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.
The decision by Merck & Co. Inc. to end its Phase III program with preladenant based on three studies that failed to show efficacy in Parkinson's disease put the spotlight on adenosine A2A receptor antagonists as a class, which has been explored by a handful of other companies, some of them with work still under way.
The once-weekly, oral proteasome inhibitor that Takeda Pharmaceutical Co. Ltd., with its Millennium oncology unit, hopes will eventually replace Velcade (bortezomib), which loses patent protection later this decade, entered a Phase III trial in newly diagnosed multiple myeloma (MM).
Oncolytics Biotech Inc. followed up March's promising data from a Phase II trial testing Reolysin in squamous cell lung cancer with results from a Phase II study in metastatic melanoma, where the reovirus variant for Ras-mutant cancers, combined with carboplatin and paclitaxel, met its primary endpoint in the first stage.
Last month's FDA workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) – the first of its kind, one of 20 mandated by the Prescription Drug User Fee Act – hardly transformed the treatment landscape in the aftermath of the agency's refusal to approve the Toll-like receptor 3 modulator Ampligen (rintatolimod), the CFS therapy from Hemispherx Bioscience Inc.
Generic drugmaker Actavis Inc.'s plan to take over Dublin, Ireland-based Warner Chilcott plc in a stock-for-stock transaction worth about $8.5 billion, thus forming the world's third-largest specialty pharmaceutical firm, would put the combined firm – with about $11 billion in annual revenues – on even more solid footing in the busily consolidating biosimilars realm.
MedImmune Inc., part of AstraZeneca plc, started the first patient in its Phase III hairy-cell leukemia (HCL) trial with its first-in-class antibody-drug conjugate moxetumomab pasudotox (MP), a CD22 immunotoxin made up of an anti-CD22 antibody fused to a toxin. The molecule binds to CD22, gets internalized and processed, and then releases the toxin payload to blast the tumor.
Gradalis Inc.'s interim Phase II data with its personalized cancer vaccine for advanced ovarian cancer showed the approach more than doubled the benefit in patients given therapy known as FANG, a rough acronym for "furin and granulocyte-macrophage colony-stimulating factor (GMCSF)."
AbbVie Inc.'s $70 million up front buys an option to acquire Alvine Pharmaceuticals Inc.'s drug candidate for celiac disease or the company itself, after Phase IIb trials are finished with ALV003, a two-enzyme combo that degrades gluten.
