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Autolus Therapeutics Receives FDA Orphan Drug Designation for AUTO3 for Treatment of Acute Lymphoblastic Leukemia Nasdaq:AUTL

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Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).

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Kite to Open Cell Therapy Manufacturing Facility in Frederick County Creating Significant Job Opportunities In Maryland – BioBuzz

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Kite Pharma, a California-based biopharmaceutical company that develops innovative cancer immunotherapies, announced plans today to open a new biologics manufacturing facility in Frederick County that will produce innovative cell therapies for people with cancer. A Gilead company, Kite will open the new facility on a 20-acre site in the Urbana Corporate Center, with plans to create a significant number of job opportunities.

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GlycoMimetics Announces Enrollment of First Patient in NCI-Sponsored Phase 3 Trial of Uproleselan in AML – Business Wire

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GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first patient in a Phase 3 clinical trial being conducted under the auspices of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI), part of the National Institutes of Health. The second in a series of trials designed to evaluate uproleselan across the continuum of care in AML, this NCI-sponsored study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. A third trial, to be conducted by the European HOVON consortium, is expected to initiate later this year.

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3rd Annual Downstream Purification Symposium

3rd Annual Downstream Purification Symposium

By News Archive

3rd Annual Downstream Purification Symposium

Bio‑Rad welcomes you to attend the 3rd Annual Downstream Purification Symposium at Institute for Bioscience and Biotechnology Research. This event will include discussion of new developments in purification of biologics and key industry regulatory topics. Thursday, May 9, 2019

9:00 AM–5:00 PM

Location

Institute for Bioscience & Biotechnology Research

9600 Gudelsky Drive

Rockville, MD 20850

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Key Takeaways from the Small Business Administration’s Revised Policy Directives for the SBIR and STTR Programs | Morrison & Foerster LLP – Government Contracts Insights – JDSupra

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The Small Business Administration (SBA) has statutory authority to establish federal Government-wide policies to implement the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. SBA recently issued a significantly revised final SBIR/STTR Policy Directive, which is effective May 2, 2019. See 84 FR 12794. Below we highlight the major changes implemented in the revised policy directive.

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How Biopharma Companies Use NIH and Vice Versa | RAPS

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An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings.

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NCC-PDI Announces Finalists in $250K Pediatric Pitch Competition for Orthopedic and Spine Medical Devices

By News Archive

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The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces 12 finalists that will present at the “Make Your Medical Device Pitch for Kids!” competition on April 30, 2019 at the University of Maryland, College Park. The finalists, all innovators in the orthopedic and spine sector, have a chance to win up to $50,000 in grant funding and access to the newly created NCC-PDI “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.

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