The Senate added its stamp of approval to H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), agreeing by unanimous vote to reauthorize the Biomedical Advanced Research and Development Authority (BARDA) and Project BioShield. The Reproductive Health Drugs and the Drug Safety and Risk Management advisory committees voted 20-1 that sponsors of calcitonin drugs in development should be required to submit fracture efficacy data for approval. The FDA released a draft

"A sequestration of the magnitude contemplated, and this late in the budget year, will have public health consequences for an agency that is already making every dollar count." – Statement from FDA "We believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high." – Jim Schoeneck, president and CEO, Depomed Inc., following the FDA's Reproductive Health Drugs Advisory Committee vote of 12-2 against its product Sefelsa. "What makes this a unique platform is that you

Financings Ablynx NV raised $40.9 million through a private placement of new shares. Active Biotech AB brought on board a new investor in a $42.6 million fundraising. DelMar Pharmaceuticals Inc. completed a $10.5 million private placement of units. Enanta Pharmaceuticals Inc. plans to raise $60 million from its IPO. EntreMed Inc. raised $10.7 million in a registered direct offering. Inovio Pharmaceuticals Inc. priced an underwritten offering for gross proceeds of $15.1 million. Mesoblast Ltd

Being a little bit infected with HIV may sound like a concept akin to being a little bit pregnant. But that may be what's behind the functional cure of a baby with HIV that had both the scientific community and the general public abuzz last week. "There is a bit of a debate about precisely what happened," Daniel Kuritzkes told BioWorld Insight. "The issue is whether this child was truly infected to begin with, or was this really post-exposure prophylaxis?" Kuritzkes, who himself reported on two

While another storm that hit the East Coast of the U.S. served to delay the scheduled FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting last week, South San Francisco-based Theravance Inc. and its partner GlaxoSmithKline plc, of London, shouldn't have too much longer to wait for what is predicted to be a positive review from the PADAC for their once-daily inhaled corticosteroid. Certainly, Theravance seems to think so. In January the company completed a $287.5 million debt financing

Acura Pharmaceuticals Inc. recently launched Nexafed, its version of pseudoephedrine that uses the biotech's abuse-deterrent technology to help disrupt the drug's conversion to methamphetamine. Acura is focusing its marketing message for the over-the-counter decongestant on pharmacists. "We've always known that abuse-deterrent technologies are best directed at the health care practitioner," Robert Jones, president and CEO of Acura, told attendees at the Cowen and Co. Health Care Conference

SAN DIEGO – The life science industry has experienced three windows of opportunity to go public in the past 15 years. The first window lasted just three years from 1998 to 2000, producing 50 initial public offerings (IPOs). The second included a whopping 92 IPOs, running from mid-2003 to 2007. The most recent window, which officially started in mid-2009, has produced only 38 IPOs despite being longer than the first and approaching the length of the second. According to data crunched by Lazard

BOSTON – Cross-disciplinary research is all the rage these days, for good reason. "It's widely agreed that creativity and innovation are combinatorial processes," Sarah Kaplan of the University of Toronto told the audience at the panel on "Confluence of Streams of Knowledge: Biotechnology and Nanotechnology" at the American Association for the Advancement of Science (AAAS) annual meeting in February. "Ideas ignore boundaries," including the boundaries of academic disciplines. But that does not

Financings Blaze Bioscience Inc. completed a Series A financing totaling $8.5 million. Brickell Biotech Inc. landed a $7 million Series B financing with a new partner, Amorepacific Ventures. Celsion Corp. received commitments from investors to purchase $15 million of the company's securities. Dezima Pharma BV raised $18.6 million for the development of its cholesteryl ester transfer protein inhibitor. Immunomedics Inc. priced a public offering of 6.1 million shares at $2.30 each looking to raise

"Qsymia disappoints, again; this is a good drug, but it can't sell itself . . ." – Simos Simeonidis, analyst, Cowan & Co., on Vivus Inc. reporting 4Q12 results, with sales of Qsymia well below consensus estimates "I think it's the fantasy of all of the heads of the franchises that they're going to be spun out and have their own company." – Barbara Yanni, vice president and chief licensing officer at Merck & Co. Ltd. "I have to confess, it is very difficult to break from the classic paradigm of

Provided budget constraints don't derail their plans, the FDA is on track to begin conducting biennial inspections of all drug facilities, both domestic and foreign, in five years, according to FDA Commissioner Margaret Hamburg.

I. COMMENCED TRADING IN February 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 There were no IPOs that commenced in February. Total: $0M Number of IPOs in February: 0 Average value of February IPOs: $0M Number of IPOs in 2013: 2 Total raised in IPOs in 2013: $108.2M Average value of IPOs in 2013: $54.1M Company (Symbol)# Date Filed Date Comm. Shares/ Units (M

Type of Financing January February Total ($M) Public offerings 2,305.0 269.1 2,574.1 Public/other 530.4 238.9 769.3 Private biotechs 210.2 161.9 372.0 Total ($M) 3,045.6 669.9 3,715.4 Notes: Public offerings = Initial, follow-on. Private biotechs = Financings of private firms. Public/other = Other financings of public companies, including loans, bridge financings, exercises of warrants, debt offerings, rights offerings, standard private placements, PIPE financings and institutional offerings

TOTAL: $238.9M Company (Location) Type Of Financing Number Of Shares, Units Or Warrants (M) Amount| Raised (M) Investors; Placement Agents; Details Date Amarantus BioScience Inc. (Sunnyvale, Calif.) Convertible note financing N/A $1.4 Amarantus secured an additional $1.4M in financing commitments through an amendment of its initial $600,000 convertible note, issued in November 2012 to Dominion Capital, to $2M 2/1/13 BioLineRx Ltd. (Jerusalem) American depositary shares agreement 2.7ADS

Company Amount Raised Ironwood Pharmaceuticals Inc. $175M OPKO Health Inc. $175M Pacira Pharmaceuticals Inc. $110M e-Therapeutics plc $62.66M

Total: $161.9M Company Location Amt. (M) Details Date Aduro BioTech Inc. Berkeley, Calif. $6.5 Aduro raised $6.5M in an equity financing primarily from current investors 2/1/13 Aerial BioPharma Inc. Morrisville, N.C. $12 Aerial raised $12M in a Series A round 2/21/13 Antabio Lebege, France €4.7 ($6.4) Antabio received a $6.4M Wellcome Trust Seeding Drug Discovery Award 2/4/13 Apceth GmbH and Co. Munich, Germany ND Apceth raised an undisclosed amount in a second round of financing 2/6/13 Aviir