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Companies
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Biotechnology Companies
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Written by Hugh McManus
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Warning: mktime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 119
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 247
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 251
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Thursday, 13 May 2010 02:59 |
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It's very possible that the fibromyalgia drug, JZP-6, from Jazz Pharmaceuticals may face an FDA review panel. The drug has a PDUFA date of October 11, so it could face a review between mid-July to mid-August at the latest. Jazz Pharmaceuticals is an emerging company in the Bay Area of California. It recently announced a public offering of 7 million shares of common stock to be priced at $8.35 a share. The stock has preformed well over the last twelve months, rising from below a dollar (about eighty cents) to a recent high of almost $14. The company closed on Wednesday at $8.65. The company has two marketed products and four active clinical programs. JZP-6 for fibromyalgia is furthest along. On February 28, 2010, the company reported that the FDA had accepted its NDA which was reported as submitted on December 15, 2009 and that it had a PDUFA date of October 11. It echoed previous reports that two successful phase III trials were completed on JZP-6. Looking at the schedule of upcoming meetings, I think it's likely that the drug could face a review panel in mid-July. A positive outcome could give the drug a boost; if the committee concurs that both phase III trials gave meaningful results and there are no safety or potential abuse issues with the drug, it could likely be approved in October. The stock could move to between $12 and $16 a share. |
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Biotechnology Companies
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Written by Hugh McManus
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Warning: mktime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 119
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 247
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 251
Warning: strftime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 252
Thursday, 13 May 2010 02:35 |
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Shares of Achillion Pharmaceuticals, an emerging pharmaceutical company based in New Haven, CT, took a nice jump today base on an early clinical success with its hepatitis C drug. If the company successfully develop and marketed an approved drug, the stock would be worth over $70 a share: a nice jump from $2.70, where it closed today. The company has a long way to go before it can celebrate. Hepatitis C is an infectious viral disease which affects the liver. The virus is spread in a manner similar to HIV. While reports claim it is slightly less infectious, the incidence of hepatitis C infection is much higher. There are estimates that as many as twenty million people in the US carry this virus. Most infected people exhibit few if any symptoms for many years. In fact, it can take over twenty to thirty years before major symptoms start to appear. Fibrosis (scarring) of the liver usually occurs first, followed in many cases by the cirrhosis and the onset of liver disease, which may lead to liver cancer or complete liver failure. Currently the standard of care is peginterferon alfa-2a or -2b and the pro-drug Reterol (Schering Plough) which is also sold as Copegus by Roche. Over three hundred drugs are in development for the hepatitis C market. About 150 companies have developmental or clinical programs for this indication. The report from Achillion was from preliminary data in a Phase 1 clinical trial on ACH-1625 a protease inhibitor. Pharmacokinetic studies show rapid partitioning to the liver; the drug has been demonstrated as potent at low (nanomolar) concentrations to the hepatitis C virus (HCV); the company also reports that the drug has no serious toxicity issues. The clinical trial is taking place in Europe, so no information is available on www.clinicaltrials.gov. The company has given periodic reports on the progress of the drug. The trial is designated as Phase 1b—safety with efficacy data. The dosing ranges from 50 to 2000 mg: typical doses for antiviral drugs are really high: 2000 mg is two grams—approximately the same mass as to M&M's. The results reported on Wednesday showed that the group dosed with either 200 mg or 600 mg of the drug showed a measurable drop in viral load. These results are good, but the company has a long way to go. It will have to work on a number of successful phase II clinical studies, long-term toxicity studies and at least two successful phase III trials. If the news continues to get better, the stock will rise; however, as a result of the HCV data, I don't expect any major surge in the stock in the near term. We're at least three to five years away from knowing if this company has a drug. Things are looking good, but fundamental questions remain to be answered. |
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Biotechnology Companies
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Written by Hugh McManus
