Lambda Therapeutic acquires Bioval

Very quick update!

• Lambda Therapeuic Research has finished its acquisition of BioVail as an Asset Purchase Agreement.  Upon the acquisition, Lambda will now have bioanalytical laboratory and full service clinical data management as well as the regulatory approvals that come with it (US FDA, Therapeutic Product Directorate, UMA and others) in Toronto, Canada.   Details of the acquisition is not disclosed. Lambda Therapeutic is a contract research organization based in Ahmedabad.  BioVail is a contract research firm based in Canada. (Source)

Medtronics initiates trial using Med PrimeADVANCED(TM) in heart failure patients

• A trial evaluating the clinical feasibility of spinal cord stimulation or neurostimulation has been initiated. The method is being studied to improve clinical signs and symptoms of heart failure. The trial is being conducted by Medtronic using its Med PrimeADVANCED™ neurostimulator in NYHA Class III systolic heart failure patients worldwide. PrimeADVANCED™ stimulator is an implant that has been approved by the FDA to be used in severe chronic pain in patients having back and leg pain, complex regional pain syndrome, and painful neuropathy. (Source)

Pharmapodia Introduces: New Drugs Approved by the FDA

PharmaPodia Introduces....
Drugs Approved by the FDA starting July, 2010.

In the process of doing the podcast, I think about keeping track of what is approved and what is not.  Just for house keeping purposes, I decide to make this list.  Once in a while, I will check it against the FDA website and update, but promises can't be made because school is about to start, but in any case, I will try my best to do so. If you see something missing, please feel free to send an email.

On the New Drug Approved by the FDA page, you will see the link to the monthly approval drug.  A bit different from the FDA website where you have to click on each drug to get the information, I will try to summarize them so you can read them as you go along. 

Hope the information is useful!

Enjoy!

New Drugs Approved by the FDA - July 2010

For the month of July, 2010: the following drugs have been approved by the FDA.  Since I start this idea at the end of the month, I haven't gotten time to go back and added all the drugs that have been approved by the FDA.  I will try to do so in the coming months when time allows.  In the mean time, I will continue to update the new list.

******************************************************************

• The FDA approved CUVPOSA as the treatment of chronic severe drooling in pediatric patients with neurologic conditions.  Cuvposa is glycopyrrolate, a competitive inhibitor of acetycholine receptors.  It is developed by Shionogi Inc.  It’s available in cherry flavored oral solution.
• The FDA has approved the new combination hypertensive medication produced by Daiichi Sankyo.  The new combination contains hydrochlorothiazide, amlodipine, and olmesartan.  Hydrochlorothiazide is a diuretic.  Amlodipine is a calcium channel blocker.  Olmesartan is the angiotension II receptor antagonist.  The marketed name of the new drug combination is Tribenzor.
• Buprenorphine or Butrans by Purdue Pharma is also approved by the FDA.  The new formulation is the transdermal system of buprenorphine that is used to manage moderate to sever pain.  
• Heparin sodium by Sagent Pharms is approved by the FDA.  Heparin is used as an anticoagulant to prevent clot formation and stop the progression of the existing clot.
• Methadone Hydrochloride Oral solution by VistaPharm Inc is approved by the FDA.  It comes in as 5mg/5ml and 10 mg/ 5ml.  It’s used in treatment of narcotic addiction and maintenance of narcotic addiction.  It’s a synthetic narcotic analgesics.
• Desoximetasone cream by Nycomed US Inc was approved in June, 2010.  It’s a 0.25% cream.  It’s a corticosteroid agent.  
• Famotidine Oral Suspension by Lupin is approved in June 2010.  It’s an antihistamine that can be used as short term treatment of active duodenal ulcer, active benign gastric ulcer, and GERD.

New Drugs Approved by the FDA

Hello and Welcome to the New Drugs Approved by the FDA Page!

On this page, you will be direct to the newly approved drug page categorized by the month, with the most updated on the top.

Thank you for your support and don't forget to come back next time!

2010

• July - 2010
• August - 2010
• September - 2010
• October- 2010
• November - 2010 (Updated on 12/16/2010 - Completed)
• December - 2010  (Updated on 1/11/2011 - Completed)

2011

• January - 2011 (Updated on 02/19//2011 - Completed)
• February - 2011 (Updated on 03/01/2011)
• March - 2011 (Updated on 04/20/2011) 
• April - 2011 (Updated on 05/08/2011)

PharmaPodia Podcast 07 29 2010

Welcome again!

Tomorrow is Friday so just hang in there!

