Thiophenes

LANNETT expands respiratory pipeline, signs exclusive distribution agreement for generic SPIRIVA® handihaler®

Retrieved on: 
Thursday, July 29, 2021
Chemical compounds, Health care, Health sciences, Muscarinic antagonists, Boehringer Ingelheim, Bromides, Epoxides, Thiophenes, Tiotropium bromide, Abbreviated New Drug Application, Inhaler

PHILADELPHIA, July 29, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva Handihaler (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd.

Key Points: 
  • PHILADELPHIA, July 29, 2021 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an exclusive U.S. commercialization agreement for a therapeutically equivalent generic of Spiriva Handihaler (Tiotropium Bromide inhalation powder) with Respirent Pharmaceuticals Co. Ltd.
  • U.S. sales of Spiriva Handihaler were $1.5 billion for the 12 months ending May, 2021 according to IQVIA, although actual generic market values are expected to be lower.
  • "With generic Spiriva Handihaler, our strategic relationship with Respirent now includes three inhaler products, each of which has the potential to be a meaningful contributor to our company's financial performance.
  • The generic Spiriva Handihaler product is currently in development and tracking to Abbreviated New Drug Application (ANDA) submission in 2023."

Hangzhou Chance Pharmaceuticals Announces NMPA Acceptance of Marketing Authorization Application for CXF11

Retrieved on: 
Friday, July 2, 2021
Respiratory diseases, Chemical compounds, Pulmonology, Chronic lower respiratory diseases, Muscarinic antagonists, Bromides, Epoxides, Thiophenes, Tiotropium bromide, Chronic obstructive pulmonary disease, COPD: Journal of Chronic Obstructive Pulmonary Disease, Bronchospasm

HANGZHOU, China, July 02, 2021 (GLOBE NEWSWIRE) -- Hangzhou Chance Pharmaceuticals (Chance), a clinical-stage biotechnology company focusing on discovering, developing, and commercializing transformative inhalation therapies for the worlds most debilitating diseases, announced that the National Medical Products Administration (NMPA) of China has accepted its Marketing Authorization Application for CXF11 for the treatment of chronic obstructive pulmonary disease (COPD).

Key Points: 
  • HANGZHOU, China, July 02, 2021 (GLOBE NEWSWIRE) -- Hangzhou Chance Pharmaceuticals (Chance), a clinical-stage biotechnology company focusing on discovering, developing, and commercializing transformative inhalation therapies for the worlds most debilitating diseases, announced that the National Medical Products Administration (NMPA) of China has accepted its Marketing Authorization Application for CXF11 for the treatment of chronic obstructive pulmonary disease (COPD).
  • The NMPA Acceptance of Marketing Authorization Application for CXF11is the first important milestone in product development for Chance.
  • CXF11 is Chances tiotropium bromide inhalation drug intended for prevention of bronchospasm in adults with chronic obstructive pulmonary disease (COPD).
  • Chance Pharmaceuticals is a clinical-stage biotechnology company focusing on discovering, developing and commercializing transformative inhalation therapies for the worlds most debilitating diseases.

SGLT2 Inhibitors Poised to Potentially Reshape Chronic Kidney Disease (CKD) and Diabetic Kidney Disease (DKD) Patient Care After AstraZeneca's Farxiga Approval

Retrieved on: 
Wednesday, May 12, 2021
Anti-diabetic drugs, Medical specialties, Glucosides, SGLT2 inhibitors, Kidney diseases, Drugs, Clinical medicine, Canagliflozin, Thiophenes, Nephrology, Dapagliflozin, Diabetic nephropathy

b'EXTON, Pa., May 12, 2021 /PRNewswire/ -- Nephrologists have long considered chronic kidney disease (CKD) progression and diabetic kidney disease (DKD) as areas in dire need of new and better therapeutic options for treatment.

