Biologics APIs

Dec 18, 2017
By Pharmaceutical Technology Editors
The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.
Dec 14, 2017
By Pharmaceutical Technology Editors
Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.
Dec 14, 2017
By Pharmaceutical Technology Editors
FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.
Dec 13, 2017
By Pharmaceutical Technology Editors
The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.
Dec 13, 2017
By Pharmaceutical Technology Editors
In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.
Dec 13, 2017
By Pharmaceutical Technology Editors
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
Dec 08, 2017
By Pharmaceutical Technology Editors
The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.
Dec 05, 2017
By Pharmaceutical Technology Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Nov 28, 2017
By Pharmaceutical Technology Editors
The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.
Nov 20, 2017
By Pharmaceutical Technology Editors
The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.
native1_300x100
lorem ipsum