The FDA Adviory Committee decided to not recommend the approval of progesterone vaginal gel 8% of Comlumbia and Watson

The FDA Advisory Committee decides to not recommend the approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester pregnancy. The panel indicated more information is needed to support the approval.

Watson and Columbia have submitted the NDA (NDA 22-139) seeking the approval of progesterone vaginal 8% for the said indication. The NDA included data from two phase III clinical trials evaluating the gel in women with a short uterine cervical length measured by transvaginal

Alnylam to cut 33% of its workforce

It must have a been a trend of some sorts, Novartis announced its restructuring program not too long ago. Takeda has announced its plan to cut its workforce (mostly in Europe and the US). Now Alnylam, an RNAi therapeutics company, said it plans to reduce 33% of its workforce in order to focus its available resources to develop its other projects including ALNYLAM 5x15. The company estimated the workforce reduction will save approximately $20M in 2012 in operating expenses. A one time $4M restructuring costs including employee severance, benefits and related cost will be incurred in the first quarter of 2012.

The company will accelerate the clinical developments for the treatment of transthyretin-mediated amyloidosis and hemophilia.

Eisai and Sannova got approval to revise Neuzym's labeling information

Eisai announced that the Japanese Ministry of Health, Labour and Welfare has agreed to remove to remove the following indications for egg white lysozyme preparation Neuzym: alveolar pyorrhea and other dental and urologic conditions following the the submission of an application seeking to remove the said indications on December 21, 2011.

Companies (Eisai, Sannova, Nippon Shinyaku, SIOE Pharmaceutical and ASKA) will conduct clinical trials to to examine the efficacy of

Eisai and EIDIA to launch LIFE CHECK

Eisai and its subsidiary, EIDIA, announced that the company will launch LIFE CHECK which is a self-monitoring blood glucose meter manufactured by Gunze Limited on Jan 27, 2012.

LIFE CHECK will be marketed as a personal self-monitoring blood glucose meter that patients with diabetes can use to measure their own blood glucose.

GUNZE has received approval to market LIFE CHECK in August 2011. The product however will be distributed and marketed by EIDIA and co-promoted byEisia.

LIFE CHECK was designed for ease of use by elderly diabetes patients. 

Mylan launched multiple strengths of levetiracetam ready-to-administer bags

Mylan announced that the company has launched multiple strengths of premixed levetiracetam in ready-to-administer bags. The bags come in the following strengths: 500 mg/100 ml, 1000 mg/100 ml, 1500 mg/100 ml.

Previously, levetiracetam is aonly available in 500 mg/5ml vial.

Levetiracetam in sodium chloride injection for intravenous use has been approved for

• partial onset seizures
• myoclonic seizures in patients with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures

Chlormethine of Ceptaris has been given orphan drug designation by EMA

Ceptaris Therapeutics announced that the European Medicine Agency has granted orphan drug designation to the company's chlormethine gel (known as mechlorethamine gel in the US) for the treatment of cutaneous T-cell lymphoma.

Ceptaris has submitted the New Drug Application for mechlorethamine gel in the US and it is currently being reviewed by the FDA for the treatment of

Eisai obtained marketing approval of Lunesta in Japan

Eisai announced that the Japanese Ministry of Health, Labour and Welfare has given the company approval to market Lunesta (eszopiclone) for the treatment of insomnia.

Lunesta has been available in the US since 205. The product was discovered and developed by Sunovion Pharmaceuticals ( a subsidiary of Dainippon Sumitomo Pharma).

In July 2007, Eisai has acquired exclusive rights to develop and market the agent in Japan from Sunovion (previously known as Sepracor). The marketing authorization application was submitted in November 2010.

Lunesta or eszopiclone is a non-benzodiazepine

Takeda to cut its workforce in Europe and the US

Just days after Novartis announced its restructuring plan, Takeda said it will also cut approximately 2,800 positions (mainly in Europe 2100 and 700 in the US). The company said the restructuring will be completed by the end of fiscal year 2015.  Eliminated positions will be in R&D, commercial, operations and G&A.

The company will consolidate a number of sites and functions. The restructuring

Watson launched Vestura

Watson announced launch of generic Yaz(R), an oral contraceptive containing 3 mg drospirenone and 0.02 mg ethinyl estradiol.

The generic Yaz(R) has been named Vestura and has been approved for the prevention of pregnancy and for the treatment of moderate acne in women at least 14 years old only if the patient desires an oral contraceptive for birth control.

According to IMS data, the sales of Yaz(R) and its generic were estimated to be approximately $510M in the twelve months ending on November 30, 2011.

Yaz(R) is currently marketed by Bayer HealthCare Pharmaceuticals Inc.

Takeda's AZILVA® has been approved in Japan for treatment of hypertension

Takeda Pharmaceuticals announced that the Ministry of Health, Labour and Welfare has approved the company’s Azilva (azilsartan) for the treatment of hypertension in Japan.
Azilstartan is an angiotensin II inhibitor. It works to decrease the action of angiotensin II which is a vasopressor hormone that can increase the constriction of blood vessels which lead to high blood pressure.
Azilsartan will be available in 20 mg and 40 mg tablets that can be administered orally daily.
The new drug application submitted to the agency included data from four phase 3 clinical trial evaluating the compound in patients with hypertension. One of the trial evaluated azilstartan against Blopress (candesartan, also discovered and marketed by Takeda). The results showed that Azilva was statistically superior to Blopress in  lowering the mean diastolic blood pressure and systolic blood pressure in 24 hours measured by ambulatory blood pressure monitoring.

