ROCKVILLE, Md., Oct. 18, 2019 /PRNewswire/ — American Gene Technologies (AGT) announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for AGT’s lead HIV program, AGT103-T, which is potentially a single-dose, lentiviral vector-based gene therapy developed for the purpose of eliminating HIV from people infected with the disease.
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The General Assembly of Maryland has enacted Senate Bill 137 (the “General Corporate Legislation”), which makes several changes to the Maryland General Corporation Law (the “MGCL”) and the Maryland REIT Law (the “MRL”). The General Assembly has also enacted Senate Bill 136 to explicitly permit the use of distributed electronic networks or databases (sometimes referred to as “blockchain” technology) in corporate record keeping (the “Distributed Ledger Legislation”). Finally, the General Assembly enacted House Bill 1116 and the identical Senate Bill 911 regarding annual reporting on the composition of the boards of directors of certain Maryland corporations (the “Annual Report Legislation”). The new legislation was signed by Governor Hogan and became effective on October 1, 2019. Unless otherwise noted, all section references below are to the MGCL.
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2019 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension (PAH).
The FDA-approved labeling has now been updated to indicate that Orenitram delays disease progression when used in conjunction with an approved oral background PAH therapy. The primary efficacy endpoint of the FREEDOM-EV study was time to first clinical worsening (morbidity or mortality) event. The new label notes that treatment with Orenitram resulted in a significant increase in the time to first clinical worsening event compared with patients who received placebo, which was associated with a reduction in the risk of an event. The treatment effect on time to first clinical worsening due to disease progression was consistent across subgroups.
(Reuters) – GlaxoSmithKline will sell two travel vaccines to Bavarian Nordic for up to 955 million euros ($1.1 billion), the British firm said on Monday, as it looks to bolster its push into the lucrative cancer drug market.
The sale of anti-rabies treatment Rabipur and Encepur, used for the prevention of tick-borne encephalitis, to the Denmark-based biotechnology firm includes an upfront payment of 301 million euros and milestone payments of up to 495 million euros.
GAITHERSBURG, Md., Oct. 21, 2019 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that the company will host an analyst and investor day on November 21, 2019 in New York City. This event, which is designed for sellside research analysts and institutional investors, will begin at 8:00 AM EST and end at 2:00 PM EST.
Institutional and analyst attendees who choose to participate onsite must register, as space is limited. To register for onsite participation at the event or for more information, please contact Robert Burrows, IRO for Emergent BioSolutions at burrowsr@ebsi.com or (240) 631-3280.
Rockville, MD – October 16, 2019 – MockV Solutions, Inc. (MockV or the Company), a company developing innovative products to analyze viral clearance during process development, announced today that it has signed a test and study agreement with REGENXBIO Inc. (REGENXBIO), Thermo Fisher Scientific Inc. (Thermo Fisher) and Texcell-North America, Inc. (Texcell NA) to evaluate MockV’s MVM-MVP Kit for predicting Minute Virus of Mice (MVM) clearance during adeno-associated virus (AAV) bioprocessing.
Gentian’s CEO Dr. Hilja Ibert, Ph.D., guests on BioTalk from the BioHealth Capital Region Investor Conference to talk about their presence in the US market, Biomarkers, and Innovate Diagnostic Efficiency.
Listen now on Google Podcasts http://bit.ly/2MwE0w8, Apple Podcasts https://apple.co/2P7e5Nw, and TuneIn http://bit.ly/2oZkv6x
Dr. Hilja Ibert has over 25 years’ experience from the international diagnostic industry, from which she also has extensive leadership experience. She is a hands-on CEO, driving development and commercialization of product solutions for the clinical diagnostics market.
Gentian is a research-driven company that Dr. Ibert knows to appreciate, as she has gained experience with the development and market introduction of innovative technology throughout her career. Gentian develops and manufactures immunoassays based on unique and proprietary technologies, which enables these products to run on a wide range of high-throughput clinical chemistry analyzers. This results in significant workflow advantages for the laboratories. Through Dr. Ibert’s leadership, the company innovates and focuses on diagnostic efficiency through development and production of accurate and high throughput immunoassays that save time and costs for the laboratories and which provide relevant information earlier to clinicians. By doing so, Gentian contributes to improved patient outcomes. Gentian’s current products and pipeline cover kidney, infectious, inflammatory and cardiovascular diseases.
CareFirst BlueCross BlueShield’s corporate investment and innovation organization, Healthworx, has partnered with the Washington, D.C.-based Halcyon incubator program to provide funding and support for healthcare entrepreneurs.
Through the partnership, Healthworx will allot up to $200,000 to support innovative healthcare ventures in the incubator. Additionally, a Healthworx team member will join the Halcyon selection committee, tasked with ensuring that at least one slot in each of the next four program cohorts will go to a healthcare entrepreneur or startup developing solutions to improve outcomes and reduce the cost of care.
Virginia Tech plans to launch a cancer research initiative to promote collaboration among engineers, veterinarians, biomedical researchers and other scientists.
“We are going to create a sense of intellectual community of common interest for people. That takes money, resources and creating things they are interested in,” said Michael Friedlander, Tech’s vice president of health sciences and technology. “We are going to make available instrumentation and facilities for cancer researchers to use from all over the campus, some of which will be here, some of which will be new things we haven’t gotten yet. And we’re going to survey people: What do you need that you don’t have at Virginia Tech for leading-edge research?”
Image: Michael Friedlander
