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Pharma: Clinic Roundup
Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson, said patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the U.S. for the investigational oral Bruton's Tyrosine Kinase inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics Inc., of Sunnyvale, Calif. The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinibBioWorld Today | Tuesday, May 7, 2013 -
All in 'Deuterium': Concert Play Maturing, Draws Celgene Deal
Concert Pharmaceuticals Inc.'s third deal in just over two years with its deuterium-modifying platform brought Celgene Corp. aboard for a single project at first – an up-front payment along with more than $300 million possible in milestone rewards – but with the potential for more compounds that would bring similar financial terms. The focus of the agreement with Summit, N.J.-based Celgene is on cancer and inflammation. Roger Tung, president and CEO of Concert, would not say which area theBy Randy Osborne | BioWorld Today | Tuesday, May 7, 2013 -
Appointments and Advancements
Aegerion Pharmaceuticals Inc., of Cambridge, Mass., added Anne M. VanLent to its board. Afraxis Inc., of San Diego, named Carmine Stengone president and CEO, and Christopher Rex chief scientific officer. BioDelivery Sciences International Inc., of Raleigh, N.C., added Thomas W. D'Alonzo to its board. Cleveland BioLabs Inc., of Buffalo, N.Y., added Julia Brown and Anthony Principi to its board, and appointed David Hohn board chairman. IntelGenx Corp., of Saint Laurent, Quebec, namedBioWorld Today | Tuesday, May 7, 2013 -
N30 Seeks Road to Cystic Fibrosis Therapy, Without VCs
Armed with a novel technology and a new target – a class of disease modifying therapies that preserve intracellular S-nitrosoglutathione (GSNO), a regulator of organ repair, regeneration and healing – N30 Pharmaceuticals Inc. has quietly evolved from a 2007 start-up into a development-stage biotech with 30 employees. Along the way, the Boulder, Colo.-based company attracted $60 million in private capital and is making steady progress in its goal to increase endogenous nitrous oxide (NO) byBy Marie Powers | BioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
AMAG Pharmaceuticals Inc., of Lexington, Mass., said a new subgroup analysis from IDA-301, a Phase III, randomized, placebo-controlled trial, was presented at the first poster session of the American College of Obstetrics and Gynecology annual meeting in New Orleans. In the full IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo, with the demographics and all baselineBioWorld Today | Tuesday, May 7, 2013 -
Arrowhead Bolsters Balance Sheet, Adds $36M for Pipeline
In the wake of promising preclinical data for its hepatitis B virus (HBV) candidate, Arrowhead Research Corp. shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infection. The cash infusion is the largest in Arrowhead's history – the firm pulled in $21 million in a 2006 funding round – and, at the current burn rate, should sustain operations into 2015, long enough to reachBy Jennifer Boggs | BioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
Esperion Therapeutics Inc., of Ann Arbor, Mich., disclosed full results of a Phase II trial of ETC-1002 in patients with Type II diabetes and hypercholesterolemia. The trial met its primary endpoint, demonstrating that ETC-1002 lowered LDL-C by up to 43 percent, and was associated with improvements in control of other cardiometabolic risk factors. ETC-1002 was well tolerated. The data were presented in an oral session at the Arteriosclerosis, Thrombosis, and Vascular Biology 2013 ScientificBioWorld Today | Monday, May 6, 2013 -
Stock Movers
BioWorld Today | Monday, May 6, 2013 -
Other News To Note
Anacor Pharmaceuticals Inc., of Palo Alto, Calif., said Valeant Pharmaceuticals International Inc., of Montreal, agreed that the launch of efinaconazole, its topical product for the treatment of onychomycosis will not occur until after the September 2013 arbitration hearing to resolve the companies' breach of contract dispute. As a result, the preliminary injunction hearing set for May 6 has been cancelled. Anacor previously disclosed a breach of contract dispute with Dow PharmaceuticalBioWorld Today | Monday, May 6, 2013 -
Pharma: Other News To Note
Allergan Inc., of Irvine, Calif., said the FDA's General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted unanimously that the benefits of Juvederm Voluma XC, an injectable hyaluronic acid dermal filler for cheek augmentation to correct age-related volume deficit in the mid-face, outweigh the risks. If approved, Juvederm Voluma XC would be the first dermal filler in the U.S. for that indication. Bristol-Myers Squibb Co., of New York, said the FDA approved aBioWorld Today | Monday, May 6, 2013 -
Radioprotective Entolimod Broadly Protective in Liver
