Pyridines

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.

Poxel Presents Phase 1b Clinical Results for PXL065 and New Preclinical Data for PXL770 at AASLD The Liver Meeting® 2020

Monday, November 16, 2020 - 4:45pm

Further analysis from our Phase 1b clinical study highlights dose-equivalence for 15 mg of PXL065 vs. 45 mg of Actos.

Key Points: 
  • Further analysis from our Phase 1b clinical study highlights dose-equivalence for 15 mg of PXL065 vs. 45 mg of Actos.
  • On the heels of positive, topline Phase 2a results, these additional data support the continued development of PXL770.
  • Additionally, across several clinical parameters and preclinical studies, PXL770 has demonstrated broader potential in other chronic metabolic indications.
  • Based upon preclinical and Phase 1 results to date, Poxel believes that PXL065 may have a better therapeutic profile than pioglitazone for NASH.

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.

Akebia Presents Results from its PRO2TECT Global Phase 3 Program of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients Not on Dialysis During Late-Breaking Session at American Society of Nephrology Kidney Week 2020 Reim

Friday, October 23, 2020 - 4:15pm

"The PRO2TECT results show that orally administered vadadustat achieved both primary and secondary efficacy endpoints in patients not on dialysis with anemia associated with CKD.

Key Points: 
  • "The PRO2TECT results show that orally administered vadadustat achieved both primary and secondary efficacy endpoints in patients not on dialysis with anemia associated with CKD.
  • Akebia's vadadustat development program also includes INNO2VATE, the global Phase 3 program for the treatment of anemia due to CKD in adult patients on dialysis.
  • Results from this program were presented at ASN Kidney Weekin an oral presentation on October 22, 2020.
  • In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

Nanoform initiates GMP campaign for first-in-human trial of nanoformed drug by year end - ahead of schedule

Tuesday, October 20, 2020 - 3:59pm

The clinical trial is a progression of Nanoform's first GMP campaign, which the company has now initiated, and will be made in partnership with Quotient Sciences ("Quotient"), a leading provider of drug development and manufacturing solutions.

Key Points: 
  • The clinical trial is a progression of Nanoform's first GMP campaign, which the company has now initiated, and will be made in partnership with Quotient Sciences ("Quotient"), a leading provider of drug development and manufacturing solutions.
  • In the clinical trial, Nanoform will investigate the behavior of an oral immediate release (IR) nanoformedformulation of piroxicam, an anti-inflammatory drug.
  • Nanoform will manufacture the nanoformed piroxicam active pharmaceutical ingredient (API), which will then be transferred to Quotient's facilities in Nottingham, UK.
  • Quotient will support the project by developing a standard drug formulation for the nanoformed piroxicam API and administering it to healthy volunteers.

Eyenovia to Present Clinical Study Updates at the American Academy of Optometry Annual Meeting

Monday, October 5, 2020 - 12:00pm

Siddarth Rathi and April Jasper will present the latest analyses and updates from the companys clinical studies at the American Academy of Optometry Academy 2020 At Home Con .

Key Points: 
  • Siddarth Rathi and April Jasper will present the latest analyses and updates from the companys clinical studies at the American Academy of Optometry Academy 2020 At Home Con .
  • Clinical results will cover Pupil Dilation Speed with MAP Fixed Combination (FC) Tropicamide 1% Phenylephrine 2.5% (TR-PH)-Ophthalmic Solution.
  • Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics.
  • MicroPine (atropine ophthalmic solution) is being evaluated in the CHAPERONE Phase 3 clinical study for reduction in pediatric myopia progression.

Europe Pruritus Market and Competitive Landscape Report 2020 - ResearchAndMarkets.com

Monday, September 21, 2020 - 12:11pm

The "Europe Pruritus Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Europe Pruritus Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.
  • Europe Pruritus Market and Competitive Landscape - 2020, provides comprehensive insights into the Pruritus pipeline, epidemiology, market valuations, drug sales, market forecast, drug forecasts, and market shares.
  • This research analyzes and forecasts the Pruritus market size and drug sales.
  • This research covers the following:
    Pruritus treatment options, Pruritus late stage clinical trials pipeline, Pruritus prevalence by countries, Pruritus market size and forecast by countries, key market events and trends, drug sales and forecast by countries, and market shares by countries.

LYNPARZA® (olaparib) Reduced the Risk of Death by 31% in BRCA1/2 or ATM-mutated Metastatic Castration-Resistant Prostate Cancer in Phase III Profound Trial

Sunday, September 20, 2020 - 5:30pm

AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer including the ongoing Phase III PROpel trial testing LYNPARZA as a 1st-line medicine for patients with mCRPC in combination with abiraterone versus abiraterone alone.

Key Points: 
  • AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer including the ongoing Phase III PROpel trial testing LYNPARZA as a 1st-line medicine for patients with mCRPC in combination with abiraterone versus abiraterone alone.
  • Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1).
  • Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm.
  • LYNPARZA is the foundation of AstraZenecas industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

AVEO Oncology Announces European Urology Publication of Final Overall Survival Data from Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma

Tuesday, September 15, 2020 - 9:05pm

AVEO Oncology (Nasdaq: AVEO) today announced that final overall survival (OS) results from its Phase 3 TIVO-3 study were published in the journal European Urology.

Key Points: 
  • AVEO Oncology (Nasdaq: AVEO) today announced that final overall survival (OS) results from its Phase 3 TIVO-3 study were published in the journal European Urology.
  • The article, titled Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma, is available online first via this link .
  • We expect that Tivozanibs TIVO-3 data has the potential to guide important treatment decisions in this setting and ultimately improve outcomes and patient experience.
  • AVEO is working to develop and potentially commercialize tivozanib in North America as a treatment for renal cell carcinoma and hepatocellular carcinoma.

Knight Therapeutics Announces Filling of Supplement to a New Drug Submission for NERLYNX® (neratinib) to Treat HER2-Positive Metastatic Breast Cancer

Thursday, September 3, 2020 - 10:15pm

MONTREAL, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, announced filing of the Supplement to a New Drug Submission (SNDS) of NERLYNX for HER2-Positive Metastatic Breast Cancer in Canada.

Key Points: 
  • MONTREAL, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) ("Knight"), a pan-American (ex-US) specialty pharmaceutical company, announced filing of the Supplement to a New Drug Submission (SNDS) of NERLYNX for HER2-Positive Metastatic Breast Cancer in Canada.
  • Knight and Puma Biotechnology, Inc. (NASDAQ: PBYI) signed a licensing agreement in January 2019 granting Knight the exclusive right to commercialize NERLYNX (neratinib) in Canada.
  • Under the terms of the License Agreement, Knight will be responsible for all commercial activities and future regulatory submissions for NERLYNX in Canada.
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death2.