Latest News in the pharma Industry

Policy & Regulation

Teva Receives EU Approval for Oral Contraceptive Tablet

Teva Receives EU Approval for Oral Contraceptive Tablet

8 Aug 2011

Teva holds marketing rights for new oral contraceptive tablet in France, Italy, Belgium and Spain and expects the first launch in 2011.

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FDA Approves Solution Form of Oncology Medication

FDA Approves Solution Form of Oncology Medication

8 Aug 2011

Hospira is the first company to offer gemcitabine in a solution formulation for the U.S. market. The solution formulation is designed to improve pharmacist convenience and handling safety.

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India's Health Ministry Completes Vaccine Policy to Strengthen Immunisation Programme

India's Health Ministry Completes Vaccine Policy to Strengthen Immunisation Programme

8 Aug 2011

The policy seeks to streamline the decision-making process on new and underutilised vaccine introduction, besides addressing issues of vaccine security, management, regulatory guidelines, vaccine research and development, and product development.

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Covidien Morphine Sulfate Oral Solution Wins FDA Approval

Covidien Morphine Sulfate Oral Solution Wins FDA Approval

5 Aug 2011

Covidien has received the FDA approval for its Mallinckrodt business for morphine sulfate oral solution.

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EC Approves Roche’s Roactemra against Active Systemic Juvenile Idiopathic Arthritis

EC Approves Roche’s Roactemra against Active Systemic Juvenile Idiopathic Arthritis

4 Aug 2011

Roche has won European approval for broader use of its arthritis drug RoActemra to treat children with a rare and severe form of the disease.

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SEC Charges Biopharmaceutical Company and Executives with Securities Fraud

SEC Charges Biopharmaceutical Company and Executives with Securities Fraud

3 Aug 2011

The Securities and Exchange Commission has charged a California-based biopharmaceutical company, three shareholder companies, and four senior executives for fraudulently misleading investors about the regulatory status of the company’s sole produc...

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AstraZeneca Receives Positive Agreement for AXANUM in Europe

AstraZeneca Receives Positive Agreement for AXANUM in Europe

3 Aug 2011

AstraZeneca's AXANUM for prevention of cardiovascular events has received positive agreement for approval in 23 European Union member countries and in Norway.

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FDA Approves Morphine Sulfate Oral Solution

FDA Approves Morphine Sulfate Oral Solution

2 Aug 2011

Covidien has received approval from the FDA for morphine sulfate oral solution used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.

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BMS Gets FDA Clearance of Rheumatoid Arthritis Drug

BMS Gets FDA Clearance of Rheumatoid Arthritis Drug

2 Aug 2011

BMS says Orencia is the only biologic for treating RA that has been approved both in an intravenous infusion formulation and as a self-injectable subcutaneous formulation.

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U.S. Court of Appeals Backs Validity of Lilly's Strattera Patent

U.S. Court of Appeals Backs Validity of Lilly's Strattera Patent

1 Aug 2011

Eli Lilly won an appeals court ruling in its effort to block generic versions of attention-deficit treatment Strattera.

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FDA Provides Response to Eisai New Drug Application

FDA Provides Response to Eisai New Drug Application

1 Aug 2011

FDA has issued a Refusal to File letter in response to the company's New Drug Application for perampanel.

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EC Conditionally Approves Multiple Sclerosis Drug Fampyra

EC Conditionally Approves Multiple Sclerosis Drug Fampyra

29 Jul 2011

Under terms of the approval conditions, the European regulator is recommending the firm carry out a further study to evaluate long-term benefits and safety of the drug.

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