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Takeda Bio initiates Orteronel Phase III clinical trials in Japan
Takeda Pharmaceutical and Millennium, the Takeda Oncology Company have announced that Takeda Bio Development Center (Takeda Bio) has commenced patient enrollment for the two ongoing global Phase III clinical trials for the anti-prostate cancer investigational agent, Orteronel(TAK-700) in Japan.
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News
FDA clears Bydureon for Type 2 Diabetes
Amylin Pharmaceuticals and Alkermes have announced that the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) indicated for type 2 diabetes.
Regulatory Affairs > News
Regulatory Affairs > News
Infinity presents interim data of phase 2 study in metastatic pancreatic cancer
Infinity Pharmaceuticals has reported interim data from its double-blind, randomized, placebo-controlled Phase 2 study comparing saridegib (IPI-926) in combination with gemcitabine to placebo plus gemcitabine in patients with previously untreated, metastatic pancreatic cancer.
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News
FDA accepts NDA for Pfizer CML drug
The FDA has accepted Pfizer’s new drug application (NDA) for standard review of bosutinib for patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
Regulatory Affairs > News
Regulatory Affairs > News
Apricus, PediatRx sign co-promotion agreement for Granisol and Aquoral
Apricus Biosciences and PediatRx have signed an agreement for US co-promotion of Granisol (granisetron) oral solution and Aquoral spray and purchase of non-US rights to Granisol.
Contract Research & Services > Contract Services > News
Contract Research & Services > Contract Services > News
GenVec extends research collaboration with Novartis
GenVec, a biopharmaceutical company, has extended its research collaboration and license agreement with Novartis.
Contract Research & Services > Contract Research > News
Contract Research & Services > Contract Research > News
Pfizer receives FDA approval for advanced RCC drug
Pfizer has received FDA approval for INLYTA (axitinib), a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
Regulatory Affairs > News
Regulatory Affairs > News
Auxilium doses first patients in Xiaflex Phase Ib trial
Auxilium Pharmaceuticals has dosed first patient in its phase Ib trial of Xiaflex (collagenase clostridium histolyticum) to treat edematous fibrosclerotic panniculopathy (EFP, cellulite).
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News
Vanda reports positive data of tasimelteon in Non-24-Hour Disorder
Vanda Pharmaceuticals' tasimelteon has shown the ability to reset the body clock and to align it to a constant 24-hour day in patients suffering from Non-24-Hour Sleep-Wake Disorder (Non-24-Hour Disorder).
Contract Research & Services > Clinical Trials > News
Contract Research & Services > Clinical Trials > News
EC grants orphan drug status to Celator leukemia drug
Celator Pharmaceuticals' CPX-351in acute myeloid leukemia, has received orphan drug status by the European Commission (EC).
Regulatory Affairs > News
Regulatory Affairs > News
DWH, CPDD enter drug discovery deal
Scotland-based Developing World Health (DWH), focused on developing treatments for neglected tropical diseases, has entered an agreement with Consortium for Parasitic Drug Development (CPDD), based at The University of North Carolina.
Drug Research > Drug Discovery & Development > News
Drug Research > Drug Discovery & Development > News
Premier grants octylseal agreement to Medline
The Premier healthcare alliance has granted a new agreement to Medline Industries for its octylseal tissue adhesive.
Contract Research & Services > Contract Services > News
Contract Research & Services > Contract Services > News
Albemarle installs new production train for finished polyolefin catalysts
Albemarle has completed the expansion of its Process Development Center (PDC) in Baton Rouge, Louisiana by installing a new production train for finished polyolefin catalysts and a number of supporting auxiliaries.
Production & Manufacturing > Fine & Speciality Chemicals > News
Production & Manufacturing > Fine & Speciality Chemicals > News
Elite receives FDA nod for supplemental application for Hydromorphone
Elite Pharmaceuticals has received FDA approval for supplemental application for the manufacturing and packaging of Hydromorphone Hydrochloride USP 8mg.
Production & Manufacturing > Manufacturing > News
Production & Manufacturing > Manufacturing > News
Catalent expands drug development and delivery capabilities
Catalent Pharma Solutions has announced investments at its Schorndorf, Germany facility for the expansion of its drug development and delivery capabilities.
Drug Research > Drug Discovery & Development > News
Drug Research > Drug Discovery & Development > News