• Allos Therapeutics Inc., of Westminster, Colo., received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP) regarding approval of Folotyn (pralatrexate injection) for peripheral T-cell lymphoma. Allos requested a re-examination of the drug, which is approved in the U.S. Shares of Allos (NASDAQ:ALTH) fell 15 cents, to close at $1.51 on Friday.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said it will implement a strategic corporate restructuring, including an approximate 33 percent reduction in its work force. The move will save Alnylam $20 million in 2012 and allow the firm to continue to focus on its "Alnylam 5x15" strategy, particularly lead candidates ALN-TTR for transthyretin-mediated amyloidosis and ALN-APC for hemophilia.

• Capstone Therapeutics, of Tempe, Ariz., said it plans to cease clinical development of AZX100 and TP508 as it winds down operations. Some preclinical, manufacturing and regulatory projects related to AZX100 will be completed. Rights to TP508 will be returned to the University of Texas. Capstone also reduced its board of directors; the firm was already down to four employees following the Phase II failure of AZX100 in dermal scarring. (See BioWorld Today, Dec. 15, 2010.)

• Carolus Therapeutics Inc., of San Diego, published preclinical data showing CT-2009 prevented lung damage in multiple mouse models of acute lung injury. The molecule is designed to disrupt heteromers formed by the chemokines CCL5 (RANTES) and CXCL4, interfering with recruitment of neutrophils and tissue damage. The data were published in the American Journal of Respiratory and Critical Care Medicine. Carolus plans an investigational new drug application filing later this year. (See BioWorld Today, Jan. 20, 2009.)

• Cell Therapeutics Inc., of Seattle, said the European Medicines Agency may issue an opinion on the marketing authorization application for Pixuvri (pixantrone dimaleate) in non-Hodgkin's lymphoma by mid-February. The drug is also under FDA review with a decision expected April 24. Pixuvri is an aza-anthracenedione that inhibits Topo-isomerase II. It was previously rejected by the FDA. Shares of Cell Therapeutics (NASDAQ:CTIC) gained 17 cents, or 14.9 percent, to close Friday at $1.31. (See BioWorld Today, May 4, 2011.)

• Clovis Oncology Inc., of Boulder, Co., said the FDA accepted its investigational new drug application for CO-1686, an oral, covalent inhibitor of epidermal growth factor receptor mutations in non-small-cell lung cancer. Phase I/II trials are expected to start in the second quarter. After the dose is established, Clovis plans to focus on patients with the T790M mutation; it is working with Roche Molecular Systems Inc., part of Roche AG, of Basel, Switzerland, on a companion diagnostic. Clovis got CO-1686 in a $209 million deal with Avila Therapeutics Inc., of Waltham, Mass. (See BioWorld Today, May 26, 2010.)

• Innate Pharma SA, of Marseilles, France, said its scientific co-founder Eric Vivier, a professor at the Center of Immunology of Marseille-Luminy, published preclinical data in Science showing mice that do not express the NK activating receptor NKp46 have an enhanced resistance to some viral infections. Innate Pharma and INSERM, the French National Institute of Health and Medical Research, have filed patent applications relating to that discovery.

• Insmed Inc., of Monmouth Junction, N.J., said the FDA lifted its clinical hold on Arikace (liposomal amikacin for inhalation) in patients with nontuberculous mycobacterial lung disease. The hold stemmed from a long-term rat inhalation carcinogenicity study, and Insmed will now move forward with a nine-month dog inhalation toxicity study as requested by the FDA. The FDA also asked the company to conduct a Phase II trial in nontuberculous mycobacterial lung disease before restarting its Phase III. A hold on the Phase III trial of cystic fibrosis patients with pseudomonas lung infections continues. Separately, Insmed said it has depleted its inventory of Iplex (mecasermin rinfabate), which previously failed a Phase II trial for muscular dystrophy, and is looking to out-license that program. Shares of Insmed (NASDAQ:INSM) jumped $1.21, or 31.8 percent, to close at $5.01 Friday. (See BioWorld Today, Aug. 3, 2011.)

• La Jolla Pharmaceutical Co., of San Diego, acquired global rights to galectin-3 inhibitor GCS-100 from privately held Solana Therapeutics Inc. Terms were not disclosed, but George Tidmarsh, former CEO of Solana, was appointed president and CEO of La Jolla. The former management and board of La Jolla resigned. GCS-100 started clinical trials with IGG International Inc. in 1997 and has since passed through SafeScience Inc., GlycoGenesys Inc. and Prospect Therapeutics Inc. Shares (OTCPK:LJPC) jumped 60 percent Friday, but still closed at less than a penny.

• Merck & Co. Inc., of Whitehouse Station, N.J., said the European Medicines Agency adopted a positive opinion recommending the use of Remicade (infliximab) in the treatment of severely active ulcerative colitis in pediatric patients, ages 6 to 17, who have had inadequate responses to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. Remicade, a monoclonal antibody targeting TNF-alpha, is marketed in the U.S. by New Brunswick, N.J.-based Johnson & Johnson.

• PolyMedix Inc., of Radnor, Pa., presented preclinical data showing its defensin-mimetic compounds, including lead drug PMX-519, kill the fungus C. albicans by rapidly permeabilizing its cell membrane. In a mouse model, PMX-519 produced near total sterilization and was 50-fold more effective than nystatin, a commonly used antifungal agent. A separate presentation showed PolyMedix's antimicrobial compounds killed the parasite that causes malaria, Plasmodium falciparum. The data were presented at the Keystone Symposia on Molecular and Cellular Biology.

• Veracyte Inc., of South San Francisco, signed a deal with Paris-based Sanofi SA's Genzyme unit for the global promotion of Veracyte's Afirma Thyroid FNA Analysis diagnostic for thyroid cancer. Terms were not disclosed.