Tracleer and PPH News
FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs
By Peggy Peck, Senior Editor, MedPage Today
WASHINGTON, June 1-Pharmaceutical companies have completed only 42 of the 91 post-marketing studies required under the FDA's accelerated approval process, according to a report issued today by Rep. Edward J. Markey (D-Mass).
The incomplete studies include those for Celebrex (celecoxib), Gleevec (imatinib), and Iressa (gefitinib), said the report.
When the FDA grants accelerated approval it does so only on the condition that the drug maker agrees to conduct further studies to confirm safety and efficacy, a condition that Rep. Markey says both the FDA and drug companies are ignoring.
In the report, Markey cited Iressa as a textbook example of the value of timely post marketing studies. Iressa was approved in May 2003 on the basis of clinical trials that the FDA said demonstrated significant shrinkage in tumors in about 10% of non-small cell lung cancer patients treated.
In a statement issued December 20, 2004 the FDA said that evidence of tumor response "was thought likely to increase patients' overall survival time," which is why the drug received accelerated approval.
The FDA instructed the drug maker, AstraZeneca, to conduct post-marketing studies to confirm a survival benefit. But the post-marketing study in 1,700 patients demonstrated no overall survival advantage for Iressa, a finding the FDA announced December 17, 2004. (Some investigators say that they can identify by genetic testing the 10% of patients for whom Iressa is effective.)
That FDA announcement, "prevented patients from spending $1,800 a month for a drug that is ineffective," Rep. Markey said. Other Iressa post-marketing studies are pending.
Markey said 28 companies have committed to 91 post-marketing studies for 42 different drugs, but as of March 9, 2005, only 42 of the 91 studies were completed. Moreover, half of the remaining post-marketing studies have not even been started.
He lists 16 drugs that are awaiting confirmatory post-marketing studies: Alimta, Arimidex, Celebrex, Depocyt, Ethyol, Gleevec, Iressa, Luveris, Mylotarg, Proamatine, Remodulin, Sulfamylon, Synercid, Truvada, Velcade and Viread.
Finally, Markey faults the FDA for doing too little to inform the public about "which products were given full approval and which drugs are given conditional approval."
DENVER, Aug. 18, 2005 /PRNewswire-FirstCall/ -- Myogen, Inc. today announced positive top line results of its Phase 2b trial evaluating darusentan in resistant hypertension.
ALLSCHWIL, Switzerland, Aug. 16, 2005 (PRIMEZONE) -- Actelion Ltd. (Other OTC:ALIOF) (SWX:ATLN) announced today that the Journal of the American College of Cardiology (JACC) has published a new study that investigated the long-term outcome of children with pulmonary arterial hypertension (PAH) treated with the dual endothelin receptor antagonist Tracleer (bosentan) with or without concomitant prostanoid therapy.
LEXINGTON, Mass. & RAMAT GAN, Israel--(BUSINESS WIRE)--Aug 15, 2005 - Predix Pharmaceuticals, a drug discovery and development company, today announced the initiation of its first pivotal Phase III trial of PRX-00023, the company's novel 5-HT1A agonist, in patients with generalized anxiety disorder (GAD).
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 10, 2005 /PRNewswire-FirstCall/ -- United Therapeutics Corporation announced today that the European Union Mutual Recognition Procedure (MRP) has been completed for Remodulin (treprostinil sodium) Injection for the subcutaneous treatment of NYHA Class III Primary Pulmonary Hypertension patients.
ALLSCHWIL, Switzerland, Aug. 9, 2005 (PRIMEZONE) -- Actelion Ltd announced today the preliminary result of a double-blind, placebo-controlled, randomized, multi-center, 190-patient Phase III study, RAPIDS-2, with the dual endothelin receptor antagonist bosentan (Tracleer) in systemic sclerosis patients suffering from digital ulceration.
RESEARCH TRIANGLE PARK, N.C., Aug. 9, 2005 /PRNewswire-FirstCall/ -- Icagen, Inc. today reported financial results for the second quarter ended June 30, 2005. Revenues for the second quarter of 2005 totaled $1.7 million.
