In order for a drug to get approved by the FDA for market in the USA, the sponsor must ultimately demonstrate the drug has: 1) a predictable exposure profile with [….]
United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application For Priority Review
United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics expects the agency’s review to be complete in October 2021. FDA also indicated that they have not identified any potential review issues at this time.
AstraZeneca is reportedly in talks to shift production of its coronavirus vaccine to a Maryland-based factory operated by Catalent, Inc.
The Germantown Innovation Center is home to some of Maryland’s fastest-rising stars in the life sciences ecosystem. Multiple startups found a home in the Montgomery County incubator and benefit from the lab space and the strategic access to federal agencies, nearby thought leadership, and on-campus workforce access.
As one of the world’s top bio hubs, the BioHealth Capital Region (BHCR) is rife with life science assets. The region has been at the forefront of the SARS-CoV-2 vaccine race and it is rapidly becoming a center for advanced manufacturing. The BHCR cell and gene therapy ecosystem is thriving, and the area boasts one of the richest and most diverse tapestries of life science talent and workforce development programming. What’s more, Maryland, Washington, DC, and Virginia are home to several dynamic university systems that keep the talent and tech transfer pipeline humming and full.
Germantown’s QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio
QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the Emergency [….]
Akan Biosciences Announces FDA Acceptance of IND Application for StroMel™; in Osteoarthritis of Knee
StroMel™ is a proprietary adipose-derived Stromal Vascular Fraction (SVF) product. StroMel™ will be frozen and stored allowing multiple administrations with each lot. Although the current IND is for autologous administration, Akan is planning to explore allogeneic applications as well.
Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization
Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada GAITHERSBURG, Md., February 4, 2021 [….]