Latest News in the pharma Industry

Policy & Regulation

CHMP recommends EU Conditional Marketing Authorisation for Natpar for patients with chronic hypoparathyroidism

CHMP recommends EU Conditional Marketing Authorisation for Natpar for patients with chronic hypoparathyroidism

27 Feb 2017

If approved, Natpar would be the first licensed recombinant parathyroid hormone in Europe for the management of chronic hypoparathyroidism, the only endocrine-deficiency disorder with no hormone treatment.

Read more 
FDA expands approval of Spiriva Respimat inhalation spray

FDA expands approval of Spiriva Respimat inhalation spray

16 Feb 2017

Steroid-free Spiriva Respimat now approved as asthma treatment for age 6 and older.

Read more 
FDA accepts BLA for Mylan and Biocon's proposed biosimilar pegfilgrastim for review

FDA accepts BLA for Mylan and Biocon's proposed biosimilar pegfilgrastim for review

16 Feb 2017

The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.

Read more 
Valeant's treatment for plaque psoriasis gets FDA thumbs up for Siliq

Valeant's treatment for plaque psoriasis gets FDA thumbs up for Siliq

16 Feb 2017

More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year.

Read more 
EC approves once-daily Olumiant tablets for treatment of adults with active RA

EC approves once-daily Olumiant tablets for treatment of adults with active RA

14 Feb 2017

Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat RA in the EU.

Read more 
Appeals Court grants stay of permanent injunction for Praluent during appeals process

Appeals Court grants stay of permanent injunction for Praluent during appeals process

9 Feb 2017

Praluent continues to be available to patients in the US.

Read more 
Lilly's Trulicity label updated to include use in combination with basal insulin for adults with type 2 diabetes

Lilly's Trulicity label updated to include use in combination with basal insulin for adults with type 2 diabetes

8 Feb 2017

Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine.

Read more 
FDA approves first new treatment in more than a decade for secondary HPT in adults on hemodialysis

FDA approves first new treatment in more than a decade for secondary HPT in adults on hemodialysis

8 Feb 2017

Intravenous administration puts delivery in hands of healthcare provider.

Read more 
Amgen's Repatha significantly reduced the risk of cardiovascular events in FOURIER outcomes study

Amgen's Repatha significantly reduced the risk of cardiovascular events in FOURIER outcomes study

6 Feb 2017

Landmark Repatha cardiovascular outcomes study meets primary and key secondary endpoint.

Read more 
FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer

FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer

5 Feb 2017

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

Read more 
FDA approves BMS's Opdivo for bladder cancer

FDA approves BMS's Opdivo for bladder cancer

5 Feb 2017

Opdivo has now been approved in six tumour types in just over 2 years.

Read more 
Merck gets the thumbs up in Europe for Keytruda to treat patients with metastatic NSCLC

Merck gets the thumbs up in Europe for Keytruda to treat patients with metastatic NSCLC

2 Feb 2017

First anti-PD-1 therapy approved in Europe for previously untreated patients with metastatic NSCLC.

Read more