BOTHELL, Wash.--(BUSINESS WIRE)--Aug 4, 2005- ICOS Corporation today released its financial results for the three and six months ended June 30, 2005 and summarized recent events.
LEXINGTON, Mass. & RAMAT GAN, Israel--(BUSINESS WIRE)--Aug 3, 2005 - Predix Pharmaceuticals, a drug discovery and development company, today announced that it has filed a registration statement with the Securities and Exchange Commission (SEC) relating to the proposed initial public offering of primary shares of its common stock.
DENVER, Aug. 1, 2005 /PRNewswire-FirstCall/ -- Myogen, Inc. , a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today reported 2005 second quarter results.
LONDON, July 27, 2005 - On 27 July 2005 the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Revatio 20 mg film-coated tablets intended for treatment of patients with pulmonary hypertension.
HOUSTON, July 28, 2005 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced that it has completed the submission of a Marketing Authorization Application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) for Thelin (sitaxsentan) 100 mg as a once daily oral treatment for patients with pulmonary arterial hypertension (PAH).
ROCKVILLE, Md., July 26, 2005 - The Food and Drug Administration today posted on its website a warning letter sent to Actelion Pharmaceuticals over a Tracleer product page on the Actelion website.
LONDON, July 22, 2005 - The fifty-ninth meeting of the Committee for Orphan Medicinal Products (COMP) took place on 12-13 July 2005.
DENVER, July 21, 2005 /PRNewswire-FirstCall/ -- Myogen, Inc. , a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today announced the completion of enrollment of 187 patients in ARIES-2, one of the Company's two pivotal Phase 3 trials of ambrisentan in patients with pulmonary arterial hypertension (PAH).
NEW YORK, July 20, 2005 /PRNewswire-FirstCall/ -- Pfizer today reported financial results for the second quarter of 2005.
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jul 19, 2005 - Sepracor Inc. (Nasdaq: SEPR) today announced its consolidated financial results for the second quarter of 2005.
LEXINGTON, Mass. & RAMAT GAN, Israel--(BUSINESS WIRE)--Jul 13, 2005 - Predix Pharmaceuticals, a drug discovery and development company, has initiated the second of two Phase Ib multiple dose studies with PRX-03140, its highly selective, proprietary serotonin 4 (5-HT4) receptor agonist intended to treat Alzheimer's disease and other disorders of memory and cognition.
DENVER, June 26, 2005 /PRNewswire-FirstCall/ -- Myogen, Inc. today announced top line results of ESSENTIAL I & II, the Company's two Phase 3 trials of enoximone capsules in patients with advanced chronic heart failure (CHF).
LONDON, June 22, 2005--It is widely acknowledged that heart failure has reached epidemic proportions.
ALLSCHWIL, Switzerland, June 8, 2005 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) (Other OTC:ALIOF) announced today that Tracleer (bosentan) is now available upon prescription to all patients in Japan.
SOUTH SAN FRANCISCO, Calif., June 01, 2005 /PRNewswire-FirstCall/ -- CoTherix, Inc. announced today that it has initiated a Phase II trial for its marketed product, Ventavis (iloprost) Inhalation Solution, to potentially expand the indication to include pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF).
SAN FRANCISCO, June 01, 2005 /PRNewswire/ -- "While Genentech continued to impress with another excellent month, the whole sector performed well with hardly a negative number in sight," noted G. Steven Burrill, CEO of Burrill & Company, a San Francisco based life sciences merchant bank.
HOUSTON, May 25, 2005 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced that it has completed the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Thelin (sitaxsentan) 100 mg as a once daily oral treatment for patients with pulmonary arterial hypertension (PAH).
SAN DIEGO, Calif., May 23, 2005 /PRNewswire-FirstCall/ -- CoTherix, Inc. announced today that researchers have presented results involving inhaled iloprost therapy for the treatment of pulmonary arterial hypertension (PAH), a debilitating and potentially fatal disease characterized by high blood pressure in the pulmonary arteries.
