Pyridines

DGAP-News: ​​​​​​​PAION AG REPORTS ON SUCCESSFUL FISCAL YEAR 2020

Retrieved on: 
Tuesday, March 30, 2021

Outstanding milestones were the first approvals of remimazolam in key pharma markets and the first successful launches by our partners.

Key Points: 
  • Outstanding milestones were the first approvals of remimazolam in key pharma markets and the first successful launches by our partners.
  • The associated milestone payments have led to a positive full-year result in 2020," commented Dr. Jim Phillips, CEO of PAION AG.
  • In Europe, remimazolam (trade name Byfavo(R)) is approved in procedural sedation and in addition PAION is seeking approval for general anesthesia.
  • In January 2020, PAION and Hana Pharm extended their license agreement for remimazolam to include Southeast Asia (Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam).

Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia’s Vadadustat

Retrieved on: 
Tuesday, March 30, 2021

In 2016, Otsuka and Akebia signed a collaboration and license agreement for vadadustat in the U.S.

Key Points: 
  • In 2016, Otsuka and Akebia signed a collaboration and license agreement for vadadustat in the U.S.
  • The two companies subsequently signed a collaboration and license Agreement in 2017 for vadadustat in certain other areas.
  • Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.
  • Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI).

Eisai: Discovery Research on AMPA-type Glutamate Receptor Antagonist Perampanel Honored With PSJ Award for Drug Research and Development 2021

Retrieved on: 
Friday, March 26, 2021

TOKYO, Mar 26, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that drug discovery research conducted on perampanel (brand name: FYCOMPA, "perampanel"), the AMPA-type glutamate receptor antagonist discovered by Eisai, has been honored with The Pharmaceutical Society of Japan (PSJ) Award for Drug Research and Development 2021 by the PSJ.

Key Points: 
  • TOKYO, Mar 26, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that drug discovery research conducted on perampanel (brand name: FYCOMPA, "perampanel"), the AMPA-type glutamate receptor antagonist discovered by Eisai, has been honored with The Pharmaceutical Society of Japan (PSJ) Award for Drug Research and Development 2021 by the PSJ.
  • The reasons for the selection of this discovery research for the award are outlined by the PSJ as follows.
  • Although glutamate receptors, which are responsible for neuronal excitation, have long been recognized as important drug discovery targets, they have not led to the creation of any drugs.
  • It has been demonstrated that perampanel is a selective, non-competitive AMPA receptor antagonist.

Akebia Therapeutics Announces Poster Presentations and Educational Symposium at National Kidney Foundation 2021 Virtual Spring Clinical Meetings

Retrieved on: 
Thursday, March 25, 2021

CAMBRIDGE, Mass., March 25, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the National Kidney Foundation 2021 Spring Clinical Meetings (NKF SCM21), which takes place virtually April 6-10, 2021.

Key Points: 
  • CAMBRIDGE, Mass., March 25, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the National Kidney Foundation 2021 Spring Clinical Meetings (NKF SCM21), which takes place virtually April 6-10, 2021.
  • Abstracts are now available online in the NKF SCM21 Abstract and ePoster Gallery: https://casehippo.com/spa/symposium/national-kidney-foundation-2021-spri... .
  • Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability.
  • In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

Eyenovia Announces Publication of MIST Pivotal Studies Demonstrating the Efficacy and Safety of its MAP™ Fixed-Combination Tropicamide-Phenylephrine Product for Mydriasis

Retrieved on: 
Wednesday, March 17, 2021

Adverse events with tropicamide-phenylephrine were infrequent at 3% and mild with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.

Key Points: 
  • Adverse events with tropicamide-phenylephrine were infrequent at 3% and mild with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.
  • This publication follows the U.S. Food and Drug Administrations recent acceptance of Eyenovias New Drug Application (NDA) for MydCombi, the micro-dosed fixed-combination tropicamide-phenylephrine agent evaluated in these pivotal studies.
  • Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics.
  • Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis.

