BETHESDA, Md. -- A Food and Drug Administration advisory board on Monday unanimously recommended approval of Schering-Plough Corp.'s Intron A for treatment of patients with both chronic active and chronic persistent hepatitis B. Intron A is an interferon alpha-2b recombinant made from E. coli bacteria. Schering and the FDA will have to resolve several labeling issues before approval is granted, said Douglass Given, Schering's vice president for regulatory affairs. FDA approval should be
Following on its "quiet filing" for an initial public offering earlier this month (see BioWorld, Nov. 5), Genta Inc. on Monday said it will offer 2.5 million shares of common stock at a proposed price of $9 to $11 per share. Genta of San Diego is developing antisense oligonucleotides. Montgomery Securities and Alex. Brown & Sons Inc. are underwriting the offering. (c) 1997 American Health Consultants. All rights reserved.
Gregory B. Lawless, president and chief operating officer of Chiron Corp. since March 1989, is leaving the company as part of its executive reorganization under the planned merger with Cetus Corp., the companies announced Monday. When the merger was disclosed in July, it had been announced that Lawless, 51, would retain his positions in the combined organization following the planned merger on Dec. 16. Hollings Renton, president and chief operating officer of Cetus, will retain those titles at
Genetic Therapy Inc. on Monday announced a series of collaborative agreements with Sandoz Pharma Ltd. to develop and commercialize gene transfer technology in the areas of immunology/inflammation, cancer and cardiovascular disease. The companies will develop products based on GTI's gene therapy system to deliver genes into target cells using viral vectors. The ultimate goal is in vivo therapy, or the introduction of genes directly into the body to be incorporated into target cells. In the
Another influential voice was added Monday to the growing consensus that biotech stocks have peaked. Merrill Lynch chief market analyst Robert Farrell told the company's annual economic and investment outlook press conference that the music has changed for biotech stocks, indicating that the market as a whole has reached either an intermediate or a cyclical peak. In an interview with BioWorld, Farrell said he expects biotech stock prices to decline through mid-1992. "It's a tough call to say
Alza Corp. announced Monday that it has received marketing approval from Germany, the United Kingdom and Luxembourg for Actisite tetracycline fiber to treat periodontal disease. Actisite consists of a polymer fiber that releases the antibiotic tetracycline. The fiber is wrapped around the tooth and non- surgically inserted below the gum line for the duration of the treatment, after which it is removed. Actisite was developed jointly with On-Site Therapeutics Inc. of Wayland, Mass. The drug has
Led by two strong IPOs, biotech companies last week claimed $223 million from the public offering market, indicating that investor appetite for the stocks hasn't been sated despite the broad sell-off just a week earlier. Cytel Corp. on Friday said that it raised $52 million in a 4 million-share initial public offering priced at $13 per share. The offering was increased by 1 million shares. Cytel (NASDAQ:CYTL) closed unchanged Friday at $13.88. Earlier in the week, ImClone Systems Inc. brought
Alza Corp. shares emerged unscathed on Friday, rising 13 cents to $79.50, following the company's announcement that it and its marketing partner Marion Merrell Dow Inc. are being sued for patent infringement by Elan Corp. plc and American Cyanamid Co. The suit, filed last Wednesday in U.S. District Court in San Francisco, alleges that Alza (AMEX:AZA) and MMD are infringing U.S. patent No. 4,943,435. The '435 patent, issued to Pharmetrix Corp. of Menlo Park, Calif., contains claims for a
Researchers at two drug companies have devised a non-peptide inhibitor of substance P, a neurotransmitter implicated in sending pain messages to the brain, that they suggest could lead to a new class of pain blockers and other drugs. In addition to its possible role in pain, substance P, a short peptide of 11 amino acids, may help regulate the immune system and can cause other biological effects, such as inflammation. Its three receptor types have been cloned, but the peptides designed so far
Biomerica Inc. said it will begin clinical trials of two kits that identify people likely to develop diabetes. The tests measure antibodies against insulin and against the islet cells of the pancreas that make insulin. The kits could allow doctors to test the close relatives of diabetics to see if they are at risk, several years before they would actually develop the disease. During testing, the kits will be marketed for research use. Joseph Irani, company president, said Biomerica has
A Delaware Chancery Court last week heard arguments on a motion for a preliminary injunction filed by Eastman Kodak Co. against Cetus Corp. According to a Cetus spokeswoman, Judge Carolyn Berger did not say when she would rule. Kodak of Rochester, N.Y., is seeking to block the transfer of Cetus' polymerase chain reaction technology to Hoffmann-La Roche. Emeryville, Calif.-based Cetus is selling the technology for $300 million as part of its merger with Chiron Corp. In its August suit, Kodak
