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FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma
Monday, August 28, 2017Genentech a member of the Roche Group announced today that the US Food and Drug Administration FDA has accepted the companys supplemental Biologics License Application sBLA and granted Priority Review for Gazyva obinutuzumab in combination with chemo...
Kedrion Biopharma and Kamada Receive FDA Approval of KEDRAB™
Monday, August 28, 2017Kedrion Biopharma and Kamada Ltd two leading humanderived protein therapeutics companies today announced that KEDRAB rabies immune globulin Human has received US Food and Drug Administration FDA approval for passive transient postexposure prophylaxis...
Theragnostics Announces Partnership with ROTOP and Establishes U.S. Headquarters
Thursday, August 24, 2017Theragnostics Ltd a radiopharmaceuticals company developing products for the diagnosis and treatment of cancer announced a mutual distribution and manufacturing agreement with ROTOP Pharmaka GmbH covering select products in the Companies respective m...
Chugai's Emicizumab Receives Priority Review Designation by FDA for Hemophilia A with Inhibitors
Thursday, August 24, 2017Chugai Pharmaceutical Co Ltd announced that the US Food and Drugs Administration FDA has accepted the Biologics License Application BLA and has granted Priority Review for an investigational antibody emicizumab prophylaxis preventative as a onceweekl...
Argentum Pharmaceuticals and Eli Lilly Settle Patent Dispute Over CIALIS®
Wednesday, August 23, 2017Argentum Pharmaceuticals LLC a generic pharmaceutical company announced that it has reached a settlement and license agreement with Eli Lilly and Company related to Argentums generic version of CIALIS tadalifil The agreement generally provides tha...
PharmAkea Announces Successful Completion of a Phase 1 Trial in Healthy Subjects For Its Novel LOXL2 Inhibitor, PAT-1251
Wednesday, August 23, 2017PharmAkea Inc announced that it has successfully completed a Phase single and multiple ascending dose SADMAD clinical study with PAT its novel smallmolecule LOXL inhibitor being developed for the treatment of IPF and other fibrotic diseases The s...
Syros Receives FDA Orphan Drug Designation for SY-1425 for Treatment of AML
Tuesday, August 22, 2017Syros Pharmaceuticals a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of diseasedriving genes today announced that the US Food and Drug Administration FDA has granted orphan drug designation...
PAREXEL and Osaka International Cancer Institute Form Alliance to Advance Clinical Research in Japan
Tuesday, August 22, 2017PAREXEL International Corporation a leading global biopharmaceutical services provider and Osaka International Cancer Institute today announced that they have formed an alliance to advance clinical development in Japan The partnership will aim to dri...
MiMedx Signs Definitive Agreement to Divest Stability Biologics Subsidiary as Part of Company's Strategic Focus on Biopharma
Monday, August 21, 2017MiMedx Group Inc the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts and patentprotected processes for multiple sectors of healthcare announced today that i...
Samsung Bioepis and Takeda Sign Strategic Collaboration Agreement
Monday, August 21, 2017Samsung Bioepis Co Ltd announced today that it has entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited TSE to jointly fund and codevelop multiple novel biologic therapies in unmet disease areas The two compani...
