Australia and New Zealand have called it quits on trying to form a joint regulatory agency to oversee drugs and medical devices. The decision followed a comprehensive review of the progress and an assessment of the costs and benefits to each country. Read More
Foundation Medicine Inc., of Cambridge, Mass., reported that interim findings from a phase II study of Boulder, Colo.-based Clovis Oncology Inc.'s rucaparib in patients with relapsed, platinum-sensitive ovarian cancer suggest that Foundation's companion diagnostic can identify both BRCA-mutant patients and non-BRCA-mutant patients who are more likely to benefit from rucaparib than patients who are biomarker negative. Read More
Alk-Abello A/S, of Horsholm, Denmark, said its registration application for the house dust mite sublingual allergy immunotherapy, or SLIT, tablet has been accepted for review by the European health authorities via the decentralized procedure with Germany as the reference member state. Read More
Northwest Biotherapeutics Inc., of Bethesda, Md., said it completed two financings totaling $35 million, which includes a $25 million equity investment by UK-based C.F. Woodford Equity Income Fund and a $10 million mortgage on the company's recently acquired UK facility. The mortgage has a two-year term and interest-only payments until maturity. Read More
HONG KONG – The FDA has been planning for two years to expand its China office to meet significantly larger demands for inspections in the country. But for two years now, China has failed to approve visas for FDA staff, including inspectors brought in from the U.S. Read More
DUBLIN – A 2.5 percent share price drop – or a €2.5 billion (US$3 billion) loss of value – is not the best way to begin a pipeline update. But amid continued uncertainty about the leadership situation at Sanofi Group, that was the hand its chairman and interim CEO, Serge Weinberg, had to play as the company set out its stall Thursday on a late-stage pipeline that it contended will deliver cumulative revenues of €30 billion over the first five years of sales. Read More
LONDON – The knowledge of the exact structure of the enzyme that the influenza virus uses to make new influenza viruses will give a huge boost to the search for drugs to treat that infection, scientists predict. Read More
LONDON – The era of stratified medicines that are suitable for subgroups of patients only has arrived, but there are many shortcomings to address in terms of R&D, regulation, health technology assessment, access and reimbursement, to maintain momentum and ensure the benefits are delivered. Read More
While most of the companies developing Ebola vaccines and therapies are getting considerable government support, several lawmakers are proposing another incentive – transferable priority review vouchers. Read More
Purdue Pharma LP, of Stamford, Conn., said the FDA approved Hysingla ER (hydrocodone bitartrate), an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Read More
