Indian Government imposes anti-dumping duty on ceftriaxone sodium sterile from China

September 8th, 2008|

The Union Ministry of Finance has announced the anti-dumping duty imposed on the third generation parenteral cephalosporin antibiotic ceftriaxone sodium sterile imported from China as per the final recommendations of the Directorate-General of Anti-Dumping and Allied Duties (DGAD). 

Pharma-Specific SEZs Poised to Turn FDI Trickle into Investment Flood

September 6th, 2008|

The total investment in special economic zones (SEZs) across the country is likely to touch around Rs 2.84 lakh crore by December 2009 and these SEZs are likely to create around 21 lakh additional jobs…[English]-[French]-[Spanish]

Zydus Cadila gets US FDA nod for Ramipril capsules

September 6th, 2008|

Zydus Cadila has received an approval from the US FDA to market Ramipril capsules in the strengths of 1.25 mg, 5 mg, and 10 mg. The drug falls in the anit-hypertensive segment. The sale of Ramipril capsules as per NDC was estimated at US$ 1.06 billion.

US FDA ask manufacturers of TNF-Blocker Drugs to highlight Risk of Fungal Infections

September 6th, 2008|

The U.S. Food and Drug Administration announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

Elan, Biogen launch Tysabri trial in oncology

September 6th, 2008|

Biogen Idec and Elan Corp have launched the first clinical trial of their multiple sclerosis drug Tysabri for patients with relapsed or refractory multiple myeloma, the companies.

Smith & Nephew gets C1 category approval for OXINIUM in Japan

September 6th, 2008|

Smith & Nephew, a global medical technology business, specializing in Orthopaedic Reconstruction, Orthopaedic Trauma & Clinical Therapies, Endoscopy and Advanced Wound Management products and Smith & Nephew Orthopaedics KK Japan announced that it has received Japanese regulatory C1 Category Reimbursement approval for it's award winning OXINIUM oxidized zirconium technology. 

Sandoz’s Omnitrope gets US FDA approval

September 6th, 2008|

Sandoz has received US Food and Drug Administration approval for its Omnitrope Pen 10 with liquid cartridge. Omnitrope, a somatropin, is approved for long-term treatment of paediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.

U.S. FDA approves Roche hepatitis B test

September 6th, 2008|

Roche Holding AG's DNA test is a safe and effective way to help gauge how well hepatitis B virus treatments are working, U.S. health regulators.

Pfizer and Medivation enter into Global Agreement to Co-Develop and Market Dimebon

September 6th, 2008|

Pfizer Inc and Medivation, Inc announced that they have entered into an agreement to develop and commercialize Dimebon, Medivation’s investigational drug for treatment of Alzheimer’s disease and Huntington’s disease.

US FDA Approves DNA Test to Measure Hepatitis B Virus Levels

September 6th, 2008|

The U.S. Food and Drug Administration approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient’s blood. Assessing a patient’s viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

Dr Reddy and Antares Pharma ink drug development agreement

September 6th, 2008|

Antares Pharma, Inc, a specialty pharmaceutical company which focuses on improving pharmaceuticals through advanced drug delivery systems has entered into a development agreement with Dr Reddy's Laboratories, Inc for the development of an innovative, topically applied product, using Antares' ATD Gel platform, targeting specific receptor sites within the skin.

Dr Reddy’s Lab tie-ups with Cosmederm Technologies for skin care products

September 6th, 2008|

Dr Reddy's Laboratories (DRL) has announced a licensing and distribution agreement with Cosmederm Technologies (CT), a US-based specialty pharmaceutical company focused on dermatology and aesthetic medicine.

Bafna Pharma eyes branded generics market in Sri Lanka

September 6th, 2008|

The Chennai-based Bafna Pharmaceuticals Ltd is planning to set up its marketing operations in the Sri Lankan pharma market for branded generics by registering product dossiers for lifestyle diseases. With this, the company which has been supplying generic products to the Sri Lankan market is shifting its focus to capture a share in the branded generic market.

Ablynx and Merck Serono enter into an agreement to co-discover and co- develop Nanobodies(R)

September 6th, 2008|

Ablynx and Merck Serono to equally contribute to discover and develop Nanobodies(R) against two targets in oncology and immunology and equally share the resulting profits.

Strides Arcolab receives US FDA approval for two Dexamethasone products

September 2nd, 2008|

Strides Arcolab, a Rs 725-crore plus Bangalore-based pharma giant, has received two ANDA approvals for Dexamethasone injection USP, 4mg/ml, and Dexamethasone Sodium Phosphate injection USP, 10 mg/ml.

Indian Pharmaceutical Market to grow 20 percent by 2015 – CII study

September 2nd, 2008|

Indian pharmaceutical market is likely to grow at 19.4 percent. The growth will be facilitated by health consciousness, affordability due to rising incomes of expanding middle class and also health insurance facilities, Confederation of Indian Industry (CII)- Interlink report says.

US FDA issues complete response letter to Onsolis

September 2nd, 2008|

The US Food and Drug Administration (FDA) has issued a Complete Response letter to BioDelivery Sciences International (BDSI) for Onsolis – formerly known as BEMA Fentanyl, in the US.

Pro- Pharma gets US FDA nod for Davanat combo for breast cancer

September 2nd, 2008|

Pro-Pharmaceuticals, Inc announced that the U S Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Centre in Louisville, Kentucky.

Novacea, Inc. and Transcept Pharmaceuticals, Inc. Sign Merger Agreement

September 2nd, 2008|

Novacea, Inc.and  Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced  that they have entered into a definitive merger agreement under which Novacea will merge with Transcept in an all-stock transaction.

EMEA approves Etravirine for HIV combination therapy

September 2nd, 2008|

The European Medicines Agency (EMEA) has granted marketing authorisation for the anti-HIV medication INTELENCE (etravirine). INTELENCE is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and the first to show efficacy in patients with NNRTI-resistant HIV.

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