DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Japanese Patent Applications can be translated to English by EPO’s Automatic Machine Translation
Japanese Patent Applications can be translated to English by EPO’s Automatic Machine Translation
Today EPO and the Japan Patent Office (JPO) announced the launch of the Japanese-English component of the EPO’s automatic translation service Patent Translate. This is a very good news for patent applicants and inventors across the globe as they can now easily translate the patent published in Japanese language. Numerous Japanese patent specifications available via the EPO’s global patent database Espacenet (www.epo.org/espacenet) can now be translated into English at zero cost to the applicant.
Recently, EPO and Google have been working together for sometime now to provide translation service optimised for patent specifications. Currently, patent translate covers translations between English and 15 other languages, namely Chinese, Danish, Dutch, Finnish, French, German, Greek, Hungarian, Italian, Japanese, Norwegian, Polish, Portuguese, Spanish and Swedish. In the time to come more languages will be added to the database.
Patent Translate
Patent Translate…
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FDA has granted tentative approval to India-based Strides Arcolab’s HIV drug emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg.
chief executive and vice chairman Arun Kumar –Strides arcolab
Deepak Vaidya, chaiman
Headquartered in India, Strides Arcolab is a pharmaceutical company with a key focus on the development and manufacture of IP-led niche products, particularly sterile injectables. It is among the world’s largest manufacturers of soft gelatin capsules. With 14 world-class manufacturing facilities, an innovative R&D hub and a marketing network in 70 countries, Strides is well positioned to meet the demands of the global pharmaceutical industry and has partnered with several of the world’s leading pharmaceutical companies.
2 August 2013
Strides Arcolab’s HIV drug, which is generic version of Gilead Sciences’ Truvada, gets tentative approval from the US FDA.
Tentative approval implies that the drug has met all standards but cannot be marketed in the US due to existing patent protections Good news for HIV AIDS patients
FDA has granted tentative approval to India-based Strides Arcolab’s HIV drug emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg. The drug is a generic version of Truvada, 200 mg/300 mg tablets, which is manufactured by Gilead Sciences.
The product is indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1
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EMTRICITABINE
credit-chemdrug
Theravance Announces FDA Advisory Committee to Review ANORO(TM) ELLIPTA(TM) (UMEC/VI) for COPD
umeclidinium bromide
vilanterol
Theravance Announces FDA Advisory Committee to Review ANORO(TM) ELLIPTA(TM) (UMEC/VI) for COPD
SOUTH SAN FRANCISCO, CA — 08/01/13 –Theravance, Inc. today announced that on September 10, 2013, the U.S. Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee will discuss the new molecular entity New Drug Application (NDA) 203975 for umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO™ ELLIPTA™), sponsored by Glaxo Group (d/b/a GSK) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The advanced display of the Federal Register notice on the advisory committee can be found at:http://www.ofr.gov/OFRUpload/OFRData/2013-18633_PI.pdf
UMEC/VI is a combination of two investigational bronchodilator molecules — GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA™ inhaler. The Prescription Drug User Fee Act (PDUFA) goal date is December 18, 2013. UMEC/VI is in development under the LABA collaboration agreement between Glaxo Group Limited and Theravance, Inc.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance’s key programs include: RELVAR™ ELLIPTA™ or BREO™ ELLIPTA™ (FF/VI), ANORO™ ELLIPTA™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance’s web site atwww.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
RELVAR™, BREO™, ANORO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of the brand names ANORO™ and RELVAR™ has not yet been approved by any regulatory authority.
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