Several of the main points

• ETBX-001 enters phase 1 trial
• Phase I trial of MultiStem showed that it's well-tolerated at all doses
• PSI-938 has entered its phase 1b trial
• Phase II trial of ARQ 197 has been initiated
• Beclomethasone dipropionate HFA Nasal Aerosol met its primary endpoints
• Earnings have been released for: Hovione, Vertex, Cytokinetics, Neurocrine, Sangamo, Pain

Questcor reported its 2nd quarter earning of 2010

• Questcor reported an increase of 3 million in net sale at the end of the second quarter 2010. The company is currently focusing on the sales and marketing of its repository corticotrophin injection Acthar which carries an indication to treat acute exacerbations in patients with multiple sclerosis. Additional indications are currently being investigated. (Source)

PharmaPodia Podcast 07 28 2010

Welcome again!
It's Wednesday and the weekend is almost here.  Hopefully, the heat will be more bearable this time than last.




The podcast today emphasizes on the financial earnings of various companies.  Hope you find the information useful!

• Top of the line data for AG707 has been released
• Trial using light energy to activate photosensitive drug has been initiated
• Complete enrollment for phase 1 study of Universal Flu Vaccine has been reported
• Trial comparing Effie

Bionan Health Care Inc formed Partnership with Bilcare GCS

• Bionan Healthcare Inc. forms a strategic relationship with Bilcare GCS. Bionan Healthcare Inc specializes in researching, developing, and marketing nanofied treatments. Bilcare global Clinical Supplies provides clinical trial materials supports, services, and complete project management to cliets in America, Europe, and Asia. (Source)

PharmaPodia Podcast 07 27 2010

Hello!

I finally can record a podcast. It's been so long!  The podcast this time is not long, so enjoy and come back for the next one!

• Genticel is given permission to conduct phase I of ProCervix
• Phase I for biosimilar erythropoietin has started
• Ico Therapeutics has been given approval to conduct Phase II trial of ICo-007
• Oxford Biomedical has been given approval to conduct phase II trial of Trovax by the FDA
• TMC278 met its primary endpoint which was non-inferiority to efavirenz. NDA has been submitted
• MoxDuo IR by QRxPharma is now in the final stage of its pivotal phase 3 study
• Cetirizine cherry syrup by Perrigo has been approved

Newly approved antihypertensive medication : Tribenzor

Quick Update!

• The FDA has approved the new combination hypertensive medication produced by Daiichi Sankyo. The new combination contains hydrochlorothiazide, amlodipine, and olmesartan. Hydrochlorothiazide is a diuretic. Amlodipine is a calcium channel blocker. Olmesartan is the angiotension II receptor antagonist. The marketed name of the new drug combination is Tribenzor.

PharmaPodia 07 26 2010 Quick Bits!

Hello!  Welcome Monday!


Should I say this is a short updat for Monday morning? 


Hope you all have a good week! 


Normal podcast will be resuming soon!


Thanks and don't forget to come back!


Pharmapodia

• Mannkind resubmitted the new drug application for Afrezza, the inhaled-insulin-and-inhaler combination to the US FDA. The FDA will decide on the fate of the drug by the end of 2010. (Source)

• The phase I/II clinical trial using CF102 as the treatment of liver cancer suffering hepatitis C showed some positive result. Patients with severe hepatitis C infection were treated with CF102 and a decline in viral load was seen to be significant. The drug was shown to be safe and tolerable. (Source)

• Reckitt Benckiser, a British Consumer Goods Company is to buy SSL International. The deal is worth 3.8 billion, a 33% premium to SSL’s closing price. (Source)

• Researchers from Ocean University of China are developing artificial corneas from human cells. The clinical trial is to be begin in three to five months. (Source)

• Cerenis Therapeutics SA has secured a 51.7 million funding to continue to the development of its cholesterol therapy technologies. Its most advanced drug CER-001 which is being studied to treat acute coronary syndrome is to start phase II clinical trial later in 2010. Cerenis has headquarters in both Ann Harbor, Michigan and France. (Source)

• An expert panel will convene on Wednesday 28th, 2010 to look at Brilinta’s clinical date. The recommendation will be submitted to the FDA later in the year. The FDA will decide on Britinla’s marketing and approval in September 2010. Brilinta is on Brilinta is expected on Wednesday, 2010. Brilinta is a new ant-clotting drug that is developed by AstraZeneca.

• The FDA approved Momenta’s generic version of Lovenox, enoxaparin. Lovenox or enoxaparin is being used as a treatment of blood clot. Lovenox was marketed by Sanofi-Aventis. (Source)

• Sanofi-Aventis expressed interest in taking over Genzyme. The proposal has been made and it’s currently waiting for Genzyme’s response. (Source)