By Anette Breindl Science Editor Predicting protein folding has made strides in recent years, mainly through unconventional approaches. Computer games like foldit have been able to apply crowdsourcing to proteins, and solve structures that had evaded traditional computing power. (See BioWorld Today, Aug. 13, 2010.) But George Rose, who is at Johns Hopkins University, said he thinks that the problem can, and perhaps should, be solved in a more fundamental way. Current methods for predicting a
News of at least a three quarter delay in seeking regulatory approval for Fabry disease candidate migalastat unsurprisingly sent shares of Amicus Therapeutics Inc. falling 24 percent in Monday morning trading, but reports of the firm's recent meeting with the FDA left room for optimism for the Glaxosmithkline plc-partnered molecular chaperone. The agency was "extremely engaging," Amicus CEO John Crowley told BioWorld Today. "All in, I think it was a very encouraging meeting with the FDA
By Jennifer Boggs | BioWorld Today | Tuesday, June 18, 2013
DUBLIN, Ireland – In a sharp slap in the face to the company's management and its would-be acquirer Royalty Pharma, shareholders in Elan Corp. plc voted down three of four motions tabled at an extraordinary general meeting Monday. The move scuppers Royalty's bid, which was contingent on the rejection of all four proposals. But it also represents an overwhelming vote of no confidence in the M&A strategy that Elan CEO Kelly Martin put together with his management team since it sold its interest in
By Cormac Sheridan | BioWorld Today | Tuesday, June 18, 2013
Abbvie Inc., of Chicago, reported preliminary results from a Phase I study of ABT-199/GDC-0199, an investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), and in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL). The open-label, multicenter, international trial was designed to assess the safety, determine the maximum tolerated dose and recommended Phase II dose, and evaluate the
Eisai Inc., of Woodcliff Lake, N.J., expanded its Hatfield, UK-based EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Centre with a additional global packaging capability. The new facility will primarily handle the blister packaging of Eisai's investigational treatment lenvatinib which is used to treat thyroid cancer as well as other types of solid tumors. The Hatfield site is the company's EMEA headquarters and is growing in significance to Eisai's worldwide business as it
On Thursday, Cempra Inc. disclosed a successful end-of-Phase II meeting with the FDA, citing only the need for additional funding to proceed with the planned Phase III trial testing intravenous (I.V.)-to-oral administration of macrolide antibiotic solithromycin in community-acquired bacterial pneumonia (CABP). So it was little surprise when the Chapel Hill, N.C.-based biotech priced a public offering Friday, selling 7.25 million shares at $7 apiece for gross proceeds of about $50.8 million
By Jennifer Boggs | BioWorld Today | Monday, June 17, 2013
Don't Spare the Rod Scientists at the University of California at Santa Barbara and Sanford-Burnham Medical Research Institute have demonstrated that changing the shape of nanoparticles can affect their targeting to certain cell types. Rod-shaped nanoparticles or nanorods bearing antibodies targeted the endothelial cells that line blood vessels more specifically than spherical nanorods with the same antibodies, probably because an elongated rod shape allows more antibodies to interact with the
Valneva SE priced its previously flagged and fully underwritten €40 million (US$53.3 million) rights issue at €2.65 per share, a steep discount on the company's prevailing share price of €4.61 immediately prior to the final pricing decision. The move will give the Lyon, France-based company enough fuel to achieve its main strategic objective, to become financially self-sustaining by 2015. The strategy also depends on the company rolling over an existing €20 million debt facility to an
By Cormac Sheridan | BioWorld Today | Monday, June 17, 2013
Company Drug Indication Algeta ASA Xofigo Castration-resistant prostate cancer Genentech Inc. Tarceva Metastatic non-small-cell lung cancer Genentech Inc. Actemra Polyarticular juvenile idiopathic arthritis Raptor Pharmaceutical Corp. Procysbi Nephropathic cystinosis
The Supreme Court ruled last week that naturally occurring, isolated DNA is not patent eligible. However, the court's unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of complementary DNA (cDNA), which is synthetically created. The FDA etched a distinct line between orphan drug designation and exclusivity in a final rule making it clear that getting the designation doesn't guarantee seven years of market exclusivity. The FDA
Johnson & Johnson has jumped into the early stage development pool with both feet. With the opening of its California Innovation Center based in Menlo Park earlier this month, the New Brunswick, N.J.-based company has established regional innovation centers, incubators, and entrepreneurs in residence to get J&J closer to early stage products that might be licensed or acquired by the health-care giant. Previously, J&J was interacting with the outside world through different channels, but now
By Brian Orelli | BioWorld Insight | Monday, June 17, 2013
Two initiatives from different ends of the drug development spectrum are shining a bright light on nagging weaknesses in translational medicine and the urgent need to improve speed and efficiency in moving early stage discoveries into therapeutic candidates. Glaxosmithkline plc's (GSK) Discovery Fast Track competition is designed to serve as a funnel, enabling the London-based pharma to quickly sift a large number of academic discoveries and identify 10 candidates for its Discovery Partnerships
By Marie Powers | BioWorld Insight | Monday, June 17, 2013
It has been 10 years since the international human genome project (HGP) was officially declared completed two years ahead of schedule. This monumental undertaking has helped fuel the biopharmaceutical sector to its current lofty heights and one of the reasons that bioscience discoveries in overdrive can be traced back to the completion of the sequencing of the human genome. (See BioWorld Today, April 16, 2003.) This truly remarkable achievement has been the underpinning of a new wave of genomics
By Peter Winter | BioWorld Insight | Monday, June 17, 2013
In a decision that could erode the underpinnings of numerous diagnostic and biologic patent claims, the Supreme Court ruled Thursday that naturally occurring, isolated DNA is not patent eligible. However, the court's unanimous decision in The Association for Molecular Pathology v. Myriad Genetics Inc. upheld the patent eligibility of complementary DNA (cDNA), which is synthetically created. In striking down Myriad's isolated DNA claims to the BRCA1 and BRCA2 genes, the court said the Salt Lake
By Mari Serebrov | BioWorld Today | Friday, June 14, 2013
By Anette Breindl Science Editor Predicting protein folding has made strides in recent years, mainly through unconventional approaches. Computer games like foldit have been able to apply crowdsourcing to proteins, and solve structures that had evaded traditional computing power. (See BioWorld Today, Aug. 13, 2010.) But George Rose, who is at Johns Hopkins University, said he thinks that the problem can, and perhaps should, be solved in a more fundamental way. Current methods for predicting a