Pharma News

India Infoline News Service / 16:35 , Jan 04, 2013
Dr. Reddy’s Laboratories announced that it has launched Finasteride Tablets (1 mg), a bioequivalent generic version of Propecia® (Finasteride) Tablets in the US market on January 02, 2013. Dr. Reddy’s ANDA for Finasteride 1 mg Tablets has been awarded a 180-day period of marketing exclusivity in the U.S. on 2 Jan, 2013.



Top Stories

Glenmark Pharma receives nod for Crofelemer 125 mg delayed-release tablets

Glenmark Pharmaceuticals Limited announced that the US Food and Drug Administration has provided Marketing approval to its partner in US, Salix Pharmaceuticals Limited for Crofelemer 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART)

“The USFDA approval of Crofelemer for HIV associated diarrhea will pave the wave to launch Crofelemer across our territories. This is a significant approval milestone and will enable the first NCE launch by Glenmark across emerging markets. Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience non-infectious diarrhea, which often can lead to reduced treatment compliance. This will also help us accelerate filing across countries and also propel our development in additional diarrhea indications including the acute indications,” said Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals Limited.

He added “Crofelemer, a locally-acting, minimally-absorbed drug is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss seen in HIV associated diarrhea. It is this secretion that is believed to lead to diarrhea with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. Read more…

Dr Reddys Laboratories launches Finasteride Tablets

Dr. Reddy’s Laboratories announced that it has launched Finasteride Tablets (1 mg), a bioequivalent generic version of Propecia® (Finasteride) Tablets in the US market on January 02, 2013. Dr. Reddy’s ANDA for Finasteride 1 mg Tablets has been awarded a 180-day period of marketing exclusivity in the U.S. on 2 Jan, 2013.

The Propecia Tablets brand has U.S. sales of approximately $136 Million MAT for the most recent twelve months ending in October 2012 according to IMS Health*.

Dr. Reddy’s Finasteride Tablets 1 mg is available in bottle counts of 30 and 90.

Infocus

Nanotechnology can eliminate Cancer in a decade or so: Prof. RP Tandon

“Cancer may nearly be eliminated in a decade or so with the help of Nanotechnology based Cancer treatments which are under development such as “Targeted Chemotherapy”, “Radiation Therapy” and “Hyperthermia”. Currently, detection and diagnosis of cancer usually depend on changes in cells and tissues that are detected by a doctor’s physical touch or imaging expertise. With the help of Nanotechnology, doctors would be able to detect the earliest molecular changes, long before a physical exam or imaging technology becomes effective.” remarked Prof. R. P. Tandon- Materials Laboratory at University of Delhi (MatsDU), Department of Physics and Astrophysics, University of Delhi while sharing his views on “Role of New Materials in the Emerging Technologies” during the second day of the Seminar on “Nano-Pico Pharmaceutical & Invivgensome” organized at Amity University  in collaboration with World Academy of Biomedical Sciences & Technologies (WABT), Paris (France)

Emphasizing the role of Nanotechnology in the field of medicine, Prof Tandon highlighted that most animal cells are 10,000 to 20,000 nanometers in diameter and Nanoscale devices (less than 100 nanometers) can enter cells and the organelles inside them to interact with DNA and proteins. Tools developed through nanotechnology, therefore, may be able to detect diseases at initial stages”, opined Prof. Tandon

He stressed that nano- particles can be used to dissolve clots in the blood, which have already been tested by Harvard biomedical engineers who have designed drug-infused nanoparticles like platelets, so that they follow the blood flow into the vessels with clots and then release a drug called plasminogen activator, which dissolves those clots and the their leftovers biodegrade without harmful side effects. Read more…

Domestic News

Sun Pharma plans acquisition in Europe: reports

Sun Pharmaceutical Industries Ltd. is planning acquisition in Europe including a possible takeover of German generic-drug maker Stada Arzneimittel AG, according to reports.

Reports said that the company is planning to raise about $1bn for a European deal.

Sun has followed a strategy of acquiring under-performing or unprofitable companies, says report.

Glenmark Generics gets nod for Rizatriptan Benzoate

Glenmark Pharmaceuticals Ltd has announced that Glenmark Generics receives final approval for Rizatriptan Benzoate.

Aurobindo Pharma gets final nod approvals for Rizatriptan Benzoate Tablets

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rizatriptan Benzoate Tablets 5mg (base) and 10mg (base) (ANDA 202490), which was earlier tentatively approved. The product is ready for launch.

Rizatriptan Benzoate Tablets 5mg (base) and 10mg (base) is the generic equivalent of Merck and Co’s Maxalt Tablets 5mg (base) and 10mg (base) and is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. The annual sale of the product is approximately US$300mn for the twelve months ending March 2012 according to IMS.
 
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India Aurobindo now has a total of 171 ANDA approvals (146 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

Bombay Bullion Association inaugurates ambulance services

Four ambulance services were inaugurated by Ashok Raoji Chavan - Ex - Chief Minister & Shri Bhai Jagtapji - MLA, Mumbai along with Mohit Kamboj, President, Bombay Bullion Association at Zaveri Bazaar. The ambulance service is donated by Bombay Bullion Association for Zaveri Bazaar.

The leading hospitals will use these ambulance services to reach people needing medical assistance in case of emergencies at Zaveri Bazaar.

Other people present during the auspicious ocassion were Bipin Jain - Vice President, Bombay Bullion Association,  Kapil Parekh - Vice President, Bombay Bullion Associaltion.

Also Bombay Bullion Communication was inaugurated by by  Sumatichand Gouti - BBA Director today at Zaveri Bazaar.

The other people present were Shri Bhai Jagtapji - MLA & Smt. Veena Jain - Corporator & Shri Janak Sanghvi - Ex – Corporator.

Suven Life secures 3 Product Patents in Eurasia & Canada

Suven Life Sciences Ltd (Suven) announces today that the grant of three (3) product patents, two (2) from Eurasia (016594&017007) and one (1) from Canada (2683124) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2027.

The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia.

With these new patents, Suven has a total of ten (10) granted product patents from Canada & twelve (12) granted product patents from Eurasia. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-ll.

"We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally" says Venkat Jasti, CEO of Suven. Read more…

International News

Synergy Pharma reports positive constipation study results

Synergy Pharmaceuticals reported positive results from a key study of its experimental chronic constipation drug, according to reports.
Synergy shares soared as much as 25 percent to $6.58.

The highest dosage of the drug also met the study's secondary goal of showing a higher incidence of diarrhea compared with a placebo, report says.

Questcor Pharma plans to acquire BioVectra: reports

Questcor Pharmaceuticals, Inc has reportedly said that it has signed a definitive agreement to acquire all issued and outstanding shares of BioVectra Inc., for an upfront payment of C$50 mn.

The acquisition will enable Questcor to further secure the manufacturing process trade secrets surrounding Acthar, according to reports.