Latest News in the pharma Industry

Policy & Regulation

HHS Launches New Initiative to Strengthen Primary Care

HHS Launches New Initiative to Strengthen Primary Care

29 Sep 2011

Under the new initiative, Medicare will work with commercial and state health insurance plans to offer additional support to primary care doctors who better coordinate care for their patients.

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Novartis Receives Japanese Regulatory Approval for Two Innovative Therapies

Novartis Receives Japanese Regulatory Approval for Two Innovative Therapies

28 Sep 2011

The Japanese regulators have approved Novartis' once-daily Gilenya (fingolimod) 0.5mg and Illaris (canakinumab) subcutaneous injection 150mg in the Japanese market.

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India Releases Guidelines for Conservation & Development of Medicinal Plants

India Releases Guidelines for Conservation & Development of Medicinal Plants

28 Sep 2011

The scheme released by India's Department of Ayush aims to promote availability of quality plant based raw material.

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Boehringer Ingelheim Receives EU Approval for Viramune Once-daily Formulation

Boehringer Ingelheim Receives EU Approval for Viramune Once-daily Formulation

28 Sep 2011

Boehringer Ingelheim has received European approval for its once-daily Viramune tablets for HIV treatment.

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Eisai Receives Canadian Approval of Banzel as Adjunctive Treatment for Severe Epilepsy Disorder

Eisai Receives Canadian Approval of Banzel as Adjunctive Treatment for Severe Epilepsy Disorder

26 Sep 2011

Canadian regulators have given approval of Banzel for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

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Tokai Secures Financing to Advance Cancer Drug Study

Tokai Secures Financing to Advance Cancer Drug Study

26 Sep 2011

Tokai Pharmaceuticals has received $23m funding in a Series D3 financing to support its ongoing clinical development of galeterone.

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Remicade Approved to Treat Ulcerative Colitis in Children Older Than 6 Years

Remicade Approved to Treat Ulcerative Colitis in Children Older Than 6 Years

26 Sep 2011

Janssen's Remicade has been approved by FDA to treat moderately to severely active ulcerative colitis in children older than 6 years who have had inadequate response to conventional therapy.

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FDA Approves Soliris for Rare Pediatric Blood Disorder

FDA Approves Soliris for Rare Pediatric Blood Disorder

26 Sep 2011

The FDA has approved Soliris to treat patients with atypical Hemolytic Uremic Syndrome that can lead to kidney failure and is also associated with increased risk of death and stroke.

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EMA Recommends Restricting Use of Multaq

EMA Recommends Restricting Use of Multaq

23 Sep 2011

Due to an increased risk of liver, lung and cardiovascular adverse events, Multaq should only be prescribed after alternative treatment options have been considered.

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EMA Starts Review of Orlistat-containing Medicines

EMA Starts Review of Orlistat-containing Medicines

23 Sep 2011

The EMA is reviewing relevant data on the risk of hepatotoxicity of orlistat-containing medicines and will issue an opinion on whether or not the marketing authorisations should be revoked, suspended or changed.

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EMA Recommends Discontinuation of Vimpat Syrup

EMA Recommends Discontinuation of Vimpat Syrup

23 Sep 2011

The recommendation follows the voluntary recall of Vimpat 15mg/ml syrup on 15 September 2011. The recall was initiated because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup.

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NIH to Facilitate License Agreements of Medical Technologies

NIH to Facilitate License Agreements of Medical Technologies

21 Sep 2011

NIH is reducing both the cost and paperwork requirements for start-up companies to obtain an exclusive option agreement to license the extensive patents and patent applications from research laboratories.

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