Ureas

Heron Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for IV Push

Retrieved on: 
Tuesday, February 26, 2019
Medicine, Chemical compounds, Clinical medicine, Dosage forms, Morpholines, Ureas, Antiemetics, Triazoles, Intravenous therapy, Aprepitant, Bioequivalence

The sNDA requested FDA approval to expand the administration of CINVANTI beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection.

Key Points: 
  • The sNDA requested FDA approval to expand the administration of CINVANTI beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection.
  • Results from two pivotal, randomized, cross-over, bioequivalence studies of CINVANTI and EMEND IV showed subjects receiving CINVANTI reported fewer adverse events than those receiving EMEND IV, including substantially fewer infusion-site reactions.
  • Notably, data now show that the 2-minute IV push has comparable safety to the 30-minute IV infusion.
  • "Administration of CINVANTI by 2-minute IV push is an important advantage for our customers compared to EMEND IV, which requires reconstitution and an IV bag for infusion."

PharmaEssentia and AOP Orphan Receive EU Approval of Besremi™ (Ropeginterferon Alfa-2b) for Treatment of Polycythemia Vera (PV) in EU

Retrieved on: 
Thursday, February 21, 2019
Hematopathology, Medical specialties, Medicine, Branches of biology, Ureas, Polycythemia vera, Hydroxycarbamide, Polycythemia, Pharmaceutical industry

The European market authorization makes Besremi the first and only approved treatment for polycythemia vera (PV) independent of previous hydroxyurea exposure based on Phase III clinical data.

Key Points: 
  • The European market authorization makes Besremi the first and only approved treatment for polycythemia vera (PV) independent of previous hydroxyurea exposure based on Phase III clinical data.
  • The Marketing Authorization Holder for Besremi in Europe is AOP Orphan Pharmaceuticals AG (AOP Orphan).
  • "We are excited that there is now a new approved treatment for PV," said Kochung Lin, PhD, Chief Executive Officer of PharmaEssentia.
  • Besremi will be available as a solution for injection in a pre-filled pen (250 microgram/0.5 ml and 500 microgram /0.5 ml).

Eiger BioPharmaceuticals Announces Patent Protection for Lonafarnib Boosted with Ritonavir for Treatment of Hepatitis Delta Virus Infection in Europe and Japan

Retrieved on: 
Wednesday, February 6, 2019
Medical specialties, RTT, Medicine, Chemistry, Infectious causes of cancer, Hepatotoxins, Hepatitis, Ureas, Viral hepatitis, Hepatitis D, Ritonavir, Farnesyltransferase inhibitor

With the grant of these new European and Japanese patents, lonafarnib boosted with ritonavir has now obtained patent protection with claims covering treatment with lonafarnib boosted with ritonavir in key major pharmaceutical markets including the U.S., Europe, and Japan.

Key Points: 
  • With the grant of these new European and Japanese patents, lonafarnib boosted with ritonavir has now obtained patent protection with claims covering treatment with lonafarnib boosted with ritonavir in key major pharmaceutical markets including the U.S., Europe, and Japan.
  • Lonafarnib is a first-in-class, oral farnesyl transferase inhibitor in Phase 3 development for the treatment of hepatitis delta virus (HDV) infection.
  • "This method of use patent covers lonafarnib boosted with ritonavir for the treatment of hepatitis delta virus infection, including specific doses and durations that we anticipate will appear on the first approved label," said David Cory, President and CEO of Eiger.
  • Hepatitis Delta is caused by infection with the hepatitis delta virus and leads to the most severe form of viral hepatitis.

Norvir SEC - Drug Insight, 2019 - ResearchAndMarkets.com

Retrieved on: 
Friday, February 1, 2019
Health, Pharmaceutical, Psychoactive drugs, Receptor agonists, Drugs, RTT, Hepatotoxins, Ritonavir, Thiazoles, Ureas, MDMA

The "Norvir SEC - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Norvir SEC - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.
  • Norvir SEC Drug Insight, 2019 highlights the drug marketed details and the Global API Manufacturers details across the globe along with the location.
  • The report also covers the patents information and market exclusivity data, route of synthesis, market competition, and API manufacturers by country.
  • In addition to this, the report also provides the SWOT analysis for Norvir SEC and emerging therapies in this space.

AVEO Oncology Announces NDA Timing Update

Retrieved on: 
Thursday, January 31, 2019
Health, Biotechnology, Clinical trials, Oncology, Pharmaceutical, FDA, Cars, Chemical compounds, Health, Isoxazoles, Quinolines, Tivozanib, Ureas, Subcompact cars, New Drug Application, Chevrolet Aveo, Food and Drug Administration, TiVo

AVEO Oncology (NASDAQ: AVEO) today announced that it has accepted the recommendation of the U.S. Food and Drug Administration (FDA) not to submit a New Drug Application (NDA) for tivozanib (FOTIVDA) with the preliminary overall survival (OS) results from the Phase 3 TIVO-3 trial.

Key Points: 
  • AVEO Oncology (NASDAQ: AVEO) today announced that it has accepted the recommendation of the U.S. Food and Drug Administration (FDA) not to submit a New Drug Application (NDA) for tivozanib (FOTIVDA) with the preliminary overall survival (OS) results from the Phase 3 TIVO-3 trial.
  • The Company now plans to make a NDA filing decision following the availability of more mature OS results.
  • AVEO Pharmaceuticals, Inc. (the Company or AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted medicines for oncology and other areas of unmet medical need.
  • While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

Bayer to Highlight New Research at ASCO GI 2019 Cancers Symposium

Retrieved on: 
Wednesday, January 16, 2019
Cancer, Chemistry, Medicine, Infectious causes of cancer, Chloroarenes, Pyridines, Ureas, Hepatology, Regorafenib, Sorafenib, Bayer, Hepatocellular carcinoma

WHIPPANY, N.J., Jan. 16, 2019 /PRNewswire/ -- Bayer will present new data from its continued research on Stivarga (regorafenib) in metastatic colorectal cancer (mCRC) and metastatic biliary tract cancers, and Nexavar (sorafenib) in advanced liver cancer, at the 2019 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium on January 17-19 in San Francisco.

Key Points: 
  • WHIPPANY, N.J., Jan. 16, 2019 /PRNewswire/ -- Bayer will present new data from its continued research on Stivarga (regorafenib) in metastatic colorectal cancer (mCRC) and metastatic biliary tract cancers, and Nexavar (sorafenib) in advanced liver cancer, at the 2019 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium on January 17-19 in San Francisco.
  • Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen.
  • BAYER, the Bayer Cross, Stivarga and Nexavar are registered trademarks of Bayer.
  • This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management.

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma

Retrieved on: 
Monday, January 14, 2019
Health, Biotechnology, Clinical trials, Oncology, Pharmaceutical, FDA, Chemistry, Cancer, Medicine, Pyridines, Tyrosine kinase inhibitors, Chloroarenes, Ureas, Hepatology, Ipsen, Cabozantinib, Sorafenib, Exelixis

Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points: 
  • Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • This approval is an important milestone as we continue to explore how CABOMETYX may benefit people with difficult-to-treat-cancers beyond renal cell carcinoma.
  • On November 15, 2018, Exelixis partner Ipsen received approval from the European Commission for CABOMETYX tablets as a monotherapy for HCC in adults who have previously been treated with sorafenib.
  • The approval of CABOMETYX has been eagerly anticipated, making this an important day for patients diagnosed with this devastating disease.

Amneal Announces Approval of Carmustine for Injection USP, 100 mg/vial - Preparing for Launch

Retrieved on: 
Friday, October 19, 2018
Health, Chemistry, Carmustine, Nitrosoureas, Organic chemistry, Ureas, Amneal Pharmaceuticals, Food and Drug Administration

BRIDGEWATER, N.J., Oct. 19, 2018 /PRNewswire/ --Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of BiCNU (carmustine) for injection, 100 mg.

Key Points: 
  • BRIDGEWATER, N.J., Oct. 19, 2018 /PRNewswire/ --Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of BiCNU (carmustine) for injection, 100 mg.
  • "It has been a very productive year for Amneal as our generic pipeline continues to deliver new opportunities," said Rob Stewart, President and CEO of Amneal.
  • "Year to date, we have received FDA approval on 48 ANDA's, tentative approval on another 10 ANDA's and have launched 30 products."
  • According to IQVIA, U.S. market annual sales for the 12 months ended August 2018 for Carmustine for Injection USP, 100 mg/vial is estimated to be approximately $84 million.

Global Nucleic Acid Labeling Market 2018-2023 by Label Type, Technique, Application and Geography

Retrieved on: 
Tuesday, October 2, 2018
Biology, Chemistry, Biochemistry, Molecular biology, Biotin, Cofactors, Ureas, Nucleic acid, Aminoallyl nucleotide, Biotinylation

The "Global Nucleic Acid Labeling Market - Segmented by Label Type (Biotin-based, Fluorescent, Radioactive, and Others), by Technique, by Application, and by Geography - Growth, Trends, and Forecast (2018 - 2023)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Nucleic Acid Labeling Market - Segmented by Label Type (Biotin-based, Fluorescent, Radioactive, and Others), by Technique, by Application, and by Geography - Growth, Trends, and Forecast (2018 - 2023)" report has been added to ResearchAndMarkets.com's offering.
  • The Nucleic Acid Labeling market is expected to register a CAGR of 9% over the forecast period.
  • Nucleic acid labeling is a procedure in which nucleic acids are modified or attached with tags that enable their detection or purification.
  • Common labels used to generate nucleic acid probes include biotin, radioactive phosphates, fluorophores, and enzymes.

Taiho Oncology Presents Real-World Adherence Data for LONSURF® (trifluridine and tipiracil) in Metastatic Colorectal Cancer at ASCO Quality of Care Symposium

Retrieved on: 
Friday, September 28, 2018
Chemistry, Medicine, Health, Chloroarenes, Pyridines, Regorafenib, Ureas, Antineoplastic drugs, Combination drugs, Taiho Pharmaceutical, Trifluridine/tipiracil, Tipiracil

PRINCETON, N.J., Sept. 28, 2018 /PRNewswire/ --Taiho Oncology, Inc. today announced real-world adherence data for patients with metastatic colorectal cancer (mCRC) who were treated with LONSURF(trifluridine and tipiracil) or Stivarga(regorafenib).

Key Points: 
  • PRINCETON, N.J., Sept. 28, 2018 /PRNewswire/ --Taiho Oncology, Inc. today announced real-world adherence data for patients with metastatic colorectal cancer (mCRC) who were treated with LONSURF(trifluridine and tipiracil) or Stivarga(regorafenib).
  • * In this retrospective study, medication adherence was assessed among adult patients with mCRC receiving LONSURF (469) or regorafenib (311).
  • Additionally, patients receiving LONSURF before regorafenib remained on treatment longer than those receiving regorafenib followed by LONSURF.
  • In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of metastatic advanced or recurrent colorectal cancer since 2014.