Genzyme Corp. announced Friday that it has licensed from Behringwerke AG the patent rights and technology for the manufacture, distribution and sale of a direct amylase substrate. The substrate is used as a diagnostic reagent for assaying alpha amylase to determine pancreatic function. Genzyme said the direct method of amylase testing is an improvement over the blocked substrate, two-enzyme alpha amylase method it has sold since 1985. The new method will be introduced in 1992 and will gradually
Gensia Pharmaceuticals Inc. said Friday that its wholly owned subsidiary, Gensia Laboratories Ltd., has received abbreviated new drug application approvals from the Food and Drug Administration for intravenous gentamicin in two dosage strengths. Gentamicin is a broad spectrum antibiotic for treating infections associated with sepsis and Staphylococcus aureus. Gensia Laboratories, which manufactures generic injectable drugs, now has 12 approved ANDAs covering eight ANDA products. Shares of San
Jay D. Glass, Ph.D., a director at Cortex Pharmaceuticals Inc., has been named interim president and chief executive officer of the company following the resignation of Vaughan H.J. Shalson. The company said Shalson resigned for personal reasons. Cortex also said Senior Vice President Raymond T. Bartus, Ph.D., has been promoted to executive vice president and chief operating officer. Cortex (NASDAQ:CORX) of Irvine, Calif., is developing products for the treatment and diagnosis of age-related
Texas Biotechnology Corp., a Houston-based start-up focusing on cardiovascular disease, has netted $19 million in a first round of financing from private investors. The financing was put together by New York investors David and Isaac Blech, and was typical of their deals, which avoid venture capital and raise sums sufficient to enable companies to operate for several years. The Blechs helped form Icos Corp., which last year raised a record $33 million in start-up financing. Texas Biotech is
Elan Corp. plc and American Cyanamid Co. have filed a patent suit against Alza Corp. and Marion Merrell Dow Inc., alleging infringement of U.S. patent No. 4,943,435 relating to a transdermal nicotine system. The patent, which was issued to Menlo Park, Calif.-based Pharmetrix Corp., was assigned to Elan of Athlone, Ireland. According to an announcement by Alza and MMD, Elan and its licensee, American Cyanamid of Wayne, N.J., filed the suit in U.S. District Court in San Francisco on Wednesday
Procyte Corp. has received notice from the Patent and Trademark Office that a U.S. patent will issue in 1992 to cover use of its copper-peptide compounds within the body, the Kirkland, Wash., company said Thursday. The company already has patents on the topical application of the compounds for wound healing. Phase II studies of Procyte's Iamin in diabetic wound healing at 15 medical centers are expected to end by early next year. An independent investigator is conducting an initial study of the
U.S. Bioscience Inc. continued its upward march on Thursday, finishing at $62.75, up $6 on the day and up 58.4 percent in the past three days. On Tuesday, the West Conshohocken, Pa., company (AMEX:UBS) announced that the Food and Drug Administration will review the company's Ethyol product, which protects normal cells from chemotherapy. Shares of ImmuLogic Pharmaceutical Corp. rose $2.50 to $19.75, reflecting Wednesday's announcement of a major collaboration with Marion Merrell Dow Inc. to
Allelix Biopharmaceuticals Inc. said it is filing for an initial public offering of shares in Canada and Europe, with shares to be offered In the United States as a private placement. Under Canadian regulations, no price range or share amount is announced at filing. Burns Fry Ltd., ScotiaMcLeod Inc. and Richardson Greenshields of Canada Ltd. will underwrite the offering. Allelix of Mississauga, Ontario, is developing biopharmaceuticals for tissue repair and inflammation. Before the offering
Roberta Friedman, Ph.D. Special to BioWorld Researchers associated with Gliatech Inc. have demonstrated the anti-scarring effects of a carbohydrate polymer, which inhibited in spinal surgery on rats the formation of fibrous tissue that can cause adhesions and pain at surgical sites. Gliatech scientist Jerry Silver, who is also on the faculty at Case Western Reserve University, and colleagues used GL402 in a rat model of spinal surgery. When applied to the site of surgery, GL402 nearly
BETHESDA, Md. -- A Food and Drug Administration advisory board on Monday unanimously recommended approval of Schering-Plough Corp.'s Intron A for treatment of patients with both chronic active and chronic persistent hepatitis B. Intron A is an interferon alpha-2b recombinant made from E. coli bacteria. Schering and the FDA will have to resolve several labeling issues before approval is granted, said Douglass Given, Schering's vice president for regulatory affairs. FDA approval should be