Pyridines

The National Medical Products Administration (NMPA) issues product license for Abiraterone acetate 250 mg, Bioequivalance study conducted in India by Accutest Research Laboratories (I) Pvt. Ltd., one of the Top Indian CRO

Retrieved on: 
Monday, September 6, 2021
Health care, Health, Pharmaceutical industry, Pharmaceuticals policy, Abiraterone acetate, Antiestrogens, Pyridines, Contract research organization, Food and Drug Administration, Drugs Controller General of India, Pharmaceutical industry in India

BEIJING and MUMBAI, India, Sept. 6, 2021 /PRNewswire/ -- National Medical Products Administration (NMPA) China, announces the approval of Abiraterone acetate 250mg of Qilu Pharmaceuticals for marketing purpose.

Key Points: 
  • BEIJING and MUMBAI, India, Sept. 6, 2021 /PRNewswire/ -- National Medical Products Administration (NMPA) China, announces the approval of Abiraterone acetate 250mg of Qilu Pharmaceuticals for marketing purpose.
  • Applicable Bioequivalance studies for marketing authorization were conducted at Accutest Research Laboratories (I) Pvt.
  • Accutest is a Contract Research Organization (CRO) offering full range of services based in India.
  • An official from Clinical affairs department of Qilu Pharma said, "Thanks to Accutest Research Laboratories, we have successfully achieved our goal in the advance for the Abiraterone acetate projects.

Eisai's Anti-Epileptic Drug Fycompa Approved In China As Monotherapy For Partial-Onset Seizures And Pediatric Indication For Partial-Onset Seizures

Retrieved on: 
Monday, August 2, 2021
Anticonvulsants, Clinical medicine, Nitriles, Perampanel, Pyridines, Eisai, Medicine, Health, Epilepsy, Seizure, Generalized epilepsy, Syndromes

Fycompa has already been approved in China as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

Key Points: 
  • Fycompa has already been approved in China as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
  • Through this approval, Fycompa is now available in China as a monotherapy and an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older.
  • Fycompa is a first-in-class AED and a once-daily tablet discovered at Eisai's Tsukuba Research Laboratories.
  • Eisai seeks to address the diverse needs of, as well as increase the benefits provided to, patients with epilepsy and their families.

FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery

Retrieved on: 
Tuesday, July 27, 2021
Oncology, Health, FDA, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Clinical medicine, Cancer, Drugs, Orphan drugs, Breakthrough therapy, Pyridines, Antineoplastic drugs, Cancer immunotherapy, Pembrolizumab, Merkel-cell carcinoma, Sorafenib, Axitinib, Triple-Negative Breast Cancer, the Merck Access Program for KEYTRUDA, Merck’s Patient Support Program for KEYTRUDA, Merck, TRIPLE-NEGATIVE BREAST CANCER, THE MERCK ACCESS PROGRAM FOR KEYTRUDA, MERCK’S PATIENT SUPPORT PROGRAM FOR KEYTRUDA, MERCK

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points: 
  • KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.
  • KEYTRUDA is indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

Athenex Announces European Commission Approval of Klisyri® (tirbanibulin) for the Topical Treatment of Actinic Keratosis

Retrieved on: 
Monday, July 19, 2021
Chemical compounds, Organic compounds, Amides, Ethers, Morpholines, Pyridines, Tirbanibulin, Chemistry, Actinic keratosis, Almirall, AK

This approval by the European Commission marks another significant milestone for Klisyri, shortly following the marketing approval and launch of Klisyri in the U.S., said Dr. Johnson Lau, Chief Executive Officer of Athenex.

Key Points: 
  • This approval by the European Commission marks another significant milestone for Klisyri, shortly following the marketing approval and launch of Klisyri in the U.S., said Dr. Johnson Lau, Chief Executive Officer of Athenex.
  • In December 2020, Athenex received approval from the U.S. Food and Drug Administration (FDA) for the commercialization of Klisyri (tirbanibulin) in the U.S. for the topical treatment of AK of the face or scalp.
  • Our partner Almirall led the U.S. launch of Klisyri in February and is leading the launch of Klisyri in Europe.
  • Klisyri (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) of the face or scalp.

Almirall receives European Commission approval of Klisyri® (tirbanibulin), an innovative topical treatment for actinic keratosis

Retrieved on: 
Monday, July 19, 2021
Chemistry, Chemical compounds, Physical sciences, Amides, Ethers, Morpholines, Pyridines, Tirbanibulin, Actinic keratosis, Almirall, Keratosis, AK

BARCELONA, Spain, July 19, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.

Key Points: 
  • BARCELONA, Spain, July 19, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.
  • "The approval of Klisyrirepresents a breakthrough for actinic keratosis patients, who seek for new treatments that could offer them a better tolerability and short treatment duration.
  • In addition, Almirall has submitted Klisyri for a marketing authorisation in Switzerland in Q4 2020 and the dossier is currently under review by Swissmedic.
  • [4]Chetty P, Choi F, Mitchell T. Primary care review of actinic keratosis and its therapeutic options: a global perspective.

Eyenovia to Participate in a Presbyopia Panel Discussion at Eyecelerator 2021

Retrieved on: 
Monday, July 19, 2021
Professional services, Medical devices, Health, Finance, Pharmaceutical, Optical, Health, Food and Drug Administration, Chemical compounds, Muscarinic antagonists, Phenols, Pyridines, Tropicamide, Phenylephrine, Mydriasis, Prescription Drug User Fee Act, PDUFA date, Myopia, Eyecelerator, ASCRS, EYECELERATOR, ASCRS

A replay of the Ladenburg Thalmann presentation, which took place on July 14, can be found here .

