FDA accepts Sandoz application for biosimilar filgrastim
The reference product is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs...
View ArticleBiosimilars accepted for review by the EMA
The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab) from...
View ArticleNew launches into epinephrine injection device market could transform the...
Data and analytics company, GlobalData, has revealed that it believes new launches into the epinephrine injection device market will have the potential to completely transform the space.
View ArticleSandoz Hack competition seeks ways to increase access to healthcare
Novartis’ generics and biosimilars division, Sandoz, has launched the second edition of its Healthcare Access Challenge (Hack), the company has announced.
View ArticleNew certification aims to mitigate antimicrobial resistance risk in...
BSI have launched a new global minimised risk of Antimicrobial resistance (AMR) certification designed to promote and attest to the responsible manufacturing of antibiotics in the global supply chain.
View ArticleSandoz Announces Positive Results from Mylight Phase lll Study
Sandoz released positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration.
View ArticleSandoz To Acquire Cimerli For $170 Million
Sandoz has signed an agreement to acquire the US biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. for an upfront cash purchase payment of $170 million.
View ArticleSandoz Agree $265 Million U.S. Settlement
Sandoz have entered into a settlement agreement with the class of direct purchaser plaintiffs in the multidistrict litigation entitled In re Generic Pharmaceuticals Pricing Antitrust Litigation.
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