On April 2, 2019, the U.S. Small Business Administration (SBA) issued a new Policy Directive for the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs. All provisions in the new Policy Directive apply to both the SBIR and STTR programs unless specifically noted otherwise. The Policy Directive is available here.
The Biotechnology Innovation Organization (BIO) and the National Institutes of Health (NIH) today announced an agreement to feature Small Business Innovation Research (SBIR)-funded early-stage biomedical companies in an Innovation Zone at the 2019 BIO International Convention. The Innovation Zone companies, focused on drug discovery, diagnostics and other therapeutic platform technologies, will have dedicated exhibit space and participate in BIO’s One-on-One Partnering™ system. Select companies will make 15-minute company presentations in the BIO Business Forum.
Dr. Horea Rus is an expert in diagnosing and treating patients with multiple sclerosis, and his research laboratory at the University of Maryland is producing new tools for treating the disease that attacks the central nervous system.
On Tuesday, Rus and former postdoc research fellow Cosmin Tegla were issued U.S. Patent 10,280,465 for developing a biomarker, using Sirtuin 1, RGC-32, FasL, and IL-21 proteins, that indicates if a patient with relapsing-remitting MS is in relapse.
Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.
The Gaithersburg biopharmaceutical company kicked off the round last year with $25 million in Series C1 financing — one of the biggest venture deals of the year last year in a generous overall haul for Maryland biotech companies. That was followed by an $11 million raise as part of a Series C2 round in January.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option. Benlysta (belimumab) from Glaxo-Smith Kline was previously approved in 2011 by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the intravenous administration in adults with systemic lupus erythematosus (SLE) – the recent approval from the FDA extends the indication to children five years and above.
In the past year Sonavex has landed not one, but two FDA 510(k) clearances for their ultrasound-based medical devices. This first of its kind solution is comprised of two components, EchoMark and EchoSure, that use a customized ultrasound technology to perform real-time blood flow monitoring for postoperative patients.
Bahija Jallal, David Berman, Koustubh Ranadel, and now Mohammed Dar lines up as the latest AstraZeneca/MedImmune executive to jump ship into U.K. biotech Immunocore.
What do the technologies that led to the success of Kite Pharma, the creation of the pioneering immune-oncology cancer treatment avelumab (BAVENCIOⓇ) and the founding of miRecule, Inc. all have in common?
For Paragon Bioservices, news came quickly earlier this month. On a Thursday in mid-April, Gov. Larry Hogan and other state and county officials joined biotech community supporters at an Anne Arundel County site near BWI Airport that’s increasing capacity for the company’s work with large firms to manufacture new treatments. Specifically, speakers talked about the company’s expertise in gene therapy, which is an area of medicine that involves introducing DNA to fight a genetic disease.
United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system.
The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension.
