LIBERTY CORNER, N.J., July 03, 2008 /PRNewswire/ — On June 27, 2008 GeneraMedix Inc. received approval from the U.S. Food and Drug Administration (FDA) for its Epoprostenol for Injection 1.5 mg New Drug Application (NDA).
Epoprostenol for Injection 1.5 mg is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.
GeneraMedix Epoprostenol for Injection is available in 10 mL vials containing lyophilized epoprostenol sodium equivalent to 1.5 mg of epoprostenol.
(Read the full post about ‘GeneraMedix Inc. Receives Approval for Epoprostenol for Injection 1.5 mg’…)
FDA Approves Abbott’s Xience V Drug Eluting Stent
Xience V, Only Drug Eluting Stent to Demonstrate Superiority Over Market-Leading Stent in Clinical Trials, Now Available in United States for Treatment of Coronary Artery Disease
ABBOTT PARK, Ill., July 02, 2008 /PRNewswire-FirstCall/ — Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the Xience V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. Xience V is the only drug eluting stent to have demonstrated superiority over Boston Scientific’s TAXUS(R) paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials.
(Read the full post about ‘FDA Approves Abbott’s Xience V Drug Eluting Stent’…)
Screening sportsmen for signs of hidden heart conditions could save lives, a study has concluded.
Each year in the UK, hundreds of apparently fit people suffer ’sudden cardiac death’.
In Italy, athletes have to undergo ECG tests, and scientists writing in the British Medical Journal said this had detected heart problems.
UK campaigners have called for the widening of testing of UK sportspeople, and even routine testing of teenagers.
(Read the full post about ‘Sporting ‘heart screening’ call’…)
More cases of the most dangerous type of malaria than ever before are being brought back to the UK from trips abroad, official figures show.
A Health Protection Agency study identified 6,753 cases of falciparum malaria diagnosed in the country between 2002 and 2006.
This is a 30% increase over 15 years, reports the British Medical Journal.
Experts said many of the cases arose from visits to west Africa made by people visiting relatives and friends.
(Read the full post about ”Deadliest’ malaria rising in UK’…)
PARIS, June 30, 2008 /PRNewswire/ — Five years after the identification of the gene responsible for progeria, a rare disease causing accelerated and premature ageing, a team of Spanish and French researchers (Carlos Lopez-Otin and coll. - University of Oviedo - and Nicolas Levy and coll. - Inserm/AP-HM, Marseille, France) have successfully demonstrated a treatment for the disease, using mice. This treatment, combining two existing pharmacological molecules, should slow down the progression of this disease which has hitherto remained untreatable.
Subject to the authorisation of health agencies, this treatment could very soon be tested on 15 children in Europe.
(Read the full post about ‘Hope for Progeria - Successfully Validated on Mice, a Treatment Could Soon be Tested on Children’…)
SALT LAKE CITY, UT, June 30, 2008-Myriad Genetics, Inc. has today announced the outcome of a clinical phase III trial of Flurizan® (tarenflurbil) in 1,684 patients with mild Alzheimer’s disease. The clinical phase III data do not correspond to the data observed in clinical phase II in patients with mild Alzheimer’s disease. Lundbeck and Myriad will now investigate the data further to understand the outcome of the trial in which the compound did not meet the two primary endpoints.
“The clinical phase II data for Flurizan® in patients with mild Alzheimer’s disease supported further development of Flurizan®.
(Read the full post about ‘Results of Flurizan in Clinical Phase III Trial’…)
Company’s End-of-Phase II Meeting with FDA Set for Sept. 29
LA JOLLA, Calif., June 30, 2008 /PRNewswire/ — TorreyPines Therapeutics, Inc. today announced that data presented at the 50th Annual Scientific Meeting of the American Headache Society showed that, in addition to meeting the primary endpoint of headache pain relief at two hours, the company’s lead AMPA/kainate-type glutamate receptor antagonist, tezampanel, demonstrated improvement on important secondary endpoints in a 306-patient Phase IIb clinical trial in acute migraine headache.
(Read the full post about ‘Data Presented at American Headache Society’s Annual Scientific Meeting Show Primary Endpoint Met as Well as Improvement on Important Secondary Endpoints in Phase IIb Acute Migraine Trial of TorreyPines Therapeutics’ Tezampanel’…)
REYKJAVIK, Iceland, June 30, 2008 /PRNewswire-FirstCall/ — deCODE genetics today announced positive topline results from its latest clinical pharmacology study of DG041, the company’s first-in-class antagonist of the EP3 receptor for prostaglandin E2, developed as a next-generation oral anti-platelet therapy for preventing arterial thrombosis without increasing bleeding risk. The prospective, randomized, blinded, crossover study compared the effects on platelet activation and bleeding time of DG041 alone and in combination with the mainstays of current antiplatelet treatment, Plavix(TM) (clopidogrel) and aspirin.
(Read the full post about ‘DG041 Blocks Platelet Aggregation Through a Novel Mechanism and does not Increase Bleeding Time When Given Alone or with Plavix or Aspirin’…)
The GI Company Reports Additional Phase II Clinical Data of Intestinal Trefoil Factor (rhITF) Oral Spray for Oral Mucositis OMAS Scoring Confirms rhITF Demonstrates Statistically Significant Prophylaxis for Oral Mucositis
FRAMINGHAM, MA and HOUSTON, Texas - June 30, 2008 - At the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology’s 2008 International Symposium on Supportive Care in Cancer (MASCC / ISOO) held last week in Houston, Texas, The GI Company reported secondary endpoints relating to Oral Mucositis Assessment Scale (OMAS) scores from the Company’s Phase II clinical study, designed to evaluate the safety and efficacy of its lead clinical compound, Intestinal Trefoil Factor (rhITF) Oral Spray, in development for oral mucositis. (Read the full post about ‘The GI Company Reports Additional Phase II Clinical Data for Oral Mucositis’…)
An 11-year-old Romanian girl is to have an abortion in the UK despite being cleared to have one in Romania.
The girl is 22 weeks pregnant after being raped by an uncle, who has since gone missing.
Abortion is illegal in Romania after 14 weeks, but a government panel last week decided she could have a termination because of exceptional circumstances.
The British charity Marie Stopes said it had arranged for the girl to have an abortion at an unnamed London hospital.
The organisation said it was approached by representatives of the girl after her arrival in Britain several days ago.
(Read the full post about ‘Romanian girl in UK for abortion’…)