Latest News in the pharma Industry

Policy & Regulation

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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FDA approves sNDA for Xtandi capsules in advanced prostate cancer

FDA approves sNDA for Xtandi capsules in advanced prostate cancer

23 Oct 2016

Data demonstrate improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were treated with enzalutamide compared to patients who were treated with bicalutamide.

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FDA approves Genentech’s cancer immunotherapy Tecentriq for people with a specific type of metastatic lung cancer

FDA approves Genentech’s cancer immunotherapy Tecentriq for people with a specific type of metastatic lung cancer

19 Oct 2016

First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small cell lung cancer.

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CHMP adopts positive opinion of metformin

CHMP adopts positive opinion of metformin

16 Oct 2016

Includes Merck’s type 2 diabetes treatment portfolio, in patients with renal impairment.

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Allergan's Belkyra receives marketing authorisation in Sweden

Allergan's Belkyra receives marketing authorisation in Sweden

13 Oct 2016

Marketing authorization given for the treatment of moderate to severe fullness under the chin.

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