On a call with investors earlier this month, Aegerion Pharmaceuticals Inc.'s CEO, Marc Beer, said the firm was "in filing mode now," with plans to submit a new drug application for lomitapide in homozygous familial hypercholesterolemia (HoFH) by the end of this year. Read More
WASHINGTON – When it comes to patent reform, the cure may not treat the bite of a growing backlog of patent applications – about 700,000 at last count. Read More
Shares in Genmab A/S dropped 11 percent Friday on news that the company had failed to secure a deal for its epidermal growth factor receptor (EGFR) inhibitor zalutumumab and has opted to shelve the program. Read More
LONDON – The European Medicines Agency (EMA) has knocked back Amsterdam Molecular Therapeutics NV's (AMT) Glybera, leaving the winning post in the race to be the first approved gene therapy in a registered market still some distance away. Read More
When scientists and clinicians meet this week in San Diego at the 71st scientific sessions of the American Diabetes Association, they have their work cut out for them: As the global population gets older and fatter overall, diabetes cases are increasing at an alarming rate. Read More
ViroPharma Inc., of Exton, Pa., said the European Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of a pediatric use marketing authorization application for Buccolam (midazolam, oromucosal solution) for treating prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents. Read More
PCI Biotech Holding ASA, of Oslo, Norway, reported results from a Phase I/II study of combination product PC-A11, which combines the photosensitizer Amphinex with the cytotoxic agent bleomycin. The drug was well tolerated, and a dose-limiting toxicity of skin photosensitivity and ulceration occurred at the fourth dose level. Complete clinical regression of target tumors was seen in 14 of 16 patients completing the first assessment and eight of 11 patients completing the second assessment. Read More
By connecting the eye's light-sensing machinery to cellular gene expression machinery, scientists from the Swiss Eidgenoessische Technische Hochschule in Zurich, Switzerland, have managed to use external light to switch on individual genes in a cell. Read More
WASHINGTON – International will be front and center at this year's BIO International Convention taking place this week in Washington – both in who's coming and in what's being discussed. Read More
Pfizer Inc. partners Pain Therapeutics Inc. and Durect Corp. shared the pain of an FDA complete response letter (CRL) on Pfizer's resubmission of the new drug application (NDA) for Remoxy (oxycodone) extended-release capsules CII. Read More
