• Amsterdam Molecular Therapeutics Inc., of Amsterdam, the Netherlands, said the FDA granted orphan drug designation to AMT-080, a gene therapy for Duchenne muscular dystrophy.

• The law firm of Izard Nobel LLP, of West Hartford, Conn., has filed a class-action lawsuit against Arena Pharmaceuticals Inc., of San Diego, in the U.S. District Court for the Southern District of California on behalf of purchasers of the firm's common stock charging that Arena violated federal securities laws by making materially false statements about its experimental weight loss drug lorcaserin by hyping its efficacy, safety and tolerability without disclosing certain health risks associated with the drug. The FDA disclosed in briefing documents on Sept. 14 in advance of its advisory panel meeting that rat carcinogenicity data showed a potential increase in tumors. Arena's CEO acknowledged during a Sept. 17 conference call that the rat study data had not been revealed previously to stockholders because the firm said it did not consider it material to investors. (See BioWorld Today, Sept. 15, 2010, Sept. 17, 2010, and Sept. 20, 2010.)

• Merck KGaA, of Darmstadt, Germany, reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative opinion for marketing cladribine tablets as a treatment for relapsing-remitting multiple sclerosis, stating the drugs benefits do not outweigh its risks.

• SemBioSys Genetics Inc., of Calgary, Alberta, said it is working on strategic options, including a corporate sale or merger, an accelerated partnering transaction for either insulin or Apo, an asset sale, a significant restructuring and recapitalization or a wind-down of the company's business. Without additional financings, the biosimilars firm said it is unable to continue operating at current levels and has provided working notice of termination to all affected employees. As of June 30, the firm had about $1.6 million on its balance sheet. Shares of SemBioSys (TSX:SBS) fell C10 cents (US9 cents), or 59.4 percent, to close Friday at C7 cents.

• Tarsa Therapeutics Inc., of Philadelphia, and Unigene Laboratories Inc., of Boonton, N.J., reported preclinical data showing that calcitonin may have synergistic effects in combination with other drugs in reducing the collagen degradation associated with osteoarthritis. Unigene produces Fortical nasal calcitonin product for the treatment of postmenopausal osteoporosis and Tarsa's oral calcitonin, which is licensed from Unigene, is in a Phase III trial for the treatment of osteoporosis. The study was designed to identify whether the combination of salmon calcitonin and other recognized and experimental antiarthritis drugs can produce additive or synergistic effects in reducing collagen degradation in a bovine in vitro collagen matrix model.