Company (Location) Product Description Indication Status Date Baxter International Inc. (Deerfield, Ill.) FEIBA NF Anti-inhibitor coagulant complex Hemophilia A or B Submitted a BLA supplement to the FDA 2/27/13 Bayer HealthCare Inc. (Wayne, N.J.) Ra223 dichloride Oncology compound Castration-resistant prostate cancer NDA has been accepted for filing and was granted priority review 2/14/13 Bayer HealthCare Pharmaceuticals Inc. (Wayne, N.J.) Stivarga Regorafenib Advanced gastrointestinal

Company (Location) Product Description Indication Status Date CANCER ArQule Inc. (Woburn, Mass.) and Daiichi Sankyo Co. Ltd. (Tokyo) ARQ197 Tivantinib Hepatocellular carcinoma Enrolled their first patient in a pivotal Phase III trial 2/1/13 AVEO Pharmaceuticals Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Showed overall survival trends favoring the comparator drug Nexavar (sorafenib) at 29.3 months, compared with 28.8

Company (Location) Product Description Indication Status Date AUTOIMMUNE Ablynx NV (Ghent, Belgium) ALX-0061 Anti-IL-6R nanobody Moderately to severely active rheumatoid arthritis Phase I/II data showed ACR20, ACR50 and ACR70 scores of up to 100%, 75% and 63%, respectively 2/14/13 CANCER AbbVie (Chicago) ABT-199 A selective Bcl-2-targeting therapy Chronic lymphocytic leukemia Phase II was suspended after a patient died from tumor lysis syndrome 2/19/13 Acceleron Pharma Inc. (Cambridge, Mass

Company (Location) Product Description Indication Status Date AUTOIMMUNE Coronado Biosciences Inc. (Burlington, Mass.) TSO Trichuris suis ova, or CNDO-201 Psoriasis Started an open-label, multicenter study expected to enroll 20 patients 2/26/13 Xencor Inc. (Monrovia, Calif.) XmAb5871 Targets the CD32b (FcRIIb) pathway in B cells Moderate to severe rheumatoid arthritis Dosed the first patient in a Phase Ib/IIa trial 2/14/13 CANCER Gamida Cell Ltd. (Jerusalem) NiCord Umbilical cord derived stem

Company Drug Indication Celgene Corp. Abraxane Non-small-cell lung cancer Hyperion Therapeutics Inc. Ravicti Urea cycle disorders ImmunoGen Inc. Kadcyla HER2-positive metastatic breast cancer

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.