• Actelion Ltd., of Allschwil, Switzerland, said that the European Union's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion about extending the use of Zavesca (miglustat) to patients suffering from Niemann Pick type C (NP-C), a rare, fatal, degenerative genetic disease associated with multiple neurological manifestations that primarily affects children and adolescents. There is no treatment available for NP-C. Zavesca is approved in the U.S., the European Union, Canada, Switzerland, Brazil, Australia and Israel for the oral treatment of mild to moderate Type 1 Gaucher disease in patients for which enzyme replacement therapy is unsuitable. Actelion said it intends to request a re-examination of the CHMP opinion. The CHMP is expected to issue a final opinion in the first quarter of 2008.

• Biocon Ltd., of Bangalore, India, and Abraxis BioScience Inc., of Los Angeles, received approval to market Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India to treat breast cancer. A commercial launch on the Indian market is expected in 2008 following the completion of the appropriate importation certifications. Abraxis and Biocon signed a collaboration deal in August, giving Biocon rights to Abraxane in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. Meanwhile, Abraxis intends to initiate a worldwide, head-to-head Phase III registration trial comparing weekly Abraxane to Taxotere, administered every three weeks, in first-line metastatic breast cancer, and plans for additional Phase III trials of Abraxane in non-small-cell lung cancer and melanoma. Abraxane is approved for breast cancer in the U.S. and is under review in Europe, Australia, Russia and China. In a separate release Thursday, Abraxis reported that the European Committee for Human Medicinal Products issued a positive opinion recommending approval of Abraxane in Europe for metastatic breast cancer in women who have failed therapy in the first-line setting. A formal decision by European regulators on the drug's marketing application is expected within the next three to four months.

• Biocontrol Ltd., of London, raised £500,000 (US$1.1 million) in a private round led by the Capital Fund, also of London, for the further development its bacteriophage treatments against antibiotic-resistant infections. The company is developing a topically-applied veterinary phage treatment for controlling Pseudemonas aeruginosa. The product is also in clinical trials.

• BioLineRx Ltd., of Jerusalem, presented preclinical data demonstrating that BL-1040, a resorbable implant to treat acute myocardial infarction, improved cardiac function and prevented deterioration of myocardium in a pig study. The data were presented at the Transcatheter Cardiovascular Therapeutics conference. In June, BioLineRx submitted a request to European regulators to begin Phase I/II studies. Also, BioLineRx said its board of directors has directed company management to investigate various alternatives for raising additional capital and a Nasdaq listing. The company plans to hold a special shareholders meeting to approve a reverse split of its ordinary shares to reduce the number of shares outstanding, which should have the effect of increasing the price per share of the company's ordinary shares.

• BioMerieux, of Marcy l'Etoile, France, received FDA clearance to market Vidas BRAHMS PCT, an in vitro diagnostic test to be used with critically ill patients on their first day of admission to the intensive care unit. The test will aid physicians in assessing a patient's risk for progression to severe sepsis and septic shock.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, reported that preclinical studies of CF102, its drug for viral hepatitis and liver cancer, was shown to be effective in promoting liver tissue regeneration following partial hepatectomy. The drug is designed to specifically attack liver tumors and hepatitis-infected cells, and Can-Fite is preparing to move the CF102 into Phase I testing in the first quarter of 2008.

• Cellectis SA, of Romainville, France, granted TransGenic Inc., of Kobe, Japan, a non-exclusive license to a patent family relating to a process for the specific replacement or insertion of a gene in a receiver genome by homologous recombination. Cellectis says the technology is used to substitute, delete or add genetic sequences at a chosen location in a genome. The license granted to TransGenic gives it the right to use Cellectis' technologies for the generation and commercialization of genetically modified mice. The company is specialized in the production of knockout mice using the exchangeable gene-trap method, and also produces knockout by gene targeting at the request of pharmaceutical companies and research centers. Financial terms were not disclosed.

• Cobra Biomanufacturing plc, of Keele, UK, signed an agreement with Advaxis Inc., of North Brunswick, NJ, to manufacture Phase II clinical trial material of a therapeutic cervical cancer vaccine Lovaxin C. Cobra has been working with Advaxis on the development and manufacture of live listeria vaccines for cancer immunotherapy since 2003.

