News Archive

NEW YORK, Oct. 25, 2019 /PRNewswire/ — The Prix Galien USA Committee last night honored excellence in the biopharmaceutical and medical industry for research, development and innovation at its 13th annual Prix Galien Awards Gala, held at the American Museum of Natural History in New York City. In recognition of the development and discovery of products that improve the human condition, a committee of highly accomplished scientific leaders, inclusive of four Nobel Laureates, recognized winners in three categories: “Best Pharmaceutical Product,” “Best Biotechnology Product,” and “Best Medical Technology.”

Image: “Best Pharmaceutical Product:” GlaxoSmithKline, SHINGRIX

BALTIMORE, Md., Oct. 21, 2019 (GLOBE NEWSWIRE) — CoapTech LLC announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) within the National Institutes of Health (NIH) awarded the company a two-year, $1.2M R44 Small Business Innovation Research (SBIR) Phase II grant on August 29, 2019. This builds on a $225,000 Phase I SBIR R43 grant and a $200,000 Maryland Industrial Partnerships (MIPS) grant awarded to the company last year.  

The new $1.2M grant will support a 40-patient clinical trial at the University of Maryland Medical Center (UMMC) evaluating safety and cost-effectiveness characteristics of a novel medical procedure known as percutaneous ultrasound gastrostomy (PUG), which is enabled by CoapTech’s PUMA-G device.  

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.

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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.