Latest News in the pharma Industry

Policy & Regulation

BMS's Opdivo receives Breakthrough Therapy Designation from FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck

BMS's Opdivo receives Breakthrough Therapy Designation from FDA for previously treated recurrent or metastatic squamous cell carcinoma of the head and neck

25 Apr 2016

Designation signals the urgent need for new treatment approaches in recurrent or metastatic squamous cell carcinoma of the head and neck after platinum based therapy.

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Shire Submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets

Shire Submits NDA to FDA for new formulation of Vyvanse CII as chewable tablets

15 Apr 2016

New formulation, in adherence with approved indications, intended for children, adolescents and adults with difficulty swallowing or opening capsules.

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AbbVie receives FDA accelerated approval of Venclexta (venetoclax) tablets

AbbVie receives FDA accelerated approval of Venclexta (venetoclax) tablets

13 Apr 2016

The first BCL-2 inhibitor in relapsed/refractory chronic lymphocytic leukemia patients with 17p deletion.

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Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe

Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe

12 Apr 2016

Synthon is the only company to have performed such a study for glatiramer acetate and to obtain regulatory clearance in Europe.

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FDA grants Priority Review for Genentech’s cancer immunotherapy atezolizumab in specific type of lung cancer

FDA grants Priority Review for Genentech’s cancer immunotherapy atezolizumab in specific type of lung cancer

11 Apr 2016

Treatment targets people with locally advanced or metastatic NSCLC whose disease expresses the protein PD-L1 and who have progressed on or after platinum-containing chemotherapy.

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Hikma's ANDA for generic Advair Diskus accepted for filing by FDA

Hikma's ANDA for generic Advair Diskus accepted for filing by FDA

8 Apr 2016

FDA has provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, a GDUFA goal date of 10 May 2017.

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Novartis receives EU approval for Revolade as first-in-class therapy for children aged 1 year and above with chronic ITP

Novartis receives EU approval for Revolade as first-in-class therapy for children aged 1 year and above with chronic ITP

7 Apr 2016

Two formulations approved: once-daily tablet and oral suspension formulation designed for younger children who may not be able to swallow tablets.

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NDA Group releases data comparing FDA and EMA ahead of annual DIA EuroMeeting in Hamburg

NDA Group releases data comparing FDA and EMA ahead of annual DIA EuroMeeting in Hamburg

5 Apr 2016

In spite of similar approval numbers, the US continue to outpace Europe.

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GSK receives positive CHMP opinion in Europe for Strimvelis, the first gene therapy to treat very rare disease, ADA-SCID

GSK receives positive CHMP opinion in Europe for Strimvelis, the first gene therapy to treat very rare disease, ADA-SCID

4 Apr 2016

The medicine is a stem cell gene therapy created for an individual patient from their own cells which is intended to correct the root cause of the disease.

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Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia

Janssen receives CHMP Positive Opinion for Trevicta recommending approval in EU for maintenance treatment of schizophrenia

3 Apr 2016

If approved, Trevica will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the EU.

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OPKO receives Complete Response Letter from FDA for Rayaldee NDA

OPKO receives Complete Response Letter from FDA for Rayaldee NDA

3 Apr 2016

Sole issue relates to third-party manufacturing observations.

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Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion

Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion

2 Apr 2016

Flixabi to be the second anti-TNF biosimilar commercialized and manufactured by Biogen in the EU.

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