With a new year, old impatience is growing among small companies and investors eager to see the potential of federally sanctioned crowdfunding take off. In January, biotech hotbed Massachusetts, as well as Oregon and Maine, joined a growing list of states taking matters into their own hands. Irritated by the SEC's sauntering approach to finalizing proposed rules it drafted to implement crowdfunding provisions in the 2012 Jumpstart Our Business Startups (JOBS) Act, they joined a growing roster of states that have adopted their own rules for governing the offerings. (See BioWorld Insight, Aug. 11, 2014.) Massachusetts' new rules, like all...
Amgen Inc. reported after market close Tuesday that despite higher than expected fourth quarter profits, bolstered by strong sales of Enbrel (etanercept), sales of Neupogen (filgrastim) fell 11 percent year over year, driven by the impact of U.S. competition, inventory issues and foreign exchange rates.
Riding high on new interim data suggesting plasma-derived alpha-1 antitrypsin (AAT) might help patients with graft-vs.-host disease (GvHD) recover when steroids fail, Omni Bio Pharmaceutical Inc. is angling to produce an irresistible proof-of-concept package showing its preclinical recombinant AAT (rAAT) could do the same and more.
Promising multiple readouts on its HER2-focused experimental cancer therapy neratinib (PB272) in the year ahead, Puma Biotechnology Inc. unleashed plans for a $190 million follow-on offering to back clinical work and a planned first quarter 2016 new drug application (NDA) for the tyrosine kinase inhibitor.
The FDA has approved Novartis AG's new plaque psoriasis therapy, Cosentyx (secukinumab), just days after European regulators approved the therapy, making the potential blockbuster the first interleukin-17 blocker to be approved for the indication.
SAN FRANCISCO – Immune Design Corp. CEO Carlos Paya told attendees at the J.P. Morgan Healthcare Conference Thursday that the company is making solid progress toward what he believes is the future of in vivo cancer immunotherapy: combining the company's tumor-specific cytotoxic T cells (CTL)-boosting therapy CMB305 with a checkpoint inhibitor.
SAN FRANCISCO – Abbvie Inc.'s chief financial officer, Bill Chase, said competition for market share and the pricing saga playing out between its new hepatitis C virus (HCV) therapy, Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) and Gilead Sciences Inc.'s Harvoni (sofosbuvir/ledipasvir) is "exactly what we expected," but that the media's focus on price has been much heavier than merited.
SAN FRANCISCO – Gilead Sciences Inc.'s president and chief operating officer, John Milligan, told attendees of the 33rd annual J.P. Morgan Healthcare Conference that the Foster City, Calif.-based company's hepatitis C virus (HCV) therapy Sovaldi (sofosbuvir) is now broadly covered across most of the health plans in America and is making continuing progress in Europe, providing access for more patients than ever before.
