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China’s I-Mab biopharma gets USFDA’s approval for IND application for TJM2

A China-based clinical stage biopharmaceutical immuno-oncology and autoimmune diseases focused company, I-Mab Biopharma (I-Mab), said Monday it got the US Food and Drug Administration (FDA) has approval for its IND application for TJM2, a potential treatment for autoimmune and inflammatory diseases.

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GenomOncology names CEO

GenomOncology, a technology solution provider for oncology, named Brad Wertz as the new Chairman and Chief Executive Officer (CEO), who’ll assume the position from the start of year 2019.  Wertz has been a founding investor and chairman of the board since the beginning, and has increased his involvement as the company has grown over the past two years. 

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Mundipharma China to sell Swiss Helsinn’s first cancer supportive care in China

Swiss Helsinn Group and Mundipharma China Pharmaceutical will now sell ALOXI IV in China, as it got approval from the

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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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