By Catherine Shaffer Staff Writer SAN FRANCISCO – Phase II deal values surpassed Phase III in 2012, leading a senior biopharma analyst for Deloitte Recap LLC, to say "2012 was certainly the year of the Phase II" in her talk summarizing Deloitte's analysis of 1,692 deals closed in 2012 at the firm's Allicense Conference in San Francisco on Monday
By Marie Powers Staff Writer CHICAGO – Small biotechs, already smarting from the stingy venture capital (VC) market and cutbacks in government funding, are looking nervously over their shoulder at the increasingly cozy relationship between big pharmas and academic institutions
By Randy Osborne Staff Writer CHICAGO – Officials from the China Food and Drug Administration (CFDA) stammered through a question-and-answer period in which the audience sought the agency's definition of an "innovative" drug, its stance on orphan therapies and its policy with regard to biosimilars, during the first day of the BIO 2013 International Convention here
By Nuala Moran Staff Writer LONDON – Cancer specialist Activartis Biotech GmbH will present positive survival data from the Phase II trial of its dendritic cell therapy in treating glioblastoma at the American Association of Cancer Research (AACR) Wednesday, as it steps up efforts to find a partner to back a Phase III study
By Nuala Moran Staff Writer LONDON – Clavis Pharma A/S is facing a merger or an orderly shutdown following the Phase III failure of elacytarabine, its lipid-enhanced version of cytarabine, in the 380-patient CLAVELA trial in advanced acute myeloid leukemia (AML
By Sharon Kingman Staff Writer LONDON – Study of a family affected by an inherited neurological disease has helped to reveal the identity of an enzyme that could point the way to new therapies for cancer and cardiovascular disease
By Cormac Sheridan Staff Writer Without revealing much in the way of new data, TopoTarget A/S enjoyed a 45 percent bounce in its share price during early trading Tuesday, as an analysis of the final top-line results from a registration trial of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) confirmed the drug exceeded the efficacy level defined by the study's primary endpoint, a minimum objective response rate (ORR) of 20 percent
By Sharon Kingman Staff Writer LONDON – Identification of a protein that orchestrates many of the changes that permit a normal cell to turn into a cancer cell will open up an entirely new field of cancer therapeutics, the researchers who made the discovery predicted
Sharon Kingman Staff Writer LONDON – While the development of biosimilars – biological medicines designed to be very similar to ones that have already been approved for clinical use – is really still in its infancy, people already are looking to the future and considering what sorts of molecules will come next
By Catherine Shaffer Staff Writer A partnership between Roche AG and Chiasma Inc., of New York, promises to take the pain out of therapy for acromegaly, the overproduction of growth hormone
By Nuala Moran and Cormac Sheridan Staff Writers LONDON – One of the UK's oldest biotech companies looks to be on its way out after reporting the failure of the lead program in Parkinson's disease
By Nuala Moran Staff Writer LONDON – The Innovative Medicines Initiative (IMI) officially launched the European Lead Factory, a €196 million (US$266 million) project in which seven pharma companies will make at least 300,000 compounds available for screening via an open platform
By Randy Osborne Staff Writer Say "emerging markets," and anyone within earshot is likely to think of Brazil, Russia, India and China, the so-called BRIC countries
By Cormac Sheridan Staff Writer Shares in Zealand Pharmaceuticals A/S hit an all-time high Monday on news that it will shortly start logging double-digit percentage royalty payments from its partner Sanofi SA, following formal European Union approval of the once-daily glucagon-like peptide 1 (GLP-1) agonist Lyxumia (lixisenatide, AVE0010) in Type II diabetes
By Catherine Shaffer Staff Writer The FDA convened a public hearing to receive input on its proposal to expedite development of new drugs for serious or life-threatening conditions with unmet need
By Catherine Shaffer Staff Writer SAN FRANCISCO – Phase II deal values surpassed Phase III in 2012, leading a senior biopharma analyst for Deloitte Recap LLC, to say "2012 was certainly the year of the Phase II" in her talk summarizing Deloitte's analysis of 1,692 deals closed in 2012 at the firm's Allicense Conference in San Francisco on Monday