Ureas

Hoth Therapeutics Exercises Patent Licensing Option with the George Washington University to Further Develop a Therapeutic for Cancer Patients Suffering Cutaneous Changes Like Rash and Hair Loss, as Well as Other Neurogenic Inflammation Side Effects

Retrieved on: 
Wednesday, January 15, 2020
Chemical compounds, Organic compounds, Chemistry, Antiemetics, Aprepitant, Lactams, Morpholines, Triazoles, Ureas, Hoth, Patent

The option agreement included pre-negotiated business terms for the exclusive patent license, so Hoth anticipates finalizing the license this month.

Key Points: 
  • The option agreement included pre-negotiated business terms for the exclusive patent license, so Hoth anticipates finalizing the license this month.
  • In June of 2019, Hoth entered into a sponsored research agreement with GWto explore the potential use of Aprepitant in different forms.
  • Mr.Robb Knie, Chief Executive Officer of Hoth, commented, "Our research collaboration with GW has yielded positive preliminary results.
  • Management looks forward to sharing the preclinical results of our unique formulation of this topical therapeutic upon its completion later this year."

New AACC Guidance Document Outlines How Healthcare Professionals Can Prevent the Widespread Supplement Biotin From Interfering With Medical Tests

Retrieved on: 
Monday, January 13, 2020
Branches of biology, Health, Organic compounds, Biotin, Cofactors, Ureas, Vitamin, Immunoassay, Multivitamin, Dietary supplement

WASHINGTON, Jan. 13, 2020 /PRNewswire/ --Biotin's upsurge in popularity has led to a parallel rise in incidents of this health supplement interfering with critical medical tests.

Key Points: 
  • WASHINGTON, Jan. 13, 2020 /PRNewswire/ --Biotin's upsurge in popularity has led to a parallel rise in incidents of this health supplement interfering with critical medical tests.
  • A new guidance document from AACC urges clinicians and laboratory experts to collaborate to prevent this potentially harmful test interference, and to ensure that patients taking biotin receive high quality care.
  • At least a fifth of Americans take biotin, either as a beauty supplement, as part of an over-the-counter multivitamin, or as a treatment for medical conditions such as multiple sclerosis.
  • If a patient takes biotin supplements, the biotin in his or her blood sample competes with the biotin used in immunoassays and can falsely increase or decrease the results of these tests.

Heron Therapeutics Highlights Progress in Pain Management and CINV Franchises

Retrieved on: 
Monday, January 13, 2020
Chemical compounds, Drugs, Health, Food and Drug Administration, Antiemetics, Aprepitant, Morpholines, Triazoles, Ureas, Chemotherapy-induced nausea and vomiting, New Drug Application

SAN DIEGO, Jan. 13, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today highlighted progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises.

Key Points: 
  • SAN DIEGO, Jan. 13, 2020 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today highlighted progress in its pain management and chemotherapy-induced nausea and vomiting (CINV) franchises.
  • New Drug Application Resubmission for HTX-011: In September 2019, Heron resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.
  • New Drug Submission for HTX-011: In December 2019, Heron's New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was granted Priority Review status and accepted by Health Canada.
  • "We have made important advances in 2019 in both our pain management and CINV franchises, highlighted by the submission of three marketing applications for HTX-011 for postoperative pain management and strong net product sales for CINVANTI, even amid the launch of generic fosaprepitant," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron.

Tetra Bio-Pharma Provides Update on its Hepatocellular Carcinoma Drug HCC011

Retrieved on: 
Tuesday, December 10, 2019
Chemical compounds, Organic compounds, Aromatic compounds, Pyridines, Chloroarenes, Ureas, Sorafenib, Pre-clinical development

In addition to quality of life benefits to cancer patients, based on preclinical research, HCC011 should also have antitumor effects.

Key Points: 
  • In addition to quality of life benefits to cancer patients, based on preclinical research, HCC011 should also have antitumor effects.
  • Patients will receive the HCC011 by inhalation three times daily, in combination with Sorafenib, until disease progression or unacceptable toxicity.
  • Patients will also beneficiate of the anti-emetic effect of HCC011, which will participate in improving their quality of life.
  • The HCC011 orphan drug candidate benefits from Tetras significant clinical data on the pharmacokinetics, safety and pharmacodynamics of inhaled cannabinoids.

ACADIA Pharmaceuticals Presents Positive Top-line Results from Pivotal Phase 3 HARMONY Trial of Pimavanserin in Patients with Dementia-Related Psychosis at 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting

Retrieved on: 
Thursday, December 5, 2019
Mental health, Health, Consumer, Seniors, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Pimavanserin, Piperidines, Ureas, Placebo, Chemistry, Clive Ballard

HARMONY was a double-blind, placebo-controlled, relapse prevention study in 392 patients evaluating pimavanserin for the treatment of dementia-related psychosis.

Key Points: 
  • HARMONY was a double-blind, placebo-controlled, relapse prevention study in 392 patients evaluating pimavanserin for the treatment of dementia-related psychosis.
  • The Phase 3 HARMONY study included a 12-week open-label pimavanserin treatment period prior to the randomization period of the study.
  • Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of relapse compared to patients on placebo.
  • In the double-blind period, low rates of adverse events were observed, 41.0% of patients on pimavanserin and 36.6% on placebo.