Key Points: 
  • A replay of the Ladenburg Thalmann presentation, which took place on July 14, can be found here .
  • 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.
  • The companys lead product candidate, Mydcombi (tropicamide/phenylephrine fixed combination) for use in diagnostic eye exams, has an FDA PDUFA date of October 28, 2021.

DGAP-News: ​​​​​​​PAION ANNOUNCES THAT NMPA ACCEPTS SUBMISSION OF NEW DRUG APPLICATION FOR REMIMAZOLAM BESYLATE IN GENERAL ANESTHESIA BY CHINESE LICENSEE YICHANG HUMANWELL

Retrieved on: 
Friday, July 9, 2021
Medical specialties, Clinical medicine, Medicine, Anesthesia, Pyridines, Remimazolam, Yichang, Sedation, Procedural sedation and analgesia, Colonoscopy

Aachen (Germany), 09 July 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that its Chinese remimazolam licensee Yichang Humanwell informed PAION that the National Medical Products Administration (NMPA) has accepted their New Drug Application (NDA) for remimazolam besylate in general anesthesia for review.

Key Points: 
  • Aachen (Germany), 09 July 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that its Chinese remimazolam licensee Yichang Humanwell informed PAION that the National Medical Products Administration (NMPA) has accepted their New Drug Application (NDA) for remimazolam besylate in general anesthesia for review.
  • Yichang Humanwell recently successfully completed the clinical development for remimazolam besylate in general anesthesia.
  • Dr. Jim Phillips, CEO of PAION AG, commented: "Yichang Humanwell has already made great progress in the China market with Ruima(R) (remimazolam besylate) in procedural sedation, exceeding our initial expectations.
  • Remimazolam besylate (brand name Ruima(R)) was approved in China for procedural sedation during colonoscopy in July 2020.

FMC Corporation Granted Interim Injunction Against Agricultural Chemicals Manufacturer Natco for Patent Infringement

Retrieved on: 
Wednesday, July 7, 2021
Benzamides, Chlorantraniliprole, Insecticides, Pyrazoles, Pyridines, Natco, FMC Corporation, Government, Northern Areas Transport Corporation, Injunction, Patent, Insecticide

FMC Corporation (NYSE: FMC), an agricultural sciences company, announced the Delhi High Court today granted the company an interim injunction against NATCO Pharma Limited ("Natco").

Key Points: 
  • FMC Corporation (NYSE: FMC), an agricultural sciences company, announced the Delhi High Court today granted the company an interim injunction against NATCO Pharma Limited ("Natco").
  • The interim injunction restrains Natco from manufacturing, using, distributing, advertising, exporting, offering to sell and/or selling any product which contains chlorantraniliprole, FMC's leading insect control active ingredient.
  • FMC filed the lawsuit against Natco at the Delhi High Court in October 2019 for potential patent infringement of certain Indian patents covering chlorantraniliprole.
  • FMC sells chlorantraniliprole in India under the trade name Rynaxapyr active, which is the primary ingredient in Coragen and Ferterra insecticides.

DGAP-News: PAION RECEIVES UK MHRA APPROVAL OF BYFAVO (REMIMAZOLAM) FOR PROCEDURAL SEDATION

Retrieved on: 
Tuesday, June 29, 2021
Anesthesia, Chemical compounds, Organic compounds, GABAA receptor positive allosteric modulators, Pyridines, Remimazolam, Sedation, MHRA, Intensive care unit, Procedural sedation and analgesia, remimazolam, PAION, REMIMAZOLAM, PAION

Aachen (Germany), 29 June 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo(R) (remimazolam besylate) in adults for procedural sedation.

Key Points: 
  • Aachen (Germany), 29 June 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo(R) (remimazolam besylate) in adults for procedural sedation.
  • The decision follows the approval of the European Commission in the EU (including European Economic Area (EEA) countries) in March 2021.
  • Dr. Jim Phillips, CEO of PAION AG, commented: "We are excited that the MHRA has approved Byfavo(R).
  • In addition to procedural sedation and general anesthesia, intensive care unit (ICU) sedation is another possible indication for remimazolam.

Akero Therapeutics Presents at the American Diabetes Association’s 81st Scientific Sessions, Demonstrating that Improvements in Adipose Tissue Metabolism Contributed Substantially to Improved Liver Health and Better Glycemic Control in Efruxifermin (EFX

Retrieved on: 
Friday, June 25, 2021
Branches of biology, Hormones, Organ systems, Obesity, CYP17A1 inhibitors, Thiazolidinediones, Connective tissue, Pioglitazone, Pyridines, Diabetes medication, Insulin, Thiazolidinedione

The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the companys website.

Key Points: 
  • The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the companys website.
  • These improvements, including a clinically meaningful and statistically significant reduction in HbA1c, were seen on top of concomitant anti-diabetic medications.
  • These secondary analyses highlight the potential of FGFR1c-mediated reprogramming of adipose metabolism in NASH patients to improve liver health.
  • Insulin-sensitizing therapeutics acting predominantly on adipose tissue, such as pioglitazone, have historically been associated with weight gain.