GlaxoSmithKline plc, of London, and the Biomedical Advanced Research and Development Authority (BARDA) agreed to a collaboration that will support the development of several antibiotics to fight antibiotic resistance and bioterrorism. The public-private agreement calls for the Department of Health and Human Services to provide $40 million for the initial 18-month agreement and up to $200 million if the agreement is renewed over five years. The agreement will be governed by a BARDA-GSK joint

Adherex Technologies Inc., of Research Triangle Park, N.C, said it received feedback from the FDA at an end-of-Phase II meeting, during which the company proposed a small pivotal single-arm study to testing eniluracil/5-FU/leucovorin in metastatic breast cancer patients, based on data from patients who had rapid disease progression on Xeloda (capecitabine, Roche AG). The agency, however, strongly recommended that Adherex consider other larger clinical trial design alternatives. Adherex said, in

SHANGHAI, China – Chipscreen Biosciences Ltd., of Shenzhen, China, reported encouraging Phase II trial results for its Chidamide (formerly HBI-8000) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who had failed at least one prior systemic therapy. Unlike currently available treatments which are delivered intravenously, Chidamide is an oral agent and is particularly effective against the most aggressive subtype of PTCL that's far more common in Chinese patients than

BioWorld's offices were closed Monday, May 27, in observance of the Memorial Day holiday in the U.S. No issues were published that day.

Flu pandemics are a sure thing. But what is not a sure thing at all is which viral strain will be the one to cause the next pandemic. The most recent potential candidate is the H7N9 strain that first reared its head earlier this year. To date, there have been around 130 confirmed infections and 30 deaths from the new strain. Like H5N1, the even more lethal strain of influenza that is still sporadically rearing its head, the number of cases has been small. But the worry is what will happen if

Novo Nordisk A/S, of Bagsvaerd, Denmark, reported top-line results from a 56-week Phase IIIa trial testing the potential of GLP-1 drug liraglutide to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as prediabetes, hypertension and dyslipidemia. From a mean baseline weight of 106 kg and a body mass index (BMI) of 38 kg/m2, the average weight loss for those treated with liraglutide 3 mg was 8 percent vs. 2.6 percent for the placebo

The decision by Merck & Co. Inc. to end its Phase III program with preladenant based on three studies that failed to show efficacy in Parkinson's disease put the spotlight on adenosine A2A receptor antagonists as a class, which has been explored by a handful of other companies, some of them with work still under way. Merck, of Whitehouse Station, N.J., said last week that the company is "taking steps to discontinue" the extension phases of the studies and will abandon bids for regulatory

Seaside Therapeutics Inc. reluctantly terminated an open-label extension study of STX209 (arbaclofen), for Fragile X syndrome, due to resource limitations. The company said the decision was not related to any safety issues with the drug, and expressed regret that the termination of the trial would be "disruptive and disappointing for many families." STX209 did not meet its primary endpoint of reducing social withdrawal in the recently completed Phase III trial, but the Cambridge, Mass.-based

Elan Corp. plc, of Dublin, Ireland, priced its offering of $850 million aggregate principal amount of 6.25 percent senior notes due 2021 by its wholly owned subsidiaries, Elan Finance public limited co. and Elan Finance Corp. Net proceeds of the offering, set to close May 31, will be deposited into escrow pending the closing of Elan's previously announced royalty participation transaction with South San Francisco-based Theravance Inc. Earlier this month, Elan offered $1 billion in cash to buy a

3SBio Inc., of Shenyang, China, said its shareholders voted in favor of the proposal to merge with Decade Sunshine Ltd. The merger would result in 3SBio becoming a privately held subsidiary of Decade Sunshine, with its American depository shares no longer listed on Nasdaq. The company's board previously recommended that shareholders vote to authorize the merger, and the parties expect to complete the deal as soon as practicable. AVEO Pharmaceuticals Inc., of Cambridge, Mass., said in an SEC

Another Bite at Leptin Scientists at the South Korean University of Ulsan Medical Center discovered a protein in the brain that is important for regulating feeding and appetite. The protein works through its effects on the receptor for leptin, a critical weight-regulating hormone that is secreted by fat cells and signals to the hypothalamus, the area of the brain most critical for feeding and appetite. Clusterin works in concert with the protein LRP2, a leptin co-receptor. Obese individuals

In 2012, researchers reported that in mice, treatment with Eisai Inc.'s lymphoma drug Targretin (bexarotene) could reverse the symptoms of Alzheimer's disease. In a study published in Science, the authors reported that treating mice with the drug improved memories as well as social behaviors, and decreased levels of soluble A-beta. (See BioWorld Today, Feb. 13, 2012.) The most spectacular finding of the paper, however, was the report that plaques – the anatomical calling card of Alzheimer's

When it comes to the compounding of drugs, the one thing everyone agrees on is that something needs to be done to ensure the safety of the products. But how to do that is another matter. The Senate Health, Education, Labor and Pensions Committee sent a bill, S. 959, to the Senate floor Wednesday that would create a new class of drugmaker, compounding manufacturers, that would be subject to FDA oversight without having to go through the drug approval process. The new class would cover large

The once-weekly, oral proteasome inhibitor that Takeda Pharmaceutical Co. Ltd., with its Millennium oncology unit, hopes will eventually replace Velcade (bortezomib), which loses patent protection later this decade, entered a Phase III trial in newly diagnosed multiple myeloma (MM). Called TOURMALINE-MM2, the study will enroll about 700 patients and compare MLN9708 plus Revlimid (lenalidomide, Celgene Corp.) and dexamethasone to placebo plus lenalidomide and dexamethasone in patients with MM

Alkermes plc, of Dublin, Ireland, reported financial results for its fourth quarter and fiscal year ending March 31. Total revenues for the fourth quarter were $163.4 million, compared to $130.5 million for the same period in the prior fiscal year. Revenues from the company's five key commercial products grew 26 percent in the quarter, to $89.5 million, compared to $71.2 million for the same period in 2012. For the fiscal year, revenues increased by 48 percent, to $575.5 million, reflecting the

Astellas Pharma Europe BV, of Meppel, The Netherlands, a subsidiary of Astellas Pharma Inc., reported the Dutch Medicines Evaluation Board granted marketing authorization for Vesomni (solifenacin + tamsulosin) in the Netherlands. The once-daily treatment is for moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia in men who are not adequately responding to treatment with monotherapy. Merck & Co. Inc

Jennerex Biotherapeutics Inc. completed an insider-based $21.6 million private placement, capping a fruitful week that included the full enrollment of a Phase IIb study of oncolytic cancer vaccine Pexa-Vec (JX-594, pexastimogene devacirepvec) in hepatocellular carcinoma (HCC), publication of clinical and preclinical data in Science Translational Medicine and release of three abstracts scheduled for presentation at the American Society of Clinical Oncology (ASCO) meeting next week in Chicago

La Jolla Pharmaceutical Co., of San Diego, released data detailing the ability of lead product candidate GCS-100 to improve renal function. The retrospective analysis details the positive effect that GCS-100 treatment had on the estimated glomerular filtration rate in patients with poorly functioning kidneys. GCS-100 is being developed as a treatment for chronic kidney disease, with a Phase IIa trial expected to begin soon. Lpath Inc., of San Diego, began dosing in a Phase IIa trial of Asonep