Latest News in the pharma Industry

Policy & Regulation

Shire partner, Shionogi, submits NDA in Japan for ADHD treatment for children

Shire partner, Shionogi, submits NDA in Japan for ADHD treatment for children

11 Feb 2016

With submission, Shire continues to strengthen its presence in Japan.

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Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab

Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab

10 Feb 2016

The first biosimilar monoclonal antibody reviewed, for all eligible indications.

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FDA approves expanded use of BMS’s Daklinza

FDA approves expanded use of BMS’s Daklinza

8 Feb 2016

Updated label provides new treatment option for patients with HIV-1 coinfection, advanced cirrhosis, and post-liver transplant HCV recurrence.

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Oasmia submits MAA to the EMA for its lead cancer product Apealea

Oasmia submits MAA to the EMA for its lead cancer product Apealea

8 Feb 2016

The indication sought for Apealea is treatment of epithelial ovarian cancer in combination with carboplatin.

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First immunotherapy EAMS for most common type of lung cancer brings UK patients access to life-extending medicine

First immunotherapy EAMS for most common type of lung cancer brings UK patients access to life-extending medicine

5 Feb 2016

MHRA grants UK lung cancer patients access to BMS's nivolumab.

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Vertex receives Complete Response Letter from FDA regarding Kalydeco

Vertex receives Complete Response Letter from FDA regarding Kalydeco

5 Feb 2016

Company plans to meet with FDA to determine appropriate path forward.

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Merck set to launch new version of fertility pens

Merck set to launch new version of fertility pens

4 Feb 2016

EMA approves Merck's GONAL-f prefilled pen 2.0.

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Rx-360 summary of the EMA work plan for GMP/GDP Inspectors Working Group for 2016

Rx-360 summary of the EMA work plan for GMP/GDP Inspectors Working Group for 2016

4 Feb 2016

Highlights include inspections, MRAs, harmonization efforts amd GMP/GDP guidance.

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Rx-360 summary of WHO supplementary guidelines on GMP for HVAC systems for non-sterile pharmaceuticals

Rx-360 summary of WHO supplementary guidelines on GMP for HVAC systems for non-sterile pharmaceuticals

3 Feb 2016

These guidelines primarily focus on recommendations for systems for manufactures of solid dosage forms.

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BMS and AbbVie receive positive CHMP opinion for investigational antibody, Empliciti, for the treatment of multiple myeloma

BMS and AbbVie receive positive CHMP opinion for investigational antibody, Empliciti, for the treatment of multiple myeloma

29 Jan 2016

Positive opinion based on reduction in the risk of disease progression or death with Empliciti in combination with standard of care regimen for multiple myeloma demonstrated in ELOQUENT-2 study.

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Merck announces FDA acceptance of BLA for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence

Merck announces FDA acceptance of BLA for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence

27 Jan 2016

FDA grants Priority Review with target action date of 23 July 23 2016.

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Shire resubmits NDA for lifitegrast to FDA

Shire resubmits NDA for lifitegrast to FDA

25 Jan 2016

Resubmission includes positive data from OPUS-3, a Phase III efficacy and safety trial.

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