Pharmaceutical Business Review feed
Trillium Therapeutics completes dosing in Phase I study of TTI-1612
Trillium Therapeutics, a wholly owned subsidiary of Stem Cell Therapeutics, has completed dosing of patients with interstitial cystitis/bladder pain syndrome (IC/BPS) in first phase study of TTI-1612.
Categories: Pharmaceuticals
Evotec, Harvard to jointly develop new class of antibacterials
Evotec and Harvard University have entered into research collaboration to develop new class of antibacterials.
Categories: Pharmaceuticals
Helsinn, Vifor sign distribution deal for netupitant-palonosetron fixed dose combination
Helsinn Healthcare and Vifor Pharma have signed a licensing and distribution deal for netupitant-palonosetron fixed dose combination (NEPA) in Switzerland, France, Spain, Portugal, the Netherlands, Belgium and Luxembourg.
Categories: Pharmaceuticals
Janssen Biotech announces FDA approval of Simponi ulcerative colitis therapy
Janssen Biotech has announced the FDA approval of Simponi (golimumab) to treat moderately to severely active ulcerative colitis (UC) in adult patients with corticosteroid dependence or an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.
Categories: Pharmaceuticals
US FDA approves Xofigo as castration-resistant prostate cancer therapy
The US FDA has approved Xofigo (radium Ra 223 dichloride) for the treatment of symptomatic late-stage (metastatic) castration-resistant prostate cancer spread to bones but not to other organs in men.
Categories: Pharmaceuticals
Nuvo Research wins US patent for WF10 drug candidate
Canada-based pharmaceutical company Nuvo Research has received US Patent relating to compositions and methods of using WF10 and new derivative formulations for the treatment of allergic asthma, allergic rhinitis and atopic dermatitis.
Categories: Pharmaceuticals
Genentech, Astellas announce FDA approval of Tarceva tablets
Roche Group member Genentech and Astellas Pharma US announced that the US Food and Drug Administration (FDA) has cleared Tarceva (erlotinib).
Categories: Pharmaceuticals
Echevarne to distribute Natera's prenatal screening test in Spain
Natera and Echevarne have entered into a distribution agreement under which Echevarne will offer Natera's non-invasive prenatal screening test (NIPT), Panorama, in Spain.
Categories: Pharmaceuticals
Soligenix begins Phase 1 Crohn's disease study with SGX203
Soligenix has begun Phase 1 study with SGX203 for the treatment of paediatric Crohn's disease.
Categories: Pharmaceuticals
FDA approves Mylan Zolmitriptan ANDA
The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg.
Categories: Pharmaceuticals
Nordion, Navidea sign contract manufacturing agreement
Nordion has entered into a contract manufacturing agreement with Navidea Biopharmaceuticals for NAV5001 a diagnostic imaging agent used to detect Parkinsonian Syndromes and Dementia with Lewy Bodies.
Categories: Pharmaceuticals
Merck Serono, Quintiles sign five-year clinical development agreement
Merck Serono and Quintiles have entered into a five-year clinical development agreement for the development and clinical trial execution.
Categories: Pharmaceuticals
Hitachi to market Nanosphere products in Japan
Nanosphere has signed a distribution and collaboration agreement with Hitachi High-Technologies.
Categories: Pharmaceuticals
OncoMed commences OMP-59R5 Phase 1b/2 small cell lung cancer trial
OncoMed Pharmaceuticals has commenced Phase 1b/2 trial of anti-cancer stem cell therapeutic OMP-59R5 (Anti-Notch2/3) in small cell lung cancer (SCLC) patients.
Categories: Pharmaceuticals
TWi obtains FDA tentative approval for Guanfacine Hydrochloride ANDA
Taiwan-based specialty pharmaceutical company TWi Pharmaceuticals has obtained FDA tentative approval for its abbreviated new drug application (ANDA) for Guanfacine Hydrochloride Extended Release tablets 1mg, 2mg, 3mg and 4mg.
Categories: Pharmaceuticals
Rib-X commences Phase 3 acute bacterial skin and skin structure infections trial
Rib-X Pharmaceuticals, Ligand Pharmaceuticals' partner, has commenced Phase 3 trial of a Captisol-enabled intravenous (IV) formulation of delafloxacin to treat acute bacterial skin and skin structure infections (ABSSSI).
Categories: Pharmaceuticals
AbbVie, Alvine to jointly develop new therapy for celiac disease
AbbVie and Alvine Pharmaceuticals have collaborated to develop investigational oral therapy ALV003 for celiac disease.
Categories: Pharmaceuticals
Bend Research expands manufacturing capabilities to support pharmaceutical development
Bend Research has announced the expansion of its good manufacturing practice (GMP) analytical capabilities and capacity to support pharmaceutical development.
Categories: Pharmaceuticals
India develops new low-cost vaccine against diarrhea virus
The Indian government has announced the development of new low-cost vaccine referred to as Rotavac against rotavirus, a diarrhea causative agent leading to a number of childhood deaths in the developing world.
Categories: Pharmaceuticals
Actinium receives notice of patent allowance for cancer treatment with alpha emitting isotopes
Biopharmaceutical company Actinium Pharmaceuticals has received notice of patent allowance for an application covering the treatment of metastatic solid cancers with alpha emitting isotopes.
Categories: Pharmaceuticals


