LONDON - Pregnant women who undergo amniocentesis to find out whether they are carrying a fetus affected by Down's syndrome or other chromosomal disorders spend up to three weeks anxiously waiting the result of the test. Now a new test, which can provide results within a day, has been shown to be 100 percent accurate in detecting Down's syndrome. As well as speeding up the process, the new technique paves the way for tailor-made antenatal diagnosis of chromosomal disorders. Whereas all
HAMBURG, Germany - Founded by molecular biologist Burghardt Wittig, the German start-up company Mologen AG holds key patents in developing DNA vaccines. Its vision is to provide cheaper, faster and safer vaccines against infectious as well as tumor diseases. In May, Mologen, of Berlin, went public as Germany's second biotechnology company. As a spin-off from the field of gene therapy, DNA-based immunization has attracted much attention from scientists and biotechnology companies. Purified
DUBLIN, Ireland - An environmentalist's court challenge to the Irish EPA's decision to grant Monsanto Co. consent to carry out field trials of genetically modified sugar beets is expected to finish in the High Court in Dublin today. Clare Watson, a member of the campaign group Genetic Concern, is seeking to overturn the EPA's decision on the grounds the agency failed to meet requirements under Irish law in granting the consent. Monsanto, of St. Louis, has been named as the second respondent
LONDON - Cyclacel Ltd., of Dundee, Scotland, has filled a hole in its technology portfolio by obtaining worldwide rights to the nuclear transport protein Penetratin, a drug delivery agent which is able to penetrate the cytoplasm and nucleus of live cells. The company specializes in the discovery and development of cancer treatments that work by interrupting the cell cycle of malignant cells. It plans to use Penetratin in conjunction with its Pimetic drug candidates, which mimic the effects of
LONDON - Two of the U.K.'s leading biotechnology companies have faced up to the high cost of getting rid of unwanted executives as Chiroscience Group plc agreed to pay Nowell Stebbing, former CEO and deputy chairman, £3.25 million and Cortecs plc received a writ from Glen Travers, former chairman and CEO, claiming £1.5 million in compensation for his loss of office. Chiroscience, the drug discovery and development company which acquired Darwin Molecular Inc., of Seattle, in December 1996
Company** Product Description Indication Type Action (Date) CANCER Anthra Pharma- Valstar Valrubicin (injected Treatment of aggressive, FDA Advisory Commit- ceuticals Inc. directly into bladder) recurring, spreading tee voted not to recom- (IPO pending) bladder cancer (2nd-line mend approval (studies therapy) not rigorous enough to prove drug helped patients) (6/1) Diatide Inc. P829 Synthetic, somatostatin- In vivo imaging agent Submitted NDA (6/16); and Nycomed
Company** Product Description Indication Type Action (Date) CANCER Cel-Sci Corp. Multikine Natural mixture of Treatment of head and Announced preliminary human cytokines, neck cancer prior to results of small trial con- including interleukin-2 surgery or radiation ducted in Israel (5/6) therapy Matritech Inc. NMP22 Diagnostic blood test Aid in monitoring and Approved for marketing Test Kit that detects a nuclear testing for high-risk, in Japan (5/27) matrix protein
Company** Product Description Indication Type Action (Date) CANCER Biocircuits Corp. PSA Assay Point-of-care assay Aid in diagnosing and Filed 510(k) (5/11) (NASDAQ:BIOC) for prostate-specific monitoring prostate antigen cancer DepoTech Corp. DepoCyt Injectable, sustained- Neoplastic meningitis FDA sent company a non- and Chiron Corp. release formulation of arising from solid approvable letter, saying chemotherapeutic agent tumors the product failed to cytarabine
By Jennifer Van Brunt Editor The FDA seems to have taken to its mission of speeding new drugs to the market with a sort of missionary zeal. Since Congress passed the FDA Modernization Act of 1997 in mid-November, the FDA has truly taken some major steps toward fulfilling that agenda. It's obvious in almost every action the FDA has taken this year. For one thing, it's kept to the timetables set under the act — to the day. Far from being the plodding behemoth of bureaucracy it once was, the
Company** Product Description Indication Type Action/Date CANCER Cel-Sci Corp. Multikine Natural mixture of Treatment of head and Results of small trial human cytokines, neck cancer prior to conducted in Israel pre- including interleukin-2 surgery or radiation sented at 1998 Interna- therapy tional Head And Neck Cancer Congress in Hong Kong (6/8) Cytogen Corp. Quadramet Samarium-153 EDTMP Relief of bone pain in Approved for marketing (intravenous radio- patients with
* Antisoma plc, of London, received approval from the U.K. Medicines Control Agency to start pivotal Phase III trials of Theragyn for the treatment of ovarian cancer. This follows approvals from the FDA and elsewhere in Europe for the same Phase III program. Theragyn, licensed from the London-based Imperial Cancer Research Fund (ICRF), is a murine monoclonal antibody directed against polymorphic epithelial mucin, a protein produced in an abnormal form by more than 90 percent of ovarian cancers
