Embryonic stem cells have been the subject of so many political fights that it's easy to forget they have also faced formidable scientific obstacles. But they have. Human eggs, it turns out, are far more fragile than those of most other mammals – including those of other primates. And so, methods that have been used to clone mammals from Dolly the sheep to Snuppy, the cloned dog that was South Korean stem cell scientist Woo-Suk Hwang's only non-fraudulent claim to fame, have failed to produce
By Anette Breindl and Nuala Moran | BioWorld Today | Thursday, May 16, 2013
Bayer HealthCare Pharmaceuticals Inc., of Berkeley, Calif., and Onyx Pharmaceuticals Inc., of South San Francisco, said the FDA approved Bayer's Stivarga (regorafenib) for metastatic gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate. Stivarga was previously approved for metastatic colorectal cancer. Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., enrolled their first patients in Phase III COMPARE and ASCERTAIN trials of
Jennerex Biotherapeutics Inc., of San Francisco, said data demonstrating the ability of its lead product candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec) to induce functional anticancer immunity, both in patients with diverse solid tumor types and in animal models has been published in the May 15 issue of Science Translational Medicine. The paper described findings from a Phase I study evaluating the safety and efficacy of Pexa-Vec after an intratumoral administration in patients with
The American Society of Clinical Oncology (ASCO) released the first of more than 4,700 abstracts late Wednesday in anticipation of its 2013 annual meeting, scheduled to attract more than 30,000 participants to Chicago from May 31 to June 4. Early abstracts highlighted by ASCO at a Wednesday afternoon press conference suggested a significant focus this year will be advances in cancer immunotherapies, including inhibitors of PD-L1 and PD-1. Roy S. Herbst, professor of medicine at Yale University
By Marie Powers | BioWorld Today | Thursday, May 16, 2013
Algeta ASA and partner Bayer AG disclosed FDA approval Wednesday for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, with the agency's nod coming three months ahead of the Aug. 14 PDUFA date. Xofigo, an alpha particle-emitting radioactive therapeutic agent, was approved based on data showing that the drug produced an overall survival benefit with antitumor effects on bone metastases. "We're actually delighted," Algeta CEO Andrew Kay told BioWorld Today. "This is a
By Catherine Shaffer | BioWorld Today | Thursday, May 16, 2013
Development of Tokai Pharmaceuticals Inc.'s triple-acting prostate cancer drug galeterone got a $35.5 million boost, with the Cambridge, Mass.-based biotech closing a Series E round with current investors Apple Tree Partners and Novartis Venture Funds, as well as undisclosed angel investors. Proceeds will go toward expanding the ongoing Phase II ARMOR2 study into patients with castration-resistant prostate cancer (CRPC) and preparing for registrational trials. The company could not be reached
By Jennifer Boggs | BioWorld Today | Thursday, May 16, 2013
Gradalis Inc.'s interim Phase II data with its personalized cancer vaccine for advanced ovarian cancer showed the approach more than doubled the benefit in patients given therapy known as FANG, a rough acronym for "furin and granulocyte-macrophage colony-stimulating factor (GMCSF)." The trial, which has enrolled 17, treated 12 with FANG plus standard treatment and five with only the standard treatment, which consists of surgery and chemotherapy, with an eye on the primary endpoint of time to
By Randy Osborne | BioWorld Today | Thursday, May 16, 2013
By Mari Serebrov Washington Editor When is a drug compounder a manufacturer vs. a pharmacy? That's the question the Senate Health, Education, Labor and Pensions Committee grappled with Thursday as it closed in on a bill it can send to the Senate floor that would better regulate compounding pharmacies without opening a loophole around the drug approval process. The committee's draft bill proposes a new category of drugmakers, "compounding manufacturers," which would be subject to FDA regulation
Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety
LONDON – Shares in Erytech Pharma SA began trading in Paris last week following an initial public offering (IPO) that exceeded the €15 million (US$19.5 million) target, raising €16.7 million. The Lyon, France-based company added a further €11 million, mostly through the conversion of bonds, providing sufficient funding to take the lead program Graspa through to approval in Europe and to start a U.S. Phase Ib trial of the product in the treatment of acute lymphoblastic leukemia (ALL). "I'm very
By Nuala Moran | BioWorld International | Wednesday, May 15, 2013
