DUBLIN – Ireland's phantom pharma sector, a growing roster of Irish-domiciled pharmaceutical companies that perform little if any activity within the country yet which channel much of their earnings through it, is attracting uncomfortable levels of scrutiny in the global industry's current cycle of M&A and drug licensing activity. Read More
Tokyo-based Daiichi Sankyo Co. Ltd. discontinued a phase III trial for nimotuzumab on the recommendation of an independent data monitoring committee after four treatment-related deaths were observed, all in the nimotuzumab arm. Read More
HONG KONG – Four years after it was sidelined, a pentavalent vaccine produced by the Indian arm of Sanofi Pasteur (the vaccine division of Sanofi SA) – Shantha Biotechnics Ltd. – received prequalification status from the World Health Organization. The prequalification means that United Nations agencies like UNICEF can now purchase the vaccine for use across its programs, mostly in emerging countries. Read More
"Sometimes," Paula Hammond told BioWorld Today, in basic research "you learn something that's very important, but then that's hard to replicate in patients." Read More
LONDON – The EMA has opened a public consultation on moves to get its processes working in parallel with health technology assessment (HTA) bodies, with the aim of providing drug developers with scientific advice that enables them simultaneously to generate safety and efficacy data for the marketing authorization and evidence of the value-added for HTAs. Read More
The battle for obesity market share became unsurprisingly more complicated with the notice by Actavis plc that it has filed an abbreviated new drug application (ANDA) for all strengths of one of the market players: Vivus Inc.'s Qsymia (phentermine/topiramate). Read More
Imaginab Inc., of Los Angeles, completed a $21 million series B financing led by Mérieux Développement and syndicated with Novartis Venture Funds, Cycad Group and Nextech Invest. Read More
Nuvilex Inc., of Silver Springs, Md., has signed a research agreement with the University of Northern Colorado to perform initial studies in the development of cancer treatments that combine its proprietary live-cell encapsulation technology, Cell-in-a-Box, with cannabinoids. Read More
Bind Therapeutics Inc., of Cambridge, Mass., reported in its first quarter earnings call that a pre-specified evaluation of patients enrolled in its phase II non-small-cell lung cancer (NSCLC) trial with KRAS mutations showed that, of the six patients with KRAS mutations treated with BIND-014, two demonstrated a confirmed partial response and two had durable stable disease, defined as lasting 12 weeks or longer. Read More
Alimera Sciences Inc., of Atlanta, reported revenue of $2.1 million for the first quarter, with the firm citing increasing demand for intravitreal insert Iluvien (fluocinolone acetonide) for diabetic macular edema in Germany and early implementation of reimbursement guidance in the UK. The company is continuing its expansion in Europe. Read More
Pfizer Inc., of New York, reported results from two phase II studies of bivalent rLP2086, its recombinant vaccine candidate in development for the prevention of invasive meningococcal disease caused by Neisseria meningitides serogroup B in subjects ages 10 to 25. Read More
Researchers from the Chinese University of Hong Kong have reported that they were unable to replicate the results of a recent study saying that induced pluripotent stem cells could be generated through applying mild stressors, such as an acid bath or mechanical stress. Read More