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Warning: mktime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 119
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 247
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 251
Warning: strftime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 252
Tuesday, 11 May 2010 12:15 |
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Cell Therapeutics is going to hold a board meeting this Friday, May 14. It's the second attempt to hold a meeting. On April 9, the shareholder meeting collapsed for lack of a quorum. Cell Therapeutics is an emerging pharmaceutical company based in Seattle, Washington. The company was once a high flyer, with its share price surging into the stratosphere. Today the company is fighting for its survival. The meeting on Friday will be a request by the board to amend the articles of incorporation and allow them company to further dilute its shares, increasing the number authorized by 50%. With these extra four hundred million shares, the company hopes to raise cash to survive. At the current share price, accounting of the dilutive effect, etc., the company would be lucky to raise $20 to $30 million: it's a tough market out there, even for excellent companies; CTIC is going to find it really, really, tough. It generated a loss of around $44 million in the most recent quarter. The problems started on April 9, when the FDA turned down its NDA application requesting an additional clinical trial. It's a problem, but if the company can put together another convincing trial, it may be able to scrape through the approval process. For now, I think CTIC is to be avoided. If the company behaves like wounded biotechs in a similar situation, there will be ample opportunities to buy the stock at depressed prices in the coming months. If it can pull off a successful Phase III trial and successful refile, CTIC could be a buying opportunity some time in the future. I'll keep watching the company. |
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Biotechnology Companies
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Written by Hugh McManus
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Warning: mktime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 119
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 247
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 251
Warning: strftime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 252
Monday, 10 May 2010 17:52 |
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Nymox reported good safety data for its lead drug, NX-1207, which is about to enter Phase III. The lead drug, NX-1207, targets benign prostatic hyperplasia—an enlarged prostate—a common ailment in older males. The company has successfully completed trials in phase I and II; today, it reported, that on safety data as preparations are underway for the investigational drug to enter phase III clinical trials. The company reported no significant safety concerns for the program. Patient recruitment for two trials continues. The first trial is designated as NX02-0017 www.clinicaltrials.gov/ct2/show/NCT00918983?term=nymox&rank=1 The first trial has a tentative end date of August 2011. The control group will take a placebo administered intravenously. The experimental group will take a single intraprostatic injection of 2.5 mg NX-1207. The company hopes to recruit 500 patients. The second trial is designated as NX02-0018 www.clinicaltrials.gov/ct2/show/NCT00945490?term=nymox&rank=2 where recruiting started about six weeks later from the first appears to be a duplicate effort. The FDA requires two, successful (that is, meets the endpoint) clinical trials before approving a drug. Nymox is thinly traded, but may be worth considering as an investment closer to the conclusion of the current phase III trials. |
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Biotechnology Companies
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Written by Hugh McManus
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Warning: mktime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 119
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 247
Warning: date(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 251
Warning: strftime(): It is not safe to rely on the system's timezone settings. You are *required* to use the date.timezone setting or the date_default_timezone_set() function. In case you used any of those methods and you are still getting this warning, you most likely misspelled the timezone identifier. We selected the timezone 'UTC' for now, but please set date.timezone to select your timezone. in /hermes/bosnacweb08/bosnacweb08az/b29/ipw.wellbeyo/public_html/libraries/joomla/utilities/date.php on line 252
Monday, 10 May 2010 17:47 |
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The posts that follow provide a tenative schedule of meetings of the various FDA advisory committees. A definition of an advisory committee, which is sometimes referred to as a panel, is provided in the glossary. May 2010 Advisory Committee MeetingsMay 11 - Dental Products Panel
May 12 - Joint Meeting of the Arthritis Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committees
May 13-14 - Neurological Devies Panel
May 17 - Science Board to the Food and Drug Administration
May 19 - Ear, Nose, and Throat Devices Panel
