UCI Extension will offer a new program in regulatory affairs this spring, starting with “Regulatory Requirements for Pharmaceutical Products,” an online class that will start March 31. Read the rest of this entry »
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 Archive for the 'Government regulation' CategoryUCI Extension program will help navigate U.S. biomedical regulationsFebruary 18th, 2008, 6:38 am by Colin StewartFDA turns back Botox rival Reloxin (update)January 31st, 2008, 7:13 am by Colin Stewart
The Food and Drug Administration has rejected the application for approval of the wrinkle-smoothing drug Reloxin, says drug maker Medicis Pharmaceutical Corp. of Scottsdale, Ariz. The denial, based on problems with paperwork the company submitted, doesn’t eliminate Reloxin from its position as the No. 1 potential rival to Botox as a wrinkle fighter. But Medicis said in a Securities and Exchange Commission filing that the move could delay the FDA’s eventual approval of it. Medicis had hoped to start selling Reloxin later this year, but now the company has to aim for a launch date sometime in 2009. An estimated five-month delay will mean the Irvine-based Allergan will sell about $30 million more Botox next year, says Wachovia Capital Markets analyst Larry Biegelsen. Both Reloxin and Botox are injectable versions of botulinum toxin, with similar effects against facial wrinkles according to doctors who have used both. The FDA said the application didn’t spell out Medicis’ responsibilities as manufacturer of the product, which is made by the French drug maker Ipsen. Medicis says it will work with the FDA and Ipsen promptly to resolve the issue so it can refile the application. In early trading this morning, Medicis shares dropped 13 percent, to $19.02. Allergan shares rose 5 percent, to $67.54. This post includes information from the Associated Press and Reuters. It was updated at 7:20 a.m. to include stock prices. Botox is much safer than scary headlines suggestJanuary 29th, 2008, 1:55 pm by Colin Stewart
Last week’s headlines about the possible dangers of Botox were scary:
My article in the O.C. Register and on the Register Web site does a better job than most — perhaps a better job than all others — at setting the record straight. “Blues for Botox? Cosmetic version of botulinum toxin has least serious health effects,” is our headline. It makes clear that the health problems reported in connection with injections of Botox and a similar treatment are primarily related to the more potent therapeutic uses of the drug, which can relieve muscle spasms, among many other ailments. Botox for cosmetic use is implicated in at most one 47-year-old woman’s death during its multi-year history. More likely no deaths. Read the rest of this entry » Edwards Lifesciences wins OK to expand heart-valve trialJanuary 29th, 2008, 8:14 am by Colin Stewart
Edwards Lifesciences of Irvine has moved one step closer to its goal of winning approval to sell two versions of its minimally invasive heart-valve replacement system in the United States. Edwards announced today that the U.S. Food and Drug Administration has given conditional approval to its plan for clinical trials of its Ascendra system, which implants a replacement aortic valve by means of a catheter that goes between the ribs and through the base of the heart. The Ascendra trial will be run as part of the ongoing clinical trial for the company’s RetroFlex system, which runs a catheter from a leg artery up to the heart. Both methods are designed to help patients who are too weak for open-heart surgery – an estimated 120,000 a year worldwide. The Ascendra system is for patients whose arteries are too narrow or clogged for the RetroFlex catheter to get through. Both systems are already on the market in Europe. For more on the status of minimally invasive heart-valve surgery (in Europe and in the United States, at Edwards and at CoreValve, via the ribs and via the leg), see my earlier column, “Irvine is HQ for heart valve warriors” and continuing coverage of developments at Edwards. See also my video of how the two systems work and the company’s explanations and videos. Broadcom chips will help with 2009 shift to digital TVJanuary 28th, 2008, 6:40 am by Colin Stewart
Irvine-based chip maker Broadcom announced today that its “system on a chip” is at the heart of an RCA converter box that converts old-fashioned analog TV broadcast signals to the new digital format. The RCA DTA800B device, available next month, is one of several that have been certified as eligible for $40 coupons that the National Telecommunications and Information Administration will distribute to households to ease the transition to digital. On Feb. 17 of next year, analog TV broadcasting is scheduled to end in the United States. For more information, call 1-888-CALL-FCC (1-888-225-5322) or visit the NTIA Web site. Viewers with analog TV sets can apply online for up to two coupons per household. Botox needs warning label because of toxin-related deaths, FDA told (update)January 24th, 2008, 8:15 am by Colin Stewart
Wrinkle-fighting Botox should be labeled with black-box hazard warnings, the advocacy group Public Citizen said today, citing 16 reported deaths and other serious problems after the weakened form of botulinum toxin that’s used in Botox spread inside patients’ bodies. In a petition, Public Citizen also told the Food and Drug Administation that the same warning should apply to Solstice Neuroscience Inc.’s Myobloc, a form of botulinum toxin that is approved as a treatment for rigid neck muscles. Irvine-based Allergan, which makes Botox, said in a statement that current labeling is adequate. “There are no safety issues raised in the petition that are not already addressed in the labeling for Botox,” the company said. Botox is the most widely used cosmetic medicine in the United States. As a wrinkle remover, it was injected more than 4 million times in 2006, according to the American Society of Plastic Surgeons. Read the rest of this entry » SenoRx launches breast-cancer device that limits radiation exposureJanuary 17th, 2008, 8:54 am by Colin Stewart
Eight months after winning approval from the Food and Drug Administration, SenoRx of Aliso Viejo has launched its Contura MLB system for catheter-delivered breast-cancer radiation. Contura is a partial-breast-radiation device, which reduces treatment time to five days from the more typical six- to eight-week span of traditional whole-breast radiation therapy. Partial breast irradiation is more convenient, obviously, and early clinical results are promising. But in the long term is it as effective as traditional whole-breast radiation at preventing the recurrence of breast cancer? That’s the subject of an ongoing 3,000-patient study by the National Surgical Breast and Bowel Project. (PDF file here describes the launch of that study.) The research, a cooperative effort started in 2005 by about 150 medical centers, will compare the effectiveness of partial and whole-breast radiation therapies. My June 2007 column about SenoRx describes a number of its breast-cancer treatment innovations. An accompanying video shows the workings of a new SenoRx device that uses ultrasound to position a biopsy probe accurately. ADVERTISEMENT
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