Latest News in the pharma Industry

Policy & Regulation

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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EMA Validates BMS application for Opdivo for the treatment of classical Hodgkin lymphoma patients

EMA Validates BMS application for Opdivo for the treatment of classical Hodgkin lymphoma patients

31 Mar 2016

Opdivo has potential to become first PD-1 inhibitor approved in a hematological malignancy in European Union.

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SIR-Spheres Y-90 resin microspheres are a well-tolerated alternative to standard therapies for inoperable primary liver cancer, says new UK NICE MIB

SIR-Spheres Y-90 resin microspheres are a well-tolerated alternative to standard therapies for inoperable primary liver cancer, says new UK NICE MIB

31 Mar 2016

Unlike TACE, most patients treated with SIR-Spheres Y-90 resin microspheres usually require only a single treatment.

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