SAN DIEGO - May 23, 2005 - Actelion Ltd (SWX: ATLN) announced that data from almost 5,000 Tracleer®-treated patients amounting to 3,416 patient-years of treatment were presented on Monday at the American Thoracic Society (ATS) meeting in San Diego.
HOUSTON, May 23, 2005 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today presented additional data from STRIDE-2, the Company's second randomized, pivotal Phase III clinical trial of Thelin (sitaxsentan) for the treatment of pulmonary arterial hypertension (PAH) at the annual International Conference of the American Thoracic Society (ATS) in San Diego.
DENVER, May 19, 2005 /PRNewswire-FirstCall/ -- Myogen, Inc. , a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today announced the initiation of a clinical trial to evaluate ambrisentan in patients with pulmonary arterial hypertension (PAH) who have previously discontinued bosentan or sitaxsentan therapy due to liver function test (LFT) abnormalities, specifically elevated serum aminotransferase concentrations.
ORLANDO, Fla.--(BUSINESS WIRE)--May 17, 2005 - OSI Pharmaceuticals (Nasdaq: OSIP) provided a second informational update summarizing highlights from presentations on Tarceva (erlotinib) made at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO) being held from May 14-17 in Orlando, Fla.
ORLANDO, Fla., May 13, 2005 /PRNewswire-FirstCall/ -- Genentech, Inc. and Roche (SWX Zurich) today announced that data from a Phase III study (E4599) of Avastin (bevacizumab) plus paclitaxel and carboplatin chemotherapies in first-line non-squamous, non-small cell lung cancer (NSCLC) showed the study met its primary efficacy endpoint of improving overall survival.
BERLIN, May 13, 2005 /PRNewswire-FirstCall/ --First results from the phase III CONFIRM 1 trial showed that PTK/ZK, a new oral targeted therapy designed to block the growth of blood and lymphatic vessels, demonstrated positive drug effects in patients with metastatic colorectal cancer combined with FOLFOX chemotherapy as first-line therapy. It was announced today by Schering AG (NYSE: SHR; FSE: SCH).
BALTIMORE, May 11, 2005 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. today announced the publication of results from the STRATEGY trial of AGGRASTAT Injection (tirofiban hydrochloride) in the Journal of the American Medical Association, (May 2005 - Vol. 293, No. 17 pgs. 2109 - 2117).
PARIS, May 10, 2005 /PRNewswire-FirstCall/ -- The sanofi-aventis Group announced today that important results from Eloxatin (oxaliplatin for injection) and Taxotere(docetaxel) Injection Concentrate clinical studies, including studies on colorectal, breast, lung, prostate and gastric cancer, will be presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).
BOTHELL, Wash.--(BUSINESS WIRE)--May 5, 2005 - ICOS Corporation (Nasdaq:ICOS) today released its financial results for the three months ended March 31, 2005 and summarized recent events.
CRANBURY, N.J.--(BUSINESS WIRE)--May 3, 2005 - Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) today announced that it has entered into a strategic commercialization and research and development alliance with Biovail Corporation (NYSE: BVF) and certain of its subsidiaries in the area of cardiovascular disease.
DENVER, May 02, 2005 /PRNewswire-FirstCall/ -- Myogen, Inc. , a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today reported 2005 first quarter results.
FREMONT, Calif., May 02, 2005 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) today reported a net loss of $83.9 million, or $0.87 per basic and diluted share, for the three months ended March 31, 2005, compared with a net loss of $12.6 million, or $0.13 per basic and diluted share, for the three months ended March 31, 2004.
HOUSTON, April 28, 2005 (PRIMEZONE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced financial results for the first quarter ending March 31, 2005.
MELBOURNE, Australia, April 27, 2005 /PRNewswire/ -- Up to 30 patients with advanced incurable solid-tumours are to be involved in clinical trials of a potent new anticancer drug (CYT997), developed by Australian biotechnology company, Cytopia Limited.