LONDON - Drug discovery services company Oxford Molecular Group (OMG) plc has agreed to invest up to £2.5 million in MicroGenics Ltd., an Oxford University spin-off, with the aim of eventually turning it into a subsidiary. MicroGenics was formed by Jeff Errington, professor of microbiology at Oxford, in the U.K., to develop screening systems for novel antibiotics based on his research into bacterial cell division and spore formation. OMG is paying £500,000 for 19.99 percent of the ordinary
LONDON - The U.K. government awarded a grant of £600,000 to PPL Therapeutics plc and the Roslin Institute for research to protect the U.K.'s lead in cloning by nuclear transfer. The grant, to be matched by £600,000 of funding from PPL itself, will be spent on a three-year project to improve the precision of genetic modification using nuclear transfer. The aim is to develop techniques for removing, as well as replacing, genes, and thus to produce proteins it was not previously possible to
SYDNEY - A biotechnology group in Melbourne plans to raise about A$10 million by floating off in a separate one-project company an anti-fat treatment that has shown considerable promise in trials with mice. The money raised in the float of the new company, to be called Metabolic Pharmaceuticals Ltd., will be used for human trials in the U.S. of the treatment - a reengineered fragment of the human growth hormone that can be taken orally. To remain under the control of its parent, Melbourne
BRUSSELS, Belgium - The European Commission (EC) has decided to take Portugal to the European Union's highest tribunal, the European Court of Justice, for failure to respect rules on biotechnology. Portugal has not properly implemented the 1990 policies on contained use and deliberate release of genetically modified organisms, EC officials said, and despite repeated warnings has not changed its national laws sufficiently. The laws should have been in force by October 1991. The EC also issued
HAMBURG, Germany - Interactiva Biotechnologie GmbH, a genomics company that bills itself as a virtual laboratory, has entered an exclusive agreement with Swedish research centers covering the analysis of single nucleotide polymorphisms. Interactiva, of Ulm, Germany, was founded three years ago by Flavio Ortigao, a bioinformatics specialist at the University of Ulm. Ortigao had the idea of creating a company based on the vast opportunities of the Internet and supplies of custom-made bio-organic
BRUSSELS, Belgium - Martin Bangemann, European commissioner for industry, said the European Commission (EC) and other political authorities face a major challenge in convincing the public that "opportunities of biotechnology are immense - both in economic and in social terms." Bangemann made his comments at a pharmaceutical industry conference in Berlin late last month, locating his remarks firmly in the context of the current widespread negative sentiment toward biotechnology in Europe. "We
Perhaps the only aspects of tropical diseases that might be considered entertaining are the names they collect. Mal morado, volvulosis, Robles' disease and river blindness, for instance, all describe a single parasitic infection formally known as onchocerciasis. The cause of this nonfatal, chronic infection is the round worm Onchocerca volvulus. Spread by blood-sucking female blackflies, river blindness can produce symptoms that range from rashes to skin atrophy to blindness. Eighteen
LONDON - Therapeutic Antibodies Inc. (TAB) raised US$3.2 million in interim funding as the first stage of re-financing the company and said it will cut costs by ending a clinical trial of its CytoTAb antitumor necrosis factor (TNF) antibody in the treatment of sepsis. The US$3.2 million, raised in a private placement, will fund TAB to the end of 1998. It involved short-term interest-bearing notes with warrants. The notes carry a 15 percent coupon and are repayable in 180 days. The five-year
I. FINANCING OF PRIVATE BIOTECHNOLOGY COMPANIES: $75.6M Company Location Date Amt. (M) Investors Argonex Inc. Charlottesville, Va. 6/2 $7.5 Argonex raised $7.5M from lead investor (1st round) Healthcare Ventures LLC and other (un- named) venture capital investors Atugen Biotech- Berlin 6/16 $7 Atugen Biotechnology was formed by nology GmbH Ribozyme Pharmaceuticals Inc.; invest- (start-up funding) ments of $50M over the next 5 years will come from the private sector, led by
LONDON - Pregnant women who undergo amniocentesis to find out whether they are carrying a fetus affected by Down's syndrome or other chromosomal disorders spend up to three weeks anxiously waiting the result of the test. Now a new test, which can provide results within a day, has been shown to be 100 percent accurate in detecting Down's syndrome. As well as speeding up the process, the new technique paves the way for tailor-made antenatal diagnosis of chromosomal disorders. Whereas all