The Congressional Budget Office's latest outlook for fiscal 2013-2023 predicts the annual deficit for 2013 would shrink to $845 billion if Congress allows sequestration – with its now 5 percent automatic cuts for the FDA, National Institutes of Health and other federal agencies – to occur March 1. The FDA held a public hearing to receive input on its proposal to expedite development of new drugs for serious or life-threatening conditions with unmet need. The pathway, which is being considered
I. COMMENCED TRADING IN JANUARY Company (Symbol)# Date Filed Date Comm. Shares/ Units (M) Price Shares Out (M)@ Lead, Other Underwriters Gross (US$M) Post- Offering Market Cap (M)% INITIAL OFFERINGS KaloBios Pharmaceuticals Inc. (South San Francisco; KBIO)1 10/5/12 1/31/13 8.75S $8 24.1 Leerink Swann LLC William Blair & Co. LLC Needham & Co. LLC $70 $192.8 Stemline Therapeutics Inc. (New York; STML)2 4/2/12 1/29/13 3.8S $10 7.46 Aegis Capital Corp. $38.2 $74.6 Total: $108.2M Number
Company Amount Raised Ironwood Pharmaceuticals Inc. $175M OPKO Health Inc. $175M Pacira Pharmaceuticals Inc. $110M Pharming Group $21.71M Medicago Inc. $15M
The Department of Health and Human Services (HHS) and other federal agencies earned a "D" average on the Government Accountability Office's report card for their efforts to request and respond to public comments when making major new rules. The grade dropped to an "F" for other rules. An FDA guidance shows when and how genomic principles could be applied in early phase trials to address questions that might pop up during development and regulatory review.
"Primary liver cancer is a complicated disease. This is a tough indication." – Michael H. Tardugno, CEO, Celsion Corp., after failure of the company's product candidate ThermoDox "It really does seem to work in every malignancy we've tested." – Norman Sharpless, University of North Carolina at Chapel Hill. He and his colleagues have created a mouse with a reporter gene that appears to light up at the earliest stages of tumor development, regardless of the tissue type in which the tumor is
Financings Anthera Pharmaceuticals Inc. completed a public offering worth $40 million in gross proceeds. Ariad Pharmaceuticals Inc. completed its public offering of 15.3 million shares at $19.60 per share. Auxilium Pharmaceuticals Inc. priced $325 million of 1.5 percent convertible senior notes due 2018. Bone Therapeutics SA raised $10.4 million in new financing as a prelude to a larger round. Champions Oncology Inc. raised $9.3 million from a private placement of 18.6 million shares. Foresite
The move by six major drug discovery and development organizations to codify relationships that have existed for many years signals growing frustration in academia about the dearth of venture capital funding and big pharma support for early stage therapeutic development. Launch of the Global Alliance of Leading Drug Discovery and Development Centres represents a formal effort by the global institutions to collaborate on drug discovery projects of mutual interest and to improve the translational
By Marie Powers | BioWorld Insight | Monday, February 4, 2013
The FDA approved 39 new drugs in 2012, the highest since 1996, so it should come as no surprise that regulatory affairs and clinical development experts are in high demand these days. Even while macroeconomics and individual funding issues have caused some compression of employment at drug developers, there's been a steady demand for experts in clinical development and regulatory affairs, Victor Kleinman, executive vice president and managing director of global life sciences practice at
By Brian Orelli | BioWorld Insight | Monday, February 4, 2013
As the biotechnology industry continues to expand its global footprint it is giving rise to a plethora of new biotech clusters, particularly in emerging countries. Cities around the world are latching onto the significant economic potential that a thriving biotech hub can bring. As a result they are taking steps to build or expand regions and offering access to research excellence, highly qualified employees as well as lucrative tax and financial incentives designed to attract biotech and
By Peter Winter | BioWorld Insight | Monday, February 4, 2013
Full Credit to All Underwriters, Ranked by After-Market Performance*# Rank Underwriter (IPOs as Lead/IPOs as Lead or Co-Manager) After-Market Performance (Average) 1 ThinkEquity LLC (0/1) +128% 2 Goldman, Sachs & Co. (1/1) +89% 3 BMO Capital Markets (2/3) +71% 4 Wedbush PacGrow Life Sciences (0/3) +57% 5 Needham & Co. (0/4) +52% 6 Lazard Capital Markets (1/3) +45% 7 Piper Jaffray (1/1) +43% 8 Bank of America Merrill Lynch (3/3) +33% 9 J.P. Morgan Securities (3/3) +28% 10 Citigroup Global
Full Credit to Lead Underwriter, Ranked by After-Market Performance*# Rank Underwriter (IPOs as Lead/IPOs as Lead or Co-Manager) After-Market Performance (Average) 1 BMO Capital Markets (2/3) +93% 2 Goldman, Sachs & Co. (1/1) +89% 3 Lazard Capital Markets (1/3) +58% 4 Piper Jaffray (1/1) +43% 5 Bank of America Merrill Lynch (3/3) +33% 6 J.P. Morgan Securities (3/3) +28% 7 Citigroup Global Markets (including citibank) (3/3) +26% 8 Cowen & Co. (3/6) +26% 9 Morgan Stanley (1/1) +26% 10 Leerink
Full Credit to All Underwriters, Ranked by Gross Proceeds* Rank Underwriter (IPOs as Lead/IPOs as Lead or Co-Manager) Gross Proceeds (M) 1 Cowen & Co. (3/6) $368.00 2 Leerink Swann (4/5) $346.51 3 Bank of America Merrill Lynch (3/3) $263.98 4 Needham & Co. (0/4) $252.61 5 J.P. Morgan Securities (3/3) $232.85 6 BMO Capital Markets (2/3) $224.00 7 Wedbush PacGrow Life Sciences (0/3) $215.00 8 Lazard Capital Markets (1/3) $195.15 9 Citigroup Global Markets (including citibank) (3/3) $189.00 10
The Congressional Budget Office's latest outlook for fiscal 2013-2023 predicts the annual deficit for 2013 would shrink to $845 billion if Congress allows sequestration – with its now 5 percent automatic cuts for the FDA, National Institutes of Health and other federal agencies – to occur March 1. The FDA held a public hearing to receive input on its proposal to expedite development of new drugs for serious or life-threatening conditions with unmet need. The pathway, which is being considered