ROCKVILLE, Md., April 26, 2005 - The Food and Drug Administration today posted a warning letter sent to United Therapeutics Corporation about an advertisement for Remodulin.
MARLBOROUGH, Mass., April 25, 2005 /PRNewswire-FirstCall/ -- Sepracor Inc. today announced its consolidated financial results for the first quarter of 2005.
BASEL, Switzerland, April 21, 2005 – Commenting on the first-quarter results published today, Dr. Daniel Vasella, Chairman and CEO of Novartis, said, “We are off to a strong start in 2005. In Pharmaceuticals, we once more gained market share, especially through the dynamic performance of our oncology portfolio. Our plans to integrate Hexal and Eon Labs making Sandoz the world leader in generics are on track, and will further strengthen our ability to fulfill customer needs with a broad health-care portfolio in the context of an aging population and rising health-care needs. We anticipate delivering a competitive performance in 2005 with record sales and, on a comparable basis, record earnings.”
DENVER, April 19, 2005 /PRNewswire-FirstCall/ -- Myogen, Inc. , a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, today announced the completion of patient enrollment in DAR-201, the company's Phase 2b trial of darusentan in patients with resistant systolic hypertension.
NEW YORK, April 19, 2005 /PRNewswire-FirstCall/ -- Pfizer today reported financial results for the first quarter of 2005.
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Apr 18, 2005 - The results of an investigational study evaluating the effect of an antiemetic regimen including EMEND in the prevention of nausea and vomiting after chemotherapy in breast cancer patients were published today in the Journal of Clinical Oncology (JCO).
ROCKVILLE, Md., April 14, 2005 - The Food and Drug Administration today posted a letter on its website sent to United Therapeutics Corporation over advertisements for Remodulin
ALLSCHWIL, SWITZERLAND - 11 April 2005 - Actelion Ltd (SWX: ATLN) announced today that the Japanese Ministry of Health, Labor and Welfare has granted formal approval for Tracleer (bosentan) in Pulmonary Arterial Hypertension (PAH).
CEDAR KNOLLS, N.J., April 8, 2005 – Dimensional HealthCare (DHC), which specializes in the delivery of late-phase (IIIb/IV), community-based clinical trials for the pharmaceutical and medical device industries, has announced several changes that will further expand our ability to provide our clients with a high level of scientific expertise, while delivering creative and effective industry solutions through clinical research programs.
CHESHIRE, Conn., April 5, 2005 -- Researchers have identified a new clinical syndrome that produces serious and sometimes fatal symptoms in a variety of seemingly unrelated diseases.
WOBURN, Mass. & RAMAT GAN, Israel--(BUSINESS WIRE)--Mar 30, 2005 - Predix Pharmaceuticals, a drug discovery and development company, today announced the initiation of two Phase Ib multiple dose studies with PRX-03140, its highly selective, proprietary serotonin 4 (5-HT4) receptor agonist intended to treat Alzheimer's disease and other disorders of memory and cognition.
SOUTH SAN FRANCISCO, Calif. and BASEL, Switzerland, March 14, 2005 /PRNewswire-FirstCall/ -- Genentech, Inc. and Roche (SWX Zurich) today announced that an interim analysis of a Phase III study of Avastin (bevacizumab) plus paclitaxel and carboplatin chemotherapies in first-line non-squamous, non-small cell lung cancer (NSCLC) met its primary efficacy endpoint of improving overall survival, or a reduction in the risk of death, compared to chemotherapy alone.
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 10, 2005 /PRNewswire-FirstCall/ -- United Therapeutics Corporation announced today that the European Union Mutual Recognition Procedure (MRP) has been completed for Remodulin (treprostinil sodium) Injection for the subcutaneous treatment of NYHA Class III Primary Pulmonary Hypertension patients.
LONDON, July 27, 2005 - On 27 July 2005 the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Revatio 20 mg film-coated tablets intended for treatment of patients with pulmonary hypertension.
ROCKVILLE, Md., July 26, 2005 - The Food and Drug Administration today posted on its website a warning letter sent to Actelion Pharmaceuticals over a Tracleer product page on the Actelion website.
