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136-150 of 50152 results
MonoSol Rx files patent infringement case against BioDelivery Sciences International
MonoSol Rx has filed a patent infringement case against BioDelivery Sciences International (BDSI) for infringement of U.S. Patent No. 8,765,167 (the ‘167 patent), which is entitled “Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions.”
Drug Research > Drug Delivery > News
Horizon Discovery broadens gene editing capabilities
Horizon Discovery Group has expanded its gene editing capabilities through the amendment of a pre-existing license with ERS Genomics to include the full commercial rights for the use of CRISPR edited cell lines for the Good Manufacturing Practice (GMP) manufacturing of biotherapeutics.
Drug Research > Drug Discovery & Development > News
Chi-Med starts phase II study of sulfatinib in second-line biliary tract cancer in China
Hutchison China MediTech (Chi-Med) has started a Phase II study of sulfatinib in second-line biliary tract cancer (“BTC”) patients in China.
Contract Research & Services > Clinical Trials > News
Malin buys 33% interest in UK's Wren Therapeutics
By PBR Staff Writer
Irish life sciences firm Malin has acquired a 33% stake in UK biopharmaceutical company, Wren Therapeutics.
Drug Research > Drug Discovery & Development > News
Scottish Medicines Consortium approves Zepatier to treat chronic hepatitis C
By PBR Staff Writer
A new medicine intended to treat chronic hepatitis C is one of four accepted by the Scottish Medicines Consortium (SMC) for routine use in NHS Scotland.
Regulatory Affairs > News
Aptevo Therapeutics receives $20m payment from Emergent BioSolutions
Aptevo Therapeutics has received a $20m cash payment from Emergent BioSolutions pursuant to a promissory note granted as a result of the spin-off of Aptevo from Emergent, effective August 1, 2016.
Drug Research > Drug Discovery & Development > News
ObsEva completes phase 1 first-in-women study of OBE022 to treat preterm labor
ObsEva has completed a Phase 1 single and multiple ascending dose study of OBE022, a potential first-in-class, once daily, oral and selective prostaglandin F2α, or PGF2α, receptor antagonist for the treatment of preterm labor in weeks 24 to 34 of pregnancy.
Contract Research & Services > Clinical Trials > News
Nivalis Therapeutics unveils corporate restructuring
Nivalis Therapeutics, a clinical stage pharmaceutical firm engaged in the development of new solutions for people with cystic fibrosis (CF), announced that its board of directors has approved a restructuring plan as part of its initiative to evaluate strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources.
Drug Research > Drug Discovery & Development > News
FDA extends review period by three months for rheumatoid arthritis candidate baricitinib
By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months for investigational rheumatoid arthritis treatment, Baricitinib.
Production & Manufacturing > Process & Production > News
Sunovion’s dasotraline improves ADHD symptoms in children in phase 2/3 study
By PBR Staff Writer
Sunovion Pharmaceuticals’ novel drug candidate dasotraline has demonstrated significantly improved attention deficit hyperactivity disorder (ADHD) symptoms in children compared to placebo in a phase 2/3 study.
Contract Research & Services > Clinical Trials > News
Heron submits CINVANTI NDA to FDA for CINV prevention
Heron Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for CINVANTI (HTX-019), a polysorbate 80-free, intravenous formulation of aprepitant for the prevention of Chemotherapy-Induced Nausea and Vomiting (CINV).
Production & Manufacturing > Process & Production > News
Clinical-stage biopharmaceutical firm OncoImmune raises $15m funding
OncoImmune, a privately-held, clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel immunotherapies for cancer, inflammation and autoimmune diseases, has secured $15m in Series A round of fundraising led by 3E Bioventures Capital.
Drug Research > Drug Discovery & Development > News
FDA grants QIDP status for RedHill's RHB-104 to treat nontuberculous mycobacteria infections
By PBR Staff Writer
RedHill Biopharma has secured the Qualified Infectious Disease Product (QIDP) fast-track designation from the US Food and Drug Administration (FDA) for its candidate RHB-104 to treat nontuberculous mycobacteria (NTM) infections.
Production & Manufacturing > Process & Production > News
Novartis to commence phase 2 trial with bimagrumab in obese patients with type 2 diabetes
MorphoSys said its partner Novartis will conduct a phase 2 clinical trial of the HuCAL antibody bimagrumab in obese patients having type 2 diabetes.
Contract Research & Services > Clinical Trials > News
US appeals court upholds Eli Lilly's patent on Alimta cancer drug
By PBR Staff Writer
Eli Lilly and Company has received a favorable court ruling in the US regarding the vitamin regimen patent for its cancer drug Alimta.
Production & Manufacturing > Manufacturing > News
136-150 of 50152 results