Breakthrough Therapy Designation definition

Breakthrough Therapy Designation means “breakthrough therapy” designation granted by the FDA.
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Breakthrough Therapy Designation means a drug designated by the FDA as a Breakthrough Therapy pursuant to Section 902 of the Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-144, 126 Stat. 993 (2012), as it may be amended from time to time, and the regulations promulgated thereunder.
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Breakthrough Therapy Designation means the FDA designation, described in section 506(a) of the FD&C Act. Such designation may be assigned to a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
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Examples of Breakthrough Therapy Designation in a sentence

  • IMMU-132 has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease.

  • Verastem Oncology Receives Breakthrough Therapy Designation for VS-6766 with Defactinib in Recurrent Low-Grade Serous Ovarian Cancer.

  • On July 17 the FDA assigned Breakthrough Therapy Designation status for pirfenidone.

  • It received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with TNBC who have failed prior therapies for metastatic disease.

  • Lumasiran has received both U.S. and EU Orphan Drug Designations, a Breakthrough Therapy Designation and pediatric rare disease designation from the U.S. Food and Drug Administration (FDA), and a Priority Medicines (PRIME) designation from the European Medicines Agency (EMA).

  • Based on interim data from L-MIND, in October 2017 the U.S. FDA granted Breakthrough Therapy Designation for tafasitamab plus lenalidomide in this patient population.

  • On July 17, 2014, InterMune reported that Pirfenidone had been granted Breakthrough Therapy Designation by the Federal Drug Administration (“FDA”).

  • The unmet medical need has been exemplified by FDA's Breakthrough Therapy Designation in 2015 for Actemra based on a Phase 2 study that only showed an improving trend in skin fibrosis! There currently are no options for treating the underlying fibrotic changes which represents the core pathophysiology.

  • In 2016, sacituzumab govitecan received Breakthrough Therapy Designation from the FDA for the treatment of patients with TNBC who have failed prior therapies for metastatic disease.

  • The Breakthrough Therapy Designation put pirfenidone on the “fast track” to FDA approval.


More Definitions of Breakthrough Therapy Designation

Breakthrough Therapy Designation means, with respect to a Licensed Product, the approval of an application filed with the FDA granting such Licensed Product a “Breakthrough Therapy” designation in accordance with the rules and regulations promulgated under the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Breakthrough Therapy Designation means, with respect to a Licensed Product, the approval of an application filed with the FDA granting such Licensed Product a “Breakthrough Therapy” designation in accordance with the rules and regulations promulgated under the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time.
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Related to Breakthrough Therapy Designation

  • Step therapy protocol means a protocol or program that establishes the specific

  • Step therapy means a protocol or

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Moving beam radiation therapy means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.

  • Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Stationary beam radiation therapy means radiation therapy without displacement of one or more mechanical axes relative to the patient during irradiation.

  • Physical therapy licensing board or "licensing board" means the agency of a state that is responsible for the licensing and regulation of physical therapists and physical therapist assistants.

  • Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Medical cannabis dispensary means an organization issued a

  • Radiation therapy simulation system means a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Conversion therapy means any practice or treatment as defined in § 54.1-2409.5 A of the Code of Virginia.

  • External beam radiation therapy means therapeutic irradiation in which the source of radiation is at a distance from the body.

  • Mental health therapist means the same as that term is defined in Section 58-60-102.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Cardiopulmonary resuscitation or "CPR" means artificial ventilation or external

  • Type designation means a combination of letters and numerals assigned by the Government to a major end item, assembly or subassembly, as appropriate, to provide a convenient means of differentiating between items having the same basic name and to indicate modifications and changes thereto.

  • Behavioral therapy means interactive therapies derived from evidence-based research, including applied behavior analysis, which includes discrete trial training, pivotal response training, intensive intervention programs, and early intensive behavioral intervention.

  • National Medical Support Notice or “NMSN” shall mean a notice that contains the following information:

  • Radiation therapist means a person, other than a Licensed Practitioner or Nuclear Medicine Technologist, who applies radiation to humans for therapeutic purposes under the supervision of a Licensed Practitioner;

  • Non-Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Statewide popular election means a general election in which

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.