SAN DIEGO - May 23, 2005 - Actelion Ltd (SWX: ATLN) announced that data from almost 5,000 Tracleer®-treated patients amounting to 3,416 patient-years of treatment were presented on Monday at the American Thoracic Society (ATS) meeting in San Diego.
ROCKVILLE, Md., April 26, 2005 - The Food and Drug Administration today posted a warning letter sent to United Therapeutics Corporation about an advertisement for Remodulin.
ROCKVILLE, Md., April 14, 2005 - The Food and Drug Administration today posted a letter on its website sent to United Therapeutics Corporation over advertisements for Remodulin
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., March 08, 2005 /PRNewswire- FirstCall/ -- United Therapeutics Corporation announced today that AFSSAPS, the French drug regulatory agency, has issued an approval letter for Remodulin (treprostinil sodium) Injection for subcutaneous treatment of NYHA Class III Primary Pulmonary Hypertension patients.
PHILADELPHIA, February 28, 2005 /PRNewswire/ -- The Claims Facilitating Committee (CFC), announced today that lawyers representing nearly half of all claimants who have pending lawsuits against Wyeth related to the ingestion of diet drugs have agreed to recommend that their clients participate in the settlement process negotiated between Wyeth and the CFC.
ALLSCHWIL, Switzerland, Feb. 1, 2005 - Actelion Ltd (SWX: ALTN) announced today the publication of the scientific paper evaluating disease outcome of patients with advanced primary pulmonary arterial hypertension receiving Tracleer(bosentan).
CHICAGO--(BUSINESS WIRE)--Jan 31, 2005 - Fitch Ratings has affirmed Wyeth's 'A-' senior unsecured credit rating and 'F2' commercial paper rating.
DENVER, May 24, 2004 /PRNewswire-FirstCall/ -- Myogen, Inc. (NASDAQ:MYOG) , a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disorders, announced that Lewis Rubin, M.D. presented detailed results of AMB-220, the Company's Phase II safety and efficacy study of ambrisentan in patients with pulmonary arterial hypertension (PAH), at a mini symposium on "Emerging Therapies for PAH" at the American Thoracic Society (ATS) 2004 International Conference.
BEAUMONT, Texas, May 17, 2004 /PRNewswire/ -- The following was released today by Majority Counsel:
WESTON, Fla.--(BUSINESS WIRE)--Apr 30, 2004 - Coming on the heels of a Texas jury's $1 billion award to the family of a woman who died after taking one of the now banned phen-fen diet drugs, Freedland, Farmer, Russo & Sheller PL await a trial date for a strikingly similar case against Wyeth-Ayerst Laboratories.
West Sussex, England, April 28, 2004--Profile Therapeutics plc ("Profile"), which develops and commercialises specialist inhaled therapies, is pleased to announce that, as expected, it has received regulatory approval from the US Food and Drug Administration ("FDA") for its Prodose Adaptive Aerosol Delivery ("AAD ") system.
MADISON, N.J., April 27, 2004 /PRNewswire-FirstCall/ -- Wyeth (NYSE:WYE) said today it will appeal today's verdict in the case of Jerry Coffey (representing the estate of Cynthia Cappel-Coffey), et al. v. Wyeth, et al.
BEAUMONT, Texas, April 27 /PRNewswire/ -- The following was released today by Majority Counsel:
A Beaumont, Texas jury today returned a more than $1 billion verdict against Wyeth-Ayerst Laboratories in a landmark Fen-Phen trial. Experts predict that this outcome against drug-maker Wyeth will set the standard by which the company will be judged in the tens of thousands of Fen-Phen cases currently in the court system awaiting trial dates.
WESTON, Fla.--(BUSINESS WIRE)--March 22, 2004--After almost a decade of stories of death and illness, billions of dollars in settlements, and persistent fears about Phen-Fen's damaging effects on those who've used it, news is emerging about lingering health risks related to the once-popular diet drug.
