The FDA accepted the NDA submitted by Teva for the product intended for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis

Teva announced that the US FDA has accepted the company's new drug application submitted for beclomethasone dipropionate hydrofluoroalkane for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis.  The company submitted the NDA on May 24, 2011.

The product was studied in two phase III trials which data were submitted as part of the application for the treatment of SAR and PAR.  The results of the trials showed significant improvement in nasal symptom scores of sneezing, runny nose, nasal itching and nasal congestion when they were compared between the treatment group and the placebo group.

The product is designed to be a pressurized, non-aqueous aerosol solution propelled by HFA.

Beclamethasone is a corticosteroid that works to decrease inflammation.

Mylan launched generic Uroxatral

Mylan announced that it has launched the 10-mg alfuzosin extended release tablet which is the generic version of Uroxatral marketed by sanofi-aventis for the treatment of signs and symptoms of benign prostatic hyperplasia or an enlarged prostate.

 The company said from IMS data, the sales of Uroxatral was estimated to be approximately @241M in the 12-month ending on June 30, 2011.

About alfuzosin:

Alfuzosin is an antagonist

NeoloMed Biosciences is to distribute Onko-Sure cancer test of Radient

Radient Pharmaceuticals announced that its Onko-Sure cancer test will be made available through NeoloMed BioSciences, a New Jersey-based diagnostics laboratory.

the test has been approved for its use in the monitoring of colorectal cancer during treatment and post-treatment periods.

The test has also been approved as a general cancer tumor marker and lung cancer detection, treatment and recurrence monitoring outside of the US.

NeoloMed BioSciences plans to make the test available to its networks of physicians' offices and hospitals in its region which will include New Jersey, Connecticut, Delaware, Pennsylvania, Washington DC, Virginia, and Maryland.

Radient pharmaceuticals has recently signed an agreement with Uni Pharma to distribute Onko-Sure in Taiwain.

Avanir filed lawsuit against Actavis and Par Pharmaceuticals

Avanir (currently marketed Nuedexta for the treatment of pseudobulbar affect) has filed a lawsuit against Par Pharmaceutical and Actavis South Atlantic LLC with the US District Court for the District of Delaware in regard to the Abbreviated New Drug Applications submitted by the company for Nuedexta.

The lawsuit indicated that the companies have filed the ANDA to a medication that is currently protected with US Patent 7,659,282 and RE38,115.  Hence, this makes it a patent infringement lawsuit.

By filing the lawsuit against the companies, Avanir has prevented

Watson's Anda distribution center is to move to Mississippi from Ohio

Watson is expanding or may i say relocating?

The company announced that its Anda Distribution center plans to build a 234K sq ft pharmaceutical ware house and distribution facility in Olive Branch, DeSoto County in Mississippi.   The company has decided to relocate current facility in Groveport, Ohio to MS.

The company plans to have the facility up and running

Watson gets tentative approval from the FDA for its rosuvastatin zinc

It's been a bit of time since Watson released any news related item.

Watson announced that the FDA has tentatively approved its NDA of rosuvastatin zinc 5, 10, 20, and 40 mg tablets.  This is a different salt form of Crestor or rosuvastatin calcium tablet makreted by AstraZeneca.

Needless to say, AstraZeneca did not stay put after the application was submitted.  The company filed the lawsuit against Watson on October 26, 2010 with the US District Court

The FDA is to review the application for Bydureon again!

Amylin and Eli Lilly happily announced that the companies have received news from the FDA that its resubmission of the New Drug Application for Bydureon will be reviewed on Jan 28, 2012.

The resubmission was given a category 2 and the FDA has up to 6 months to decide whether to approve the drug.

The companies previously submitted the NDA for Bydureon or exenatide

The FDA deemed Adventrx's vinorelbine not approvable

Why life has gotten so busy even when I think it shouldn't be to busy?  Hopefully things will start slowing down soon (even though it's a wishful thinking on my part!)

Adventrx announced that the FDA has issued a complete response letter in regard to the company's new drug application submitted for vinorelbine injection emulsion as potential treatment of non-small cell lung cancer.  The company has just recently released its second quarter results with a net loss of 4.4 M which was slightly lower than the $5M that it lost in the same period of last year.  the company had a total of 42M as of June 30, 2011 (the amount was reduced to 40.7M as of July 31, 2011)

The complete response letter indicated that the present NDA is not yet approvable due to questionable authenticity of the drug products used in the pivotal bioequivalence trial (study 530-01).  The FDA requested Adventrx to repeat the bioequivalence trial to address the issue.

The FDA also required the company to submit all information regarding the product quality or CMC matters.

Although the FDA raised the issued about the questionable products used in the trial, the company said that it is unlikely that the mistake was done because Exelbine and the reference products have different physical characterisics in addition to different preparation procedures and package presentations.  But the company acknowledged the reason why the FDA raised questions about the authenticity of the tested products which were due to the methods done to select testing and reserve samples in the study as well as the availabilty of testing and reserve samples for inspection.

