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FDA accepts Optimer's fidaxomicin NDA for filing

Optimer Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI.

24 Jan 2011

China Sky third quarter total revenue decreases 16.3% to $36.2 million

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China, today announced financial results for the third quarter of 2010.

8 Nov 2010

Optimer presents two fidaxomicin Phase 3 trials data for CDI infection at IDSA Annual Meeting

Optimer Pharmaceuticals, Inc. announced today the presentation of combined data from its two fidaxomicin Phase 3 trials in patients with Clostridium difficile infection (CDI) at the 48th Annual Meeting of the Infectious Disease Society of America (IDSA) in Vancouver, British Columbia, Canada.

25 Oct 2010

Progenics receives NIH grant to develop novel monoclonal antibodies to treat C. difficile infection

Progenics Pharmaceuticals, Inc. today announced the award of a grant totaling $4,143,652 from the National Institutes of Health (NIH) for Progenics' program to develop novel monoclonal antibodies to treat Clostridium difficile (C. difficile) infection.

7 Oct 2010

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.

21 Sep 2010

Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Optimer Pharmaceuticals, Inc. announced the presentation of new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.

15 Sep 2010

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Progenics Pharmaceuticals, Inc. today presented preclinical findings for its humanized monoclonal antibodies against the disease-causing toxins produced by the bacterium Clostridium difficile.

14 Sep 2010

Fidaxomicin, CDA1/CDB1 effective for treating CDI : Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in first- and second-line treatment of Clostridium difficile infection, nearly 70 percent of surveyed infectious disease specialists and internists will use Optimer's fidaxomicin and nearly half will use Medarex/Merck's CDA1 and CDB1, one year after the launch of these agents. The lower recurrent/relapse rate associated with fidaxomicin and CDA1/CDB1 is the most influential attribute surveyed clinicians cite in their decisions to prescribe these emerging agents for CDI.

6 Aug 2010

Abbott presents 48-week PROGRESS study results at 28th International AIDS Conference

Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.

20 Jul 2010

Progenics presents preclinical data on novel monoclonal antibodies against toxins produced by C. difficile

Progenics Pharmaceuticals, Inc. today announced the presentation of preclinical data on novel monoclonal antibodies against toxins produced by the bacterium Clostridium difficile (C. difficile). The monoclonal antibodies effectively neutralized the cell-killing activities of the toxins in vitro and significantly improved survival in a stringent animal model of C. difficile infection. C. difficile is the leading cause of hospital-acquired diarrhea in the United States and represents a growing global public health challenge.

28 May 2010

Sagent Pharmaceuticals recalls metronidazole injection

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL (NDC number 25021-131-82) manufactured by Claris Lifesciences and distributed by Sagent.

18 May 2010

Second fidaxomicin Phase 3 clinical study data in patients with CDI to be presented at DDW 2010

Optimer Pharmaceuticals, Inc. announced the presentation of new data from its second fidaxomicin Phase 3 clinical study in patients with Clostridium difficile infection. The data, presented by Stuart Johnson, M.D. during an oral session at the annual meeting of Digestive Disease Week in New Orleans, indicated that treatment with fidaxomicin significantly improved the recurrence rate and global cure rate in CDI patients requiring concomitant antibiotics, compared to vancomycin.

5 May 2010

Optimer Pharmaceuticals announces results from second Phase 3 clinical study of fidaxomicin

Optimer Pharmaceuticals, Inc. announced that the top-line results from its second fidaxomicin Phase 3 clinical study in patients with Clostridium difficile infection were presented today at the 20th Annual European Congress of Clinical Microbiology and Infectious Diseases in Vienna, Austria.

12 Apr 2010

Proper diagnosis, treatment and good skin care help control acne and rosacea

Acne and rosacea are two seemingly different skin conditions that have one important thing in common: both are chronic and extremely common skin conditions. However, dermatologists recommend that with proper diagnosis, treatment and a healthy dose of good, old-fashioned skin care, acne and rosacea can be less of a nuisance for patients.

5 Mar 2010

FDA grants approval for Abbott's antiretroviral medication Norvir

Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir ® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients.

11 Feb 2010

Top-line results from Optimer Pharmaceuticals' second fidaxomicin Phase 3 trial in CDI patients

Optimer Pharmaceuticals, Inc. today announced positive top-line results from the second of two pivotal Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI). This study was conducted in approximately 100 clinical sites throughout North America and Europe. The Company plans to use data from this study to support submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2010.

5 Feb 2010

Men who buy fake internet drugs for ED problems face significant health risks

Men who buy fake internet drugs for erection problems can face significant risks from potentially hazardous contents and bypassing healthcare systems could leave associated problems like diabetes and high blood pressure undiagnosed.

21 Jan 2010

Over 44% of internet Viagra is counterfeit

Research by UK, Swedish and American researchers shows that taking internet drugs can kill and bypassing health systems can leave life-threatening problems undiagnosed. It's estimated that 90% of counterfeit drugs are sold on the internet, 44% of internet Viagra is fake, the global sale of counterfeit drugs will reach $75 billion this year and EU seizures have risen dramatically. Counterfeit drug deaths include men who took fake erectile dysfunction drugs, pregnant women injected with fake iron for anaemia and children who took paracetamol syrup contaminated with antifreeze.

20 Jan 2010

New analysis suggests physicians should change their diagnosis and treatment for sore throat

New analysis from the University of Alabama at Birmingham (UAB) suggests that physicians need to re-think their diagnosis and treatment of sore throat, or pharyngitis, in adolescents and young adults to consider a more newly identified and potentially dangerous culprit as the source of that infection.

1 Dec 2009

Tips for treating age-related dermatologic concerns

Everyone expects their bodies to change as they get older. From wrinkles and sagging skin to brittle bones and aches and pains, the aging process is inevitable. In addition, there are a number of medical dermatologic conditions that surface with age that can cause people even more stress. Fortunately, dermatologists can help diagnose and treat these conditions no matter when they strike.

11 Nov 2009