RTF

Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia

Retrieved on: 
Thursday, March 28, 2024
PSVT, Letter, Refusal, Paroxysmal supraventricular tachycardia, New Drug Application, Patient, NDA, Aes, RTF, Agency, Safety, FDA, Food, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).

Key Points: 
  • MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).
  • “We appreciate FDA’s guidance through the resubmission process.
  • We believe we have addressed all the issues raised in the Refusal to File letter and look forward to working with the Agency as it reviews our application,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals.
  • The resubmission package included restructured data sets that captured timing of reported AEs and certain data files reformatted to facilitate FDA’s analyses.

Return to Freedom's Wild Horse Sanctuary in Lompoc, Calif., to Celebrate Opening Day, Spirit's Birthday on May 4

Retrieved on: 
Monday, April 8, 2024
DreamWorks Animation, Trail, Netflix, Horse, Central Coast, Animation, RTF, Wine, Family Day, Mission, Multimedia, Amusement park

LOMPOC, Calif., April 8, 2024 /PRNewswire/ -- From 3 p.m. to 6:30 p.m. on Saturday, May 4, Return to Freedom's American Wild Horse Sanctuary will celebrate the start of its summer program season and the 29th birthday of Spirit.

Key Points: 
  • LOMPOC, Calif., April 8, 2024 /PRNewswire/ -- From 3 p.m. to 6:30 p.m. on Saturday, May 4, Return to Freedom's American Wild Horse Sanctuary will celebrate the start of its summer program season and the 29th birthday of Spirit.
  • The Kiger stallion served as muse and model for the beloved animated film "Spirit: Stallion of the Cimarron."
  • The Opening Day event will feature: a Native American blessing the horses and land, staff-led walking tours, wine pourings from local wineries and eclectic locavore food, and shopping in RTF's store.
  • A national nonprofit wild horse and burro advocacy organization, RTF opened its first sanctuary in 1998 on 300 acres among the rolling hills of the Central Coast.

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Regulatory and Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, American Heart Association, Letter, Arrhythmia, Refusal, Offering, Paroxysmal supraventricular tachycardia, Safety, Atrial fibrillation, New Drug Application, Patient, Shanda, NDA, Aes, Science, Net, RTF, Investment, AHA, Milestone, Revera, FDA, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.

Key Points: 
  • - FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2 Meeting expected mid-2024
    MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.
  • There was no revenue recorded for the fourth quarter of 2023, compared with $3.5 million the fourth quarter of 2022.
  • Commercial expense for the fourth quarter of 2023 was $5.0 million, compared with $2.6 million for the prior year period.
  • For the fourth quarter of 2023, net loss was $13.6 million, compared to $13.2 million for the prior year period.

Return to Freedom: Lower Wild Horse, Burro Numbers on Range Don't Equal Success

Retrieved on: 
Tuesday, March 26, 2024
Congress, Growth, Face, AML, BLM, Education, Sterilization, Bureau, History, RTF, Senate, Population growth, Agriculture

More than 64,000 wild horses and burros live not on the range but warehoused in government facilities, including more than 23,000 in often overcrowded "short-term" corrals.

Key Points: 
  • More than 64,000 wild horses and burros live not on the range but warehoused in government facilities, including more than 23,000 in often overcrowded "short-term" corrals.
  • Return to Freedom Wild Horse Conservation (RTF ) is a national nonprofit organization dedicated to wild horse preservation through sanctuary, education, conservation, and advocacy since 1998.
  • It also operates the American Wild Horse Sanctuary at three California locations, caring for more than 420 wild horses and burros.
  • Follow us on Facebook , Twitter, and Instagram for updates about wild horses and burros on the range and at our sanctuary.

Return to Freedom: BLM should not pursue sterilization of wild mares

Retrieved on: 
Monday, March 18, 2024
Congress, Growth, Infection, AML, Horse, BLM, Education, Sterilization, Bureau, Rest, Death, Oophorectomy, RTF, Behavior, Bleeding, Culdocentesis, Wild horse, Animal, Fiscal, Birth control

LOMPOC, Calif., March 18, 2024 /PRNewswire/ -- Return to Freedom Wild Horse Conservation announced on Monday that it will remain vigilant that the Bureau of Land Management (BLM) not again pursue the invasive surgical sterilization of wild mares.

