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Clinical Trial

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LIVING
May 24, 1999 | By Huntly Collins, INQUIRER STAFF WRITER
For two days after he was born, Brandon Joseph Ross was constantly feeding at his mother's breasts. But try as he would, he couldn't make his lips form a seal around her nipples, and little of her protein-rich milk ever reached his belly. With his weight rapidly dropping, his parents were concerned. On the morning of May 14, Susan and David Ross decided to try a radical new way to feed their son - at least from an American perspective. Sitting in a chair next to her bed in the maternity ward at Pennsylvania Hospital, Susan Ross swaddled her new baby in a cotton cloth and gently lifted a small stainless-steel cup to his lips.
NEWS
February 12, 2004 | By Walter F. Naedele INQUIRER STAFF WRITER
Colleen Jacoby last spoke to Traci Johnson on Friday, the night before Johnson is reported to have committed suicide. "On the phone, she was laughing, she was happy," Jacoby said of her call from Northeast Philadelphia to her best friend in Indianapolis. At 9 p.m. Saturday, a doctor at Indiana University Hospital pronounced Johnson dead, a suicide, according to an incident report from the Indianapolis Police Department. Johnson, 19, a 2002 graduate of Bensalem High School, had been found hanging by a scarf from a bathroom shower rod in the Lilly Laboratory for Clinical Research.
BUSINESS
July 21, 2005 | By Linda Loyd INQUIRER STAFF WRITER
Shares of Neose Technologies Inc. tumbled nearly 20 percent yesterday after the company said the Food and Drug Administration had placed a hold on a key clinical trial of its experimental anemia drug. The Horsham-based biopharmaceutical company recently filed an investigational new-drug application for NE-180, a potential treatment for anemia caused by chemotherapy. Neose announced late Tuesday, after the stock market had closed, that the FDA has placed the proposed Phase 1 clinical trial on hold.
BUSINESS
November 3, 2010 | By Mike Armstrong, Inquirer Columnist
   All eyes may be on General Motors Co.'s efforts to drive 365 million shares into the hands of the public at a guesstimated $26 to $29 per share in an initial public offering.    But a much smaller pending IPO for a Philadelphia-area life-sciences firm caught my attention.    If Cutanea Life Sciences Inc. succeeds in selling 2.3 million shares for between $6 and $7 per share, it would be the third IPO for a Philadelphia-area health-care company in 2010.    Based in Malvern, Cutanea is a virtual company that in-licenses compounds from other companies.
BUSINESS
July 12, 2006 | By Linda Loyd INQUIRER STAFF WRITER
Shares of Neose Technologies Inc. sank yesterday after the company said U.S. regulators have additional questions about development of its key drug and continued to place a hold on an early-stage clinical trial. The Food and Drug Administration has raised new questions about the stability testing of its experimental anemia treatment, NE-180, further delaying the start of a human study that has been held up since last July. The Horsham company said the FDA raised questions about the reliability of the potency test used to measure the stability of the product, a potential treatment for anemia, a deficiency in red blood cells, caused by chemotherapy.
NEWS
October 8, 2014 | By Marie McCullough, Inquirer Staff Writer
More than a decade after prostate cancer became the economic driver behind proton beam therapy in the U.S., it still isn't clear that men treated with the technology do better than those who get less costly radiation treatments. That's why expert groups have recently advised against insurance coverage of proton therapy for prostate cancer - and why some private plans are refusing to pay for it. The Catch-22 is that this pullback is hampering a clinical trial co-led by the University of Pennsylvania that would finally settle the question of superiority.
NEWS
August 26, 2008
Your articles "Merck faces more criticism" (Inquirer, Aug. 19) and "Journal vs. the bad seed" (Aug. 20) drew the wrong conclusion. The Advantage study was published by the Annals of Internal Medicine in 2003 after passing the journal's editorial and peer-review process that determined the study to be important new information for physicians. Dr. Harold Sox recently wrote in Annals that the way to identify a good clinical trial is to look at the importance of the scientific question it tries to answer.
NEWS
January 5, 2002 | By Stacey Burling INQUIRER STAFF WRITER
Sixty days after he received an artificial heart at Hahnemann University Hospital, James Quinn was doing well enough that the staff is planning his transfer to a private nursing facility nearby, the hospital announced yesterday. When Quinn was chosen to be part of a limited trial of the new, completely implantable device, doctors estimated that he had a 70 percent chance of dying of heart failure within a month. Designers of the clinical trial defined a successful outcome as 60 days of survival with improved quality of life, the hospital said.
BUSINESS
August 29, 2006 | By Linda Loyd INQUIRER STAFF WRITER
Cellegy Pharmaceuticals Inc. said yesterday that a Nigeria-based study of its product to prevent HIV infection has been stopped because of a lack of convincing evidence that the microbicide gel protects against HIV. The announcement was the latest bad news for the small Huntingdon Valley firm. In July, U.S. regulators informed Cellegy that its ointment Cellegesic was "approvable," but the agency wanted more evidence - another clinical trial - showing the nitroglycerin product was effective, before approving it for sale to treat pain associated with chronic anal fissures.
BUSINESS
September 28, 2006 | By Linda Loyd INQUIRER STAFF WRITER
Cellegy Pharmaceuticals Inc. said yesterday that it was selling its technology for several products to a British-based firm for $9 million, but will continue to develop one potential product, a contraceptive. ProStrakan Group P.L.C., a publicly traded company in Galashiels, Scotland, will acquire four Cellegy drug candidates and all related intellectual property. ProStrakan is Cellegy's marketing partner for two of the products in Europe. Cellegy, a small firm based in Huntingdon Valley, intends to remain a public company, with five employees, and will move next week to smaller offices in Quakertown.
