Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B

Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B

GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct. ...  Read more

Creatv Announces Ability to Predict Immunotherapy Treatment Response for Non-Small Cell Lung Cancer (NSCLC) using a Simple Blood Test

Creatv Announces Ability to Predict Immunotherapy Treatment Response for Non-Small Cell Lung Cancer (NSCLC) using a Simple Blood Test

June 12, 2020 09:00 AM Eastern Daylight Time

ROCKVILLE, Md.–(BUSINESS WIRE)–Creatv Microtech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with stage II-III NSCLC treated with chemoradiation therapy (CRT) and consolidated immunotherapy. Clinical data presented at the ASCO 2020 virtual annual meeting shows the ability to predict which NSCLC patients will benefit from anti-PD-L1/PD-1 immunotherapies. “We are delighted to present a method to stratify patients responding to immunotherapy by a single tube of blood collected after completion of CRT,” said Dr. Cha-Mei Tang, CEO of Creatv. “Early identification of patients that do not respond to immunotherapy will reduce unnecessary patient suffering from ineffective and costly treatment, allowing patients to proceed to alternative therapies.” Currently, no other blood test can predict immunotherapy treatment response for lung cancer. Read More Here...  Read more

Vision Technologies Celebrates 20th Anniversary and Moves to New Headquarters

Vision Technologies Celebrates 20th Anniversary and Moves to New Headquarters

GLEN BURNIE, MD, May 1, 2020 – Vision Technologies, Inc. (Vision), a leading network integrator with national and global reach, celebrates 20 years of providing IP-converged technologies. The company offers Internet of Things (IoT) solutions for Audio Visual, Security, Wireless, Intelligent Buildings, as well as Network Infrastructures and Professional Services, plus post-implementation support for commercial, federal, state and local clients across all 50 states and on three continents. ...  Read more

Pharmaceutics International, Inc. (Pii) Expands Aseptic Filling Capabilities with Fully Robotic Filling Line

Pharmaceutics International, Inc. (Pii) Expands Aseptic Filling Capabilities with Fully Robotic Filling Line

Pharmaceutics International, Inc. (Pii), a pharmaceutical contract development and manufacturing organization (CDMO), announces the expansion of its aseptic filling capacity and capabilities with the addition of a new, fully robotic filling line. ...  Read more

Amarex Executes Three Rush COVID-19 Related Submissions to the FDA in March for Expedited Approval of: 1) Diagnostic, 2) Device, 3) Therapeutic

Amarex Executes Three Rush COVID-19 Related Submissions to the FDA in March for Expedited Approval of: 1) Diagnostic, 2) Device, 3) Therapeutic

Germantown, MD, USA (March 30, 2020) – On March 27, Amarex executed a rush submission to the US FDA of an Emergency Use Authorization (EAU) for a PCR-based IVD for the rapid detection of the coronavirus (SARS-CoV-2). The FDA quickly acknowledged receipt of the EUA and Amarex awaits a decision. The IVD has been through the regulatory approval process in Korea and Amarex and its client are therefore hopeful for a rapid FDA approval result. ...  Read more