Key Points: 
  • LOMPOC, Calif., March 18, 2024 /PRNewswire/ -- Return to Freedom Wild Horse Conservation announced on Monday that it will remain vigilant that the Bureau of Land Management (BLM) not again pursue the invasive surgical sterilization of wild mares.
  • The BLM shouldn't make yet another wrong turn, and Congress should not enable it," said Neda DeMayo, president of Return to Freedom (RTF), a national nonprofit wild horse and burro advocacy organization.
  • When the BLM has pursued surgical sterilization of mares, it has been halted by litigation and public opposition.
  • Return to Freedom Wild Horse Conservation (RTF ) is a national nonprofit organization dedicated to wild horse preservation through sanctuary, education, conservation, and advocacy since 1998.

Return to Freedom: Congress must push BLM forward on wild horse management

Retrieved on: 
Tuesday, March 12, 2024
Congress, Horse, BLM, Education, Bureau, Fertility, House, RTF, Assyrian, Wild horse, Fiscal, Senate, Animal husbandry

LOMPOC, Calif., March 11, 2024 /PRNewswire/ -- Return to Freedom Wild Horse Conservation on Monday urged lawmakers to push wild horse management forward on public lands, not let it take a step back.

Key Points: 
  • LOMPOC, Calif., March 11, 2024 /PRNewswire/ -- Return to Freedom Wild Horse Conservation on Monday urged lawmakers to push wild horse management forward on public lands, not let it take a step back.
  • "Changing the BLM's antiquated management of America's wild horses, burros and their habitats cannot wait any longer."
  • Return to Freedom Wild Horse Conservation (RTF ) is a national nonprofit organization dedicated to wild horse preservation through sanctuary, education, conservation, and advocacy since 1998.
  • It also operates the American Wild Horse Sanctuary at three California locations, caring for more than 420 wild horses and burros.

Procedural advice for orphan medicinal product designation: Guidance for sponsors

Retrieved on: 
Wednesday, April 3, 2024
Community, Reproduction, Letter, European Commission, European Communities, Inn, Patient, Agency, Translation, European Medicines Agency, Council, European, Deference, VSI, Marketing, Legislation, Certification, MHLW, Annex, European Economic Area, PDF, Public, Medication, Committee, Policy, Bibliography, EMA, CAT, COMP, SME, Language, Ministry, CHMP, Decision, Cisco Webex, Prevalence, Disease, Part, Classification, Regulation (European Union), Privacy, Commission, RTF, EEA, Sponsor, PMDA, FDA, Guideline, Diagnosis, Civil service commission, European Council, European Parliament, Recognition, Art, INN, Official Journal, Record, TEAMS, Mutual, Microsoft PowerPoint, ID, Pharmaceutical industry

Frequently asked questions ................................................................... 10

Key Points: 
    • Frequently asked questions ................................................................... 10

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 2/13

      1.

    • This Regulation lays down the procedure for
      the designation of medicinal products as orphan medicinal products and provides incentives for the
      development and placing on the market of designated orphan medicinal products.
    • The Regulation also
      establishes the Committee for Orphan Medicinal Products (COMP) within the European Medicines
      Agency (EMA), which is responsible for examining applications for orphan medicinal product
      designation.
    • As of 28 April 2000, the date this Regulation entered into force, sponsors have been able to
      submit applications for orphan medicinal product designation to the EMA.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 3/13

      2.

    • Objectives
      In examining an application for orphan medicinal product designation, the COMP will focus on
      determining whether the sponsor has established that the designation criteria are met, i.e.
    • To assist in the development of a policy on orphan medicinal products, an expert network will
      be built up by the Committee, with expert(s) identified as appropriate to be involved in the evaluation
      of applications for orphan medicinal product designation.
    • ?

      The complete application should include:

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 5/13

      Document

      Format

      General administrative and scientific information completed online via the portal.

    • Important:
      In preparing an application for orphan medicinal product designation, sponsors are requested to follow
      the Commission guideline (2022/C 440/02) on the format and content of applications for designation
      as orphan medicinal products.
    • Please refer to the Procedural advice on
      appeal procedure for Orphan Medicinal Product Designation (EMEA/2677/01 Rev.3).
    • The grounds for the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 9/13

      appeal should be based only on the original information provided in the application for orphan
      designation.

    • ?

      The European Commission will enter the designated medicinal product in the Community Register
      of Orphan Medicinal Products.

    • General advice
      ?

