By Sharon Kingman Staff Writer 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
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
By Mari Serebrov | BioWorld Today | Tuesday, June 11, 2013
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
By BioWorld Staff | BioWorld Today | Tuesday, June 11, 2013
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
By Cormac Sheridan | BioWorld Today | Tuesday, June 11, 2013
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
By Randy Osborne | BioWorld Today | Tuesday, June 11, 2013
Advaxis Inc., of Princeton, N.J., sent a letter to stockholders recommending they vote in favor of proxies allowing the company to pursue access to additional sources of capital, namely institutional investors. Executives want to implement a reverse stock split and up-list onto a national market in connection with the proposed capital raise. Affymax Inc., of Palo Alto, Calif., said in an SEC filing that it entered an amendment to terminate its development and supply agreement with Bachem
After acknowledging in a conference call Friday that the FDA would not in all likelihood approve its lead product tivozanib for renal cell carcinoma (RCC), Aveo Pharmaceuticals Inc. said Monday it received a complete response letter (CRL) from the agency informing the biotech it will not approve in its present form the new drug application (NDA) for the product. Reasons cited were the inconsistent progression-free survival and overall survival results and imbalance in post-study treatments
By Peter Winter | BioWorld Today | Tuesday, June 11, 2013
Hopes for a resubmitted Heplisav application by the end of this year were dashed Monday, after Dynavax Technologies Corp. said a recent meeting with the FDA indicated that an additional safety study would be required before the agency would consider approving the hepatitis B vaccine. Also nixed was the possibility of submitting a new application seeking initial use of Heplisav in restricted patient populations, such as subjects with chronic kidney disease (CKD), or limiting the vaccine to
By Jennifer Boggs | BioWorld Today | Tuesday, June 11, 2013
"The success of ipilimumab clearly showed that if you got the right immune response, you can have a very effective treatment. Best of all that response appears to be long-lived which might prove immunotherapy's most effective trick against cancer. – Charles Link, chairman and CEO, NewLink Genetics Corp. "It's always a kind of balancing act between finding a partner with experience in the field vs. a partner with competing programs and compounds." – Simon Moroney, CEO, Morphosys AG, on its
Arena Pharmaceuticals Inc.'s Belviq (lorcaserin) launched last week, nearly a year after the obesity drug was approved by the FDA. (See BioWorld Today, June 28, 2012.) The launch by Arena's marketing partner, Eisai Inc., was delayed while the company waited for the Drug Enforcement Agency (DEA) to determine scheduling for the drug and a 30-day wait for the designation became effective. Vivus Inc.'s competing obesity drug, Qsymia (phentermine/topiramate extended-release capsules), was approved by
By Brian Orelli | BioWorld Insight | Monday, June 10, 2013
CHICAGO – At the American Society of Clinical Oncology (ASCO) annual meeting last week, there were plenty of individual trial results vying for attention. But there were also presentations that focused on the science of the trials: how one might make those trials better at observing the true effects of drugs on tumors and, ultimately, on patients. In randomized controlled trials RECIST – the Response Evaluation Criteria in Solid Tumors – is the gold standard of these studies. First published in
By Anette Breindl | BioWorld Insight | Monday, June 10, 2013
Company Amount Raised Ophthotech Corp. $175M Intrexon Corp. $150M Symphogen A/S $54.1M Auris Medical AG $50.8M Karyopharm Therapeutics Inc. $48.2M Jounce Therapeutics Inc. $47M Effector Therapeutics Inc. $45M Opsona Therapeutics Ltd. $43.2M Radius Health Inc. $43M GenSight Biologics $41.6M
By Sharon Kingman Staff Writer 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