AVEO Oncology Announces Lancet Oncology Publication of Data from Phase 3 TIVO-3 Study of Tivozanib in Renal Cell Carcinoma

Retrieved on: 
Wednesday, December 4, 2019
Oncology, Health, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Clinical medicine, Ureas, Angiogenesis inhibitors, Pyridines, Cancer treatments, Quinolines, Tivozanib, Sorafenib, Oncology, Renal cell carcinoma, Tivozanib (FOTIVDA®), AVEO

AVEO Oncology (NASDAQ: AVEO) today announced that previously reported data from its Phase 3 TIVO-3 study were published in The Lancet Oncology.

Key Points: 
  • AVEO Oncology (NASDAQ: AVEO) today announced that previously reported data from its Phase 3 TIVO-3 study were published in The Lancet Oncology.
  • The article, titled Tivozanib versus sorafenib in patients with advanced renal cell carcinoma (TIVO-3): a phase 3, multicentre, randomised, controlled, open-label study, is available online first via this link .
  • Data from this study reinforce that tivozanib has the potential to serve as an effective, tolerable therapy in the evolving RCC treatment landscape.
  • We are committed to maximizing the full potential of tivozanib both as a monotherapy and in the immunotherapy combination setting.

ACADIA Pharmaceuticals Announces Positive Top-line Results from ADVANCE Trial of Pimavanserin as Treatment for Negative Symptoms of Schizophrenia

Retrieved on: 
Monday, November 25, 2019
Biotechnology, Mental health, Health, Pharmaceutical, Clinical trials, Psychiatry, Schizophrenia, Chemical compounds, Atypical antipsychotics, Organic compounds, Pimavanserin, Piperidines, Ureas, Antipsychotic, Acadia Pharmaceuticals

ADVANCE evaluated the efficacy and safety of adjunctive pimavanserin treatment in patients with predominantly negative symptoms of schizophrenia who have achieved adequate control of positive symptoms with their existing antipsychotic treatment.

Key Points: 
  • ADVANCE evaluated the efficacy and safety of adjunctive pimavanserin treatment in patients with predominantly negative symptoms of schizophrenia who have achieved adequate control of positive symptoms with their existing antipsychotic treatment.
  • Historically, it has been a challenge for clinicians to treat and significantly improve the negative symptoms of schizophrenia.
  • There are no FDA-approved treatments indicated for the treatment of the negative symptoms of schizophrenia and there remains a serious and significant unmet need.
  • ACADIA will discuss top-line results from its ADVANCE study of pimavanserin for adjunctive treatment for the negative symptoms of schizophrenia via conference call and webcast today at 5:00 p.m. Eastern Time.

STI Pharma Announces US Launch of Generic BICNU® for Injection

Retrieved on: 
Thursday, November 21, 2019
Health, Articles, Pharmaceutical industry, Carmustine, Nitrosoureas, Organochlorides, Ureas, Generic drug, Abbreviated New Drug Application, STI, Food and Drug Administration, New Drug Application

NEWTOWN, Pa., Nov. 21, 2019 /PRNewswire/ -- STI Pharma, LLC today announced the US launch of Carmustine for Injection, USP: 1 Kit (100mg per Vial & Diluent), a generic version of AVET's (formerly Heritage) BiCNU.

Key Points: 
  • NEWTOWN, Pa., Nov. 21, 2019 /PRNewswire/ -- STI Pharma, LLC today announced the US launch of Carmustine for Injection, USP: 1 Kit (100mg per Vial & Diluent), a generic version of AVET's (formerly Heritage) BiCNU.
  • STI received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
  • "The launch of Carmustine Injection is an important milestone for STI, representing our first oncology injectable approval," said STI President Frank Mullery.
  • STI Pharma, located in Newtown, PA, was founded in 2008 by a team of industry veterans.

Exelixis’ Partner Ipsen Announces Health Canada’s Approval of CABOMETYX® (cabozantinib) Tablets for the Treatment of Patients With Previously Treated Advanced Hepatocellular Carcinoma

Retrieved on: 
Tuesday, November 12, 2019
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Aromatic compounds, Pyridines, Chloroarenes, Ureas, Tyrosine kinase inhibitors, Ipsen, Hepatology, Sorafenib, Cabozantinib, Exelixis, the CELESTIAL Study, HCC, the Exelixis and Ipsen Collaboration, CABOMETYX® (cabozantinib), Exelixis

Exelixis, Inc. (NASDAQ:EXEL) today announced that its partner Ipsen Biopharmaceuticals Canada Inc. received Health Canada approval of CABOMETYX (cabozantinib) tablets for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points: 
  • Exelixis, Inc. (NASDAQ:EXEL) today announced that its partner Ipsen Biopharmaceuticals Canada Inc. received Health Canada approval of CABOMETYX (cabozantinib) tablets for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • The Health Canada approval was based on results from the CELESTIAL phase 3 pivotal trial of CABOMETYX for patients with advanced HCC who received prior treatment with sorafenib.
  • Under the terms of the Collaboration Agreement with Ipsen, Exelixis will receive a milestone payment of $2 million for the Health Canada approval.
  • In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced renal cell carcinoma and for the treatment of patients with HCC who have been previously treated with sorafenib.

AVEO Oncology Announces Regulatory Update for Tivozanib in Renal Cell Carcinoma

Retrieved on: 
Monday, November 4, 2019
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Life sciences, Chemical compounds, Articles, Angiogenesis inhibitors, RTT, Ureas, Specialty drugs, Quinolines, Tivozanib, Cancer, Oncology, Biopharmaceutical, TIVO-3, Tivozanib, AVEO

The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib.

Key Points: 
  • The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib.
  • Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.
  • AVEO Pharmaceuticals is a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs.
  • While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.