Monthly Archives: February 2009

Dr Reddy’s trims non-US operations

February 24th, 2009|

Pharma major, Dr Reddy’s Laboratories (DRL) is understood to be scaling back its non-US global operations. The company is trimming operations in many CIS countries, in the Middle East and Africa.

Waters XenoTech LLC offers drug industry new metabolite profiling

February 24th, 2009|

Waters XenoTech has begun offering new metabolite profiling services. This has been possible with the Synapt High Definition Mass Spectrometry (HDMS) System.

NeoStem gets worldwide licence to stem cell tech for skin therapies

February 24th, 2009|

NeoStem, Inc, which is pioneering the pre-disease collection, processing and long-term storage of adult stem cells for future medical need, has signed a license agreement to obtain the exclusive worldwide rights to innovative stem cell technology and applications for cosmetic facial and body procedures and skin rejuvenation.

Orchid Pharma gets USFDA nod for Cetirizine Hydrochloride tablet

February 23rd, 2009|

Chennai-based Pharma major, Orchid Chemicals (Q, N,C,F)* & Pharmaceuticals has received ANDA (Abbreviated New Drug Application) approved from US Food and Drug Administration (US FDA) for its drug Cetirizine Hydrochloride tablet.

Pharma cos may face penalties for overpricing

February 23rd, 2009|

Drugmakers, such as Dr Reddy’s Laboratories, Wyeth, GlaxoSmithKline (GSK) Pharmaceuticals and Alkem Laboratories, may now have to face state officials for failing to pay up penalties for overpricing.

Govt committed to help small, medium pharma units: Paswan

February 23rd, 2009|

Union minister of chemicals and fertilisers Ram Vilas Paswan assured the small scale pharmaceutical sector that extending support to them has been an on-going agenda of the present government and it would continue further.

Excise duty reduction from 8 to 4% likely to continue after 2008-09

February 23rd, 2009|

The excise duty reduction from 8 per cent to 4 per cent, announced by the central government on December 8, 2008 as part of a stimulus package to the industry to tide over the sagging economic scenario, is likely to continue after the end of this financial year as the economic downturn, analysts believe, is yet to be bottomed out.

Eisai to sell Bial’s anti-epileptic drug Zebinix in Europe

February 23rd, 2009|

Eisai Europe Limited a European subsidiary of Eisai Co, Ltd entered into a license and co-promotion agreement with Bial – Portela & CA, SA, which gives Eisai Europe Ltd rights to sell Bial's anti-epileptic drug Zebinix (eslicarbazepine acetate) in Europe.

Nuvo may get US FDA nod to market Pennsaid

February 23rd, 2009|

Nuvo Research Inc, a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, announced that the US Food and Drug Administration (FDA) has accepted Nuvo's resubmission of its application for FDA approval to market Pennsaid in the US as a complete response to the FDA's December 28, 2006 Approvable Letter.

US FDA approves humanitarian device exemption for deep brain stimulator for OCD symptoms

February 23rd, 2009|

The US Food and Drug Administration (US FDA) approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

US FDA seeks additional study results from Gilead’s aztreonam for inhalation

February 23rd, 2009|

Gilead Sciences, Inc has received a response from the US Food and Drug Administration (FDA) to its appeal, submitted under the formal Dispute Resolution process, regarding the Agency's Complete Response Letter for its New Drug Application (NDA) for aztreonam for inhalation solution.

Access, JCOM sign license pact to develop, commercialize ProLindac & MuGard

February 23rd, 2009|

Access Pharmaceuticals, Inc and JCOM Ltd, an affiliate of DONG-A Pharmaceuticals, the premier pharmaceutical company in the Republic of Korea, signed a definitive licensing agreement under which JCOM and DONG-A will manufacture, develop and commercialize Access' proprietary products ProLindac and MuGard for the Republic of Korea.

Frontage and Beijing Pharma Expand R&D Agreement

February 23rd, 2009|

Frontage Laboratories expanded its R&D agreement with Beijing Second Pharmaceuticals and plans to collaborate with the company to develop 12 ANDA products within the next three to five years. These will be marketed in China, Europe, and the U.S. One of the products the companies developed was filed to the FDA in 2008 with more scheduled to be filed this year.

Sinclair signs pacts with BMG on further development of Sinclair pipeline & technologies

February 23rd, 2009|

Sinclair Pharma plc, the international specialty pharma company, announces two separate product development and commercialization deals with BMG Pharma, a privately-owned US-based company. The deals present Sinclair with significant pipeline development opportunities and new product assets.

CII pharma task force finalises recommendations on the fate of SME sector

February 22nd, 2009|

Confederation of Indian Industry (CII) will take up the persisting issues of the small scale pharma units in the country with the ministries of Chemicals, Finance and Environment and Forest, based on the recommendation of its task force.

Rs 761-cr package to revive IDPL ready’

February 22nd, 2009|

Chemical and Pharmaceuticals Minister, Mr Ram Vilas Paswan on Monday said a Rs 761-crore revival package has been prepared for the state-run pharma firm IDPL that would soon be presented before the cabinet for approval.

Kerala Drug Controller suggests a set of changes to D&C Act

February 22nd, 2009|

The State Drug Regulator of Kerala, M P George, has submitted a set of comprehensive suggestions to the Drug Controller General of India (DCGI) in the context of ongoing process of amendment to the Drugs and Cosmetics Act 1940. He made the proposal in the wake of a decision made at the 39th Drugs Consultative Committee (DCC) held on December 10 last year.

Union govt grants Rs 90 cr for starting 6 State Institute of Yoga & Naturopathy centres

February 22nd, 2009|

Union government has sanctioned Rs 90 crore to set up six dedicated 'State Institute of Yoga and Naturopathy' centres across the country. To begin with, these centres will come up in Karnataka, Haryana and Jharkhand.

Defence Research Lab identified potential herbs to develop malaria drug from North East

February 22nd, 2009|

The Defense Research and Development Organisation (DRDO) has succeeded in identifying two species of herbs carrying elements for a potential drug for malaria and is hopeful of bringing it to the market within two years as an alternative to existing drugs like chloroquine.

Gen Next turns its back on small, medium pharma companies

February 22nd, 2009|

Chennai-based T S Jaishankar and his wife Rajam are worried about the future of their healthcare businesses. They are not sure whether their only daughter Swetha and son-in-law and Indian tennis player Mahesh Bhupathi would takeover the reins of Chemech Laboratories and contract research company Quest Lifesciences when they decide to retire.