Researchers have discovered that the TLR5 agonist Entolimod (CBLB502, Cleveland BioLabs Inc.), which is in development as a radioprotective agent, work primarily on receptors in the liver, and that it may be useful to fight liver metastases and, more broadly, as a liver-protective agent. Andrei Gudkov, who is chief scientific officer at Cleveland BioLabs as well as senior vice president of basic science at the Roswell Park Cancer Institute and the paper's corresponding author, told BioWorldBy Anette Breindl | BioWorld Today | Monday, May 6, 2013 -
Re-verb: Conjugates Lure BMS to Ambrx Deal Number Three
An existing partner with two other deals jumped aboard Ambrx Inc.'s site-specific, antibody drug conjugate (ADC) bandwagon, as Bristol-Myers Squibb Co. provided $15 million up front plus funding for discovery and research, as well as milestone payments of that could total $97 million per oncology product emerging from the collaboration. "I think it is based on the relationship we've built with BMS, but this is a different franchise area, a different portion of our technology platform," saidBy Randy Osborne | BioWorld Today | Monday, May 6, 2013 -
Bench Press: BioWorld Looks at Translational Medicine
Eggs: Fresh or Stale? Researchers from the Carnegie Institution for Science have weighed in on the question of whether female mammals have germ-line stem cells that are capable of generating new egg cells. Recent reports have questioned the long-held notion that female mammals are born with all the eggs they will ever possess, suggesting instead that they have stem cells capable of generating new eggs. In their work, the researchers used a sensitive labeling system to see whether they couldBioWorld Today | Monday, May 6, 2013 -
Galapagos Lands $71M from Stoked U.S. Investors
LONDON – Galapagos NV has raised €53.9 million (US$70.7 million) in an over-subscribed placing in which it has tapped into the strong appetite U.S. investors currently have for biotechnology. This is Galapagos' fourth private placing since it went public in May 2005. "It definitely was easier than previous rounds: there was a minimal discount and we have attracted premier investment groups, in particular in the U.S.," said Onno von de Stolpe, CEO. "It's been a fantastic success," he toldBy Nuala Moran | BioWorld Today | Monday, May 6, 2013 -
Arena Yanks MAA, Falls on Belviq Launch Delay in U.S.
Shares of Arena Pharmaceuticals Inc. were down nearly 10 percent Friday following Thursday's after-market release of first-quarter earnings, which included news that the San Diego-based biotech is pulling its European marketing application for obesity drug Belviq (lorcaserin), though the bigger disappointment may be the ongoing delay in Belviq's U.S. launch. The stock (NASDAQ:ARNA), which traded at more than 30 times its normal volume, closed Friday at $7.63, down 77 cents. Arena's drug madeBy Jennifer Boggs | BioWorld Today | Monday, May 6, 2013 -
Other News To Note
Acceleron Pharma Inc., of Cambridge, Mass., said Shire plc, of Dublin, Ireland, concluded the firms' collaboration on ACE-031 and related molecules. The development of ACE-031 was suspended in February 2011, and the firms since have conducted preclinical studies to determine whether to resume clinical testing. Shire and Acceleron have now decided not to restart the development of that program. Acceleron said it remains focused on the 11 Phase II studies under way across its threeBioWorld Today | Friday, May 3, 2013 -
Pharma: Other News To Note
ChemRar Ventures, of Moscow, said it signed a scouting agreement, for a period of 18 months, with Sanofi SA to source a venture investment in Russia. ChemRar will be concentrating on early and late-stage compounds within a certain defined area of Sanofi's therapeutic interest and will be negotiating the potential pharma partnering engagement with Sanofi. Within the framework of the agreement, ChemRar said it will partner with a number of academic Institutions, including the Moscow Institute ofBioWorld Today | Friday, May 3, 2013 -
Stock Movers
BioWorld Today | Friday, May 3, 2013 -
Earnings Roundup
Acorda Therapeutics Inc., of Ardsley, N.Y., reported net revenues from sales of multiple sclerosis drug Ampyra (dalfampridine) totaling $62.3 million for the first quarter. Sales were down from the fourth quarter of 2012, said Acorda, citing several factors, including patients switching health care plans, inventory stocking in the fourth quarter and increased discounts and allowances from Medicare patients entering the "donut hole" at the start of the year. Sales rebounded in March, howeverBioWorld Today | Friday, May 3, 2013 -
Abide with Me: Merck Paying up to $430M in Diabetes Deal
Abide Therapeutics Inc.'s potential $430 million deal with Merck & Co. Inc. is focusing on Type II diabetes by way of small molecules that take aim at members of the serine hydrolase enzyme family. San Diego-based Abide's platform involves proteomic technology from the Scripps Research Institute. A probe labels the active sites of serine hydrolases, after which Abide scientists screen the Scripps-made, 1,000-member small-molecule library to find compounds that obstruct the probe's labeling of aBy Randy Osborne | BioWorld Today | Friday, May 3, 2013
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