Latest News in the pharma Industry

Policy & Regulation

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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Novartis LEE011 granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer

Novartis LEE011 granted FDA Priority Review for first-line treatment of HR+/HER2- advanced breast cancer

2 Nov 2016

Trial showed LEE011 plus letrozole reduced the risk of progression or death by 44% over letrozole alone.

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AmpliPhi Biosciences granted Small and Medium Enterprise status by EMA

AmpliPhi Biosciences granted Small and Medium Enterprise status by EMA

1 Nov 2016

Europe to be a key market for the company's phage-based therapies to treat bacterial infections in patients with unmet medical needs.

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EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma

EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma

31 Oct 2016

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

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Regeneron and Sanofi receive Complete Response Letter from FDA for sarilumab

Regeneron and Sanofi receive Complete Response Letter from FDA for sarilumab

28 Oct 2016

Deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished.

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Clobazam oral suspension approved in seven European countries

Clobazam oral suspension approved in seven European countries

25 Oct 2016

Provides pan-European availability of widely used and much needed oral liquid version clobazam tablets.

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FDA approves Merck’s Keytruda in metastatic NSCLC

FDA approves Merck’s Keytruda in metastatic NSCLC

25 Oct 2016

Approval is for first-line treatment of patients whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations.

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