Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib
Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival, Lynparza from AstraZeneca. It’s approved to treat all women with recurrent ovarian, fallopian tube or peritoneal cancer who’ve previously responded to platinum chemo, not just those who test positive for the BRCA genetic mutation. With 2022 sales expectations of $1.9 billion, Zejula is one of the top drug launches of 2017. And with some strong data showing its ability to hold off cancer progression for more than a year in some patients, it could be a quick challenger for market share when it launches, expected in late April.
XELJANZ® receives marketing authorisation in the EU for moderate to severe rheumatoid arthritis
Pfizer Inc. announced that the European Commission (EC) has approved XELJANZ® 5 mg twice daily (BID) oral tablets in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). XELJANZ can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. XELJANZ belongs to a new class of therapies called Janus kinase (JAK) inhibitors. The EC approval is based on a submission package that included results from the Phase 3 Oral Rheumatoid Arthritis triaLs (ORAL) global development program and real world data.
Innovus Pharma nabs European patent for Sensum+
Innovus Pharmaceuticals received a Notice of Intention to Grant from the European Patent Office for a patent titled “Sensitization composition and method of use” covering its Sensum + product for reduced penile sensitivity. The Notice of Intention to Grant from the EPO adds great value to the CPNP notification to market Sensum+® in Europe. Having a patented product has increased the ability of the company to enter into new commercial partnerships for Sensum+® in Europe. Sensum + is a non-medicated cream used by men to enhance sexual satisfaction.
Alexion brings on former Baxalta chief Hantson to fill vacant CEO spot
Alexion’s CEO search is over. The Connecticut biotech, which bade its skipper farewell late last year, is bringing former Baxalta chief Ludwig Hantson into the fold. Hantson will take the reins from David Brennan, who stepped in as interim CEO after David Hallal made his exit last December. Brennan will remain on Alexion’s board, which expects to appoint him chairman at the company’s mid-May annual meeting, Alexion said.