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Advaxis Announces FDA Acceptance of Its Investigational New Drug Application to Commence Clinical Trials of ADXS-HPV in Combination With MedImmune’s MEDI4736 for the Treatment of HPV-Associated Cancers Nasdaq:ADXS

By News Archive

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Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study of ADXS-HPV (ADXS11-001) alone or in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The trial is expected to begin patient enrollment in early 2015. 

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Human Cellular Models for Predicting Individual Responses to CFTR (Cystic Fibrosis Transmembrane Conductance Regulator)-Directed Therapeutics

By News Archive

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NHLBI is soliciting applications from small businesses to develop and validate novel in vitro human cell-based tools for predicting the responses of individual patients to cystic fibrosis transmembrane conductance regulator (CFTR)-directed therapeutics for cystic fibrosis (CF) lung disease. Proposed research projects are expected to focus on the development of highly innovative cell-based systems that recapitulate a patient-specific CFTR phenotype to create a personalized study platform to examine response to CFTR-directed therapeutics. The models developed must be based on live cells from humans harboring CFTR mutations associated with CF. While the primary goal of this initiative is to promote precision medicine and optimization of treatment at the personal level, it may also yield as a secondary benefit the ability to select appropriate treatments for CF at an earlier age.

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New NHLBI Funding Opportunity: Stem Cell-Derived Blood Products for Therapeutic Use

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Stem cell-derived blood and platelet products have the potential to meet critical medical needs. Remaining challenges exist in both the manufacturing process and additional discovery research. The manufacturing process needs to be made more efficient and cost-effective while assuring the effectiveness and safety of the blood products and enable their commercial viability. RFA-HL-15-022 supports R01 grants to address the basic or early translational research needs whereas RFA-HL-15-029 and RFA-HL-15-030 support small business awards to enable further advances in the manufacturing processes (tools and technologies) to take advantage of the existing knowledge and recent advances in the field to produce safe and functional blood and platelet products at reduced costs.

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Barbara Mikulski

Mikulski Announces Increased Support for U.S. Jobs and Innovation

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Barbara Mikulski

Chairwoman of the Senate Appropriations Committee and the Commerce, Justice, Science (CJS) Appropriations Subcommittee, today announced the Consolidated and Further Continuing Appropriations Act of 2015 provides increased funding to support American jobs and innovation, including funds for trade and economic development programs, and investment in scientific research and exploration.

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Who Is An Accredited Investor? New Recommendations From The SEC

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On October 9, 2014, the Investment Advisory Committee of the SEC issued its much awaited recommendations on the “Accredited Investor” definition of Regulation D of the ’33 Act. This is in response to the SEC’s Request for Comments on the definition of “Accredited Investor” in its release relating to Proposed Rules for Regulation D and Form D, which mainly related to general solicitation (for the full text of that release, see here).

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