Mydriasert: An Ophthalmic Insert Containing 0.28mg Tropicamide and 5.4mg Phenylephrine Hydrochloride - Global Drug Insight and Market Forecast to 2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 9, 2021

The "Mydriasert - Drug Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Mydriasert - Drug Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
  • Further, it also consists of market assessments inclusive of the market forecast, SWOT analysis, and detailed analyst views.
  • Mydriasert is an ophthalmic insert containing 0.28mg tropicamide and 5.4mg phenylephrine hydrochloride.
  • It is an ophthalmic pellet inserted into the lower conjunctival fornix prior to surgery or diagnostic procedure.

Trevena to Release Fourth Quarter and Full Year 2020 Financial Results on March 9, 2021

Retrieved on: 
Friday, March 5, 2021

Company to host conference call on March 9th, 2021, at 8:00 a.m.

Key Points: 
  • Company to host conference call on March 9th, 2021, at 8:00 a.m.
  • ET
    CHESTERBROOK, Pa., March 05, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it will release its financial results for the fourth quarter and full year ended December 31, 2020, prior to the market open on Tuesday, March 9th, 2021.
  • The Company will host a conference call and webcast with the investment community at8:00 a.m. ETthat same day, featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Bob Yoder, SVP and Chief Commercial Officer, Mark Demitrack, M.D., SVP and Chief Medical Officer, and Barry Shin, SVP and Chief Financial Officer.
  • Additionally, Dr. Gregory Hammer, Professor of Anesthesiology, Stanford University Medical Center, will be providing additional remarks on the role of OLINVYK (oliceridine) injection in acute pain management and key considerations in the formulary review process at his institution.

DGAP-News: PAION GRANTS EXCLUSIVE LICENSE TO TTY BIOPHARM FOR DEVELOPMENT AND COMMERCIALIZATION OF REMIMAZOLAM IN TAIWAN

Retrieved on: 
Friday, March 5, 2021

Aachen (Germany), 05 March 2021 - PAION AG, a specialty pharma company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), and TTY Biopharm Company Limited ("TTY") today announce that they have entered into a license agreement for remimazolam with PAION granting TTY an exclusive license for the development and commercialization of PAION's lead drug candidate, remimazolam, in Taiwan.

Key Points: 
  • Aachen (Germany), 05 March 2021 - PAION AG, a specialty pharma company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), and TTY Biopharm Company Limited ("TTY") today announce that they have entered into a license agreement for remimazolam with PAION granting TTY an exclusive license for the development and commercialization of PAION's lead drug candidate, remimazolam, in Taiwan.
  • Under the terms of the agreement, TTY has the right and obligation to further develop remimazolam in all indications in Taiwan with PAION's support.
  • Dr. Jim Phillips, CEO of PAION AG, commented: "We are excited to have TTY as our partner for remimazolam in Taiwan.
  • Remimazolam, developed by PAION, has been approved in many countries and is a promising medicine for physicians and patients.

Trevena, Inc. to Present at the 10th Annual SVB Leerink Global Healthcare Conference

Retrieved on: 
Monday, February 22, 2021

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders.

Key Points: 
  • Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders.
  • The Company has one approved product in the U.S., OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
  • The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients.
  • The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

Athenex Announces New England Journal of Medicine Publication of Phase III Data on the Efficacy and Safety of Klisyri® (tirbanibulin)

Retrieved on: 
Thursday, February 11, 2021

This important publication represents a significant achievement for Athenex and all of our colleagues who have worked to discover, develop, and bring Klisyri to market, said Dr. Johnson Lau, CEO of Athenex.

Key Points: 
  • This important publication represents a significant achievement for Athenex and all of our colleagues who have worked to discover, develop, and bring Klisyri to market, said Dr. Johnson Lau, CEO of Athenex.
  • The Phase III trials evaluated the efficacy and safety of Klisyri ointment 1% (10 mg/g) in adults with actinic keratosis on the face or scalp and included 702 patients across 62 sites in the United States.
  • Dr. Volker Koscielny, MD, Chief Medical Officer of Almirall said We are delighted by the publication of the Phase III data for Klisyri in the NEJM, one of the most prestigious and rigorously peer-reviewed medical journals in the world.
  • The clinical trial data presented not only demonstrates significant efficacy, but importantly a proven tolerability and safety profile.