Key Points: 
  • b'EXTON, Pa., May 12, 2021 /PRNewswire/ -- Nephrologists have long considered chronic kidney disease (CKD) progression and diabetic kidney disease (DKD) as areas in dire need of new and better therapeutic options for treatment.
  • While Invokana remains nephrologists\' preferred SGLT2 inhibitor, the gap has narrowed in recent quarters with Farxiga making substantial gains in the market as physicians grow more familiar with the agent.
  • "\nOther nephrologists note that they do not feel comfortable or want to manage a patient\'s diabetes and are concerned about hypoglycemia.
  • We specialize in select immunology, nephrology, and neurology markets.\nAll company, brand or product names in this document are trademarks of their respective holders.\n'

KidneyIntelX Demonstrates Performance and Informs Treatment Decisions in Multinational CANagliflozin CardioVAScular Assessment Study (CANVAS)

Retrieved on: 
Tuesday, April 20, 2021
Medical specialties, Anatomy, Organ systems, Anti-diabetic drugs, Kidney diseases, Glucosides, SGLT2 inhibitors, Canagliflozin, Thiophenes, Diabetic nephropathy, Chronic kidney disease, Diabetes

b'NEW YORK, April 20, 2021 (GLOBE NEWSWIRE) -- Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces the findings of a new study in which the commercially available KidneyIntelX test accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS)1 with early-stage DKD (stages 1-3).

Key Points: 
  • b'NEW YORK, April 20, 2021 (GLOBE NEWSWIRE) -- Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces the findings of a new study in which the commercially available KidneyIntelX test accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS)1 with early-stage DKD (stages 1-3).
  • \xe2\x80\x9cThe new data from CANVAS supports primary care physicians using the KidneyIntelX score to risk stratify and make informed care decisions with their patients.
  • Canagliflozin is FDA approved to reduce the risk for end-stage renal disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure among adults with type 2 diabetes and DKD.
  • The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD).

Bayer Receives Approval in the UK for Xarelto®▼ (rivaroxaban) to Treat Children With Venous Thromboembolism (VTE) and to Prevent VTE Recurrence

Retrieved on: 
Monday, February 1, 2021
Pharmaceutical, Health, Clinical trials, Cardiology, Chemical compounds, Companies, Chloroarenes, Janssen Pharmaceutica, Morpholines, Rivaroxaban, Thiophenes, Aspirin, Bayer, Economy of Germany

Dr Philip Connor, Paediatric Haematologist at Noah's Ark Children's Hospital for Wales, said: this is great news for children and their parents in the UK.

Key Points: 
  • Dr Philip Connor, Paediatric Haematologist at Noah's Ark Children's Hospital for Wales, said: this is great news for children and their parents in the UK.
  • We are delighted that rivaroxaban is now approved for use in children with VTE and for the prevention of recurrent VTE in children in the UK.
  • This provides physicians with an alternative treatment option and the ability to manage this potentially life-threatening condition in a vulnerable patient population group, said Brendon Gray, Medical Director at Bayer UK.
  • Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world.

Spectrum Provides Poziotinib Update after Successful Pre-NDA Meeting with the FDA

Retrieved on: 
Tuesday, December 22, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, United States Public Health Service, Food and Drug Administration, Thiophenes, Biotechnology, Life sciences, Health, Poziotinib, ZENITH20, Spectrum Pharmaceuticals, Inc.

The company had a successful pre-NDA meeting with the FDA which resulted in an agreement to submit an NDA for poziotinib.

Key Points: 
  • The company had a successful pre-NDA meeting with the FDA which resulted in an agreement to submit an NDA for poziotinib.
  • During the meeting, Spectrum confirmed with the FDA that Cohort 2 data could serve as the basis of an NDA submission.
  • The company will continue to work with the FDA as it prepares the application for submission in 2021.
  • Cohort 2 enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib.

Sunovion Highlights Data from Its Late-Stage Psychiatric Medicine Pipeline at the American College of Neuropsychopharmacology (ACNP) Annual Meeting 2020

Retrieved on: 
Thursday, December 10, 2020
Biotechnology, Mental health, Health, Pharmaceutical, Clinical trials, Antipsychotics, SEP-363856, Thiophenes, Management of schizophrenia, Sunovion, Medicine, Psychiatry, Clinical medicine, SEP-363856, Schizophrenia, SEP-4199, Bipolar Disorder, Sunovion Pharmaceuticals Inc. (Sunovion), Sumitomo Dainippon Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that new data and analyses of late-stage compounds SEP-363856 and SEP-4199 were presented at the 59th Annual Meeting of the American College of Neuropsychopharmacology virtual meeting, which took place December 6-9.

