Industry Dynamics

Industry News

04-03

2019

EU approves new dosing schedule for MSD’s Keytruda

MSD’s Keytruda (pembrolizumab) has been approved by the European Commission with a new six-weekly dosing schedule at 400mg, as opposed to the previous schedule of 200mg every three weeks, across all monotherapy indicatio……

02-28

2019

PFIZER ANNOUNCES SEROTYPES INCLUDED IN 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE CANDIDATE BEING INVESTIGATED FOR THE PREVENTION OF INVASIVE DISEASE AND PNEUMONIA IN ADULTS AGED 18 YEARS AND OLDER

Pfizer Inc. (NYSE: PFE) announced today the new serotypes included in its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia ……

02-01

2019

Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents

Merc (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that V224, the company’s investigational 25-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designatio……

01-31

2019

Amgen Receives NMPA Approval For Repatha? (evolocumab) In China To Reduce The Risk Of Cardiovascular Events

Amgen (NASDAQ:AMGN) today announced that the National Medical Products Administration (NMPA) has approved a new indication for Repatha? (evolocumab) as the first PCSK9 inhibitor in China for……

01-07

2019

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for RAVICTI? (glycerol phenylbutyrate) Oral Liquid to Include Newborns

Dec. 27, 2028-- Horizon Pharma plc(NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for RAVICTI? (gl……

12-29

2018

I-Mab Receives U.S. FDA IND Approval for Proprietary Anti-GM-CSF Monoclonal Antibody TJM2

- The first I-Mab proprietary drug candidate to enter clinical trials in the United StatesI-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development o……

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