News Archive

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.

Viela Bio spun out of AstraZeneca last year with six autoimmune and inflammation-aimed programs and $250 million. Now, the biotech is reporting positive pivotal data for its lead drug in a rare, autoimmune disease, teeing it up for an FDA filing later this year. 

Two years after Johns Hopkins Technology Ventures opened new office and lab space for its FastForward 1812 incubator on the Johns Hopkins Hospital campus, two companies have moved on to bigger space. LifeSprout, which had been in the incubator for about a year, moved last month to City Garage, where it will have manufacturing capabilities.

BrainScope announced today the publication of a study conducted by physicians at Washington University Barnes Jewish Medical Center in St. Louis in the peer-reviewed journal The American Journal of Emergency Medicine entitled “Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device.” The study demonstrated that the FDA-cleared BrainScope One medical device reduced the use of unnecessary head CT scans by nearly one-third in a hospital emergency room setting when compared to the use of standard clinical practice.

Project Onramp today announced they have placed more than 50 students in well-paid internships with top companies for summer 2019 through its first-in-the-nation Project Onramp program. The program will give the students – many of them the first in their families to attend college – hands-on experience and a valuable start towards a career in biotechnology.

“Project Onramp has created a new model for extending opportunities in the thriving biotech industry for high-achieving students who don’t have the personal or family connections that often play a big part in awarding internships,” said David Lucchino, chairman of MassBio and CEO and co-founder of Frequency Therapeutics. “The enthusiastic response from leading life sciences companies in Massachusetts has been overwhelming.”