An antibiotic that was once dropped from clinical development because bacteria quite easily develop genetic resistance to it may get a second lease on life – because as part of a combination therapy, it can kill so-called bacterial persisters in biofilms.
Shares in Paion AG surged more than 40 percent Thursday on news that its fast-acting anesthetic remimazolam hit the primary endpoint of a Phase II/III trial conducted by its Japanese partner, Osaka-based Ono Pharmaceutical Co. Ltd., and demonstrated a better cardiovascular safety profile than a widely used control drug.
A federal judge cut short the first patent dance involving a biosimilar, calling it premature. Judge Maxine Chesney denied Sandoz Inc.’s request for declaratory judgment that the Enbrel (etanercept) biosimilar it’s developing doesn’t infringe two patents owned by Roche AG and exclusively licensed to Amgen Inc.
The FDA gave drug developers a shot of good news Wednesday afternoon with the approval of Imbruvica (ibrutinib), the oral Bruton’s tyrosine kinase (BTK) inhibitor developed by Pharmacyclics Inc. and Johnson & Johnson unit Janssen Biotech Inc., as a single agent to treat patients with mantle cell lymphoma (MCL) who received at least one prior therapy.
Synta Pharmaceuticals Corp.’s new money from a public offering – about $52.5 million in gross proceeds – will fuel an expanded Phase III push with the heat-shock protein 90 inhibitor ganetespib in non-small-cell lung cancer (NSCLC).
• Apricus Biosciences Inc., of San Diego, signed an exclusive license agreement with Laboratoires Majorelle, of Paris, to market Vitaros, its topical product to treat erectile dysfunction, in France, Monaco and certain African countries.
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it submitted applications to extend the indication for the use of tiotropium (Spiriva) Respimat to the treatment of asthma in adults.
• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., reported results from its maximal use systemic exposure (MUSE) study of boron-based phosphodiesterase-4 inhibitor AN2728 in pediatric and adolescent patients, ages 2 to 18, with atopic dermatitis, with data showing that AN2728 ointment, 2 percent, appears to be safe, well tolerated and efficacious when applied twice daily.
• Baxter International Inc., of Deerfield, Ill., said it completed enrollment in its Phase III trial of BAX 855, an extended half-life recombinant Factor VIII treatment for hemophilia A.