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FDA Recommends Approval Of Sanofi Treatment For Adults With Type 2 Diabetes

Sanofi announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. FDA recommended the approval of the NDA for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the...

GSK, Fondazione Telethon and Ospedale San Raffaele announce publication of pivotal safety and efficacy of gene therapy for children with ADA-SCID

GSK, Fondazione Telethon and Ospedale San Raffaeletoday announced the publication in BLOOD of the long-term safety and efficacy data from an analysis of 18 children with ADA-SCID treated. with hematopoietic stem cell gene therapy between 2000...

Daiichi Sankyo Launches Antiplatelet Agent Efientยฎ Tablets 20mg

Daiichi Sankyo Company, Limited announced that it has launched the antiplatelet agent Efientยฎ Tablets 20mg ย (JAN: Prasugrel Hydrochloride; approval to market: January 20, 2016; NHI drug price listing: May 25, 2016) in Japan. Efientยฎ is an...

EISAI To Launch In-House Developed Antiepileptic Drug Fycompa (Perampanel Hydrate) As Adjunctive Therapy For Partial-Onset And Generalized Tonic-Clonic Seizures In Japan

Eisai Co Ltd announced that it will launch its in-house-discovered antiepileptic drug (AED) Fycompaยฎ Tablets 2 mg and 4 mg (perampanel hydrate) as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures). ย  or primary...

FDA Expands Invokamet Label to Include First-Line Treatment of with type 2 diabetes

Janssen Pharmaceuticals, Inc announced the U.S. FDA has approved INVOKAMETยฎ, a fixed-dose combination therapy of INVOKANAยฎ (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. With this new approval, INVOKAMETยฎ may now...

Bayer Comments on Monsantoโ€™s Statement Regarding Proposed Transaction

Bayer announced that it looks forward to engaging in constructive discussions with Monsanto regarding the proposed transaction. Bayer reiterated that its USD 122 per share all-cash proposal provides full and certain value for Monsanto shareholders. โ€œWe...

Novo Nordisk IDegLira receives positive 16-0 vote in favour of approval from FDA

Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a...

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