As the U.S. House and Senate continued their down-to-the-wire game of chicken Monday, government departments dusted off and updated their contingency plans in preparation for what threatened to be the first shutdown in nearly two decades should neither side give on a continuing resolution to fund federal programs after 12:01 a.m. (EDT) Tuesday, the dawn of fiscal 2014. Read More
Just a couple of weeks after the FDA’s Oncologic Drugs Advisory Committee voted overwhelmingly in favor of supporting approval of Genentech Inc.’s supplemental biologics license application (sBLA) for Perjeta (pertuzumab) in neoadjuvant treatment of breast cancer, the FDA granted accelerated approval of the drug. Read More
As Achillion Pharmaceuticals Inc.’s stock reeled from the FDA’s refusal to lift the clinical hold imposed this summer on the hepatitis C virus (HCV) candidate sovaprevir because of elevated liver enzymes, analysts mulled the larger meaning and the company sought to reassure investors during a conference call. Read More
Riding high on recent positive Phase III data for its hyperkalemia candidate, Relypsa Inc. filed for a $126.5 million initial public offering (IPO) to ramp up commercial operations for launch of patiromer, which is designed to remove potassium in the colon. Read More
Following disappointing results from Arqule Inc.’s Phase III study in non-small-cell lung cancer (NSCLC) a year ago, analysts had all but written off tivantinib in that indication. But detailed data reported at this week’s European Cancer Congress in Amsterdam suggested the oral MET inhibitor might have an opportunity in NSCLC after all. Read More
LONDON – Procarta Biosystems Ltd. was awarded more than £1 million (US$1.6 million) in two European Union (EU) grants, enabling it to prepare the first of a new generation of antibiotics based on transcription factor decoys for the clinic, and providing a stepping stone to a funding round in which the company aims to raise £10 million. Read More
Little Lion Biotechnologies Inc., the surviving entity of a merger earlier this year with Genesis Biopharma Inc., reported promising long-term findings from a Phase II trial in Stage IV metastatic melanoma. The study was conducted by the National Cancer Institute (NCI) using tumor-infiltrating lymphocyte (TIL) technology licensed by the company and in development under a five-year Cooperative Research and Development Agreement that Genesis inked with the Institute in 2011. Read More
• Lithera Inc., of San Diego, reported positive results from its 513-patient Phase IIb RESET study of LIPO-202 (salmeterol xinafoate for Injection) designed to measure safety and efficacy of three different doses (0.4, 1 and 4 mcg [total dose]) in healthy, non-obese subjects with abdominal bulging due to excess subcutaneous fat. Read More
• Cardiome Pharma Corp., of Vancouver, British Columbia, said that the Medicines Control Council of South Africa approved Brinavess (vernakalant intravenous) for atrial fibrillation. Read More
• Exelixis Inc., of South San Francisco, provided updated results from BRIM7, an ongoing Phase Ib trial conducted by Roche AG and Genentech, Exelixis’ collaborator and part of Roche, of Basel, Switzerland, the BRAF inhibitor (BRAFi) vemurafenib in combination with the MEK inhibitor cobimetinib (GDC-0973/XL518) in patients with locally advanced/unresectable or metastatic melanoma carrying a BRAFV600 mutation. Read More
• Vansen Pharma Inc., of Montreal, said that its shares will trade under a new ticker symbol, VNSN, beginning Oct. 1. It previously changed its name from Okana Ventures Inc. Read More
