Latest News in the pharma Industry

Policy & Regulation

India's Supreme Court to Hear Novartis Patent Case

India's Supreme Court to Hear Novartis Patent Case

28 Nov 2011

The case is the final act in a legal battle over the patentability of the salt form of the anti-cancer drug imatinib and section 3(d) of the Indian patent law that stretches back over five years.

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Takeda Submits NDA for Type 2 Diabetes Therapy

Takeda Submits NDA for Type 2 Diabetes Therapy

25 Nov 2011

Takeda submitted a New Drug Application to the FDA for the fixed-dose combination therapy alogliptin/metformin.

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EMA Recalls Ben Venue Cancer Drugs

EMA Recalls Ben Venue Cancer Drugs

24 Nov 2011

Four cancer drugs and the antiviral medicine Vistide have been recalled owing to problems in the sterilisation process.

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Mylan Settles Drug Lawsuit with Novartis

Mylan Settles Drug Lawsuit with Novartis

23 Nov 2011

Mylan has settled a patent litigation lawsuit with Novartis Pharmaceuticals related to Vivelle-Dot.

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NMP Expected to Enhance Indian Pharma Industry

NMP Expected to Enhance Indian Pharma Industry

23 Nov 2011

Drug pharmaceutical manufacturers, drug production industry experts opine that NMP would help to leverage the benefits from improved infrastructure, simplification of business regulations and skill upgrade measures.

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FDA Accepts NDA for Northera

FDA Accepts NDA for Northera

23 Nov 2011

The FDA will review and act on the application for the drug, designed to treat symptomatic neurogenic orthostatic hypotension, by 28 March 2012.

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FDA Approves Orphan Drug Erwinaze against Acute Lymphoblastic Leukemia

FDA Approves Orphan Drug Erwinaze against Acute Lymphoblastic Leukemia

21 Nov 2011

The approval is based on the results of clinical studies in 630 acute lymphoblastic leukemia patients.

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FDA Approves Eylea to Treat Eye Disorder

FDA Approves Eylea to Treat Eye Disorder

21 Nov 2011

The safety and effectiveness of Eylea was evaluated in two clinical trials involving 2,412 adult patients. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.

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European Patent Office Grants Patent for Sativex

European Patent Office Grants Patent for Sativex

18 Nov 2011

The European Patent Office has granted a patent for endocannabinoid modulator Sativex with an exclusivity period until August 2023.

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FDA Approves First Drug to Treat Myelofibrosis

FDA Approves First Drug to Treat Myelofibrosis

18 Nov 2011

Jakafi has become the first drug approved to specifically treat patients with the bone marrow disease.

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EMA Accepts MAA for PBA Therapy

EMA Accepts MAA for PBA Therapy

18 Nov 2011

The MAA is based on comprehensive clinical data from Avanir's controlled phase 3 studies of NUEDEXTA in patients with PBA.

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FDA Approves Anti-depressant CPI-300

FDA Approves Anti-depressant CPI-300

17 Nov 2011

CPI-300 is a single dose 450mg formulation of bupropion hydrochloride for the treatment of major depressive disorder.

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