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

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

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

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

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

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

Bombs, Brains and Stem Cells Researchers from the Swedish Karolinska Institutet have used the consequences of nuclear testing in the 1960s to estimate the rate at which new neurons are born in adult human brains. Such nuclear testing raised the level of carbon-14 (as opposed to the regular carbon-12) in the atmosphere, and since it was banned in 1963 those carbon levels have been declining at a known rate. The authors used that knowledge to essentially carbon-date human neurons, and they were

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

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

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