BioHealth Innovation, Inc. (BHI) provides international companies the perfect starting point to create or locate US-based subsidiaries by offering a soft landing to companies seeking to grow their US business and access BHI, federal and state resources. For more information, click here.
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MaxCyte, the global cell-based medicines and life sciences company, announced today that the first patient has been dosed in its Phase I dose-escalation clinical trial in the United States with the Company’s lead wholly-owned chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11. The study is designed to evaluate MCY-M11, a mesothelin targeting CAR, in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.
Correction: This story originally published on 10/16 included a 2nd paragraph referencing a previous guest of BioTalk and not Monica Lopez, PhD
La Petite Noiseuse Productions Co-Founder and Executive Scientific & Artistic Director Monica Lopez, Ph.D. joins BioTalk Host Rich Bendis to discuss her career path, their consulting services, science-art integration, multidisciplinary thinking and doing in healthcare, and STEM-STEAMM education for workplace challenges of the future.
Dr. Lopez is a multilingual cognitive scientist, educator, entrepreneur, multidisciplinary artist, public speaker, and writer. At her company, Dr. Lopez leads a unique R&D program within creativity and human intelligence with the goal of advancing artificial intelligence. The result has been a novel model that merges the cognitive brain sciences with the arts, and forms the basis of the company’s consulting services in different industries (healthcare, autonomous systems, education, entertainment, and cyber) with clients from Boston, New York, and San Francisco and Europe (France, Belgium, Austria, United Kingdom, Italy, and Germany). To prepare leaders for the challenges of tomorrow, Dr. Lopez has created since 2009, as faculty at Johns Hopkins University and Peabody Institute, a STEAMM education platform. Prior to co-founding her company, she worked in business development, product evaluation, marketing, communications, and strategic partnering in various languages. Dr. Lopez is a frequent keynote and plenary speaker and panelist at international and national venues. She holds BA degrees in Psychology and French, and a MA and PhD in Cognitive Science, all from Johns Hopkins University, a Certificate of Art in Photography from Maryland Institute College of Art, and was a postdoctoral fellow at The Johns Hopkins University School of Medicine. Dr. Lopez has been recognized as a “particularly imaginative polymath” by the Imagination Institute of the University of Pennsylvania’s Positive Psychology Center. She has been a Salzburg Global Seminar Fellow and distinguished guest with their Board of Directors.
Listen now on iTunes , Google Play , and TuneIn.
More than 300 representatives of companies from throughout the BioHealth Capital Region took over BowlMore Gaithersburg last Thursday for a fun evening of networking. The 5th annual BioBowl cohosted by MedImmune and BioHealth Innovation included teams from Baltimore and DC to Montgomery and Frederick counties. Qiagen took home the First Place prize and the Women in Bio event were recognized for their efforts with a Rubber Chicken Award.
Have you register for this year’s Women Building Bio event? The third Annual Women Building Bio Conference is taking place October 17 at the Inova Center for Personalized Health. This is a one-day regional conference converging extraordinary men and women, industry and academia, researchers and innovators, professionals and decision-makers gathering together to cultivate relationships and making an impact. Click here for the agenda and more information. (For a discount code, email BHI and register by 3 p.m., Tuesday, October 16th.)
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed its acquisition of PaxVax, a company focused on developing, manufacturing, and commercializing specialty vaccines that protect against existing and emerging infectious diseases. With the closing of this transaction, Emergent acquires two marketed vaccines – Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of typhoid fever, and Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera, a potentially serious intestinal disease, caused by Vibrio cholerae serogroup O1. The acquisition broadens the company’s development pipeline with vaccines that address adenovirus types 4 and 7, which are common causes of acute respiratory disease, and chikungunya, a viral disease spread to humans by infected mosquitoes that can cause severely debilitating joint pain. The acquisition also expands the company’s sales capabilities with a global specialty salesforce and marketing and distribution partners focused on the travelers’ market and establishes an international manufacturing footprint with European-based cGMP biologics facilities.
Pharma major Lupin announced that it has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.
Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg is the generic version of Sunovion’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.
The Food and Drug Administration approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ended last month, the agency announced on Thursday.
The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) has been renewed for funding under a cooperative agreement grant from the U.S. Food and Drug Administration (FDA). A collaborative partnership led by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy, and William E. Bentley, PhD, the Robert E. Fischell Distinguished Chair of Engineering at the University of Maryland, College Park (UMCP), M-CERSI is one of only four FDA-funded CERSIs in the U.S., and the only CERSI to receive continuous funding from the FDA since it first launched in 2011. This latest renewal, which allows for up to $5 million per year over five years, will allow M-CERSI to continue its mission to contribute to modernizing and improving the ways in which drugs and medical devices are reviewed and evaluated.