Advaxis Inc., submitted an application for orphan drug designation to the FDA for ADXS-HPV, its lead drug candidate, for the treatment of invasive cervical cancer. Aeterna Zentaris Inc., of Quebec City, said the class action lawsuit filed against the company and certain of its officers by Faruqi & Faruqi LLP in the U.S. District Court for the Southern District of New York has been entirely dismissed with prejudice and without leave to amend. No payment was made by any of the defendants to the
LONDON – A new study has given hope that it may one day be possible to develop a specific treatment for neuroblastoma, which is a rare type of childhood cancer. Researchers in Sweden have shown that blocking the function of a molecule that is overexpressed in neuroblastoma cells can shrink tumors and prolong survival in a mouse model of that disease. A similar strategy may also work for many other cancers, the scientists suggested, because the molecule that is overexpressed in neuroblastoma is
By Sharon Kingman | BioWorld Today | Friday, June 7, 2013
Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., received authorization from the NYSE Euronext (NYSE MKT) to transfer the listing from Nasdaq. The company expects its common stock to begin trading on the NYSE market on June 17, under its current ticker symbol, "AMPE." Biodel Inc., of Danbury, Conn., disclosed plans to submit a new drug application (NDA) to the FDA in 2015 for a glucagon rescue device to treat severe hypoglycemia. Having previously signed a long-term commercial supply
Actavis Inc., of Parsippany, N.J., said it filed an abbreviated new drug application to market drospirenone/ethinyl estradiol/lovomefolate calcium tablets and levomefolate calcium tablets, a generic version of Safyral from Bayer AG, of Leverkusen, Germany. Safyral is approved to prevent pregnancy in women who elect to use an oral contraceptive and to provide a daily dose of folate supplementation.
A replay of the data from the RECORD trial seemed to reassure many members of two FDA advisory committees about the use of GlaxoSmithKline plc's diabetes drug Avandia, but they admitted that it's probably too late to rehabilitate the drug's reputation. After a two-day meeting that looked at independently readjudicated results from the open-label RECORD trial, seven members of the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees voted that
By Mari Serebrov | BioWorld Today | Friday, June 7, 2013
Alexion Pharmaceuticals Inc., of Cheshire, Conn., published data in the June 6, 2013, issue of the New England Journal of Medicine showing that chronic therapy with Soliris (eculizumab) was effective for hemolytic uremic syndrome. Results of two studies demonstrated that Soliris inhibited systemic complement-mediated TMA, decreased the need for TMA-related intervention, improved platelet count significantly, improved renal function and was associated with substantial kidney recovery. Chronic
LAM Therapeutics, of Guilford, Conn., closed an undisclosed Series A financing with private investors to its launch business operations. The company's mission is development of drugs for lymphangioleiomyomatosis (LAM), a rare lung disease. It will use the proceeds to identify clinical-stage drugs that might have activity against LAM and to begin clinical trials. Targovax AS, of Oslo, Norway, raised $3.6 million for development of its cancer vaccine pipeline, particularly TG01 for pancreatic
Global pharmaceutical companies have recognized China as a force to be reckoned with, as evidenced by their lockstep establishment of R&D and commercial operations in the country. However, a China strategy is a bit trickier for U.S. biotechs to achieve. Although Amgen Inc., Celgene Corp. and Gilead Sciences Inc. are among the big biotechs with offices in China, most small-cap firms have deferred a presence in the country. EntreMed Inc. is a contrarian in that respect. The Rockville, Md.-based
By Marie Powers | BioWorld Today | Friday, June 7, 2013
CytomX Therapeutics Inc.'s oncology deal with Pfizer Inc. to develop Probody-drug conjugates (PDCs) gives the pharma giant rights to develop selected candidates in exchange for a potential $25 million up front, as well as $610 million if regulatory and sales milestones are met, and tiered royalties into the double digits on sales of resulting products. The $25 million "incorporates the up-front research funding and near-term milestone payments, as we move [PDCs] through various stages of
By Randy Osborne | BioWorld Today | Friday, June 7, 2013
Astellas Pharma US Inc., of Northbrook, Ill., part of Astellas Pharma Inc., entered a distribution agreement with Tecnofarma International Ltd., of Buenos Ares, Argentina, to distribute enzalutamide (Xtandi in the U.S.) in Latin America, excluding Brazil, upon regulatory approvals in the various countries. Financial terms of the agreements were not disclosed. Bayer AG, of Leverkusen, Germany, said it has been offered 96.4 percent of the shares (about 32 million) of Conceptus Inc., of Mountain
ARCA Biopharma Inc., of Broomfield, Colo., said it closed its public offering of Series A convertible preferred stock and warrants, issuing to investors 125,000 shares of preferred stock and warrants to purchase 6.25 million shares of common stock. ARCA received about $18 million in net proceeds, which will be used primarily to fund the Phase IIb portion of the GENETIC-AF trial comparing lead compound Gencaro (bucindolol hydrochloride) to metoprolol CR/XL to prevent atrial fibrillation in
TAIPEI, Taiwan – It's been a long wait, but Taiwan's drug development industry might just be coming of age. While the island nation is still awaiting its first home-grown innovator drug, a number of companies are almost there. As evidence, market capitalization of companies in the sector has skyrocketed at an astounding rate over the past few years, jumping from $3 billion in 2009 to $15 billion in 2013, according to Taiwan's Bio Industry Organization. It's about time, since at least the mid
By Dave Silver | BioWorld Today | Thursday, June 6, 2013
Execs at BioMarin Pharmaceutical Inc. hope to repeat their Phase II success with PEG-PAL (PEGylated recombinant phenylalanine ammonia lysate) for phenylketonuria in a new Phase III program. The open-label study will evaluate safety and tolerability of the self-administered therapy on about 90 treatment-naïve adult PKU subjects during induction, titration and maintenance dosing. Secondary objectives include blood phenylalanine (Phe) levels. A double-blind, placebo-controlled Phase III will
By Catherine Shaffer | BioWorld Today | Thursday, June 6, 2013
The FDA revised its 2002 guidance on developing antiretroviral drugs to treat HIV-1 to provide more details on the nonclinical development of antiretrovirals and greater emphasis on recommended designs for trials evaluating the drugs in patients with multidrug-resistant virus and few remaining therapeutic options. The draft guidance also discusses use of a primary endpoint evaluating early virologic changes for studies in heavily treatment-experienced patients and use of the traditional path
