BLA Submission definition

BLA Submission means an application and all amendments and supplements thereto filed with the Regulatory Authority, including all documents, data, and other information concerning a pharmaceutical product which are necessary for gaining Regulatory Approval to market and sell such pharmaceutical product.
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BLA Submission means submission to the FDA of the Company’s biologics license application with respect to OTL-200 for the treatment of metachromatic leukodystrophy. For clarity, in the event the Company elects to initiate a rolling biologics license application, “BLA Submission” shall be deemed to occur upon the Company’s initial submission of information to the FDA for such purpose.
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BLA Submission is Lenders’ receipt of evidence satisfactory to Lenders that Borrower has submitted the BLA for Borrower’s product candidate, TOCA 511, to the FDA.
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Examples of BLA Submission in a sentence

  • BLA Submission A BLA will be submitted to the FDA upon obtaining sufficient clinical data, FDA meetings to support BLA, submission planning support for the CMC team, BLA strategy and meeting support, and submission preparation support activities, will all be completed.

  • BLA Submission and Amendments SDNReceived3.2 Compliance with Good Clinical Practices (b) (4)Zin-Fil-1501 and ZIN-FIL-1502 GCP compliance statements were reviewed and are adequate.

  • January, 2009 type to be developed 22 BLA Submission for Renal Cell Cancer 22.

  • OPEX Guidance* $660-755M includes regulatory milestones up to $65M 2024 Total Revenue Guidance $600-$850M PTC Therapeutics – JP Morgan 2024 Key Expected Regulatory & Clinical Milestones in 2024 13 Q1 Q2 Q3 Q4 Sepiapterin PKU MAA Submission Sepiapterin PKU NDA Submission Upstaza BLA Submission t Topline Results Utreloxastat Interim Results PTC518 PTC Therapeutics – JP Morgan 2024 Sepiapterin PKU Program Patient Living with PKU 15 PTC Therapeutics – JP Morgan 2024 Phe, phenylalanine; PKU, phenylketonuria.

  • Regulatory Matters FDA Refusal to File Letter re HIV BLA Submission In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA submission for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients.

  • January, 2011 Cancer type in development 25 BLA Submission for 2nd Cancer Type Developed 25.

  • If Immunomedics declines to exercise the Co-Promotion Option within sixty days (60) after receipt of the BLA Submission Notice for ITP, the Co-Promotion Option shall not become exercisable again.

  • A promising new approach to carbon nanotube horizontal organization, which has developed rapidly during the last three years, is the growth of carbon nanotubes directed by well-defined crystal surfaces, or “nanotube epitaxy”.

  • Cash Balance of $196 Million; BLA Submission on TargetBERKELEY, CA – March 8, 2016 – Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2015.The Company had $196.1 million in cash, cash equivalents and marketable securities as of December 31, 2015.

  • Upon receipt of such BLA Submission Notice, Immunomedics shall have sixty days (60) days to exercise the Co-Promotion Option ***.

Related to BLA Submission

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the Funder. The form, content and scheduling of the Planning Submission will be identified by the Funder;

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Electronic Submission means a successful submittal of Offeror’s proposal.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Clinical Trial means any human clinical trial of a Product.

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is: