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
By Marie Powers Staff Writer Although the official start of summer is still a few days away, the biotech world already is producing a bumper crop of initial public offerings (IPO). As a trio of companies – Bluebird Bio Inc., PTC Therapeutics Inc. and Regado Biosciences Inc. – prepared to price IPOs this week, a fourth, Onconova Therapeutics Inc., filed a registration statement with the SEC, seeking to raise up to $75 million. (See BioWorld Today, May 1, 2013, May 17, 2013, and May 20, 2013
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
Acetylon Pharmaceuticals Inc., of Boston, presented data on lead candidate ACY-1215 for the treatment of relapsed or refractory multiple myeloma at the 18th Congress of the European Hematology Association. ACY-1215 is an oral, selective HDAC6 inhibitor currently being evaluated in a Phase Ib trial in combination with Revlimid (lenalidomide, Celgene) and a Phase I/II trial in combination with the first-in-class drug Velcade (bortezomib, Millennium: The Takeda Oncology Co.) for the treatment of
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
Tacking toward the middle, the Supreme Court gave the FTC some berth Monday in challenging pay-for-delay settlements between generic and brand drugmakers, but it closed the hatch on a "quick look" approach that would presume all such agreements are unlawful. While the ruling doesn't toss the settlements overboard, it clears the way for more antitrust challenges, both by the FTC and third parties. It also could churn up some rough seas for existing settlements that may now face potential class
By Mari Serebrov | 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
Although the official start of summer is still a few days away, the biotech world already is producing a bumper crop of initial public offerings (IPO). As a trio of companies – Bluebird Bio Inc., PTC Therapeutics Inc. and Regado Biosciences Inc. – prepared to price IPOs this week, a fourth, Onconova Therapeutics Inc., filed a registration statement with the SEC, seeking to raise up to $75 million. (See BioWorld Today, May 1, 2013, May 17, 2013, and May 20, 2013.) Onconova filed its S-1 Friday
By Marie Powers | BioWorld Today | Tuesday, June 18, 2013
Bristol-Myers Squibb Co. (BMS), of New York, and Simcere Pharmaceutical Group, of Nanjing, China, expanded their strategic relationship formed in 2010. The companies have agreed to collaborate in China on the development and commercialization of the subcutaneous formulation of BMS' Orencia (abatacept), for the treatment of rheumatoid arthritis. Orencia is already on the market for the indication in the U.S., Europe and Japan. Ipsen SA, of Paris, said that, as part of an accelerated execution
Astex Pharmaceuticals Inc., of Dublin, Calif., updated Phase I trial results for SGI-110 in a poster session at the 18th Congress of the European Hematology Association, June 13-16 in Stockholm, Sweden. Of 15 heavily treated intermediate or high-risk patients with myelodysplastic syndrome, six achieved a clinical response with a median duration of 92 days. The company said the updated results showed promise for clinical activity of the drugs in heavily pretreated MDS patients and confirmed
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
SHANGHAI, China – A licensing agreement may help troubled Israeli Biolinerx Ltd. get a toehold in China with its hepatitis C virus (HCV) treatment BL-8030. In a deal worth as much as $30 million in initial and milestone payments, Biolinerx, of Jerusalem, entered an agreement for the development, manufacture and commercialization of BL-8030 with liver therapy specialist Jiangsu Chia-tai Tianqing Pharmaceutical Co. Ltd. (CTTQ), of Jiangsu, China. CTTQ is a subsidiary of Hong Kong-based Sino
By Shannon Ellis | BioWorld Today | Monday, June 17, 2013
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
Conatus Pharmaceuticals Inc., which has quietly labored on liver drug emricasan (IDN-6556) since gaining global rights to the asset in its 2010 acquisition of Pfizer Inc. spin-out Idun Pharmaceuticals Inc., became the latest biotech to register with the SEC for an initial public offering (IPO). Filing its S-1 as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, the San Diego-based firm is seeking to raise up to $69 million to continue the clinical development of
By Marie Powers | BioWorld Today | Monday, June 17, 2013
When Trevor Baglin, a hematologist at Addenbrooke's Hospital at Cambridge University had a head injury patient with a much better-than-expected outcome, he did something unusual. He got very curious. Physicians had found in the patient a degree of anticoagulation consistent with severe hemophilia, and yet the bleeding stopped normally. Rather than writing it off as good luck, Baglin teamed up with Jim Huntington, of the Cambridge Institute for Medical Research, to design a synthetic version of
By Catherine Shaffer | BioWorld Today | Monday, June 17, 2013
Astex Pharmaceuticals Inc., of Dublin, Calif., presented updated clinical results of its hypomethylating agent, SGI-110, in a poster session at the 18th Congress of the European Hematology Association in Stockholm, Sweden. The update focused on details of the biological and clinical activity as well as safety in the group of intermediate or high-risk relapsed or refractory myelodysplastic syndromes patients treated in the dose-escalation, Phase I part of the SGI-110-01 study. The study enrolled
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