Bristol-Myers Squibb Co.’s (BMY) blockbuster cancer treatment Opdivo has been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use as monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy. In the U.S., the drug was approved for this indication last November.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
This is the first CHMP positive opinion to recommend a PD-1 inhibitor for this type of treatment for squamous cell cancer of the head and neck, according to the company. Opdivo is already approved by the EC for six indications in four distinct tumor types.
Global sales of Opdivo in 2016 were $3.77 billion, up from $942 million in 2015.
BMY closed Friday’s trading at $55.89, up 0.22%.
Nabriva Therapeutics AG (NBRV) expects 2017 to be a transformational year for the company.
The company is continuing to make progress in its ongoing pivotal phase III clinical trials, known as LEAP 1 and LEAP 2, evaluating Lefamulin for the treatment of patients with moderate to severe community-acquired bacterial pneumonia.
The top-line clinical data from LEAP 1 are anticipated in the third quarter of 2017 while patient enrollment for LEAP 2 is expected to be completed in the fourth quarter of 2017 – with top-line data anticipated in the first quarter of 2018.
NBRV closed Friday’s trading at $10.80, down 3.14%.
Neuren Pharmaceuticals Ltd. (NURPF.OB) has reported encouraging results from its phase II trial of Trofinetide in pediatric Rett syndrome patients.
Rett syndrome is a rare, serious and life threatening condition that affects exclusively girls, affecting their speech, mobility, eating and even breathing.
According to the trial results, the highest dose of Trofinetide achieved statistically significant clinical benefit compared with placebo for each of three…