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Sandoz receives positive CHMP opinion for proposed biosimilar infliximab

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion

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First Japanese company joins CARB-X partnership in the fight against drug resistant bacteria

CARB-X is partnering with Shionogi of Osaka, Japan, to support the development of a novel β-lactam antibiotic with potent activity

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Sobi launches Ravicti in Europe and advances the care for patients with Urea Cycle Disorders

Swedish Orphan Biovitrum has gained reimbursement for Ravicti, a new therapy option for the treatment of patients with Urea Cycle

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Hikma launches Ritonavir Tablets USP

Hikma Pharmaceuticals’s wholly owned US subsidiary West-Ward Pharmaceuticals, has launched Ritonavir Tablets USP, 100 mg, the first AB-rated generic to

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BMS welcomes new Board member

Bristol-Myers Squibb’s Board of Directors has elected José Baselga, M.D., Ph.D., to the Board, effective March 1, 2018. Dr. Baselga will

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EMA grants accelerated assessment for Shire’s Lanadelumab being evaluated for the prevention of attacks in Hereditary Angioedema patients aged 12 years and older

Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment for

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Novo Nordisk files for regulatory approval in the US and the EU for treatment of haemophilia A

Novo Nordisk has submitted a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing

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FDA rejects Celgene’s NDA for multiple sclerosis treatment

Celgene Corporation (NASDAQ:CELG) has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug

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BASF reports 26% EBIT increase in chemical business

BASF has reported financial results for the year 2017. The company said that following a successful 2017 business year, BASF

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Lillys breast cancer drug gets additional FDA approval

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s (NYSE: LLY) Verzenio (abemaciclib) in combination with an aromatase

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