Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer

Pfizer Inc., of New York, said the European Commission granted conditional marketing authorization for Bosulif (bosutinib) for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitors and for whom Gleevec (imatinib, Novartis AG), Tasigna (nilotinib, Novartis AG) and Sprycel (dasatinib, Bristol-Myers Squibb Co.) are not considered appropriate

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch

Johnson & Johnson, of New Brunswick, N.J., said unit Janssen R&D Ireland reported that the European Commission approved Prezista (darunavir) 800-mg tablet, allowing HIV patients once-daily darunavir treatment

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved an extension for once-daily Zytiga (abiraterone acetate), expanding the indication to include its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

Pfizer Inc., of New York, said the European Commission approved expanding the use of pneumococcal conjugate vaccine Prevener 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) to older children and adolescents, ages 6 to 17, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type Streptococcus pneumoniae

Abbott, of Abbott Park, Ill., said the European Commission approved Humira (adalimumab) for the treatment of pediatric patients, ages 6 to 17, with severe active Crohn's disease who failed, are intolerant to or have contraindications to conventional therapy

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, said the European Commission approved Eliquis (apixaban) for prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation with one or more risk factors...LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can lead to squamous cell carcinoma if not treated

Bristol-Myers Squibb Co., of New York, and AstraZeneca plc, of London, said the European Commission approved Forxiga (dapaglifozin) tablets for Type II diabetes in the European Union

In April, the European Commission approved pasireotide under the brand name Signifor for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed

The European Commission approved New York-based Bristol-Myers Squibb Co.'s Baraclude (entecavir) Summary of Product Characteristics update after reviewing new efficacy and safety data in patients with chronic hepatitis B following a liver transplant

Eli Lilly and Co., of Indianapolis, said the European Commission approved Cialis (tadalafil) 5 mg for once-daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH

Janssen-Cilag International, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved a 100-mg/mg oral suspension of Prezista (darunavir) and the use of the drug co-administered with low-dose ritonavir for the treatment of HIV-1 infection in antiretroviral therapy-experienced pediatric patients, ages 3 and older, weighing at least 15 kg

Pfizer Inc., of New York, said the European Commission gave conditional marketing authorization for Xalkori (crizotinib) for the treatment of adults with previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

A final decision from the European Commission is anticipated in the next several weeks

Bristol-Myers Squibb Co., of New York, said the European Commission granted marketing authorization for the subcutaneous formulation of Orencia (abatacept) in combination with methotrexate for the treatment of adults with moderate to severe active rheumatoid arthritis

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission granted approval for the subcutaneous administration of Velcade (bortezomib) in multiple myeloma

Pfizer Inc., of New York, said the European Commission granted marketing authorization for Inlyta (axitinib) in adult patients with advanced renal cell carcinoma after failure of prior treatment with Sutent (sunitinib) or a cytokine

Abbott, of Abbott Park, Ill., said the European Commission approved Humira (adalimumab) in moderately active Crohn's disease (CD) in adult patients who have not adequately responded to conventional therapy