Intrigued by results from a 13-patient, phase II pilot study with peroxisome proliferator-activated receptor (PPAR) delta agonist MBX-8025 for homozygous familial hypercholesterolemia (HoFH), Cymabay Therapeutics Inc. has begun exploring the prospect of combining it with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to make the drug work even better. Read More
TOKYO – A long-standing and wide divide between Japan's academia and the country's pharmaceutical industry is resulting in top-notch research being left behind in university labs and science journals. Patients, of course, have the most at stake in this disconnected environment. Read More
LONDON – Atlantic Healthcare plc announced the closing of a $24 million round and said Lorin Johnson, co-founder of the world's biggest gastrointestinal (GI) diseases specialist, Salix Pharmaceuticals Inc., is joining the company as chief scientific adviser. Read More
Researchers from Gilead Sciences Inc., with colleagues from academia, have identified the mechanism by which a major protein of the hepatitis B virus (HBV) promotes transcription of viral DNA – a finding that could lead to new drug targets. Read More
SAN FRANCISCO – As whole genome sequencing and other molecular diagnostic efforts take wing worldwide, new troves of biomedical data are being built daily. The power of that data, however, continues to be diminished by disconnection between data stores, hindering opportunities to accelerate progress in human health. One group, The Global Alliance for Genomics & Health (GA4GH), is working to reverse that trend, leading an effort to bring order to just a small corner of this world: BRCA1/2. Read More
Bergenbio A/S, of Bergen, Norway, said it secured a capital raise of NOK212 million (US25.4 million) in a private placement from existing shareholders, including Investinor AS and Meteva AS. The company will use the proceeds, along with existing cash, to advance its pipeline of cancer drugs, in particular lead asset BGB324, an Axl kinase inhibitor, which is in phase Ib testing in acute myeloid leukemia and in stage IIIb and stage IV non-small-cell lung cancer. Read More
Breckenridge Pharmaceutical Inc., of Boca Raton, Fla., said the FDA approved its abbreviated new drug application for Gabapentin Oral Solution 250 mg per 5 mL, a generic of Neurontin (gabapentin, Pfizer Inc.), as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients with epilepsy. Read More
Aerie Pharmaceuticals Inc., of Irvine, Calif., provided further details on the safety profile for Rhopressa (netarsudil ophthalmic solution), a once-daily eye drop in development for lowering intraocular pressure (IOP) in patients with glaucoma or ocular hypertension, showing it has indicated any drug-related systemic effects and has not generated any serious adverse events. Read More
Eagle Pharmaceuticals Inc. said the FDA issued a complete response letter (CRL) for Kangio (bivalirudin injection), which the company is advancing through the 505(b)(2) pathway as a ready-to-use, stable liquid intravenous formulation of 5 mg/mL bivalirudin, a new version of the anticoagulant Angiomax (bivalirudin, The Medicines Co.). Read More
