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November 12, 2018
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.
November 09, 2018
Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.
November 08, 2018
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
November 02, 2018
A London-based pharmaceutical company has been charged with offences relating to the nature and quality of medicinal product used for parenteral nutrition in babies.
The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
October 31, 2018
Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
October 30, 2018
The companies announced the European launch of Imraldi (adalimumab), a biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.