Tecfidera definition

Tecfidera means the product sold as of the Agreement Date by Licensee under Licensee’s tradename and marketing authorization for its oral formulation of dimethyl fumarate indicated for the treatment of multiple sclerosis at the recommended dose of 480 mg/day associated with NDA No. 204063 and equivalent approvals in Designated Countries.
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Tecfidera means Biogen’s oral DMF pharmaceutical product.
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Examples of Tecfidera in a sentence

  • Receipts from Tecfidera milestone payments are presented as Proceeds from available for sale debt securities on the Statement of Cash Flows.

  • The patient’s medication history includes the use of TWO (preferred*) disease modifying agents for the treatment of relapsing forms of MS (*If client has preferred disease modifying agents: Aubagio, Avonex, Betaseron, Copaxone, Gilenya, Glatopa, Plegridy, Rebif, or Tecfidera) OR1.

  • Defendant Narula echoed Defendant Malik, stating in relevant part:Base business erosion includes price and volume decline in our North American generics business, including competition across complex products such as Wixela, XULANE, Miacalcin and our generic for Tecfidera.

  • OTHER CRITERIAN/A MEDICATION(S)EXTAVIA PA INDICATION INDICATOR1 - All FDA-Approved Indications OFF LABEL USESN/A EXCLUSION CRITERIAN/A REQUIRED MEDICAL INFORMATIONDocumentation of trial and failure, contraindication, or intolerance to two (2) of the following: interferon-beta 1a (Avonex, Rebif or Plegridy), interferon-beta 1b (Betaseron), dimethyl fumarate (Tecfidera), glatiramer acetate (Copaxone), teriflunomide (Aubagio) or fingolimod (Gilenya).

  • Tacrolimus 77, 95 Tadalafil 105 Tafinlar 51 Tagrisso 51 Talzenna 50 Tamoxifen Citrate 49 Tamsulosin HCl 84 Targretin 52 Tarina 24 Fe 90 Tarina Fe 1/20 90 Tasigna 51 Tazarotene 77 Tazicef 36 Tazorac 77 Taztia XT 69 TDVAX 98 Tecfidera 75 Tecfidera Starter Pack 75 Tegsedi 83 Telmisartan 67 Telmisartan-Amlodipine 71 Telmisartan-HCTZ 71 Temazepam 107 Tenivac 98 Tenofovir Disoproxil Fumarate ...............................................

  • Application Date Country Forward Pharma has applied for Supplementary Protection Certificates based on EP 2 801 355 and the Marketing Authorisation for Tecfidera (EU/1/13/837) in the following countries: Albania, Austria, Belgium, Bosnia and Herzogovina, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Portugal, Serbia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

  • To illustrate this, the sales growth and then decrease of two of Biogen’s blockbusters: Tecfidera – which eventually became Fumarate – and Spinraza – are discussed in the preceding paragraphs.

  • It was an immediate success and complimented the continuing impressive earnings from Tecfidera.

  • In the second quarter of 2019, U.S. sales of Tecfidera continued to fall year over year for 3- and 6-month period at 0% and 3% respectively.

  • During the same call, Kingsley responded to an analyst’s question (about third-quarter Tecfidera growth being the lowest of the previous five quarters) by noting that growth was moderating and difficult to predict.

Related to Tecfidera

  • ESMP or “Environmental and Social Management Plan” means with respect to each activity under the Project pursuant to which the ESMF requires it, a plan to be prepared by the Recipient pursuant to Section I.D.1 of Schedule 2 to this Agreement, in accordance with the provisions of the ESMF and approved by the Association, setting out measures to mitigate any adverse environmental and social impacts arising from such activities; and “ESMPs” means more than one ESMP.

  • POPIA means the Protection of Personal Information Act, No 4 of 2013;

  • EPFO means Employees' Provident Fund Organization

  • Soda fountain means a place especially equipped

  • CIMA means the Cayman Islands Monetary Authority whose contact details are available from www.cima.ky;

  • QFII means a qualified foreign institutional investor approved pursuant to the relevant PRC regulations (as amended from time to time).

  • RQFII means a Renminbi qualified foreign institutional investor approved pursuant to the relevant PRC regulations (as amended from time to time).

  • Diocese means the Church of England diocese in which the Academies are situated;

  • CESA means the California Endangered Species Act (California Fish and Game Code, §§2050-2115.5) and all regulations promulgated pursuant to that Act.

  • MiFID II means Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU;

  • SADC means the Southern African Development Community;

  • South Caucasus/Central and South Asian (SC/CASA) state means Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Pakistan, Tajikistan, Turkmenistan, or Uzbekistan.

