Latest News in the pharma Industry

Policy & Regulation

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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Theratechnologies to move forward with development of new single vial formulation for Egrifta

Theratechnologies to move forward with development of new single vial formulation for Egrifta

28 Sep 2016

The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection).

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Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy

Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy

27 Sep 2016

Submission of Marketing Authorization Application to the EMA planned in the coming weeks.

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FDA approves Amgen's new biosimilar for multiple inflammatory diseases

FDA approves Amgen's new biosimilar for multiple inflammatory diseases

25 Sep 2016

Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases.

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