Latest News in the pharma Industry

Policy & Regulation

FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus

FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus

15 Jun 2017

Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference medicine.

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Achelios Therapeutics concludes successful Type C meeting with FDA regarding Topofen

Achelios Therapeutics concludes successful Type C meeting with FDA regarding Topofen

14 Jun 2017

Currently there are no approved topical NSAIDs indicated for the treatment of migraine.

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FDA requests removal of certain prescription opioid for risks related to abuse

FDA requests removal of certain prescription opioid for risks related to abuse

9 Jun 2017

Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatit.is C

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FDA Advisory Committee to review Avastin biosimilar candidate

FDA Advisory Committee to review Avastin biosimilar candidate

7 Jun 2017

The Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with NSCLC.

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Spinraza approved in the EU as first treatment for spinal muscular atrophy

Spinraza approved in the EU as first treatment for spinal muscular atrophy

2 Jun 2017

Robust data from Phase III studies demonstrated positive impact on motor milestone achievement; increased survival in infants with SMA.

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NICE approves first use of Opdivo in blood cancer

NICE approves first use of Opdivo in blood cancer

2 Jun 2017

NICE has recommended immunotherapy drug nivolumab for the treatment of adult patients with classical Hodgkin lymphoma.

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Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA

Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA

31 May 2017

Biosimilar infliximab alone could potentially save the NHS £89 million.

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Lupin Pharmaceuticals announces nationwide recall of Mibelas 24 Fe tablets

Lupin Pharmaceuticals announces nationwide recall of Mibelas 24 Fe tablets

30 May 2017

Recall due to out of sequence tablets and missing expiry/lot information.

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FDA accepts for priority review BMS’s application for Opdivo in previously treated hepatocellular carcinoma

FDA accepts for priority review BMS’s application for Opdivo in previously treated hepatocellular carcinoma

26 May 2017

Application is based on results from the Phase I/II CheckMate -040 trial.

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WuXi STA, CFDA and Jinshan Government to co-host Marketing Authorization Holder regulatory summit in Shanghai

WuXi STA, CFDA and Jinshan Government to co-host Marketing Authorization Holder regulatory summit in Shanghai

25 May 2017

Industry and regulators combine to run afternoon congress on the implications of regulatory changes.

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FDA approves Kevzara for the treatment of moderately to severely active RA in adults

FDA approves Kevzara for the treatment of moderately to severely active RA in adults

23 May 2017

Kevzara is now available to US patients.

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FDA approves Genentech’s Actemra for giant cell arteritis

FDA approves Genentech’s Actemra for giant cell arteritis

22 May 2017

Sixth FDA approval for Actemra since its US launch in 2010,

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