  • biofuels means liquid or gaseous fuel for transport produced from biomass;

  • NCI means the National Cancer Institute.

  • South Caucasus/Central and South Asian (SC/CASA) state means Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Pakistan, Tajikistan, Turkmenistan, or Uzbekistan.

  • SOFRi means the SOFR for:

  • OPWC means the Ohio Public Works Commission created pursuant to Revised Code Section 164.02.

  • SWDocID [[6027980]]" "" [[6027980]] elect or decline, in its sole discretion, to provide a New Commitment. Such New Commitments shall become effective as of such Increased Amount Date, and in the case of Incremental Term Loans, shall be made on such Increased Amount Date; provided that (i) the conditions set forth in paragraphs of (b) and (c) of Section 4.02 shall be satisfied or waived by the Required Lenders on such Increased Amount Date before or after giving effect to such New Commitments and Loans; (ii) such increase in the Revolving Facility Commitments and/or the Incremental Term Loans shall be evidenced by one or more joinder agreements executed and delivered to Administrative Agent by each New Lender, as applicable, and each shall be recorded in the register, each of which shall be reasonably satisfactory to the Administrative Agent and subject to the requirements set forth in Section 2.17(f); and (iii) the Borrower shall make any payments required pursuant to Section 2.16 in connection with the provisions of the New Commitments; provided that, with respect to any Incremental Term Loans incurred for the primary purpose of financing a Limited Conditionality Acquisition (“Acquisition-Related Incremental Term Loans”), clause (i) of this sentence shall be deemed to have been satisfied so long as (A) as of the date of execution of the related Limited Conditionality Acquisition Agreement by the parties thereto, no Default shall have occurred and be continuing or would result from entry into such Limited Conditionality Acquisition Agreement, (B) as of the date of the borrowing of such Acquisition-Related Incremental Term Loans, no Event of Default under Section 7.01(a), 7.01(b), 7.01(h) or 7.01(i) is in existence immediately before or after giving effect (including on a Pro Forma Basis) to such borrowing and to any concurrent transactions and any substantially concurrent use of proceeds thereof, (C) the representations and warranties of the Loan Parties set forth in this Agreement and the other Loan Documents shall be true and correct in all material respects as of the date of execution of the applicable Limited Conditionality Acquisition Agreement by the parties thereto, except to the extent any such representations or warranties are expressly limited to an earlier date, in which case such representations and warranties shall be true and correct in all material respects as of such specified earlier date (provided that no materiality qualifier set forth in this subclause (C) shall be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof) and (D) as of the date of the borrowing of such Acquisition-Related Incremental Term Loans, customary “Sungard” representations and warranties (with such representations and warranties to be reasonably determined by the Lenders providing such Acquisition-Related Incremental Term Loans) shall be true and correct in all material respects immediately before and after giving effect to the incurrence of such Acquisition-Related Incremental Term Loans, except to the extent any such representations or warranties are expressly limited to an earlier date, in which case such representations and warranties shall be true and correct in all material respects as of such specified earlier date (provided that no materiality qualifier set forth in this subclause (D) shall be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof).

  • EUMA means the “SAP Delivered Support Agreement” which sets out the terms and conditions under which SAP provides support to End Users and which will be provided by SAP on a deal by deal basis.

  • COGSA means the Carriage of Goods by Sea Act of the United States of America approved on 16th April 1936.

  • STSMA means the Sectional Titles Schemes Management Act 8 of 2011, as amended and include the Regulations issued under the said act;

  • DTS means Days to Settlement, i.e., the number of actual days elapsed from and including the original Closing Day with respect to such Accepted Note (in the case of the first such payment with respect to such Accepted Note) or from and including the date of the next preceding payment (in the case of any subsequent delayed delivery fee payment with respect to such Accepted Note) to but excluding the date of such payment; and "PA" means Principal Amount, i.e., the principal amount of the Accepted Note for which such calculation is being made. In no case shall the Delayed Delivery Fee be less than zero. Nothing contained herein shall obligate any Purchaser to purchase any Accepted Note on any day other than the Closing Day for such Accepted Note, as the same may be rescheduled from time to time in compliance with paragraph 2B(7).

  • BG means Bank Guarantee

  • POPI means the Protection of Personal Information Act, 4 of 2013;

  • SA means the booklet that describes the Health Care Coverage provided to Enrolled Members. The Subscriber Agreement(s) applicable to the initial Rating Period are listed in Section III.

  • ESBD means the Electronic State Business Daily, the electronic marketplace where State of Texas bid opportunities over $25,000 are posted. The ESBD may currently be accessed at http://www.txsmartbuy.com/sp.