May 20-21 - General and Plastic Surgery Devices Panel
May 27 - Endocrinologic and Metabolic Drugs Advisory Committee
May 27 - Circulatory System Devices Panel June 2010 Advisory Committee MeetingsJune 2 - Antiviral Drugs Advisory Committee
June 8-9 - Tobacco Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee
June 9-10 - Orthopaedic and Rehabilitation Devices Panel
June 10 - Peripheral and Central Nervous System Drugs Advisory Committee
June 16-17 - Clinical Chemistry and Clinical Toxicology Devices Panel
June 17 - Advisory Committee for Reproductive Health Drugs
June 17-18 - Gastroenterology-Urology Devices Panel
June 18 - Advisory Committee for Reproductive Health Drugs
June 21-22 - Pediatric Advisory Committee
June 23 - Anesthesiology and Respiratory Therapy Devices Panel
June 24-25 - Ophthalmic Devices Panel
June 28 - Dermatologic and Ophthalmic Drugs Advisory Committee July 2010 Advisory Committee MeetingsJuly 8-9 - Hematology and Pathology Devices Panel
July 8-9 - Neurological Devices Panel
July 13 - Dental Products Panel
July 13-14 - Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committees
July 15 - Endocrinologic and Metabolic Drugs Advisory Committee
July 15-16 - Obstetrics and Gynecology Devices Panel
July 20 - Oncologic Drugs Advisory Committee
July 21 - Radiological Devices Panel
July 22 - Device Good Manufacturing Practice Advisory Committee
July 22-23 - Joint Meeting of the Anesthetic and Life Support Drugs and Drug Safety & Risk Management Advisory Committees
July 26-27 - Blood Products Advisory Committee
July 28 - Cardiovascular and Renal Drugs Advisory Committee
July 28-29 - General Hospital and Personal Use Devices Panel
July 29 - Cardiovascular and Renal Drugs Advisory Committee
July dates to be announced - Tobacco Products Scientific Advisory Committee August 2010 Advisory Committee MeetingsAugust 12-13 - General and Plastic Surgery Devices Panel
August 16 - Science Board to the Food and Drug Administration
August 19 - Anesthetic and Life Support Drugs Advisory Committee
August 19-20 - Risk Communication Advisory Committee
August 25 - Ear, Nose, and Throat Devices Panel
August 25-26 - Antiviral Drugs Advisory Committee September 2010 Advisory Committee MeetingsSeptember 1 - Oncologic Drugs Advisory Committee
September 2 - Oncologic Drugs Advisory Committee
September 7 - Anti-Infective Drugs Advisory Committee
September 9-10 - Gastroenterology-Urology Devices Panel
September 14 - Dental Products Panel
September 14 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Nonprescription Drugs Advisory Committee
September 15 - Radiological Devices Panel
September 15 - Anesthesiology and Respiratory Therapy Devices Panel
September 15 - Immunology Devices Panel
September 15-16 - Endocrinologic and Metabolic Drugs Advisory Committee
September 15-16 - Cellular, Tissue and Gene Therapies Advisory Committee
September 15-16 - Vaccines and Related Biological Products Advisory Committee
September 16 - Device Good Manufacturing Practice Advisory Committee
September 17 - Cardiovascular and Renal Drugs Advisory Committee
September 20-21 - Pediatric Advisory Committee
September 23 - Circulatory System Devices Panel
September 23 - Microbiology Devices Panel October 2010 Advisory Committee MeetingsOctober 5-6 - Molecular and Clinical Genetics Panel
October 7-8 - Neurological Devices Panel
October 13-14 - Orthopaedic and Rehabilitation Devices Panel
October 20-21 - Clinical Chemistry and Clinical Toxicology Devices Panel
October 21-22 - Hematology and Pathology Devices Panel
October 21-22 - Obstetrics and Gynecology Devices Panel
October 26 - Allergenic Products Advisory Committee
October 28-29 - Transmissible Spongiform Encephalopathies Advisory Committee
October 28-29 - Ophthalmic Devices Panel
October dates to be announced - Anti-Infective Drugs Advisory Committee November 2010 Advisory Committee MeetingsNovember 3-4 - Ear, Nose, and Throat Devices Panel
November 4-5 - General and Plastic Surgery Devices Panel
November 8-9 - Risk Communication Advisory Committee
November 10 - Anesthesiology and Respiratory Therapy Devices Panel
November 15 - Science Board to the Food and Drug Administration Advisory Committee
November 17 - Radiological Devices Panel
November 17-18 - Science Advisory Board to the National Center for Toxicological Research
November 17-18 - Vaccines and Related Biological Products Advisory Committee
November 17-18 - General Hospital and Personal Use Devices Panel
November 18-19 - Blood Products Advisory Committee
November 18-19 - Cellular, Tissue and Gene Therapies Advisory Committee
November 18-19 - Ophthalmic Devices Panel
November dates to be announced - Tobacco Products Scientific Advisory Committee
November dates to be announced - Gastrointestinal Drugs Advisory Committee December 2010 Advisory Committee MeetingsDecember 1 - Oncologic Drugs Advisory Committee
December 1-2 - Orthopaedic and Rehabilitation Devices Panel
December 2 - Oncologic Drugs Advisory Committee
December 2-3 - Gastroenterology-Urology Devices Panel
December 6 - Immunology Devices Panel
December 6-7 - Pediatric Advisory Committee
December 8 - Cardiovascular and Renal Drugs Advisory Committee
December 8-9 - Circulatory System Devices Panel
December 9-10 - Neurological Devices Panel
December 16-17 - Obstetrics and Gynecology Devices Panel |
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