• Critical Outcome Technologies Inc., of London, signed a pilot project agreement with Merck Serono, a division of Darmstadt, Germany-based Merck KGaA, to identify drug development candidates for an undisclosed oncology cellular target. The scope of the project consists of COTI using its technology Chemsas to discover four to six drug candidates built on two to three scaffolds against a specific cellular target chosen by Merck, and Merck will then evaluate the compounds and decide whether to synthesize and test the suitability of the molecules as leads for the target. Financial terms call for Merck Serono to make a project commencement payment to COTI, and additional payments will be earned upon achievement of individual milestones in the preclinical development of drug candidates. Specific terms were not disclosed.

• ProStrakan Group plc, of Galashiels, UK, announced a deal with NovaQuest, the partnering group of Quintiles Transnational Corporation, to commercialize ProStrakan's products in the U.S. NovaQuest will set up a 75-strong sales force ahead of the US launch of Sancuso, a skin patch for the prevention of chemotherapy-induced emesis, and make up-front and milestone payments to ProStrakan totaling US$10 million in cash over the first three years of the collaboration. In return NovaQuest has been granted warrants over 2.6 million new ordinary shares in ProStrakan at 75.5 pence per share and ProStrakan will pay a tapering royalty on US Sancuso sales to NovaQuest over seven years.

• ReNeuron Group plc, of Guildford, UK, presented pre-clinical efficacy and characterization data for its stem cell line for Huntington's disease at the World Congress on Regenerative Medicine, in Leipzig, Germany. A master cell bank for the product, ReN005 has been manufactured to GMP standards. The project is supported by a government grant.

• Sareum Holdings plc, of Cambridge, UK, a structure-based drug discovery business, is placing 138.9 million shares at 0.9p per share to raise pounds 1.25 (US$2.5 million) before expenses. The funds will used to advance the company's in-house pipeline of cancer drug candidates.

• Sinovac Biotech Ltd., of Beijing, entered a purchase agreement with the Beijing Public Health Bureau for Sinovac's seasonal influenza vaccine Anflu. The drug is distributed in China by Sinovac and its partner GlaxoSmithKline (China) Investment Co. Ltd., a subsidiary of GlaxoSmithKline, of London. Terms of the deal were not disclosed.• Starpharma Holdings Ltd., of Sydney, Australia, has signed an agreement with condom-maker SSL International plc for a co-development program for condoms with a VivaGel coating. Undisclosed fees are payable to Starpharma under the agreement, which also provides for the commencement of regulatory and market development activities by the two parties. VivaGel has been shown to have contraceptive and microbicidal properties in animal studies, and also is under development as a stand-alone gel to prevent the transmission of sexually transmitted diseases.

• Starpharma Holdings Ltd., of Sydney, Australia, has signed an agreement with condom-maker SSL International plc for a co-development program for condoms with a VivaGel coating. Undisclosed fees are payable to Starpharma under the agreement, which also provides for the commencement of regulatory and market development activities by the two parties. VivaGel has been shown to have contraceptive and microbicidal properties in animal studies, and also is under development as a stand-alone gel to prevent the transmission of sexually transmitted diseases.

• Stem Cell Sciences plc, of Edinburgh, Scotland, in-licensed muscle stem cells discovered at San Raffaele Scientific Institute, Milan, Italy, for use in drug discovery and preclinical toxicology testing. Financial terms were not disclosed. The muscle stem cells, a subset of pericyte cells located around the circumference of small blood vessels, retain the capacity to turn into muscle cells on demand. They were discovered by Giulio Cossu, Director of the Stem Cells Institute, at the San Raffaele. Stem Cell Sciences will develop the pericyte assays at its automated cell production facility in Cambridge, UK.

• Summit Corporation plc, of Oxford UK, completed recruitment of a Phase I trial of SMT D002 for the treatment of seborrhoea (excessive sebum production), a symptom of Parkinson's disease and the primary cause of acne. The study will examine the effects of repeat oral doses of SMT D002 on sebum secretion rates, adding to the results of an earlier double-blind Phase I study in healthy volunteers that showed up to a 70 percent reduction in secretion levels. The results from this study are due early in 2008. SMT D002 has potential use in acne and future studies planned in this indication.

• Vivalis, of Nantes, France, granted rights to Paris-based Sanofi-Aventis SA to evaluate its EBx cell lines, cell substrates derived from avian embryonic stem cells, from the production of monoclonal antibodies. Financial terms were not disclosed.