Atlanta's Emory University launched a new initiative to help bridge the ever-widening gap between the laboratory discoveries that trumpet the possibility of breakthrough medical treatments and the proof-of-concept data that are needed to entice significant industry investment – known as the dreaded "Valley of Death" in the landscape of drug discovery. Emory, which in 2009 established the Emory Institute for Drug Development (EIDD), now has set up DRIVE (Drug Innovation Venture at Emory LLC), an

Algeta ASA, of Oslo, Norway, and Avipep Pty Ltd., of Parkville, Australia, inked a collaboration to evaluate a targeted thorium conjugate based on combining Algeta's thorium-227 alpha-pharmaceutical payload with a next-generation antibody fragment, known as an Avibody, from Avipep that targets a number of solid tumor types. Avipep will provide access to an Avibody, and Algeta will provide access to chelation and conjugation technologies and its alpha particle-emitting payload. Both companies

Agios Pharmaceuticals Inc., of Cambridge, Mass., filed for an initial public offering (IPO) to raise up to $86 million to fund development of its pipeline in cancer and inborn errors of metabolism (IEMs), a subset of orphan genetic metabolic diseases. Agios's partner, Celgene Corp., of Summit, N.J., agreed to concurrently purchase an as-yet undetermined amount of common stock at the public offering price. Agios' two lead cancer programs target mutations in isocitrate dehydrogenase 1 and 2

Privately held Dermira Inc. lifted its veil of silence, at least partially, to disclose $35 million in new funding. The infusion came in a Series B financing that included Japanese dermatology specialist Maruho Co. Ltd., of Osaka, and existing investors Bay City Capital, New Enterprise Associates and Canaan Partners as well as a "related transaction" that CEO Tom Wiggans coyly sidestepped. "It's a very good deal with a very good company and allows us to really drive our programs forward

It's not every day that a multimillion-dollar market suddenly opens up, inviting all comers to the ground floor of competition. But that's exactly what happened when the FDA put out its "open for business" sign for biosimilars. Even before the agency issued its first draft guidances last year on developing biologic copies and began meeting with interested sponsors, drugmakers were weighing their opportunities, developing strategies for entering the field and seeking out partners to strengthen

Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started a Phase II trial of Iclusig (ponatinib) in adults with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The open-label study is designed to enroll about 45 patients and will provide initial data on the drug's efficacy and safety in patients with GIST following failure of prior tyrosine kinase inhibitor therapy. Patients whose tumors have an activating mutation in exon 11 of the cellular KIT, the primary

LONDON – The identification of the exact molecule on the insides of blood vessels to which malaria parasites stick will allow an immediate start on work to develop vaccines and new therapies for severe forms of malaria, the scientists who made the discovery predict. Research published in Nature showed that the malaria parasite, Plasmodium falciparum, binds to a human protein that plays a key role in regulating blood clotting and the response to inflammation. Thomas Lavstsen, assistant

For drug developers, it's hardly news that markets such as Brazil, Russia, India and China (BRIC) are not the once hoped-for promised land, and Frost & Sullivan has put together a report that outlines the reasons the situation may get worse. "I think the biggest challenge today for selling into BRIC for global companies is the need to understand customer segmentation and behavior – how to optimize this and ensure your product is customized to that need – trying to sell value beyond the product

Achillion Pharmaceuticals Inc., of New Haven, Conn., named Milind Deshpande president and CEO. Agendia BV, of Amsterdam, the Netherlands, named Peter W. Schineller chief commercial officer. Bioinvent International AB, of Lund, Sweden, named Michael Oredsson president and CEO, to be effective within six months. Altherx Pharmaceuticals Inc., of Exton, Pa., added Michael R. Dougherty to its board. Cannabis Science Inc., of Colorado Springs, Colo., named Dorothy Bray CEO and director. Cellular

Breckenridge Pharmaceutical Inc., of Boca Raton, Fla., entered into a development agreement with Welding GmbH & Co., of Hamburg, Germany, and SK Chemicals, of Seoul, South Korea, to develop and market an undisclosed drug candidate with potential U.S.-branded sales of approximately $500 million. Under terms of the agreement, Welding and SK will develop and manufacture the product, using SK's drug delivery system, for Breckenridge, which will have exclusive marketing and distribution rights in

Acknowledging that the train may have already left the station for Glaxosmithkline plc's (GSK) Avandia, some advisory committee members and other experts looked down the track last week to give the FDA an earful on how to get more meaningful data about diabetes drugs and avoid the process that derailed the one-time blockbuster Avandia. Ideally, data should come from randomized, controlled, double-blind, superiority trials – not from meta-analyses and observational studies, which can be loaded

Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported new findings presented during the APASL Liver Week in Singapore, highlighting the efficacy and safety of faldaprevir(+) plus pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve patients with genotype-1 hepatitis C virus (HCV) in Asia. The post-hoc sub-analysis of the Phase III STARTVerso 1 and 2 trials showed that both doses of faldaprevir were associated with high viral cure rates and a shorter treatment duration in that

Clovis Oncology Inc., of Boulder, Colo., said it commenced a public offering to raise $170 million. The number of shares and share price was not disclosed. Underwriters J.P. Morgan Securities LLC, Credit Suisse Securities and Leerink Swann will have a 30-day option to purchase up to an additional 15 percent of the number of shares sold to cover overallotments. Proceeds will be used for general corporate purposes, including funding of Clovis' development programs, general and administrative

Argos Therapeutics Inc., of Durham, N.C., has expanded its ADAPT Phase III study for AGS-003 to additional cancer centers in the U.S., Canada and will soon be expanding into Europe and Israel. To date, more than 50 sites have been activated and more than 30 subjects have been enrolled in North America. The study is expected to expand to more than 120 global sites by early fall. The study is evaluating AGS-003, an investigational, fully personalized immunotherapy designed to stimulate a tumor

Public biotechnology companies have represented one of the capital market's hottest sectors over the past several months. Due to this considerable growth, the Nasdaq OMX Group Inc., of New York, said it is modifying the methodology used to arrive at a valuation for the Nasdaq Biotechnology Index (NBI). While it will continue to employ a modified market capitalization weighting, the rebalancing procedures will be conducted each quarter to ensure the maximum weight of any index security does not

DUBLIN, Ireland – Royalty Pharma's bitter and protracted takeover battle for Elan Corp. plc will, one way or another, reach a climax next Monday when Elan shareholders vote on the company's recent M&A deals. Acceptance of those transactions, which requires a vote representing 50 percent of Elan's equity plus one share, would scupper Royalty's takeover bid. Rejection would signal the end of the road for Dublin, Ireland-based Elan, a company that has, over the years, taken its shareholders

Twice-per-day dosing (rather than once) and an inhaler that patients already know how to use, along with strong efficacy, could give Pearl Therapeutics Inc.'s therapy for chronic obstructive pulmonary disease (COPD) an edge in the increasingly competitive therapeutic space. Those factors, along with the prospect of a triple-combination drug for COPD, led Astrazeneca plc to its takeover plan, which brings $560 million up front for Redwood City, Calif.-based Pearl, along with potentially $450