PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: BioMedReports.com

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

BioMedReports.com Releases FDA and Clinical Trial Calendars Updates - FDA Clinical Trial Updates at BiomedReports for Pro-Pharma Theravance Johnson & Johnson [OTC: PRWP]
BioMedReports.com Releases FDA and Clinical Trial Calendars Updates

 

NewswireToday - /newswire/ - Pasadena, CA, United States, 2009/04/28 - FDA Clinical Trial Updates at BiomedReports for Pro-Pharma Theravance Johnson & Johnson [OTC: PRWP].

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Theravance (NASDAQ: THRX): The FDA accepted as complete for review Theravance's response to the February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The PDUFA decision date for the cSSSI indication for telavancin is 9/16/09 while the decision date for the HAP indication occurs later in the year on 11/26/09.

Johnson & Johnson (NYSE: JNJ): SIMPONI (golimumab) recieved FDA approval as the first once-monthly anti-TNF treatment for three types of auto-immune arthritis conditions, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Medarex (NASDAQ: MEDX) is set to receive royalties on the drug as part of the UltiMAb (a technology platform for the development of human monoclonal antibody treatments) licensing agreement with JNJ while Schering-Plough (NYSE: SGP) holds the exclusive marketing rights to Simponi outside of the U.S. (ex-Japan, Taiwan, and Indonesia).

In mid-April, Pro Pharma (biomedreports.com) announced that a review of Phase 1 and 2 clinical trial data revealed that about 100 patients treated with the Company's lead compound in development called DAVANAT in combination with chemotherapy (including 5-FU regimens) experienced no incidence of mucositis serious adverse events (SAEs). Mucositis is a common side effect of many cancer treatments which can interfere with treatment and the ability to eat or drink normally. The condition causes painful inflammation, ulceration, and sores of the mucous membranes within the gastrointestinal (GI) tract.

Pro-Pharma (OTC: PRWP) Looks Promising and investors wanting more information about that company's developments should see the full report at the website.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Pharma/BioTech/Nutrition Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: BioMedReports.com

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 

 
  Your Banner Ad showing on ALL
Pharma/BioTech/Nutrition articles,
CATCH Visitors via Your Competitors Announcements!


BioMedReports.com Releases FDA and Clinical Trial Calendars Updates

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

|
Publisher Contact: M. Garza - BioMedReports.com 
323-472-4480 garza[.]biomedreports.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any BioMedReports.com securities in any jurisdiction including any other companies listed or named in this release.

Pharma/BioTech/Nutrition via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From BioMedReports.com / Company Profile


Read Pharma/BioTech/Nutrition Most Recent Related Newswires:

BD Veritor™ System Meets FDA’s New Performance Requirements for Rapid Influenza Antigen Detection Tests
MDxHealth Announces Agreement with Istituto Diagnostico Varelli for Distribution of SelectMDx Throughout Central-South Italy
Sub-Sahara Africa - Increase in Western Lifestyles Leads to Dire Need for Chronic Prescription Drugs Finds Frost & Sullivan
BD Initiates New Industry Alliance to Combat Rising Opioid Crisis
BTG and Society of Interventional Oncology to Explore Role of Minimally Invasive Therapies in Immuno-oncology
Ipsen to Acquire a Portfolio of Select Consumer Healthcare Products from Sanofi
BD Announces Early Access Program for BD Resolve™ Single-Cell Analysis Platform
Precision Medicine Unlocks the Future of Targeted Therapy in the Global Healthcare Industry Finds Frost & Sullivan
Sciformix Corporation Receives Prestigious 2017 Global Outsourcing Customer Service Leadership Award from Frost & Sullivan
Arven Pharmaceuticals Selects GE Healthcare’s FlexFactory to Improve Turkish and Regional Access to Biopharmaceuticals
Ipsen to Acquire Primary Care Platform in Italy from Akkadeas Pharma
Cost-Containment and Client-Centric Services Catalyse European Custom Procedure Trays and Packs Market Finds Frost & Sullivan
New BD Institute for Medication Management Excellence Aims to Improve Patient Safety and Outcomes through Collaboration
New Varicose Vein Treatment Offers Minimally Invasive Non Surgical Procedure to Canadians
Greenphire and Exostar Partner to Deliver Seamless, Secure Access to Clinical Research Site Payment Solution

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  BizJobs.com

Visit  La Bella Bakery Artisan Bakery Arizona





 
  ©2017 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)