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According to the Pharmaceutical Research and Manufacturers of America, as of 1993, 124 cancer drugs were in some stage of development at 49 pharmaceutical companies and the National Cancer Institute. The report was based on an NCI survey.

ROCKVILLE, Md--The FDA has denied a request by CellPro, Inc. (Bothell, Wash) to approve its cell sorting device Ceprate SC, used investigationally to purify bone marrow or peripheral blood autografts by concentrating CD34+ stem cells. The FDA has asked the company to provide additional information on the device.

NEW YORK--Two new studies show that the human immunodeficiency virus (HIV) wages a constant, near steady-state battle with the immune system--from the onset of infection throughout the course of the disease.

ROCKVILLE, Md--The FDA Oncologic Drugs Advisory Committee has recommended approval of two agents: Hoffmann-La Roche's Vesanoid (tretinoin, all-trans-retinoic acid) and Pharmacia Inc.'s Zinecard (dexrazoxane for injection).

NASHVILLE--An experimental high-speed clinical cell selection device has been shown to be capable of isolating a pure population of hematopoietic stem cells (HSCs), essentially free from cancer cells, and the machine's developer (SyStemix, Inc., Palo Alto, Calif) has received FDA allowance for an active IND (investigational new drug) for clinical testing of HSCs purified by cell selection in cancer patients who are undergoing transplantation.

WILMINGTON, Del--Zeneca Group PLC, London, the parent company of Zeneca Pharmaceuticals, has entered into an agreement to purchase a 50% interest in Salick Health Care, Inc., Los Angeles, a provider of health-care services to patients with cancer and other complex illnesses. It may be the first time a pharmaceutical company has purchased a health-care provider.

SAN ANTONIO--Gynecologic evaluation of women taking prophylactic tamoxifen (Nolvadex) should be restricted to patients with endometrial thickening that exceeds 8 mm and possibly to premenopausal women with amenorrhea, a British study suggests.

WASHINGTON--Samuel Broder, MD, director of the National Cancer Institute since 1989, has announced his resignation effective in April. He will become senior vice president and chief scientific officer at IVAX Corp., Miami.

CHICAGO--By creating a virtual reality environment, physicians in the not-too-distant future will be able to move through, around, and into a patient's airways to search for tumors, enlarged lymph nodes, and abnormal masses in the walls of the bronchi and surrounding tissue on a computer screen, David J. Vining, MD, predicted at the annual scientific meeting of the Radiological Society of North America.

The second part of this three-part series discusses the various types of fraud and abuse laws, reviews the laws on false claims, and provides suggestions for limiting a physician's exposure to fraud and abuse claims. Part 1, which appeared in the January, 1995, issue of Oncology News International (page 18), discussed the Stark statute, which prohibits self-referrals for certain services covered by Medicare and Medicaid, while the final article will review the Medicare and Medicaid anti-kickback statute.

ELK GROVE VILLAGE, Ill--SoloPak Pharmaceuticals, Inc. has signed an agreement with Sloan-Kettering Institute for Cancer Research to acquire the exclusive worldwide rights to gallium nitrate (Ganite), which was FDA approved in 1991 for the treatment of acute hypercalcemia in cancer patients and had been manufactured by Fujisawa USA (Deerfield, Ill).

NEW YORK--Yogi Berra had the last word at a panel discussion on health-care reform sponsored by the Medical Society of the State of New York. Television talk show host Larry King moderated the discussion and fielded the caustic remarks of doctors, pharmacists, and medical students who packed a Waldorf-Astoria ballroom to debate whether quality medical care can be maintained under health-care reform.

DALLAS--Two pediatricians at The University of Texas Southwestern Medical Center at Dallas have established the Umbilical Stem Cell Project to procure, test, and store human umbilical cord and placental blood for use as an alternative to bone marrow in allogeneic transplant patients who lack a related compatible marrow donor.

WEST CONSHOHOCKEN, Pa--The Medicines Control Agency, the regulatory agency for the United Kingdom, has granted a product license for the marketing of Ethyol (amifostine), manufactured by U.S. Bioscience, Inc.

NEW YORK--Health-care professionals treating pain are hindered by the lack of an objective way to measure pain, says Johns Hopkins researcher Fannie Gaston-Johansson, DrMedSc, who has introduced a new device that may help the situation (see figure).

NEW YORK--Despite its aim of cost containment, health-care reform threatens to increase the economic toll of pain because it may encourage undertreatment, Daniel Carr, MD, said at a media briefing on pain, sponsored by the American Medical Association and Ortho-McNeil Pharmaceutical Corp.

WASHINGTON--Samuel Broder, MD, head of the National Cancer Institute (NCI) for the past 5 years, says that he will resign his post in April of this year. He will join IVAX Corporation (Miami), a manufacturer of generic drugs and IV drug delivery devices, where he plans to work on developing new drugs.

LISBON, Portugal--Doxorubicin coupled with cisplatin (Platinol) confers a distinct survival edge over the anthracycline alone in women with advanced inoperable or recurrent endometrial carcinoma, according to the latest findings of the Gynaecological Cancer Cooperative Group (GCCG) of the European Organization for Research and Treatment of Cancer (EORTC).

BETHESDA, Md--As expected, the number of reported AIDS cases increased substantially in 1993 due to the expansion of the surveillance case definition in January of that year, but an adjusted analysis shows only a slight overall increase.

LISBON, Portugal--Recent evidence linking low-grade gastric lymphoma with chronic Helicobacter pylori infection, which is said to trigger antigenic stimulation and lymphoid cell invasion of the stomach mucosa, has raised the provocative question of whether eradication of H. pylori infection can cure gastric lymphoma.

WASHINGTON--The US Court of Appeals for the Federal Circuit has ruled in favor of Burroughs-Wellcome, the manufacturer of zidovudine (Retrovir or AZT), on five of six patents that had been challenged by two pharmaceutical companies hoping to win the right to produce a generic version of the drug. The ruling should provide the company with a monopoly on zidovudine until the year 2005.

Investigators at the University of California, San Diego (UCSD) School of Medicine have discovered a second pathway that the Ras proto-oncogene uses to cause cancer. The work sets the stage to develop new approaches for cancer treatment by

LONDON, UK--As Oncology News International (ONI) went to press, we received news that Zeneca Group PLC has agreed to buy a 50% interest in Salick Health Care, Inc (Los Angeles). The agreement is subject to shareholder approval and US regulatory review, the company said.

GENEVA, Switzerland--A newly established United Nations AIDS program based in Geneva has announced plans to initiate large-scale clinical trials of two HIV vaccines as early as mid-1996, probably in Brazil and Thailand. Dr. Peter Piot, chief of research at the World Health Organization's Global Program on AIDS, will head the new group, which will involve six UN agencies.