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
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
AB Science SA, of Paris, began a Phase III trial of masitinib, a drug it already has studied broadly in cancer indications, in Alzheimer's disease. The company documented significant efficacy for masitinib in Phase II as an add-on to standard care over 24 weeks, with improvement in cognitive function and functional capacity in the treatment group, plus sustained and statistically significant response on the Alzheimer's Disease Assessment Cooperative Study Activities on Daily Living (ADAS-ADL
By Catherine Shaffer | BioWorld Today | Wednesday, May 22, 2013
LONDON – As pharma's quest for pipeline-boosting innovation pushes further into academia, GlaxoSmithKline plc (GSK) has launched Discovery Fast Track to accelerate the translation of target biology into drug candidates. The company is organizing a competition in which academics submit a one-page application outlining a novel drug development concept. Ten winners will get access to GSK facilities to scale up biological reagents and develop assays to underpin high-throughput screening against the
By Nuala Moran | BioWorld Today | Wednesday, May 22, 2013
Addex Therapeutics SA, of Geneva, said its gamma-aminobutyric acid B (GABA-B) receptor positive allosteric modulator, ADX71441, caused dose-dependent changes in growth hormone (GH) plasma concentrations compared to vehicle control in a rodent preclinical model. The data were consistent with published scientific literature demonstrating that GABA, the endogenous neurotransmitter for GABA-B receptors, plays both a stimulatory and inhibitory role in modulating the neuroendocrine regulation of GH
Late Monday, Pfizer Inc. disclosed its decision to halt a Phase III trial (B1931008) of inotuzumab ozogamicin, an investigational antibody-drug conjugate (ADC) composed of a monoclonal antibody targeting CD22, administered in combination with Rituxan (rituximab, Roche AG and Biogen Idec Inc.), in relapsed or refractory CD22-positive aggressive non-Hodgkin's lymphoma (NHL). New York-based Pfizer said it would discontinue development of the drug in NHL after an independent data monitoring
By Marie Powers | BioWorld Today | Wednesday, May 22, 2013
The growth equity arm of Novo A/S has clocked up its first major pharmaceutical investment, a $700 million buyout of generic antibiotics developer and manufacturer Xellia Pharmaceuticals AS, under a new investment strategy it formulated more than a year ago. The deal exemplifies Hellerup, Denmark-based Novo's intentions to build large-scale, long-term positions in mature, low-risk companies. That represents a shift from its original strategy, involving earlier-stage companies approaching
By Cormac Sheridan | BioWorld Today | Wednesday, May 22, 2013
AstraZeneca plc, of London, said results from two pivotal Phase III studies of naloxegol showed that the 25-mg dose met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies. Naloxegol is a peripherally acting mu-opioid receptor antagonist in development for opioid-induced constipation. Data were presented at the Digestive Disease Week conference in Orlando, Fla. Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported that tiotropium
Acadia Pharmaceuticals Inc., of San Diego, completed its public offering of 9.2 million shares, including 1.2 million shares sold to cover overallotments, priced at $12.50 per share, for gross proceeds of $115 million. Funds will be used to support ongoing and new clinical trials and development and commercialization of Parkinson's psychosis drug pimavanserin and for general corporate purposes. Epizyme Inc., of Cambridge, Mass., set terms for its proposed initial public offering (IPO), aiming
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