      Full information on the procedure for orphan medicinal products designation is available on the
      EMA orphan designation website.

    • In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the sponsor may submit an
      application for orphan medicinal product designation to the Agency at any stage of development of the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 10/13

      medicinal product as long as the criteria for designation may be justified.

    • A request for orphan medicinal product designation may be made for
      a new orphan indication for an already authorised medicinal product.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 11/13

      Which are the sponsor?s options in case of negative outcome for orphan designation?

Theratechnologies Receives Refusal to File Letter for Trogarzo® Intramuscular Method of Administration sBLA from FDA

Retrieved on: 
Tuesday, February 27, 2024
FDA, TSX, File, Senior, RTF, Letter, Pharmaceutical industry

MONTREAL, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) has issued a refusal to file letter (RTF) regarding the Company’s supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk).

Key Points: 
  • MONTREAL, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that the United States Food and Drug Administration (FDA) has issued a refusal to file letter (RTF) regarding the Company’s supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of Trogarzo® (ibalizumab-uiyk).
  • The sBLA filing was announced on January 2, 2024.
  • Upon preliminary review, the FDA determined that the sBLA was not sufficiently complete to permit a substantive review.
  • The RTF states that the sBLA did not contain the data required to establish the pharmacokinetic bridge between the IM and the intravenous infusion route of administration of Trogarzo®.

EudraVigilance - EVWEB user manual

Retrieved on: 
Sunday, March 10, 2024
International Organization (journal), Level 2, Automation, Chapter Two, ACK, ISO, Classification, SSL, Sender, Clinical trial, Radio, Immediate, European, CAPS, European Medicines Agency, Report, MDN, ICH, Medicine, HTML, Internet, Medical dictionary, NCA, Originality, HTTPS, SHTTP, European Economic Area, Headquarters, NASK, Three-body problem, Privacy, Match, Database, Data entry, European Economic Community, MSSO, Module, ZIP, Acknowledgment, Acronym, Environment, Message, MLM, Access, Conference, Pharmacovigilance, XML, EMA, Gateway, Chapter One, MedDRA, Active ingredient, Communication, Validation, Public, Data analysis, Precision, RTF, Navigation, Salt, Security, Chapter Five, Contextual, International organization, Convention, SME, URL, Chapter Four, ID, MAH, Rich Text Format, Microsoft Edge, EudraVigilance, Name, MSK, UNK, Risk, Create, Tree view, ICSR, Chapter Three, Web browser, Commercial, R2, Socs, TAB, Literature, Courier, CIOMS, EV, Built-in self-test, Documentation, Coreidae, Council, S-HTTP, File Explorer, UI, Import, Calendar, WEB, Reproduction, Jousting, PDF, Economic union, Mobile phone
Key Points: 

    Climate transition risk in the banking sector: what can prudential regulation do?

    Retrieved on: 
    Saturday, February 17, 2024
    Working, RWE, Workshop, N2O, Climate, DD, Policy, CES, Macroeconomics, Research Papers in Economics, University, Deleveraging, A.6, PFC, A.7, AWI, Canadian International Council, FRB, Paper, RTF, NX, Household, Economy, Carbon, BTI, Central bank, Classification, Lit, Capital, UH, Government, Parameter, Q54, Credit, Social science, Constantine Dafermos, Simons Foundation, PD, LE, Investment, Part, A.4, AA, A.5, PB, Section 2, Probability, E61, Um, LCI, COVID-19, Coronavirus, Financial regulation, Equation, MCI, Control Engineering (magazine), Environment, CIT, Bank of England, GSF, Directorate, Shock, Relaxation, European Central Bank, DP, Abstract, PTI, DPF, Face, AWB, DSGE, Website, Calibration, Prudential, Ben Bernanke, Climate change, Macroprudential regulation, Money, CRRA, Bank, LH, Methodology, HCI, RF, D58, BK, European Commission, Risk, Biophysical environment, NF3, NCDF, CO2, Acquisition, JEL, Sustainability, American wire gauge, QT, Journal of Financial Stability, BCBS, CSS, Motion, ECB, HFC, RT, CTH, Exercise, Tax, European Parliament, Literature, Qi, Reproduction, LGD, KT, European Green Deal, SF6, Council, DT, FOC, Journal, LG, RSS, EPF, University of Poitiers, UI, ESG, CC, Internalization, CH4, PDF, DTH, RTÉ, Communications satellite
    Key Points: