joimax® Roll Out its Endoscopic Generation 4 Devices and Showcases New 3D-Printed Titanium implants at the German Spine Society (DWG) Convention
joimax®, the Germany-based market leader of technologies and training methods for full-endoscopic minimally-invasive spinal surgery, is well positioned for Germany’s principal spine convention, German Spine Society (DWG), taking place December 6 to 8 in Wiesbaden, Germany.
Cosmo Issues EUR 175 million Convertible Bond
Cosmo Pharmaceuticals N.V. announces that it has successfully placed EUR 175 million senior unsecured convertible bonds (the “Bonds”) due 2023. The net proceeds from the Offering will be used for general corporate purposes, potential acquisitions and
in-licensing transactions.
Cosmo announces its licensee Dr. Falk Pharma received approval in the European Decentralized Procedure for Relafalk (Rifamycin SV MMX) in Travelers’ Diarrhea
Cosmo Pharmaceuticals N.V. announces that its licensee Dr. Falk Pharma has received today approval in the European Decentralized Procedure (DCP) for Relafalk (Rifamycin SV MMX) for the treatment of Travelers’ Diarrhea. This approval follows the approval of AEMCOLO (Rifamycin SV MMX) by the FDA on November 16 for the same indication.
The DCP concerned the following Member States: Germany, United Kingdom, Spain, Denmark, Greece, Finland, Hungary, Norway, Portugal, Poland, Sweden and Bulgaria.
FDA Approves AEMCOLO™ (Rifamycin), the First Antibiotic Approved for the Treatment of Travelers’ Diarrhea in Over a Decade
Cosmo Pharmaceuticals N.V. announced that the U.S. Food and Drug Administration (FDA) has approved AEMCOLO™ (Rifamycin), containing 194mg of Rifamycin as delayed-release tablets, a new minimally-absorbed antibiotic that is delivered to the colon, for treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO, AEMCOLO should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for
AEMCOLO. With the QIDP designation, intended for antibacterial or antifungal drugs
that treat serious or life-threatening infections, together with new chemical entity (NCE)
designation, marketing exclusivity for AEMCOLO runs through 2028. AEMCOLO will
be available in pharmacies in the first quarter of 2019.
Heidelberg Pharma Announces Several Presentations of Research Results on ATAC Technology at the ASH Annual Meeting 2018
Heidelberg Pharma AG today announced that its collaboration partners MD Anderson Cancer Center, Houston, TX, USA, and Magenta Therapeutics, Cambridge, MA, USA, will present preclinical data at the 60th Annual Meeting of the American Society of Hematology (ASH), the leading convention for hematology. The meeting will take place from 1 to 4 December 2018 in San Diego, USA.
Cosmo Pharmaceuticals Methylene Blue MMX Regulatory Update:
Initial appeal outcome – Next steps
Cosmo Pharmaceuticals N.V. today provided a regulatory update after receipt of the answer to the initial appeal filed after reception of the Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Methylene Blue MMX, a product for visualization of lesions in patients undergoing colonoscopy to improve overall detection of adenomas and carcinomas.
NOVALIQ ANNOUNCES POSITIVE TOPLINE RESULTS FOR ITS SEECASE PHASE 2 RIAL OF NOV03 FOR THE TREATMENT OF PATIENTS WITH DRY EYE DISEASE
Novaliq, a specialty pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology for ophthalmology, today announces positive topline results for its EECASE phase 2 clinical trial of NOV03 for the treatment of dry eye disease (DED) in ore than 300 patients.
Apogenix to Present at Five Upcoming International Conferences
Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, announced today that company representatives will attend several upcoming international conferences. In a total of five presentations, Apogenix will give updates on its hexavalent TNF superfamily receptor agonists (HERA-ligands) as well as its phase III-ready lead drug candidate asunercept.
NOVALIQ ANNOUNCES POSITIVE TOPLINE RESULTS FOR ITS CYCLASOL® PHASE 2b/3 ESSENCE TRIAL IN PATIENTS WITH DRY EYE DISEASE
Novaliq, a specialty pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology for ophthalmology, today announces positive topline results from ESSENCE, its first pivotal clinical trial of CyclASol® 0.1% for the treatment of dry eye disease (DED).
Cassiopea announces attainment of all primary and secondary endpoints and highly satisfactory safety data in its Phase 3 for Winlevi (Clascoterone) cream in Treating Acne
Cassiopea SpA, a clinical-stage specialty pharmaceutical company focused on developing and commercializing innovative and differentiated medical dermatology products, today announced that the results of its two pivotal phase 3 clinical trials for its topical anti-androgen Clascoterone (Winlevi® cream 1%) demonstrated highly statistically significant improvements for all primary and secondary clinical end points and that the drug is generally safe and well tolerated. The results of both the primary and secondary endpoints are consistent with the Special Protocol Assessment agreed to with the FDA prior to the start of the study.
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