By Brian Orelli BioWorld Insight Contributing Writer It's become routine for current venture capital (VC) investors to buy additional shares when a biotech goes public. Initial public offerings (IPO) are no longer an exit strategy, but a further round of funding to get the insiders to the end game. The extra cash from insiders reduces the amount that needs to be raised, helps support the price and, with recent IPO pricing difficulty, has been a way for insiders to reduce their cost base. Before

By Mari Serebrov Washington Editor Legislation to broaden the accelerated approval path is being gussied up for its Senate debut within the next few months. The Transforming the Regulatory Environment to Accelerate Access to Treatments Act, or the TREAT Act, would expand accelerated approval to more drugs for unmet needs in serious or life-threatening diseases or conditions. The Biotechnology Industry Organization (BIO), which is working with Sen. Kay Hagan (D-N.C.) on the bill, had originally

By Cormac Sheridan BioWorld International Correspondent Santhera Pharmaceuticals AG is looking for a new partner for its Parkinson's disease drug fipamezole after Ipsen SA returned its rights to the drug, which covered territories outside of North America and Japan. Paris-based Ipsen would receive milestone and royalty payments should Liestal, Switzerland-based Santhera enter another deal on the drug. It is also retaining a call option that would allow it to gain worldwide rights should Santhera

By BioWorld Staff SAN FRANCISCO – The J.P. Morgan Healthcare Conference is always fun, frenetic and a little overwhelming. This year was no different – unless you count the ire of innocent tourists and locals who were turned away from conference headquarters at the Westin St. Francis Hotel. Here, enjoy a few parting shots from members of the BioWorld Today staff who covered the biotech industry's annual lollapalooza. Badges? We Don't Need No Stinkin' Badges Actually, attendees of the 30th

By Mari Serebrov Washington Editor WASHINGTON – In yet another signal that it's seriously considering drugmakers' use of social media, the FDA plans to survey health care professionals on the impact direct-to-consumer (DTC) drug promotion, whether online or in traditional media, has on their practice. "With the proliferation of social media platforms, the emergence of online pharmaceutical marketing and evolution of office detailing practices . . . FDA will benefit by knowing more about health

By Anette Breindl Science Editor Cancer treatment is a field that has seen impressive advances in many areas, but no home run in terms of a cure. Many cancer researchers have pinned their hopes on cancer stem cells to change all that. Current treatments, the theory goes, do not target the self-renewing cells that initiate tumors in the first place. Kill those self-renewing cells and the often impressive but ultimately temporary regressions will be replaced by permanent victory. The concept has

By Cormac Sheridan BioWorld International Correspondent Quality management problems at its contract manufacturer, Ben Venue Laboratories Inc., have forced Clavis Pharma ASA to slow recruitment in a Phase III trial of elacytarabine in late-stage acute myeloid leukemia (AML) and will result in a delay of one quarter in the reporting of its results. The company now expects to report top-line data from the study, dubbed CLAVELA, in the first quarter of 2013, having previously guided the final

By Catherine Shaffer BioWorld Today Contributing Writer Although expected, results from Medivation Inc.'s Phase III CONCERT trial of Dimebon (laterpirdine) in Alzheimer's disease were still a letdown. Dimebon failed to reach statistical significance on the Alzheimer's Disease Assessment Scale when added to ongoing treatment with donepezil HCL for patients with mild to moderate disease. San Francisco-based Medivation and partner Pfizer Inc. will discontinue development of Dimebon for all

By Nuala Moran BioWorld International Correspondent LONDON – Nanomedicine specialist Midatech Ltd. closed a £6.3 million (US$9.7 million) funding round as it confirmed the formal launch of its joint venture with MonoSol Rx, in which the two partners will develop a gold nanoparticle-based formulation of insulin, designed to be delivered via a patch that adheres to the inside of the mouth. "This new money is the biggest investment in the history of the company. It allows us to expand our

By Mari Serebrov Washington Editor WASHINGTON – Regulatory uncertainty at the FDA is often cited as a source of industry heartburn. But rather than turning down the heat, the agency is looking for ways to make that uncertainty less irritating, recognizing it as a natural part of the scientific process. "Uncertainty is one of the more challenging things for people to understand," Jesse Goodman, the FDA's chief scientist, told the agency's Science Board Friday. "In fact, scientists don't seem to