ALLSCHWIL/BASEL, SWITZERLAND - March 2, 2004 - Actelion Ltd (SWX: ATLN) today announced its financial results for the year 2003. With net revenues of CHF 307.5 million (FY 2002: CHF 132.4 m) and operating expenses of CHF 309.2 million (FY 2002: 164.5 m), the company reported an operating loss of CHF 1.7 million (FY 2002 loss: 32.0 m), mainly the result of a one-time In-Process R&D charge, related to the acquisition of Axovan in late 2003.
WEST SUSSEX, Feb. 19, 2004 - Profile Therapeutics plc ('Profile'), which develops and commercialises specialist inhaled therapies, today announces that it has received positive opinion for Promixin from the respective regulatory authorities in eight of the fourteen markets in which it submitted, and therefore anticipates full regulatory approval in these markets over the coming months.
HOUSTON, Feb. 17, 2004 /PRNewswire-FirstCall/--Encysive Pharmaceuticals today announced the publication of an article titled "Sitaxsentan Therapy for Pulmonary Arterial Hypertension" in the February 15 issue of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine (AJRCCM) (Vol. 169, pp. 441-447).
BELMONT, Calif., Jan. 29, 2004 /PRNewswire/--CoTherix, Inc., announced today the addition of two senior management team members.
FLEMINGTON, N.J., Jan. 28, 2004--The FDA has granted Emphycorp Orphan Drug Designation for investigational drug N115 for the treatment of Cystic Fibrosis.
WEST SUSSEX, England, Jan. 8, 2004 - Profile Therapeutics plc ('Profile'), which develops and commercialises specialist inhaled therapies, is pleased to announce the following key highlights for the 6 months ended 31 December 2003:
HOUSTON, Nov. 10, 2003--Encysive Pharmaceuticals (Nasdaq:ENCY) today announced that data from its Phase IIb/III STRIDE (Sitaxsentan To Relieve ImpaireD Exercise) trial in Pulmonary Arterial Hypertension (PAH) was presented Sunday at the American Heart Association's Scientific Sessions 2003 in Orlando.
WEST SUSSEX, England, Oct. 24, 2003--Profile Therapeutics plc ("Profile"), which develops and commercialises specialist inhaled therapies, is delighted to announce the signing of an agreement with Schering Health Care Ltd. ("Schering"), a division of Schering AG.
BELMONT, Calif., Oct. 14, 2003-- /PRNewswire/ -- CoTherix, Inc. has acquired exclusive United States development and marketing rights to Ventavis (iloprost), a synthetic prostacyclin analogue for the treatment of primary pulmonary hypertension developed by Schering AG (FSE: SCH; NYSE: SHR).
BELMONT, Calif., Oct. 14, 2003-- /PRNewswire/ -- CoTherix, Inc., formerly known as Exhale Therapeutics, Inc., has closed its Series C round of financing, raising approximately $55 million.
BERLIN, Sept. 22, 2003 /PRNewswire-FirstCall/ -- Schering AG, Germany (NYSE: SHR; FSE: SCH) announced today that the European Commission in a Centralized Procedure approved Schering's new drug Ventavis(R) for marketing in all EU countries.
ALLSCHWIL/BASEL, Switzerland, Sept. 2, 2003 - Actelion Ltd (SWX: ATLN) today announced results of a study assessing its oral dual endothelin receptor antagonist (ERA) Tracleer® (bosentan) in the treatment of pulmonary arterial hypertension (PAH) related to HIV (human immunodeficiency virus) infection.
NASHVILLE, Tenn. & IRVING, Texas, Sept. 2, 2003--Caremark Rx, Inc. (NYSE: CMX), one of the nation's leading pharmaceutical services companies, and AdvancePCS (Nasdaq: ADVP), the nation's leading health improvement company, today announced the signing of a definitive merger agreement.
ALLSCHWIL/BASEL, SWITZERLAND - 29 July 2003 - Actelion Ltd (SWX: ATLN) today announced its financial result for the first six months of 2003. With operating revenues for H1 2003 of CHF 133.6 million (H1 2002: CHF 51.1 m) and operating expenses of CHF 105.5 million (H1 2002: 74.0m), the company reported an operating profit of CHF 10.1 million (H1 2002 loss: -29.7m).
