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
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
By Marie Powers | BioWorld Today | Friday, May 24, 2013
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
Advaxis Inc., of Princeton, N.J., filed a Form DEFR14A, a proxy statement supplement, with the SEC. The filing revises certain proposals in the proxy statement originally filed on April 30, 2013, including the proposal to approve a reverse stock split, to now limit the high end of the range proposed to 1-for-125 (in the earlier proxy, the company proposed a range of 1-for-70 to 1-for-200). Also, it revises the proposal to decrease the total number of authorized shares of common stock, dropping
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
Merck & Co. Inc., of Whitehouse Station, N.J., said it entered an accelerated share repurchase (ASR) agreement with Goldman, Sachs & Co. to repurchase $5 billion of common stock. Proceeds from Merck's recently concluded debt offering were used to execute the ASR, which is part of the big pharma's previously disclosed $15 billion share repurchase program. Under terms of the ASR, Merck agreed to an initial delivery of about 99.5 million shares based on current market prices. The final number of
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
Portola Pharmaceuticals Inc. has become the latest biotech to go public in a rush driven by surging financial markets. The South San Francisco-based company has become the 12th biotech in the 2013 IPO class, and another dozen are filed and pending, signaling a definitive end to the long wait for markets to regain avid interest in new biotech opportunities following the market crash of 2008. Portola priced 8,422,758 shares of common stock at $14.50 per share, with a 30-day option for
By Catherine Shaffer | BioWorld Today | Thursday, May 23, 2013
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
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