By Jennifer Boggs Managing Editor SAN FRANCISCO – On the periphery of the 30th annual J.P. Morgan Healthcare Conference, with its 8,000 registered attendees and crowded hallways at the Westin St. Francis hotel, another tier of activity reigns: the small and medium-sized life sciences companies hoping to gain an audience with the right investor or partner to bolster shrinking cash balances and propel R&D work to the next levels. One such firm is Sernova Corp., a regenerative medicine cell therapy

By Marie Powers Staff Writer SAN FRANCISCO – The nexus of clinical development, regulation and capital was the focus of a panel convened Tuesday at the 30th annual J.P. Morgan Healthcare Conference to discuss a biomedical industry CEO survey conducted by the nonprofit California Healthcare Initiative (CHI), the Northern California life science association BayBio and the pharmaceutical, medical device and life sciences industry group at PricewaterhouseCoopers (PwC). Although the promise of new

By Marie Powers Staff Writer AVEO Pharmaceuticals Inc. and partner Astellas Pharma Inc. reported top-line data from the global, randomized Phase III TIVO-1 trial indicating that lead compound tivozanib demonstrated superiority over Nexavar (sorafenib, Onyx) in advanced renal cell carcinoma (RCC), meeting the primary endpoint of progression-free survival (PFS). TIVO-1 is the first registration study comparing an investigational agent – in this case, an oral, once-daily, investigational tyrosine

By Catherine Shaffer BioWorld International Contributing Writer Pfizer Inc. has signed a collaboration agreement with Karo Bio AB, of Stockholm, Sweden, for the development of small-molecule modulators of retinoic acid-related orphan receptor (ROR-gamma), an enticing newer target with relevance for autoimmune disease. ROR-gamma controls production and secretion of cytokine IL-17. Recent clinical studies using monoclonal antibodies to neutralize IL-17 have validated the pathway's significance for

By Anette Breindl Science Editor Sepsis is widely believed to be due to an out-of-control inflammatory response, and efforts to develop drugs to treat that condition have focused on reining in the immune system. Those approaches, to put it mildly, haven't worked. More than 25 drugs have failed in clinical trials in as many years. In fact, so have approved drugs: In October, Eli Lilly and Co. said it was withdrawing Xigris [drotrecogin alfa (activated)] after a study failed to demonstrate

By Catherine Shaffer BioWorld Today Contributing Writer Alexion Pharmaceuticals Inc., of Cheshire, Conn., closed out 2011 with an impressive all-cash acquisition of Montreal-based Enobia Pharma Corp. for $610 million up front and $470 million in sales and regulatory milestones. Enobia's lead product, asfotase alfa (ENB-040), is a Phase II enzyme therapy for the ultra-orphan disease hypophosphatasia (HPP), which causes death and severe morbidity in its sufferers. The disease is caused by a

Nuala Moran BioWorld International Correspondent LONDON – Closing the year with some cheer for the sector, Tissue Regenix Group plc has raised £25 million (US$39 million) in a placing, enabling the regenerative medicine specialist to begin to advance several programs in parallel. "We found the market very receptive. This helps us to immediately progress our product pipeline in parallel, rather than in series," Antony Odell, managing director told BioWorld International. Tissue Regenix' products

By Jennifer Boggs Managing Editor Shares of Endocyte Inc. plummeted 65.3 percent Tuesday on news that the company's ovarian cancer drug EC145 appeared to be bested in a Phase IIb study and a planned Phase III study could be delayed due to doxorubicin shortages. Executives of the West Lafayette, Ind.-based firm tried to spin the data as positive, arguing that the study was underpowered and hailing the promising data supporting the use of companion diagnostic EC20 to identify patients whose tumors

By Anette Breindl Science Editor Researchers have discovered that two proteins best known for their roles in fighting infection play a role in cognitive processes, in particular in memory formation. The double-stranded RNA-activated protein kinase, or PKR, and interferon gamma "are controlling, in the brain, the kind of processes that lead to memory formation," Mauro Costa-Mattioli told BioWorld Today. Costa-Mattioli is an assistant professor of neuroscience at the Baylor College of Medicine and