Latest News in the pharma Industry

Policy & Regulation

Novartis achieves regulatory milestone for AMG 334 in migraine prevention with EMA filing acceptance

Novartis achieves regulatory milestone for AMG 334 in migraine prevention with EMA filing acceptance

21 Jun 2017

AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance.

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FDA accepts Amgen's sBLA to expand indication for Xgeva to include multiple myeloma patients

FDA accepts Amgen's sBLA to expand indication for Xgeva to include multiple myeloma patients

19 Jun 2017

Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US.

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Sandoz receives approval in Europe for Rixathon to treat blood cancers and immunological diseases

Sandoz receives approval in Europe for Rixathon to treat blood cancers and immunological diseases

19 Jun 2017

Sandoz now has four biosimilars approved in Europe - more than any other company.

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FDA updates on Pfizer drug shortages

FDA updates on Pfizer drug shortages

18 Jun 2017

Pfizer says shortages caused by manufacturing, distribution and third party delays.

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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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