BERLIN, May 27, 2003 /PRNewswire-FirstCall/ -- Schering AG, Germany (FSE: SCH, NYSE: SHR) announced today that Ventavis(R), a product for the treatment of patients with primary pulmonary hypertension, received a positive opinion from the Committee of Proprietary Medicinal Products (CPMP).
Berlin, Germany, May 23, 2003 - Schering AG, Germany (FSE: SCH, NYSE: SHR) announced today that Ventavis®, a product for the treatment of patients with primary pulmonary hypertension, received apositive opinion from the Committee of Proprietary Medicinal Products (CPMP).
ALLSCHWIL/BASEL, SWITZERLAND - May 19, 2003 - Actelion Ltd (SWX: ATLN) today announced the analysis of long-term follow-up data of primary pulmonary hypertension patients from Tracleer® pivotal registration studies.
RESEARCH TRIANGLE PARK, N.C., Jan. 24, 2003 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (NASDAQ:UTHR) today announced that the article "Efficacy and Safety of Treprostinil: An Epoprostenol Analog for Primary Pulmonary Hypertension"
SILVER SPRING, Md., Nov. 20, 2002 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that a preliminary assessment of potential survival benefit associated with Remodulin(R) (treprostinil sodium) Injection therapy
ALLSCHWIL, SWITZERLAND - 29 October 2002 - Actelion Ltd (SWX: ATLN) announced that Joseph H. Korn, MD, Professor of Medicine and Biochemistry, School of Medicine, Boston University, will present the
ALLSCHWIL/BASEL, SWITZERLAND, June 5, 2002 /PRNewswire-FirstCall/ -- Actelion Ltd (SWX New Market: ATLN) announced today positive results from the clinical
Allschwil, Switzerland – 20 May 2002 – Actelion Ltd (SWX New Market: ATLN) today announced that the European Commission has
MADISON, N.J., Jan. 24, 2002 -- American Home Products Corporation (the Company) (NYSE: AHP) today reported net revenue and earnings results for the 2001 fourth quarter and full year.
SACRAMENTO, Calif., Jan. 10, 2002 -- People who have opted out of the class-action lawsuit against American Home Products and
Allschwil, Switzerland - 3 December 2001 - Actelion Ltd (SWX New Market: ATLN) today announced that Tracleer™ (bosentan) tablets have
SACRAMENTO, Sept. 10, 2001 -- Two wrongful death complaints filed today in California could signal a renewed wave of lawsuits against American Home Products just as the pharmaceutical company coaxes investors back with predictions that its legal troubles over Fen-Phen/Redux are coming to an end.
SACRAMENTO, Calif., Sept. 10, 2001 -- Donald Holmes of San Juan Bautista was the 63-year-old owner of a trucking company
LEXINGTON, Mass.--May 30, 2001-- Agreement Is Milestone in Resolution of Legal Actions Against Interneuron Company Now in a Position to Focus on Product Development Pipeline
LEXINGTON, Mass.--May 30, 2001-- Agreement Is Milestone in Resolution of Legal Actions Against Interneuron Company Now in a Position to Focus on Product Development Pipeline
Allschwil, Switzerland - March 1, 2001 - Actelion Ltd, (SWX New Market: ATLN) announced today that it has filed for EU marketing authorization for its oral dual endothelin receptor antagonist bosentan (TracleerTM) in the treatment of pulmonary arterial hypertension. In the United States, a New Drug Application (NDA) for TracleerTM in the same indication was filed with the U.S. Food and Drug Administration in November of last year.
March 1, 2001--Profile Therapeutics plc ("Profile"), the drug delivery company specialising in "intelligent inhaler" systems, announces its interim results for the six months ended 31 December 2000.
RESEARCH TRIANGLE PARK, N.C., Feb. 26, 2001-- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has completed enrollment in its Phase III study of oral beraprost in patients with pulmonary hypertension.
