Latest News in the pharma Industry

Policy & Regulation

GSK receives FDA approval for expanded indication for FluLaval Quadrivalent

GSK receives FDA approval for expanded indication for FluLaval Quadrivalent

21 Nov 2016

Indication now includes use in children 6 months and older.

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Intarcia's NDA tackles glycemic control and poor patient adherence head on

Intarcia's NDA tackles glycemic control and poor patient adherence head on

21 Nov 2016

ITCA 650 is the first investigational drug to use Intarcia's disruptive Medici Drug Delivery System to deliver chronic medicines just once or twice yearly.

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NICE ‘yes’ for chronic myeloid leukaemia pill

NICE ‘yes’ for chronic myeloid leukaemia pill

17 Nov 2016

For patients this could mean more are able to achieve a normal life expectancy, without compromising on their quality of life.

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Adherium’s Smartinhaler dramatically improves clinical outcomes and medication adherence in children with asthma

Adherium’s Smartinhaler dramatically improves clinical outcomes and medication adherence in children with asthma

17 Nov 2016

Trial results also provide a cost-saving argument for introducing Smartinhaler into routine practice.

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Xellia Pharmaceuticals receives green light from FDA to commence packaging and distribution operations at Cleveland site

Xellia Pharmaceuticals receives green light from FDA to commence packaging and distribution operations at Cleveland site

14 Nov 2016

Company prepares to start the production of sterile anti-infective injectable products at this site during 2018.

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EC approves Parsabiv for the treatment of secondary hyperparathyroidism in adults on hemodialysis

EC approves Parsabiv for the treatment of secondary hyperparathyroidism in adults on hemodialysis

13 Nov 2016

First treatment advance for secondary hyperparathyroidism in more than a decade.

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Sanofi receives CHMP recommendation for approval of Suliqua in the EU

Sanofi receives CHMP recommendation for approval of Suliqua in the EU

11 Nov 2016

Treatment combines two widely used and complementary medicines into a single daily injection for people with type 2 diabetes who are struggling to keep their blood sugar levels under control.

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BMS's Opdivo is the first immuno-oncology treatment to receive FDA approval

BMS's Opdivo is the first immuno-oncology treatment to receive FDA approval

11 Nov 2016

Treatment proven in a Phase III trial to significantly extend overall survival for patients with recurrent or metastatic squamous cell head and neck cancer.

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Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab

Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab

8 Nov 2016

Potential to be first submission of a proposed biosimilar trastuzumab in the US.

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SMC ‘yes’ to first immunotherapy combination for skin cancer patients

SMC ‘yes’ to first immunotherapy combination for skin cancer patients

7 Nov 2016

Allows adult patients with advanced melanoma to receive first-line treatment with the potentially life-extending combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) on the NHS in Scotland.

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Mylan and Biocon announce regulatory submission for insulin glargine accepted for eeview by EMA

Mylan and Biocon announce regulatory submission for insulin glargine accepted for eeview by EMA

3 Nov 2016

Filing includes analytical, functional and pre-clinical data, and results from the pharmacokinetics and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan's and Biocon's Insulin glargine with Lantus.

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Positive NICE recommendation for Halaven for patients with locally advanced or metastatic breast cancer

Positive NICE recommendation for Halaven for patients with locally advanced or metastatic breast cancer

3 Nov 2016

Is the first breast cancer treatment to be recommended by NICE in nearly a decade.

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