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
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
Arena Pharmaceuticals Inc., of San Diego, said that Belviq (lorcaserin) will be available in the U.S. by prescription beginning June 11. Eisai Inc., of Woodcliff Lake, N.J., is responsible for marketing and distribution of the drug. Belviq is approved for chronic weight management in adults with a body mass index of 30 or more, in addition to a reduced calorie diet and increased physical activity. Bio-Path Holdings Inc., of Houston, completed the fifth dose cohort in a Phase I trial of BP-100
Chronic fatigue syndrome (CFS) has been at the center of a vortex of controversy since the FDA handed down a complete response letter on the Toll-like receptor 3 modulator Ampligen (rintatolimod) from Hemispherx Bioscience Inc. – the only drug in development for CFS – despite the impassioned pleas of patients at an Arthritis Advisory Committee meeting in December 2012. (See BioWorld Today, Dec. 21, 2012, and Feb. 6, 2013.) Although pressure from those patients and from the Chronic Fatigue and
By Marie Powers | BioWorld Today | Monday, June 10, 2013
Pfizer Inc., of New York, began a Phase I trial of PF-06410293 (adalimumab), its biosimilar version of Humira. The trial will enroll about 210 subjects. Its primary objective will be measuring pharmacokinetic values, with secondary objectives including incidence of anti-adalimumab antibodies and neutralizing antibodies, time to maximum serum concentration, systemic clearance and serum decay half-life.
SHANGHAI – BeiGene Co. Ltd. has licensed a second-generation BRAF inhibitor as a promising preclinical candidate oncology drug to Merck KGaA, of Darmstadt, Germany, for the treatment of melanoma, colorectal cancer and other cancers. It marks what may be only the second instance of a Chinese company licensing a novel molecule to a multinational pharma firm. The first was the deal with AstraZeneca plc for Shanghai-based Hutchison MediPharma Ltd.'s c-Met inhibitor anticancer candidate volitinib
By Larry Schuster | BioWorld Today | Monday, June 10, 2013
Researchers have gained new insights into the structure of an unusual type of antibody that is made mainly by cows. They hope those insights will ultimately allow them to make antibodies for indications where traditional antibodies have not been successful. In their work, which was published in the June 6, 2013, issue of Cell, the researchers focused on one particular region of the antibody – the complementarity-determining region 3 (CDR3). Complementarity-determining regions are the business
By Anette Breindl | BioWorld Today | Monday, June 10, 2013
SHANGHAI – While the presidents from the U.S. and China have met in a summit to address human rights and cyber-attack issues, it's become clear that U.S. biopharmaceutical firms have not been immune to targeted hacking out of China. These efforts may have yielded valuable data from clinical trials or drug registration applications. Since the earliest identified cases in 2008, there has been a visible uptick in the number of hacking incidents involving biotech firms, according to Mandiant, a
By Shannon Ellis | BioWorld Today | Monday, June 10, 2013
With data from the first clinical trial of anti-TNF polyclonal antibody AVX-470 in ulcerative colitis (UC) due toward the end of this year, Avaxia Biologics Inc. shored up its balance sheet with an additional $5 million, bringing its total Series B funding to $11.4 million. As with past funding rounds, the Lexington, Mass.-based biotech reached out to angel groups. Existing investors Cherrystone Angels and Golden Seeds led the round, with participating investments from new Ariel Southeast Angel
By Jennifer Boggs | BioWorld Today | Monday, June 10, 2013
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