LONDON – Creabilis SA reported positive Phase IIb results for its topical TrkA kinase inhibitor CT327 in the relief of chronic pruritus (itch) caused by psoriasis, paving the way for a Phase III study designed to gain approval for treating itch in any dermatological disease. "We are delighted by the outcome," said Eliot Forster, CEO. "In addition to some benefits in terms of the underlying disease, CT327 showed a highly significant impact on itch, which in psoriasis and other dermatological
By Nuala Moran | BioWorld International | Wednesday, May 15, 2013
LONDON – There may be a completely new way to block the estrogen receptor on breast cancer cells, which normally thrive on estrogen. Researchers working in the Netherlands have shown that blocking the receptor at that point reduces the growth rate of breast tumor cells. What is more, they have already found a small molecule that blocks the receptor, and they have crystallized the binding pocket, which should make it possible to design or find other small molecules that can be used as drugs to
By Sharon Kingman | BioWorld International | Wednesday, May 15, 2013
Cardio3 BioSciences (C3BS) closed a €19 million (US$25 million) investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure, C-Cure. Just €7 million of the total represents new money, however. The remainder comprises an equity conversion of existing loans. The new cash comes from the company's existing investors. C3BS, of Mont-Saint-Guibert, Belgium, is developing a therapy that originated at the Mayo Clinic in Rochester, Minn. C-Cure
By Cormac Sheridan | BioWorld International | Wednesday, May 15, 2013
Cosmo Pharmaceuticals SpA landed a hefty chunk of upside, that all-too-elusive commodity, by grossing $89.2 million from a sale of Santarus Inc. stock. The transaction will enable the already-profitable company to begin paying dividends to its shareholders. The Lainate, Italy-based drug delivery specialist disposed of 4.25 million shares, priced at $18.25 per share, Friday. On Monday, Jefferies LLC, which underwrote the offering, exercised its option to purchase an additional 637,500 Santarus
By Cormac Sheridan | BioWorld International | Wednesday, May 15, 2013
DUBLIN, Ireland – Elan Corp. plc is putting down a $1 billion bet that the respiratory franchise shared by Theravance Inc. and GlaxoSmithKline plc will pay generous dividends over the next decade. Elan is acquiring a 21 percent stake in Theravance's future royalty streams from four drugs that are partnered with London-based GSK. One of them, Breo (fluticasone furoate [FF] and vilanterol inhalation powder), which is administered using the Ellipta inhaler, has just gained FDA approval as a daily
By Cormac Sheridan | BioWorld International | Wednesday, May 15, 2013
Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. is gaining access to several key vaccine candidates targeted against major infectious diseases in the developing world such as dengue and hand, foot and mouth disease (HFMD), through its acquisition of Inviragen Inc., of Fort Collins, Colo. Takeda will pay $35 million up front and up to $215 million contingent on various clinical and commercial milestones. The transaction will be conducted through Takeda's wholly owned subsidiary Takeda America
By Peter Winter | BioWorld International | Wednesday, May 15, 2013
Arbor Pharmaceuticals Inc., of Atlanta, said the FDA approved its new drug application for Nymalize (nimodipine) oral solution. The drug has orphan status for use in improving neurological outcome in adults with subarachnoid hemorrhage. Prior to the approval of Nymalize, nimodipine was available only in gel capsule form. Arbor said it will launch the drug in the next few months. Cempra Inc., of Chapel Hill, N.C., signed an exclusive license and development agreement for oral solithromycin
Pearl Therapeutics Inc. launched its much-anticipated Phase III (PINNACLE) trial of PT003, a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered by pressurized hydrofluoroalkane, in chronic obstructive pulmonary disease (COPD). The Redwood City, Calif.-based company raised $65 million in a Series D financing in November to support the trial. (See BioWorld Today, Nov. 14, 2012.) The product is a combination of a long-acting muscarinic antagonist (LAMA), glycopyrrolate
By Catherine Shaffer | BioWorld Today | Wednesday, May 15, 2013
Embryonic stem cells have been the subject of so many political fights that it's easy to forget they have also faced formidable scientific obstacles. But they have. Human eggs, it turns out, are far more fragile than those of most other mammals – including those of other primates. And so, methods that have been used to clone mammals from Dolly the sheep to Snuppy, the cloned dog that was South Korean stem cell scientist Woo-Suk Hwang's only non-fraudulent claim to fame, have failed to produce