Bexsero, Novartis' Meningococcal Group B Vaccine, has won a positive opinion from European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion indicates the use of the broad coverage vaccine in ...
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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Astellas Pharma Europe's Betmigatm (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency ...
Tags: symptomatic treatment of urgency, pharmaceutical product
Novartis' Exjade has received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Exjade is used to treat chronic iron overload requiring chelation therapy when ...
Tags: Medicinal Products, iron overload, CHMP recommendation
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 ...
Ferrer Internacional has decided to withdraw the marketing authorisation application (MAA) for Egrifta (tesamorelin) 2mg, powder for solution for injection in Europe. Ferrer formally notified the European Medicines Agency of its decision. ...
Tags: DME, healthcare products, pSivida
CSL Behring has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen (immune globulin intravenous [human], 10% liquid for intravenous administration) in Chronic Inflammatory Demyelinating ...
Tags: CSL Behring, Variation Application, Privigen, CIDP
AET BioTech and BioXpress Therapeutics have signed a research deal for the development of a biosimilar version of the TNF inhibitor MAb Adalimumab. Under the agreement, both the companies will be responsible for the development, ...
Tags: AET BioTech, BioXpress Therapeutics, TNF Inhibitor, research deal
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended SkyePharma's flutiform (fluticasone propionate/formoterol fumarate) for European marketing approval. Flutiform is a ...
Tags: Skyepharma Flutiform, SkyePharma, long-acting beta-agonist
Australian Therapeutic Goods Administration (TGA) has cleared Genzyme's once daily oral Aubagio 14mg dose for the treatment of relapsing multiple sclerosis (MS). Aubagio, which has anti-inflammatory properties, is expected to minimize ...
Ten biopharmaceutical companies, Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech and Sanofi have established a non-profit organization ...
Tags: biopharmaceutical companies, non-profit organization, new medicines
European Medicines Agency's (EMA) Committee for Orphan Medicinal Products has announced positive opinion for granting orphan disease designation to Aspireo Pharmaceuticals' Somatoprim for the treatment of acromegaly. Somatoprim, the ...
The European Medicines Agency (EMA) has granted orphan drug status to AlphaCore Pharma's ACP-501 (rhLCAT) to treat familial LCAT deficiency (FLD). FLD causes lipid deposition in eyes, red blood cells and kidneys which can lead to corneal ...
Tags: EMA, orphan drug status, AlphaCore FLD
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 ...