its expansion into the Asia-Pacific (APAC) region.
  • Capitalizing on recently acquired landmark clients in Australia, Medigate's investment reflects its overall commitment to healthcare providers across the region.
  • And because care critical devices cannot be managed by traditional IT tools, demand for solutions that address such challenges is high.
  • "Global expansion has always been the goal for us," said Jonathan Langer, Co-Founder and CEO at Medigate.