Latest News in the pharma Industry

Policy & Regulation

FDA Advisory Committee recommends approval of Jardiance for cardiovascular indication

FDA Advisory Committee recommends approval of Jardiance for cardiovascular indication

29 Jun 2016

Endocrinologic and Metabolic Drugs Advisory Committee votes in favour of cardiovascular mortality benefit for JARDIANCE for adults with type 2 diabetes.

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BMS Opdivo receives Breakthrough Therapy Designation from FDA for advanced form of bladder cancer

BMS Opdivo receives Breakthrough Therapy Designation from FDA for advanced form of bladder cancer

27 Jun 2016

This milestone marks the sixth Breakthrough Therapy Designation for Opdivo.

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Allergan announces FDA approval of sNDA for Avycaz

Allergan announces FDA approval of sNDA for Avycaz

26 Jun 2016

Label now includes Phase III clinical data evaluating the safety and efficacy of Avycaz (in combination with metronidazole) in patients with complicated intra-abdominal infections.

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Mylan launches generic Avodart Capsules

Mylan launches generic Avodart Capsules

24 Jun 2016

Product is indicated as monotherapy for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related sur...

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EMA starts review of medicines manufactured at Pharmaceutics International Inc.

EMA starts review of medicines manufactured at Pharmaceutics International Inc.

24 Jun 2016

Shortcomings include insufficient measures to reduce the risk of cross-contamination, as well as quality assurance.

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OPKO’S Rayaldee product receives FDA approval

OPKO’S Rayaldee product receives FDA approval

22 Jun 2016

First drug to use Catalent’s proprietary OptiShell capsule technology to achieve extended release profile.

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PaizaBio: China approves Drug Marketing Authorization Holder pilot plan

PaizaBio: China approves Drug Marketing Authorization Holder pilot plan

20 Jun 2016

Move approves the use of contract manufacturing organisations.

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Breakthrough combination for patients with skin cancer receives fast-tracked ‘yes’ from NICE

Breakthrough combination for patients with skin cancer receives fast-tracked ‘yes’ from NICE

17 Jun 2016

This represents one of the fastest ever approvals by NICE – UK patients will be the first to benefit across Europe.

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NICE denies NHS patients access to Vertex's Orkambi

NICE denies NHS patients access to Vertex's Orkambi

17 Jun 2016

“As a result of applying the wrong appraisal process, approximately 2,700 people in England who could benefit from Orkambi are being forced to continue waiting for access.”

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Rx-360 summary of the draft WHO HVAC GMPs for non-sterile products

Rx-360 summary of the draft WHO HVAC GMPs for non-sterile products

14 Jun 2016

Document is intended to provide guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, installation, qualification and maintenance of the HVAC systems.

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Health Canada approves Inflectra (biosimilar infliximab) for three additional indications

Health Canada approves Inflectra (biosimilar infliximab) for three additional indications

14 Jun 2016

The addition of Crohn's disease, fistulising Crohn's disease and ulcerative colitis to the approved indications was granted on the basis of similarity between Inflectra and the reference product, Remicade.

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Shire receives FDA Breakthrough Therapy Designation for SHP621 and SHP625, investigational products for rare GI conditions

Shire receives FDA Breakthrough Therapy Designation for SHP621 and SHP625, investigational products for rare GI conditions

13 Jun 2016

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