Latest News in the pharma Industry

Policy & Regulation

Cladribine Tablets receives positive CHMP opinion for treatment of relapsing forms of MS

Cladribine Tablets receives positive CHMP opinion for treatment of relapsing forms of MS

25 Jun 2017

Cladribine Tablets is the first and only investigational medicinal product to have shown a sustained 4 years of disease control with a maximum of 20 days of oral treatment over 2 years in clinical trials.

Read more 
Pfizer receives expanded Health Canada approval for Ibrance in HR+, HER2- metastatic breast cancer

Pfizer receives expanded Health Canada approval for Ibrance in HR+, HER2- metastatic breast cancer

25 Jun 2017

New indication supported by results of Phase III PALOMA-3 Trial of Ibrance in combination with fulvestrant.

Read more 
Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP

Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP

23 Jun 2017

If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.

Read more 
FDA approves  Mydayis – a once-daily option for ADHD symptom control in patients 13 years plus

FDA approves Mydayis – a once-daily option for ADHD symptom control in patients 13 years plus

22 Jun 2017

Mydayis demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-administration, compared with placebo, in total score on a skill-adjusted math test that measures attention in ADHD.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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.

Read more 
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

Read more 
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.

Read more