Decision welcomed as step forward for patients
The FDA has approved Genentech’s Rituxan (rituximab) for use in adults with moderate-to-severe pemphigus vulgaris (PV), making it the first treatment for the condition in more than 60 years.
The European Commission (EC) has approved Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence.
NICE has issued a Final Appraisal Determination that recommends the use of Pfizer’s Xalkori (crizotinib) in England under the Cancer Drugs Fund (CDF) for patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).
Pfizer’s janus kinase (JAK) inhibitor drug Xeljanz (tofacitinib) has received expanded approval from the FDA for adults with moderately-to-severely-active ulcerative colitis.
The US FDA has approved a label extension for UCB’s Cimzia (certolizumab pegol) for adults with moderate-to-severe plaque psoriasis
The European Commission (EC) is proposing to adjust intellectual property (IP) rules to help Europe’s pharma companies tap into fast-growing global markets.
NICE blocks access to 65% of patients on cost grounds
But Sanofi/Regeneron could have advantage thanks to price cut and better data
First disease modifying therapy approved in paediatric MS
NICE calls for price cut before possible CDF funding