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
By Anette Breindl | BioWorld Today | Friday, May 24, 2013
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
By Mari Serebrov | BioWorld Today | Friday, May 24, 2013
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
By Randy Osborne | BioWorld Today | Friday, May 24, 2013
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
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
BTG plc grossed £106.3 million (US$160.2 million) in an accelerated book build in order to fund the acquisition of two businesses: the targeted therapies division of Nordion Inc. and Ekos Corp. London-based BTG is paying Ottawa, Ontario-based Nordion approximately $200 million for its targeted therapies business and is acquiring Bothell, Wash.-based Ekos for $180 million up front, plus another potential $40 million in milestones linked to future revenue performance. BTG placed about 32.2
By Cormac Sheridan | BioWorld Today | Friday, May 24, 2013
AMAG Pharmaceuticals Inc., of Lexington, Mass., said Takeda Pharma AG, a unit of Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, is recalling one batch of Rienso (ferumoxytol) from the Swiss market. The decision was based on a cluster of four postmarketing adverse event (AE) reports in Switzerland concerning hypersensitivity reactions of varying severity following the administration of Rienso from this batch. One of the cases included a report of a fatality. The batch was only distributed to
Over the past few years, a shift has occurred in how researchers think of neurodevelopmental disorders. Such disorders were once considered immutable once the faulty wiring that was presumed to be at their heart was put in place during development. But recent studies have shown that many such disorders can in fact be reversed, sometimes even at very late stages. (See BioWorld Today, April 12, 2012, and March 4, 2013.) Now, researchers have added schizophrenia to the group of disorders that may
By Anette Breindl | BioWorld Today | Thursday, May 23, 2013
Oncolytics Biotech Inc. followed up March's promising data from a Phase II trial testing Reolysin in squamous cell lung cancer with results from a Phase II study in metastatic melanoma, where the reovirus variant for Ras-mutant cancers, combined with carboplatin and paclitaxel, met its primary endpoint in the first stage. Three of 14 melanoma patients achieved a partial response (PR) and seven more showed stable disease, for a disease control rate of 71.5 percent. In the lung cancer trial's
By Randy Osborne | BioWorld Today | Thursday, May 23, 2013
Salix Pharmaceuticals Ltd. said its two pivotal studies of budesonide foam in active to moderate ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS) hit the primary endpoints, with a statistically significant number of patients in the treatment arm achieving clinical remission vs. placebo. Detailed data were not released but the Raleigh, N.C.-based specialty pharma firm anticipates filing a new drug application by the end of September, seeking approval of the topical
By Jennifer Boggs | BioWorld Today | Thursday, May 23, 2013
Despite an increase in transparency and collaboration in China, the safety of drugs and other products imported from the country remains a concern in the U.S. Currently, the FDA has 74 active import alerts, many of which involve Chinese companies, and nine countrywide alerts pertaining to China. While several of the countrywide alerts involve food imports, the greatest risks are posed by Chinese-produced drugs and medical devices because of manufacturing quality issues, the Congressional
By Mari Serebrov | BioWorld Today | Thursday, May 23, 2013
Grifols SA, of Barcelona, Spain, presented results from a study demonstrating that a higher dose of Prolastin-C (alpha1-proteinase inhibitor [human]) increased levels of the alpha1 protein in patients with alpha1antitrypsin (AAT) deficiency to levels that are considered within the normal range for healthy individuals. AAT deficiency is a life-threatening, genetic condition in which low levels of the alpha1 proteinase inhibitor (A1PI) protein can lead to emphysema. Results of the PROLASTIN-C
Acelrx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data that showed its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met the primary and secondary efficacy endpoints in a placebo-controlled, Phase III study. In the 48 hours following major orthopedic surgery, patients treated with sufentanil NanoTabs realized a significantly greater score in the Summed Pain Intensity Difference (SPID) than placebo-treated patients. Secondary endpoint data showed
By Cormac Sheridan Staff Writer DUBLIN, Ireland – Elan Corp. plc continues to execute its M&A strategy at a dizzying pace, while its would-be acquirer, Royalty Pharma, has tabled a revised offer for the company, worth $12.50 per share or $6.37 billion. On Monday, Elan unveiled an acquisition agreement with AOP Pharmaceuticals AG worth €263.5 million (US$339.3 million) in cash (€175.7 million) and shares (€87.8 million) initially – plus another potential €270 million in milestones – and a deal to
The Cell Therapy Catapult, which focuses on the development of the UK cell therapy industry, said it will work with London-based GlaxoSmithKline plc to explore potential collaborations in a range of areas relevant to the development of cell therapies, from research projects to technical and regulatory strategy. GSK is developing a bone marrow-derived stem cell gene therapy through late phase development and has a small number of collaborations in that field.
Last month's FDA workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) – the first of its kind, one of 20 mandated by the Prescription Drug User Fee Act – hardly transformed the treatment landscape in the aftermath of the agency's refusal to approve the Toll-like receptor 3 modulator Ampligen (rintatolimod), the CFS therapy from Hemispherx Bioscience Inc. But patients and their advocacy groups were given hope, and the FDA is taking comments from the public until August
By Randy Osborne | BioWorld Today | Wednesday, May 22, 2013
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