Benzodiazepines

DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

Thursday, November 19, 2020 - 10:07pm

- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol

Key Points: 
  • - Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
    - EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
    Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia.
  • Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST NINE MONTHS OF 2020

Wednesday, November 11, 2020 - 7:01am

In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In October 2020, the Drug Enforcement Administration (DEA) designated BYFAVO(TM) as a Schedule IV medicine, which was a prerequisite for launch.
  • The overall evaluation of opportunities and risks has not changed significantly in the first nine months of 2020.
  • PAION confirms its financial outlook for the current fiscal year announced on 12 August 2020 with the publication of the half-year results for 2020.

Neurelis Announces Four Poster Presentations For The Joint Meeting Of The International Child Neurology Association And Child Neurology Society

Friday, October 16, 2020 - 2:00pm

SAN DIEGO, Oct. 16, 2020 /PRNewswire/ -- Neurelis, Inc., announced today the company has four posters being presented at the 16th annual International Child Neurology Association Congress/49th annual Child Neurology Society Meeting.

Key Points: 
  • SAN DIEGO, Oct. 16, 2020 /PRNewswire/ -- Neurelis, Inc., announced today the company has four posters being presented at the 16th annual International Child Neurology Association Congress/49th annual Child Neurology Society Meeting.
  • Neurelis Chief Medical Officer Enrique Carrazana, M.D., said the poster presentations continue to validate the safety, pharmacokinetics, and tolerability of VALTOCO (diazepam nasal spray) in children with epilepsy aged 6 and older.
  • "The data continue to demonstrate that VALTOCO is an important treatment option for children with epilepsy suffering from seizure clusters,"Dr. Carrazana said.
  • The details for the poster presentations are as follows and are available online here ; type VALTOCO in search bar to view.

DGAP-News: PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2020

Wednesday, August 12, 2020 - 7:01am

In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In July 2020, after market approval of BYFAVOTM, PAION, Cosmo and Acacia agreed to assign the BYFAVOTM license agreement signed in 2016 between Cosmo and PAION to Acacia.
  • In Europe, PAION is seeking approval for remimazolam in procedural sedation and in general anesthesia.
  • Procedural sedation: PAION submitted a Marketing Authorization Application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019.

DGAP-News: PAION ANNOUNCES PROGRESS WITH REMIMAZOLAM BY ITS PARTNER YICHANG HUMANWELL IN CHINA

Tuesday, August 11, 2020 - 10:03am

Aachen (Germany), 11 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its Chinese remimazolam licensee Yichang Humanwell has recently launched Ruima(R) (remimazolam) in procedural sedation in China.

Key Points: 
  • Aachen (Germany), 11 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its Chinese remimazolam licensee Yichang Humanwell has recently launched Ruima(R) (remimazolam) in procedural sedation in China.
  • Remimazolam (brand name Ruima(R)) was approved in China for procedural sedation in July 2020.
  • We are delighted by the strong commitment to remimazolam by our Chinese partner Yichang Humanwell.
  • In China, licensee Yichang Humanwell received market approval in procedural sedation in July 2020.

DGAP-News: PAION ANNOUNCES SUCCESSFUL PRODUCT LAUNCH OF ANEREM (REMIMAZOLAM) IN JAPAN BY MUNDIPHARMA

Friday, August 7, 2020 - 7:00am

Aachen (Germany), 07 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that Mundipharma, remimazolam licensee for Japan, informed PAION about the successful launch with first commercial product sales of Anerem(R) (remimazolam) for the use in general anesthesia in Japan.

Key Points: 
  • Aachen (Germany), 07 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that Mundipharma, remimazolam licensee for Japan, informed PAION about the successful launch with first commercial product sales of Anerem(R) (remimazolam) for the use in general anesthesia in Japan.
  • PAION is eligible to royalties between 16-18% in Japan.
  • In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020.
  • The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.

DGAP-News: PAION REPORTS FULL CONVERSION OF CONVERTIBLE NOTES

Wednesday, July 8, 2020 - 6:07pm

Aachen (Germany), 08 July 2020 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the EUR 5 million convertible notes issued to Yorkville Advisors Global, LP (Yorkville) in September 2019 have been converted into a total of 2,363,350 PAION shares.

Key Points: 
  • Aachen (Germany), 08 July 2020 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the EUR 5 million convertible notes issued to Yorkville Advisors Global, LP (Yorkville) in September 2019 have been converted into a total of 2,363,350 PAION shares.
  • The convertible notes have thus been converted completely and a further use of the financing agreement with Yorkville is not planned.
  • Abdelghani Omari, CFO of PAION AG, commented: "We would like to thank Yorkville for their support over the last year.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM IN ITALIAN HOSPITAL

Tuesday, June 2, 2020 - 9:01am

PAION was contacted by the San Raffaele Hospital as to whether remimazolam could be delivered since a shortage of propofol and midazolam due to the coronavirus pandemic occurred.

Key Points: 
  • PAION was contacted by the San Raffaele Hospital as to whether remimazolam could be delivered since a shortage of propofol and midazolam due to the coronavirus pandemic occurred.
  • PAION will fulfill the request from the hospital and will deliver the material free of charge.
  • Remimazolam has received marketing authorization in Japan, and marketing approval applications have been submitted inter alia in the U.S. and in Europe.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

Neurelis Announces Three Poster Presentations At The Annual Meeting Of The Child Neurology Society

Tuesday, October 22, 2019 - 2:00pm

VALTOCO is a proprietary formulation of diazepam, incorporating the unique combination of a vitamin Ebased solution and Intravail transmucosal absorption enhancement technology.

Key Points: 
  • VALTOCO is a proprietary formulation of diazepam, incorporating the unique combination of a vitamin Ebased solution and Intravail transmucosal absorption enhancement technology.
  • In a long-term, open-label clinical trial, the safety of VALTOCO was evaluated: 190 patients were enrolled and 2,274 seizures were treated.
  • Approximately 92% of the seizures treated with a single dose of VALTOCO did not require a second dose within at least 24 hours.
  • Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to target unmet medical needs.

Nordiazepam (CAS 1088-11-5) Market Research Report 2019: Build Up a Clear View of the Market, Identify Major Players in the Industry, and Estimate Main Downstream Sectors - ResearchAndMarkets.com

Wednesday, March 27, 2019 - 8:44pm

The "Nordiazepam (CAS 1088-11-5) Market Research Report 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Nordiazepam (CAS 1088-11-5) Market Research Report 2019" report has been added to ResearchAndMarkets.com's offering.
  • This report is a result of industry experts' diligent work on researching the world market of Nordiazepam.
  • The report helps to build up a clear view of the market (trends and prospects), identify major players in the industry, and estimate main downstream sectors.
  • The fourth chapter deals with Nordiazepam market trends review, distinguish Nordiazepam manufacturers and suppliers.