Piperazines

Aspargo Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting with FDA on Sildenafil Oral Spray for the Treatment of Erectile Dysfunction

Retrieved on: 
Monday, May 4, 2020

The FDA was supportive of a single dose bioequivalent study comparing Aspargos Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.

Key Points: 
  • The FDA was supportive of a single dose bioequivalent study comparing Aspargos Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.
  • We look forward to advancing Sildenafil Oral Spray in the U.S. market to provide men who suffer from erectile dysfunction a differentiated dosing formulationthat provides convenient administration, flexible dosing and access for ED patients who have difficulty swallowing oral tablets.
  • Aspargo is the exclusive U.S. licensee of the U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. of Madrid, Spain ( www.farmalider.com ).
  • Except as required by law, Aspargo disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

European Commission approves nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Retrieved on: 
Tuesday, April 21, 2020

Boehringer Ingelheim today announced that the European Commission has approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.2 The approval comes after the Committee for Medicinal Products for Human Use had adopted a positive opinion for nintedanib in treatment of SSc-ILD on 27 February 2020.

Key Points: 
  • Boehringer Ingelheim today announced that the European Commission has approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults.2 The approval comes after the Committee for Medicinal Products for Human Use had adopted a positive opinion for nintedanib in treatment of SSc-ILD on 27 February 2020.
  • Nintedanib, being the first and only approved treatment for SSc-ILD, is serving a high unmet need making a real positive difference to those living with this life-changing condition.
  • The European Commissions decision is very welcome news for the European scleroderma community, commented Sue Farrington, President of the Federation of European Scleroderma Associations (FESCA).
  • Nintedanib is approved in over 75 countries for the treatment of IPF, and it is the first approved treatment for SSc-ILD.8
    View source version on businesswire.com: https://www.businesswire.com/news/home/20200421005328/en/

Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration

Retrieved on: 
Friday, April 10, 2020

A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements.

Key Points: 
  • A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements.
  • Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
  • FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation.
  • Health Canada approves Astellas' XOSPATA (gilteritinib) for patients with relapsed or refractory acute myeloid leukemia with a FLT3 mutation.

Zipeprol (CAS 34758-83-3) Industry Analysis, 2020 - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 26, 2020

The "Zipeprol (CAS 34758-83-3) Market Research Report 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Zipeprol (CAS 34758-83-3) Market Research Report 2020" report has been added to ResearchAndMarkets.com's offering.
  • This global report is a result of industry experts' diligent work on researching the world market of Zipeprol.
  • The report helps to build up a clear view of the market trends and development, identify major players in the industry, and estimate main downstream sectors.
  • The Zipeprol global market report key points:

Zipeprol | World Market Insights and Outlook 2020

Retrieved on: 
Wednesday, March 25, 2020

DUBLIN, March 25, 2020 /PRNewswire/ -- The "Zipeprol (CAS 34758-83-3) Market Research Report 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, March 25, 2020 /PRNewswire/ -- The "Zipeprol (CAS 34758-83-3) Market Research Report 2020" report has been added to ResearchAndMarkets.com's offering.
  • This global report is a result of industry experts' diligent work on researching the world market of Zipeprol.
  • The report helps to build up a clear view of the market trends and development, identify major players in the industry, and estimate main downstream sectors.
  • The Zipeprol global market report key points:

CURE Pharmaceutical [OTCQB:CURR] Secures Chinese Patent on its Oral Thin Films to Treat Erectile Dysfunction

Retrieved on: 
Tuesday, March 17, 2020

OXNARD, Calif., March 17, 2020 (GLOBE NEWSWIRE) -- CURE Pharmaceutical (OTC:CURR), an innovative drug delivery and development company, today announced the allowance of Chinese Patent No.

Key Points: 
  • OXNARD, Calif., March 17, 2020 (GLOBE NEWSWIRE) -- CURE Pharmaceutical (OTC:CURR), an innovative drug delivery and development company, today announced the allowance of Chinese Patent No.
  • Securing this key patent supports our global commercialization strategy for CUREfilm Blue as well as follow-on drugs delivered using thin film, said Rob Davidson, CEO of CURE Pharmaceutical.
  • The ED drug market is expected to reach USD$6.5 billionat a6%compound annual growth rate by 2025, according to QYResearch .
  • This enables CURE to differentiate its oral thin film product from sildenafil oral soluble films.

FDA approves Ofev® as first treatment for chronic fibrosing ILDs with a progressive phenotype

Retrieved on: 
Monday, March 9, 2020

RIDGEFIELD, Conn., March 9, 2020 /PRNewswire/ --Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

Key Points: 
  • RIDGEFIELD, Conn., March 9, 2020 /PRNewswire/ --Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
  • Ofev received Breakthrough Therapy Designation from the U.S. FDA for chronic fibrosing ILDs with a progressive phenotype in October 2019.
  • This new approval now makes Ofev available for patients with chronic fibrosing ILDs in which lung fibrosis continues to worsen.
  • Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs.

Daré Bioscience Presents Positive Sildenafil Cream, 3.6% Data Supporting Further Development for the Treatment of Female Sexual Arousal Disorder

Retrieved on: 
Monday, March 9, 2020

DarBioscience, in collaboration with Strategic Science & Technologies, LLC (SST), is developing Sildenafil Cream as a potential treatment for FSAD.

Key Points: 
  • DarBioscience, in collaboration with Strategic Science & Technologies, LLC (SST), is developing Sildenafil Cream as a potential treatment for FSAD.
  • While oral sildenafil is effective for men, it is not an optimized way to achieve the same response in women, said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.
  • The thermography study is part of a comprehensive clinical development and regulatory plan for Sildenafil Cream that Dar Bioscience intends to implement in collaboration with SST.
  • Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens health.

Prices for Three Major ED Drugs Drop in Second Half of 2019

Retrieved on: 
Wednesday, January 22, 2020

Though some prices crept up slightly toward the end of the year, December prices for all of these drugs were lower than their July prices.

Key Points: 
  • Though some prices crept up slightly toward the end of the year, December prices for all of these drugs were lower than their July prices.
  • These trends were extracted from pricing data on branded and generic ED drugs collected from 15 retail chain pharmacies and three online medical facilitators including eDrugstore.com.
  • Of the branded ED drugs, Levitra experienced the biggest drop in average price, of 9.9% from July through December.
  • Once generic ED drugs hit the market a few years ago, patients experienced significant price relief when treating erectile dysfunction.

Health Canada Approves Astellas' XOSPATA® (gilteritinib) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

Retrieved on: 
Tuesday, January 14, 2020

XOSPATA is the first and only targeted treatment approved by Health Canada for patients with relapsed or refractory Acute Myeloid Leukemia with a FLT3 mutation.

Key Points: 
  • XOSPATA is the first and only targeted treatment approved by Health Canada for patients with relapsed or refractory Acute Myeloid Leukemia with a FLT3 mutation.
  • The study enrolled 371 patients with relapsed or refractory AML and FLT3 mutation present in bone marrow or whole blood.
  • FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation.
  • European Commission Approves Astellas' XOSPATA (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation.