Latest News in the pharma Industry

Policy & Regulation

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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FDA grants Orphan Drug Designation for True North Therapeutics' lead product candidate, TNT009

FDA grants Orphan Drug Designation for True North Therapeutics' lead product candidate, TNT009

13 Oct 2016

TNT009 is currently in clinical development for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia.

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Arch Biopartners receives patent for Metablok

Arch Biopartners receives patent for Metablok

11 Oct 2016

Is the first patent issued protecting the composition and method of use for Metablok, the company's drug candidate targeting inflammation, sepsis and cancer metastasis.

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FDA accepts sNDA for Avycaz

FDA accepts sNDA for Avycaz

11 Oct 2016

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated urinary tract infections.

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FDA approvs infant-specific dose of Pertzye delayed-release capsules to treat EPI due to cystic fibrosis

FDA approvs infant-specific dose of Pertzye delayed-release capsules to treat EPI due to cystic fibrosis

11 Oct 2016

The new formulation will be offered in 4,000 lipase units capsule.

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Patent trial and appeal board upholds the validity of Lialda patent

Patent trial and appeal board upholds the validity of Lialda patent

6 Oct 2016

Shire pleased with the decision and will continue to vigorously defend its patents.

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