CHICAGO – John Mendlein may not look like the typical biotech exec – the long hair and laid-back manner suggest he might be more at home catching a few waves rather than moderating a panel on orphan and rare diseases, as he did Tuesday morning at the BIO 2013 International Convention.
CHICAGO – Getting through an FDA advisory committee is an oft-dreaded rite of passage for developers of novel drug candidates, and stories of disastrous adcoms have a tendency to circulate around the biopharma industry like urban myths.
CHICAGO – Improved technologies for molecular imaging agents and wider use of biomarkers may be moving the drug development industry away from the blockbuster model – and toward a niche market strategy where smaller patient populations are treated by more effective, targeted drugs – but that doesn't mean treating disease, particularly cancer, will get any less complex.
Continuing a flurry of 2013 dealmaking, nanomedicine firm BIND Therapeutics Inc. kicked off the BIO International Convention with a potential $199 million-plus deal with AstraZeneca plc to develop and commercialize an Accurin therapeutic based on a molecular targeted kinase inhibitor.
UK-based GW Pharmaceuticals plc set the terms for its proposed U.S. initial public offering (IPO), which would provide a listing on Nasdaq and nearly double its cash position ahead of the anticipated launch of lead cannabinoid product Sativex in the U.S.
Celltrion Inc,. which scored a big win last year with the world's first officially approved biosimilar monoclonal antibody – Remsima, a biosimilar version of autoimmune blockbuster Remicade (infliximab, Johnson & Johnson) – has halted a late-stage trial testing a Rituxan/MabThera (rituximab) biosimilar.
The initial public offering (IPO) window may be creaking open for biotech – thanks in part to the new emerging growth company designation included in last year's JOBS Act – but running a publicly listed small biotech requires as much dedication as ever.
Briefing documents released ahead of Wednesday's Pulmonary-Allergy Drugs Advisory Committee pointed to some inconsistent data for Breo (fluticasone furoate/vilanterol), the combination inhaled corticosteroid and long-acting beta2 agonist (LABA) from GlaxoSmithKline plc and Theravance Inc.
With regulatory filings expected later this year for antibiotic dalbavancin, Durata Therapeutics Inc. continues to shore up its cash position. A month after inking a $20 million debt facility agreement, the Chicago-based biotech priced a $50 million public offering, selling 7.15 million shares priced at $7 apiece, a slight discount to Thursday's closing price.
Receptos Inc. became the seventh U.S. biotech to file for an initial public offering (IPO) this year, taking advantage of the emerging growth company provision in the Jumpstart Our Business Start-ups Act and aiming to raise as much as $86.3 million to support clinical work in multiple sclerosis, inflammatory bowel disease (IBD) and allergic/immune-mediate disorders.