USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures

Biocon partners with Tabuk to commercialize its Glucagon-like peptide-1 products in the Middle East

Avient expands healthcare TPU manufacturing in China

Showcases specialty and sustainable materials for healthcare at Medtec China 2024

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity

Suven Pharmaceuticals names Vivek Sharma as Executive Chairman

Based out of Boston, Vivek will build on the foundation created by Vaidheesh, and will help build a stronger customer connect and further drive global expansion of the platform

Merck receives positive EU CHMP opinions for pembrolizumab regimens for gynecologic cancers

Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma

Briefs: Eugia Steriles and Shelter Pharma

Eugia Steriles receives EIR from USFDA for new injectable facility

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable

Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market

Briefs: Medicamen Biotech, Aurobindo Pharma and Ajooni Biotech

The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility

Merck announces positive top-line results from Phase 3 trial evaluating efficacy and safety of Gardsil 9

The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9