The European Commission granted marketing authorization for privately-held HRA Pharma's novel emergency contraceptive ellaOne in 27 countries May 15, with the first wave of product launches expected this fall.
Continue reading "HRA Pharma’s Novel Emergency Contraceptive ellaOne Gains EMEA Marketing Approval" »
Windhover Information's Euro-Biotech Forum, June 29-July 1 in Barcelona, Spain, is the best global partnering meeting for American and European life science companies, with the highest concentration of senior level biopharma executives.
Continue reading "Major Mid- to Large-Sized European Pharma Representatives Present Their In-licensing Opportunities at Euro-Biotech Forum" »
Furthering its mission to offer a wide range of drugs across many different price-points, Novartis announced May 20 that it is buying the specialty generic injectables business of Austria's privately-owned Ebewe Pharma.
Continue reading "Novartis Buys Injectable Cancer Drug Business from Austria's Ebewe" »
Biosimilars haven’t had a huge impact in Europe—yet. Sponsors and analysts expect that to change over time. Will the US market parallel the European experience?
Continue reading "European Biosimilars’ Market Performance Mirrors US Legislative Progress: Slow but Steady " »
UCB’s Cimzia deserved a break. After a troubled developmental and regulatory history (read about it here and here) the drug finally received FDA approval for RA today, earlier than most expected, and with a label that analysts describe as “the best possible.”
Continue reading "UCB's Cimzia gets FDA approval--at last" »
UK biotech Antisoma can breathe a little easier following a deal that will fund operations for at least the next two years, taking the company through key Phase III data points for its two lead oncology compounds.
Continue reading "Oral Fludarabine Gives Antisoma Breathing Room" »
In a creative deal that echoes the strategic tie-up last year between Infinity and Mundipharma, Italy's privately-owned mid-sized pharma Chiesi Farmaceutici is buying a majority stake in Cornerstone Therapeutics, which gets $15.5 million along with U.S. rights for 10 years to Chiesi's marketed lung surfactant Curosurf.
Continue reading "Another Hybrid License Deal: Chiesi Buys Majority Stake In Cornerstone" »
U.S. biopharma manufacturers should be cautious about importing the British National Institute for Health and Clinical Excellence's approaches to reimbursement risk-sharing, as such schemes could have unanticipated consequences for obligations such as Medicaid rebates.
Continue reading "UK-Style Insurance Risk-Sharing Could Affect Medicaid Rebates, Part B ASPs" »
Costs appear to be an almost inevitable part of the expanded federal comparativeness research program, and the UK's 10-year old cost-effectiveness watchdog, the National Institute of Clinical Excellence, offers strategic clues for how the U.S. biopharma industry should respond, experts from the law firm Sidley Austin law firm advise.
Continue reading "NICE Lessons On What To Expect from U.S. Comparative Effectiveness" »