Although Amgen Inc.'s top-line data from TRINOVA-1, the first of three Phase III trials evaluating trebananib, also known as AMG 386, proved positive in ovarian cancer with regard to progression-free survival (PFS), whether this will be enough for approval remains in question.

For drug developers, it's hardly news that markets such as Brazil, Russia, India and China (BRIC) are not the once hoped-for promised land, and Frost & Sullivan has put together a report that outlines the reasons the situation may get worse.

Twice-per-day dosing (rather than once) and an inhaler that patients already know how to use, along with strong efficacy, could give Pearl Therapeutics Inc.'s therapy for chronic obstructive pulmonary disease (COPD) an edge in the increasingly competitive therapeutic space.

So urgently did I think I wanted to read Ben Goldacre’s Bad Pharma, that I ordered it from Amazon’s UK site last November, unwilling to wait for U.S. publication – which happened just as I reached the end, polishing off the book’s afterword, called “Better Data.” Goldacre, it turns out, is as much bothered by the secrecy of data as by its quality, and he has also set up an activist website, where the public can petition for “all [clinical] trials to be registered, for all summary results to be reported, and for full clinical study reports [CSRs] to be...

CytomX Therapeutics Inc.'s oncology deal with Pfizer Inc. to develop Probody-drug conjugates (PDCs) gives the pharma giant rights to develop selected candidates in exchange for a potential $25 million up front, as well as $610 million if regulatory and sales milestones are met, and tiered royalties into the double digits on sales of resulting products.

Although efficacy below AstraZeneca plc's standard caused the pharma firm to give up rights to fostamatinib, the spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis (RA) met important endpoints, and Rigel Pharmaceuticals Inc. could find another partner and explore new diseases with it.

Analysts, inspecting early stage data, hailed the "paradigm-changing" potential in the treatment of at least one set of non-small-cell lung cancer (NSCLC) patients with Clovis Oncology Inc.'s oral CO-1686, for which results from Phase I/II trials were reported at ASCO 2013.

Epizyme Inc.'s initial public offering (IPO) hit the top end of the pricing range and added more than a million more shares than expected, with a next-day aftermarket performance that suggests enthusiasm about epigenetics will continue to grow.

Biogen Idec Inc.'s hiccup in the European launch of Tecfidera (dimethyl fumarate), known as BG-12 in trials, sparked a mild kerfuffle among analysts trying to figure out the status of intellectual property (IP) protection for the multiple sclerosis (MS) therapy approved in the U.S. earlier this year.

AstraZeneca plc's planned buyout of Omthera Pharmaceuticals Inc. to gain Phase III-validated Epanova, the anti-triglyceride therapy based on ultra-pure fish oil, puts the firm at a "distinct commercial advantage" over Amarin Corp. plc, with its recently launched Vascepa (icosapent ethyl), said Decision Resources (DR) analyst Paramjit Narang.