My note: Adventrx...it makes me wonder whom they hired to conduct this study? If you have seen and talked to any drug monitor, every single pill was accounted for (or at least they said so but I really think they do.. but then it really depends on the clinical site).  If the company chose the right and good clinical site to conduct its study, a procedure should be implemented to make things like this no happen.  Not only the clinical site is important, the place where the drug is stored and preserved is also important.  This will just cost them additional money and hence lose money and confidence in investors.  If things can happen once, it can happen again unless changes are made.

I have to side with the FDA on this one.  Although physical appearance is hard to mask and it is unlikely that the mistake was made, it is still not a good thing to not have a proper procedure of accounting.

With all the major stock indexes were up and down like a sine curve these days, Adventrx took a 58% decrease in value after the news was announced.  This might be the reason why the company reported its current cash holdings as of July 31, 2011 as a way to keep investors' confidence. 

Leixcon reported positive results of the phase II trial of telotristat

Lexicon announced positive results of the phase II trial evaluating LX1031 or telotristat etiprate for the treatment of carcinoid syndrome. 

About carcinoid syndrome: the syndrome is caused by neuroendocrine tumors that are stemmed from the gastrointestinal tract.  The condition is often characterized by severe diarrhea and flushing episodes.  Patients with carcinoid syndrome often suffer from long-term consequences of malnutrition, heart disease and death.

The phase II trial is a randomized, double-blind, placebo-controlled study that was conducted in the US evaluating telotristate etiprate in 23 patients who were diagnosed with carcinoid syndrome who were refractory to currently available therapy.  At baseline, patients with metastatic carcinoid disease had an average of six bowel movements a day.  Five patients were randomized into the placebo group and eighteen patients were randomized to the telotristat group that were further divided into 4 different dosing groups.  The duration of treatment was 28 days.

The study primary endpoint was

Apricus intends to file a marketing application for Vitaros in Latin America

Apricus Bio announced its intention to file a marketing authorization application for Vitaros in Latin America for the treatment eretil dysfunction. 

The company has been working with Quintiles Global Regulatory Affairs to prepare for its regulatory filing of Vitaros in the following countries:  Mexico, Brazil, Argentina, Colombia, Chile and Peru. 

Based on the company analysis, sales of Vitaros could reach $347M in Brazil if commercialized.

Apricus has been approved and commercialized in Canada since

Alexza posted a net loss and resubmitted the NDA for AZ-004

Alexza posted a net loss of $9M in the second quarter 2011 and has recently resubmitted the NDA for AZ-004.  The company had $38.7M in consolidated cash, cash equivalents and marketable securities as of June 30, 2011.

Alexza announced that it has resubmitted the New Drug Application for AZ-004 for the rapid treatment of agitation in schizophrenia or bipolar disorder to the US FDA after receiving the complete response letter from the FDA in October 2010. The company expects to hear back from the FDA in 6 months because it believes the resubmission is classified as class II.

The resubmitted application contained additional analysis from the original

Pozen got favorable rulings from US District Court

While the US stock market (or should I say the global stock market) is down, Pozen comes out with victory in the court room...

Pozen Inc announced that the US District court for the Eastern District of Texas has issued a favorable verdict favoring Pozen in regard to the Abbreviated New Drug Applications submitted to the US FDA to market generic Treximet or the combination of sumatriptan and naproxen sodium for the acute treatment of migraine attacks.  Treximet was developed using GSK's RT technology.

Pozen has also entered into a settlement with Teva Pharmaceuticals

Hospiral received US FDA approval for gemcitabine solution for injection

Hospira announced that the FDA has approved generic gemcitabine solution for injection 200 mg, 1 gm and 2 gm at a concentration of 38 mg/mL.  Gemcitabine is the generic version of Gemzar which is marketed by Eli Lilly.  Gemzar has the sales of $750M in 2010.

The company plans to launch the product in early

AZD2820 enters phase 1 trial for obesity

Palatin announces that the phase I trial evaluating AZD2820 for the treatment of obesity has been commenced. 

AstraZeneca selected AZD2820 as a clinical candidate which is part of the collaborative research program it made with Palatin Technologies in 2007.

The trial which is a randomized,

Merck teamed up with Serum Institute of India for vaccine development

Merck announced that it has teamed up with Serum institute of India Limited to develop and commercialize a pneumococcal conjugate vaccine for use in the emerging and developing world countries.

Both companies will form a Product Advisory Committee who will be responsible for the overseeing of the development and seeking product approval as well as pursuing the World Health Organization prequalification.

Under the terms of the agreement, Merck will have specific rights to market the pneumococcal vaccine in certain designated territories and Serum Institute will have marketing rights in other designated territories.