MADISON, N.J., Jan. 25, 2001 -- American Home Products Corporation (the Company) (NYSE: AHP) today reported net revenue and results of operations for the 2000 fourth quarter and full year.
NEW YORK--Dec. 18, 2000--The Wall Street Transcript has published an in-depth interview with Christy Shaffer, CEO of Inspire Pharmaceuticals (Nasdaq:ISPH), in which she talks at length about the company's future.
TORONTO, Nov. 22, 2000 - Access to justice for more than 155,000 Canadians who took the diet pills Ponderal and Redux which are alleged to cause serious illnesses is now a reality following an important ruling released today from Madam Justice Susan Gray of the Ontario Divisional Court.
UPPER SADDLE RIVER, N.J. and SILVER SPRING, Md., Nov. 1, 2000 -- Professional Detailing, Inc. (Nasdaq: PDII) and United Therapeutics Corporation (Nasdaq: UTHR) today announced that they have signed a five year agreement for PDI to provide a broad range of pre-launch and launch commercialization services for beraprost, a novel compound under development for peripheral vascular disease in the United States.
RESEARCH TRIANGLE PARK, N.C., Oct. 19, 2000 -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has been informed by the FDA that six month Priority Review has been granted for its New Drug Application (NDA) for pulmonary hypertension.
MADISON, N.J., Oct. 19, 2000 -- American Home Products Corporation (the Company) (NYSE: AHP) today reported sales and earnings results for the 2000 third quarter and first nine months.
September 14, 2000 - Profile Therapeutics plc (LSE: PTP) announces the Company/s first set of preliminary results since its successful flotation on the London Stock Exchange in March 2000.
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Aug. 28, 2000 -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that results of its Phase III clinical trial of Uniprost (also known as UT-15) for pulmonary hypertension -- the largest double blinded placebo-controlled pulmonary hypertension study -- were presented today at a satellite symposium organized for clinicians attending the European Society of Cardiology's annual meeting in Amsterdam, The Netherlands.
SILVER SPRING, Md., July 20, 2000 -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that a gene responsible for primary pulmonary hypertension has been identified by a team working at Columbia University and the New York State Psychiatric Institute.
July 20, 2000 - Significant highlights for the 2000 second quarter and first half:
-- Income from continuing operations rose 19% and 18%, respectively
-- Worldwide net sales increased 14% for both periods
-- Diluted earnings per share from continuing operations increased 19% and 20%, respectively
-- Liquidity strengthened as the Company received $3.8 billion from the sale of its Cyanamid Agricultural Products business and a $1.8 billion merger termination fee during the 2000 first half
-- Three FDA approvals broaden the pharmaceutical product base, including new drug approvals for acute myeloid leukemia and gastric acid reflux disease, and enhanced labeling in rheumatoid arthritis
RESEARCH TRIANGLE PARK, N.C. and SILVER SPRING, Md., May 8, 2000 -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it had filed with the FDA to commence a clinical study to investigate the safety of transitioning pulmonary hypertension patients from the intravenous drug Flolan to the investigational subcutaneous drug Uniprost.
Research Triangle Park, NC, (May 2, 2000)-Glaxo Wellcome Inc. announced today that Flolan‚ brand epoprostenol sodium for Injection, a treatment for severe cases of primary pulmonary hypertension (New York Heart Association (NYHA) classes III & IV), has now received approval for a new indication, the long-term intravenous treatment of pulmonary hypertension secondary to scleroderma spectrum of diseases (PH/SSD, NYHA classes III & IV) for patients who do not respond to conventional therapy.
HOUSTON, March 13, 2000 -- Fleming & Associates, L.L.P., lead counsel for two severely injured Sioux Falls, South Dakota, women who ingested Fen-Phen, has successfully petitioned the court to order John R. Stafford, chairman, president and CEO of American Home Products Corporation (NYSE: AHP) (AHP), to undergo an immediate deposition by plaintiffs’ attorney George M. Fleming.
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