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ARTICLES BY DATE
NEWS
November 9, 2014 | By Laura Weiss, Inquirer Staff Writer
Women, racial minorities, and people over 75 are underrepresented in the clinical trials that help determine the way all cardiac patients are treated, a study from Lankenau Medical Center researchers has found. This means that the recommendations that doctors use to treat heart problems may not be the best for all groups, said senior author Peter Kowey, head of Cardiology for Main Line Health. A team at Lankenau Heart Institute and Lankenau Institute for Medical Research laid out the disparities in a research letter published online by the Journal of the American Medical Association.
NEWS
October 8, 2014 | By Marie McCullough, Inquirer Staff Writer
More than a decade after prostate cancer became the economic driver behind proton beam therapy in the U.S., it still isn't clear that men treated with the technology do better than those who get less costly radiation treatments. That's why expert groups have recently advised against insurance coverage of proton therapy for prostate cancer - and why some private plans are refusing to pay for it. The Catch-22 is that this pullback is hampering a clinical trial co-led by the University of Pennsylvania that would finally settle the question of superiority.
NEWS
September 15, 2014 | By Paul Jablow, For The Inquirer
For the eight years since her diagnosis in 2006, drugs, surgery, and chemotherapy had kept Debra Hinkle's breast cancer at bay. But now, the conventional treatments were failing, and the disease was spreading. So when her oncologist decided it was time for the Bucks County woman to consider relatively untested therapies, she was more than willing. "I thought that if I didn't do a clinical trial now, maybe I wouldn't be able to later," said Hinkle, 54, who lives in Newtown Township and works as a software-development project manager.
BUSINESS
June 19, 2014 | By David Sell, Inquirer Staff Writer
Taxes, takeovers, and preschoolers are the topics of the moment with drugmaker Shire P.L.C., whose closing stock price reached an all-time high Monday. With official headquarters in low-tax Ireland and operations in Wayne, Exton, and Lexington, Mass., Shire is the subject of takeover speculation. That's largely due to a recent trend of health-care companies trying to buy smaller outfits registered in Ireland and other countries to avoid higher U.S. corporate taxes, a move known as a tax inversion.
NEWS
June 13, 2014 | By Jessica Parks, Inquirer Staff Writer
A Fort Washington woman is embarking on a 27-day hike to raise money and awareness about progeria, an extremely rare genetic mutation that causes premature aging and death. Amy Ruhf began planning the trip soon after meeting Phyllis Falcone, a fellow member of First Presbyterian Church of Ambler and the mother of two young boys with progeria. Nathan, 8, and Bennett, 5, are part of a clinical trial of a drug that may help slow the disease's progression. Their father said the treatment appears to be helping, but it is still taking a toll on their young bodies.
NEWS
March 9, 2014 | By Samantha Melamed, Inquirer Staff Writer
With surgery and chemotherapy, Roberta Bash, 67, of Downingtown beat advanced-stage ovarian cancer in 2010. Then, it came back. "Cancer can go dormant, and I didn't know that," she said. The second time, Bash wanted to explore all her options - including an experimental treatment at Penn Medicine that manipulates a patient's tumor cells to trigger an immune response. So, during her surgery last March, instead of allowing her tumor to be tossed out or donated for research, she saved it. The company StoreMyTumor, which markets itself as a concierge service for tumors, negotiated the tissue's harvest, processing, and cryopreservation.
NEWS
September 23, 2013 | By Bonnie L. Cook, Inquirer Staff Writer
  Evelyn Boss Cogan, 65, a professor at La Salle University, died Saturday, Sept. 14, of lung cancer at her home in Center City. Known to friends as Evie, she fought an eight-year battle with cancer and chronicled the experience in a 2013 article for Philadelphia Lawyer magazine. It started in 2005 with a bad cough, she wrote. After cancer was found in her right lung, a doctor told her to go home and get her affairs in order; she had six months to live. Undaunted, she sought out Corey Langer, a doctor at Fox Chase Cancer Center, who scheduled chemotherapy, radiation, and more chemo.
BUSINESS
October 14, 2012 | By David Sell, Inquirer Staff Writer
In a significant departure from industry practice, GlaxoSmithKline P.L.C., said it would make available to outside researchers the raw but anonymous patient data from clinical trials for drugs it has developed or discontinued, and its tuberculosis compound library. Pharmaceutical companies generally don't divulge such information, claiming that it is a proprietary secret. "As a truly global health care company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges," Glaxo chief executive Andrew Witty said in a statement.
BUSINESS
November 3, 2010 | By Mike Armstrong, Inquirer Columnist
   All eyes may be on General Motors Co.'s efforts to drive 365 million shares into the hands of the public at a guesstimated $26 to $29 per share in an initial public offering.    But a much smaller pending IPO for a Philadelphia-area life-sciences firm caught my attention.    If Cutanea Life Sciences Inc. succeeds in selling 2.3 million shares for between $6 and $7 per share, it would be the third IPO for a Philadelphia-area health-care company in 2010.    Based in Malvern, Cutanea is a virtual company that in-licenses compounds from other companies.
NEWS
July 19, 2010
Wayne-based Encorium Group Inc., which runs clinical trials and patient registries for pharmaceutical companies, announced today that it has acquired Swiss-based Progenitor Holdings AG, for euro 1.7 million (about $2.2 million). Progenitor has wholly owned subsidiaries in Mexico, Panama, Argentina, Chile, Switzerland, India and Hong Kong. Encorium said in a statement that the acquisition would give it access clinical trials being conducted in such emerging markets as Latin America, India and the Asia Pacific region.
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