Latest News in the pharma Industry

Policy & Regulation

FDA Approves Shire’s Xiidra

FDA Approves Shire’s Xiidra

12 Jul 2016

Xiidra is the only treatment Indicated for the signs and symptoms of dry eye disease.

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Scots first to receive breakthrough immunotherapy for lung cancer

Scots first to receive breakthrough immunotherapy for lung cancer

11 Jul 2016

Eligible patients in Scotland will be the first in the UK to access this life-extending treatment and will be ahead of those patients in England and Wales.

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FDA approves first and only single monthly injection for a PCSK9 inhibitor

FDA approves first and only single monthly injection for a PCSK9 inhibitor

11 Jul 2016

Amgen's Repatha (evolocumab) Pushtronex system (on-body infusor with prefilled cartridge) provides a new, monthly single-dose administration option.

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EC grants marketing authorization for Gilead’s Epclusa for the treatment of all genotypes of chronic hepatitis C

EC grants marketing authorization for Gilead’s Epclusa for the treatment of all genotypes of chronic hepatitis C

10 Jul 2016

Epclusa is the first and only all-oral, single tablet regimen for all genotypes (1-6) of chronic hepatitis C virus infection and is Gilead’s third Sofosbuvir-based treatment.

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FDA approves Genentech’s Xolair for allergic asthma in children

FDA approves Genentech’s Xolair for allergic asthma in children

8 Jul 2016

Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma.

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Shire receives extension of Market Authorization in Europe for Revestive

Shire receives extension of Market Authorization in Europe for Revestive

7 Jul 2016

First therapy indicated in the EU for use in patients aged one year and above with Short Bowel Syndrome, a rare gastrointestinal condition.

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EC approves extended indication for Amgen's Kyprolis

EC approves extended indication for Amgen's Kyprolis

4 Jul 2016

Head-to-head Phase III trial demonstrated superiority of Kyprolis and dexamethasone over Velcade and dexamethasone in patients with relapsed multiple myeloma.

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Chinese authorities issue operating approval to Siegfried Nantong

Chinese authorities issue operating approval to Siegfried Nantong

30 Jun 2016

This significant site addition to Siegfried’s production network strengthens the company’s long-term competitiveness.

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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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