News Archive

April 11, 2023 at 7:30 AM EDT

GAITHERSBURG, Md., April 11, 2023 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company (the Company), today announced that it has completed enrollment in its Phase 2 clinical trial of HepTcell, an immunotherapeutic for the treatment of chronic hepatitis B (CHB). With the achievement of this milestone, data readout is planned for the first quarter of 2024.

The multicenter clinical trial, which is being conducted at 26 sites in North America, Europe and Southeast Asia, enrolled approximately 80 subjects with inactive CHB and low levels of hepatitis B surface antigen (HBsAg). Subjects were randomized 1:1 to HepTcell or placebo. The primary endpoint of the trial is clinical response, defined as a 1-log or greater reduction in HBsAg. Secondary endpoints include changes in the levels of hepatitis B virus (HBV) DNA, pre-genomic RNA and other markers of virologic response.

• RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO’s proprietary NAV® AAV8 vector
• Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
• AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and recruiting patients; anticipated to report initial trial data in the second half of 2023

ROCKVILLE, Md., April 11, 2023 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne).

The Biden administration has announced a $5 billion program to accelerate the development of next-generation COVID-19 vaccines and treatments.

Like Operation Warp Speed, which developed and distributed vaccines in the early days of the pandemic, Project NextGen will cut across government agencies and involve public-private collaborations, a senior Biden official told USA TODAY.

Image: https://www.usatoday.com – From Video

BioHealth Innovation’s Renée Arnold is set to lead an insightful panel discussion at the upcoming ISPOR 2023 conference, which will take place on May 8, 2023, one at 12:45 and the other at 3:15 pm. The session, “Blazing The Trail for Digital Health Innovation: Resources and Examples Based on a Digital Health Application for Dementia Family Caregivers,” aims to shed light on digital health technologies’ research and development pathway. It will also cover the evolving US regulations framing evidence requirements for the approval of digital health applications.

TL/DR: For participation in the SBIR and STTR programs, agencies now have a standard set of questions to ask small business concerns about their foreign investments and affiliations. Companies can use the questions to prepare for their disclosures.

The Small Business Administration (SBA) is amending the Policy Directive of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to harmonize participating agencies’ collection of information about applicants’ foreign investments and affiliations. Participating agencies have been required to collect such disclosures since passing of the SBIR and STTR Extension Act of 2022.

Register to attend a free NIH webinar. Attendees will learn about a new method for administering Transcranial Magnetic Stimulation (TMS). This new method improves both the instrumentation used to deliver TMS treatment, and the treatment’s magnetic pulse pattern; which when applied to an awake rat treatment model, was shown to provide significant improvement over conventional TMS treatment methods.

Continuous manufacturing (CM) is an exciting frontier in drug manufacturing with the capacity to increase process efficiency while reducing costs. Manufacturers are now looking at ways to apply CM to make biologics. Biopharmaceutical continuous manufacturing (BCM) could increase product quality and productivity, enhance the process and product control, and increase flexibility, while also decreasing certain fixed costs associated with facility size and equipment maintenance, thereby reducing the environmental impact. There are barriers to the
widespread adoption of BCM, however

Maryland should see a boost in direct public funding toward manufacturing and lab space later this year as Gov. Wes Moore said he plans to sign a bill that will help build out the state’s science and technology industries through a new fund.

Image: Wes Moore spoke about several of his plans to boost Maryland’s innovation infrastructure at the TechStars Equitech Demo Day on April 4, 2023.
Photo by Matt Hooke/Baltimore Business Journal