Key Points: 
  • Sunovion Pharmaceuticals Inc. (Sunovion) today announced that new data and analyses of late-stage compounds SEP-363856 and SEP-4199 were presented at the 59th Annual Meeting of the American College of Neuropsychopharmacology virtual meeting, which took place December 6-9.
  • We look forward to continuing clinical investigation of these important compounds and sharing additional data in the future.
  • Continued negative symptom improvements were observed during 26 weeks of additional treatment with SEP-363856 on the BNSS total score and other negative symptom assessments.
  • SEP-363856 is a TAAR1 agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia and other psychiatric conditions.

OWP Pharmaceuticals Announces Patent Application for the First-Ever Powder for Oral Liquid Formulation of Duloxetine Hydrochloride for the Treatment of Major Depressive and Generalized Anxiety Disorder

Retrieved on: 
Wednesday, July 8, 2020
Psychoactive drugs, RTT, Serotonin-norepinephrine reuptake inhibitors, Antidepressants, Chemical compounds, Psychiatry, Amines, Duloxetine, Thiophenes, Serotonin–norepinephrine reuptake inhibitor, Generalized anxiety disorder, Norepinephrine reuptake inhibitor

Duloxetine hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) and the delayed-release capsules, for oral use, were first approved in the U.S. in 2004.

Key Points: 
  • Duloxetine hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) and the delayed-release capsules, for oral use, were first approved in the U.S. in 2004.
  • In major depressive and generalized anxiety disorders, duloxetine hydrochloride is indicated for treatment in adults.
  • If approved, this would represent the first-ever powder for oral liquid formulation available for duloxetine hydrochloride.
  • Healthcare providers may also find that in this form, the dosage may be easier to titrate and adjust.

DGAP-News: XPhyto Therapeutics Corp.: Parkinson's Generic Transdermal Drug Delivery System

Retrieved on: 
Monday, June 8, 2020
Pharmacology, Health, Dosage forms, Routes of administration, Amines, Phenols, Rotigotine, Thiophenes, Transdermal patch, Generic drug, Transdermal, Dermal patch

VANCOUVER, BC / ACCESSWIRE / June 8, 2020 / XPhyto Therapeutics Corp. (CSE:XPHY / FSE:4XT / OTC:XPHYF) ("XPhyto" or the "Company") is pleased to announce that its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor"), has finalized the formula for its novel transdermal delivery system ("TDS") for the neurologic drug Rotigotine.

Key Points: 
  • VANCOUVER, BC / ACCESSWIRE / June 8, 2020 / XPhyto Therapeutics Corp. (CSE:XPHY / FSE:4XT / OTC:XPHYF) ("XPhyto" or the "Company") is pleased to announce that its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor"), has finalized the formula for its novel transdermal delivery system ("TDS") for the neurologic drug Rotigotine.
  • Rotigotine, the active pharmaceutical ingredient, is a generic "off-patent" drug that is typically formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours.
  • "XPhyto's Parkinson's drug patch is an excellent example of the Company's generic drug delivery strategy whereby approved generic drugs can be delivered using Vektor's novel drug delivery platforms," said Hugh Rogers, CEO of XPhyto.
  • "For both our transdermal patches and oral dissolvable films, we see the generic drug delivery model as a major opportunity for scalable value creation through expedited clinical evaluation and product launch, particularly in Europe."

Trevena Announces Advancement of Oliceridine Clinical Development in China by Jiangsu Nhwa Pharmaceutical Co.

Retrieved on: 
Wednesday, June 3, 2020
Organic compounds, Chemical compounds, Drugs, Morphine, Analgesics, Oliceridine, Pyridines, Thiophenes, Opioid, Medication, Heroin, μ-opioid receptor

Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of oliceridine in China.

Key Points: 
  • Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of oliceridine in China.
  • The Company expects to receive future milestone payments, as well as a 10% royalty on net sales of oliceridine in China.
  • Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted.
  • Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders.