Pfizer has received positive opinion from the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency for the marketing authorization of axitinib to treat patients with advanced renal cell carcinoma. The European ...
The European Commission (EC) has granted marketing authorization to Pfizer's INLYTA (axitinib) oral therapy, designed to treat adult patients with advanced renal cell carcinoma (RCC). INLYTA, a kinase inhibitor, is designed to ...
The European Commission (EC) has approved Bayer HealthCare's EYLEA (aflibercept solution for injection) at a recommended dose of 2 mg for the treatment of wet age-related macular degeneration (wet AMD). Formulated as an iso-osmotic ...
Tags: European Commission, Bayer, Aflibercept Solution, EYLEA
The National Security Agency of Medicines and Health Products in France has granted marketing authorization to pSivida's ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME). The injectable, ...
Affymax has earned $50m development milestone payment from Takeda Pharmaceutical Company for the US approval of OMONTYS (peginesatide) injection. The company has also received another $5m milestone payment, which was triggered by the ...
Skuldtech and AB Science have discovered a new set of blood markers predictive of a higher survival rate in pancreatic cancer patients. The companies are also planning to use the new markers for future companion test commercialization ...
Tags: skuldtech, AB science, blood markers, pancreatic cancer patients
The SFJ Pharmaceuticals Group (SFJ) has partnered with Pfizer to co-develop Dacomitinib as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal ...
Tags: Cancer Drug, cell lung cancer, therapy
Mylan has unveiled Atorvastatin calcium tablets of strengths 10mg, 20mg, 40mg and 80mg in Belgium, France, the UK, Ireland and the Netherlands. The generic version of Pfizer's Lipitor is indicated to prevent cardiovascular disease and ...
Tags: Mylan, Atorvastatin calcium tablets, cardiovascular disease
The European Commission (EC) has granted marketing authorization for Meda's Zyclara (imiquimod 3.75% cream) for the treatment of actinic keratosis (AK), in the European Union. Zyclara can detect and eliminate subclinical as well as ...
Tags: Meda Zyclara, actinic keratosis, clinical AK lesions, Skin cancer
The European Commission has granted marketing authorization for AMAG Pharmaceuticals' intravenous iron therapy, ferumoxytol, to treat iron deficiency anemia (IDA) in chronic kidney disease (CKD) patients. The marketing authorization is ...
Tags: AMAG Pharmaceuticals, Intravenous Iron Therapy, chronic kidney disease
UK-based Medicines and Healthcare products Regulatory Agency(MHRA)has granted marketing authorization to pSivida for its Iluvien insert. The marketing authorization follows the recently announced approval in Austria. The approvals were ...
Tags: pSivida Iluvien insert, MHRA, intravitreal insert, Iluvien
Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment ...
Tags: Genzyme, Lemtrada marketing, FDA
The European Medicines Agency (EMA) has accepted to review the Dynavax Technologies Marketing Authorization Application (MAA) for Heplisav. Heplisav is indicated for immunization against infection caused by all known subtypes of hepatitis ...
Boehringer Ingelheim and Eli Lilly and Company have received European Commission marketing authorization for Jentadueto (linagliptin/metformin hydrochloride) tablets. Jentadueto is a new, single-tablet treatment option, taken twice daily, ...
Tags: marketing authorization, Jentadueto tablets, glycemic control
Astellas Pharma and Medivation have announced the submission of marketing authorization application (MAA) to the European Medicines Agency (EMA) for enzalutamide to treat metastatic castration-resistant prostate cancer in men who have ...
Tags: enzalutamide, metastatic castration-resistant prostate cancer