Dara Biosciences acquired Oncogenerix and its Soltamox

Dara Biosciences announced that the company has entered into an agreement to acquire Oncogenerix and the company's Soltamox, a liquid formulation of tamoxifen for the treatment of breast cancer.  Upon completing the merger, Oncogenerix's CEO Christopher Clement will becoming the director and Chief Operating Officer.

Oncogenerix is a private company based in South Carolina.  Oncogenerix has obtained exclusive license for the US Marketing rights to Soltamox from Rosemont Pharmaceuticals, an oral

The FDA approved Voraxaze for the treatment of methotrexate toxicity

The FDA has approved Voraxaze for use in the treatment of toxic methotrexate levels due to kidney failure.

Voraxaze is the brand name of glucarpidase which is an enzyme that can break down methotrexate in order for the medication to be eliminated from the body.

Voraxaze has been given orphan drug designation and was studied in a single clinical study in 22 patients who received Voraxaze for the treatment of toxic methotrexate levels. The study evaluated the efficacy of Voraxaze in reducing the levels of methotrexate to below

Constellation inks deal with Genentech

Constellation announced that it has entered into a collaboration agreement with Genentech, a member of Roche Group to discover and develop innovative treatments for cancer and other serious diseases.
The collaborations will utilize the sciences of epigenetics and chromatic biology. Constellation will receive $95M in funding which includes an upfront payment as well as research funding for a three-year collaboration period. Under the terms of the agreement, Constellation is eligible to receive development and commercialization milestone payments. The company is also entitled to receive royalties generated from sales of products by Genentech. Constellation also will have exclusive development and commercialization rights to selected program coming from the agreed collaboration and will have to make payments to Genentech if such products are commercialized successfully.
Genentech will also have option to acquire all outstanding shares of Constellation based on pre-negotiated terms. Epigenetics in drug developments target small molecules that work on proteins that play roles in the addition, removal and recognition of various chemical modifications to specific sites on DNA or chromosomal proteins.

Constellation is based in Cambridge, MA.

http://www.constellationpharma.com/2012/01/constellation-pharmaceuticals-and-genentech-enter-broad-epigenetics-drug-discovery-collaboration/

Otsuka filed a manufacturing and marketing approval application for rotigotine patch

Otsuka announced that it has filed a manufacturing and marketing approval application for rotigotine patch for the treatment of Parkinson's disease and restless legs syndrome in Japan.

Rotigotine is a dopamine agonist that is currently marketed in many countries by UCB for the treatment of Parkinson's disease or restless legs syndrome.

In 2002, Otsuka has acquired

Glenmark provided updates about crofelemer

Glenmark Pharma announced that the Arbitration Panel has granted Glenmark's request seeking its exclusive rights to develop, commercialize and distribute Crofelemer in 140 countries according to the Collaboration Agreement signed between Napo and the Company.

Under the agreement, Napo has granted Glenmark exclusive rights to develop and commercialize crofelemer for India and several other markets for the treatment of pediatric diarrhea, acute infectious diarrhea, and chronic diarrhea in people living with HIV/AIDS. The agreement has

Otsuka to terminate its collaboration with UCB in immunology

Otsuka refocuses its effort to develop compounds for central nervous system and oncology and has agreed to discontinue the collaboration with UCB in immunology.

UCB will be filing the marketing authorization application for certolizumab with the Japanese Ministry of Health, Labour and Welfare in the first quarter of 2012.

UCB intends to seek approval to market certolizumab for

Ab Sciex entered into an agreement with Indigo BioSystems

AB Sciex and Indigo BioSystems entered into an agreement to jointly market mass spectrometry solutions that can be used to streamline data acquisition and automate data review in clinical research and forensic toxicology as well as pre-clinical and clinical trials of investigational compounds.

The company hopes that the joint solutions will help simplifying and accelerating the use of new-generation mass spectrometry technologies.

Under the terms of the agreement, the mass spectrometry of AB SCIEX will be combined to ASCENT of Indigo BioSystem in addition to new-generation algorithms in order to simplify the use of mass spectrometry for those who are not familiar with the system and are used to use easy-to-use lab analyzers.

Astex terminated agreement with GSK

Astex announced early termination of the multi-year collaboration signed between SuperGene and GSK in 2009.

The company will transfer all existing research work and assets developed under the CLIMB epigenetic collaboration to GSK. Astex will no longer be responsible or have any obligation to conduct any research on the program.  Even though the company will no longer

NobelPharma and Eisai to launch Fostoin in Japan

Eisai announced that the company and NobelPharma will launch Fostoin 750 mg for Injection on Jan 17, 2012 in Japan. The compound was approved in Japan in July 2011 and has been listed on Japan's National Health Insurance drug reimbursement price list starting November 25, 2011.

Fostoin is the brand name of fosphenytoin, an

Genentech advances its clinical develop for Lucentis implantable device

Genentech announced that it has decided to submit an Investigational New Drug Application for clinical testing of the device in combination with Lucentis (ranibizumab).  As most of us are aware, Genentech is not a medical device company. The company has signed an agreement with ForSight Vision4, Inc in December of 2010 to have exclusive license to develop and commercialize Vision4's proprietary implantable ocular device in combination with the company's anti-VEGF-A targeted ophthalmic therapies.

According to the terms of the agreement, Genentech will be