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Health department launches TB trial with emocha app – Technical.ly Baltimore

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Tuberculosis is both tough to treat and medically cumbersome to manage. Under directly observed therapy, a medical professional has to watch a patient take his or her medication for at least six months. A Baltimore health IT startup may help lighten that load.

The Baltimore City Health Department is launching a pilot with emocha Mobile Health’s app miDOT, according to a release from the Highlandtown firm.

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Army awards Baltimore’s Profectus BioSciences $8.5M for Ebola vaccine work – Baltimore Business Journal

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Baltimore biopharmaceutical company Profectus BioSciences Inc. has received a three-year, $8.5 million grant from the U.S. Army for work on an Ebola vaccine.

Profectus will share the grant with the Galveston National Laboratory at the University of Texas Medical Branch at Galveston. The grant is Profectus’ second in recent days. The company also announced a $5.8 million grant from the Biomedical Advanced Research and Development Authority (BARDA) to conduct safety studies of the company’s VesiculoVax, a potential Ebola vaccine.

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The HHS IDEA Lab – What is it?

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Earlier this year, the Secretary of the Department of Health and Human Services (HHS) launched the HHS IDEA Lab. With it, we unveiled a consolidated structure for the innovation activities at the Department of Health and Human Services, flashy new branding and a website. But when we launched, we weren’t totally clear on what the main message for the HHS IDEA Lab was, and over the past 6 months we heard the question – what is the HHS IDEA Lab all about? So we have looked at ourselves, focused on what your needs are to solve problems, become an entrepreneur, or just learn new skills, and have clearly defined what the HHS IDEA Lab is.

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Mass General, MIT form alliance to address three ‘major challenges’ in healthcare

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Massachusetts General Hospital and MIT have formed a $3 million strategic alliance in an attempt to address three “major challenges” that persist in healthcare: improving diagnoses, developing new approaches to prevent and treat infectious diseases and developing more accurate methods of diagnosing and treating neurodegenerative and psychiatric diseases.

The alliance, officials said, will add further heft to already existing efforts between individual collaborations between the two institutions, particularly as they relate to development of diagnostic tools and therapies.

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BARDA calls on Novartis, GSK, Emergent to pitch in with Ebola drug – FiercePharma Manufacturing

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The U.S. government invested $440 million in three vaccine plants in the U.S. in 2012 with the proviso that if something like a pandemic occurred, it could call on them to produce drugs that it required. With Ebola spreading, those calls have now been made.

The Ebola crisis has prompted the Biomedical Advanced Research and Development Authority (BARDA) to ask the three plant owners–Novartis ($NVS), GlaxoSmithKline ($GSK) and Emergent Biosolutions ($EBS) and their partners–to tell it what it would take for them to produce ZMapp, an experimental drug currently being produced through a novel approach using tobacco plants. BARDA wants detailed timetables and budgets for making ZMapp, Reuters reports. They are supposed to respond by Nov. 10.

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Funding & Research Opportunities and Announcements for October 21, 2014

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Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

NIH Guide Notices:

Notice of Special Accommodations for Submission and Reporting Requirements for Program Directors/Principal Investigators Responding to the West Africa Ebola Outbreak
(NOT-OD-15-010) Office of the Director, NIH

Notice to Extend the Response Date for NOT-OD-14-128 “Request for Information (RFI): Consideration of Sex As a Biological Variable in Biomedical Research”
(NOT-OD-15-012) Office of the Director, NIH

Reminder: NIH Requires the Research Performance Progress Report (RPPR) for All Type 5 Progress Reports
(NOT-OD-15-014) Office of the Director, NIH

Notice of Participation of the National Institute on Drug Abuse in PA-14-334 “Advancing Interventions to Improve Medication Adherence (R01)”
(NOT-DA-14-052)
National Institute on Drug Abuse

NHLBI Announces Frequently Asked Questions (FAQs) for RFA-HL-15-015 “Multi-Site Clinical Trials for the Pulmonary Trials Cooperative (U01)” and RFA-HL-15-016 “Network Management Core (NEMO) for the Pulmonary Trials Cooperative (U01)”
(NOT-HL-14-240)
National Heart, Lung, and Blood Institute

Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.

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Sigma-Tau, Alfa Wassermann in talks to combine Italian operations: sources – Reuters

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Italian drugmaker Sigma-Tau is in advanced talks to sell part of its Italian operations to domestic peer Alfa Wassermann that would create an over-the-counter (OTC) powerhouse, several sources familiar with the situation said.

Sigma-Tau is working with Milan-based Four Partners, an advisory firm led by Sigma board member Guido Tugnoli, said the sources, who declined to be identified because the matter is private.

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Emergent BioSolutions among three under consideration for Ebola drug manufacturing – Baltimore Business Journal

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Biopharmaceutical company Emergent BioSolutions could begin manufacturing an experimental Ebola drug at its Baltimore facility.

Rockville-based Emergent is one of three advanced laboratories asked by the Biomedical Advanced Research and Development Authority (BARDA) to submit a plan for manufacturing ZMapp. The drug has been used among infected health workers in Africa but supplies have run out. BARDA will select one or more of the labs to make more of the drug.

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ATCC Adds New Customer-driven Format to its Quality Control Standards Portfolio

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ATCC, the premier global biological materials resource and standards organization, announces the release of ATCC® Minis to support quality control (QC) testing in pharmaceutical and industrial labs, during the PDA 9th Annual Global Conference on Pharmaceutical Microbiology in Bethesda, MD, Booth # 304.

Healthcare, personal care product, and cosmetic manufacturers are required to test the bio-burden and sterility of their products and production environments to ensure consumer safety. Global alignment and harmonization of microbial testing requirements among the United States Pharmacopeia (USP), Japanese Pharmacopeia (JP), and European Pharmacopeia (EP), have resulted in the need for consistent and reliable control organisms at less than five passages from the ATCC reference stock for reproducible results.

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