IPP Bureau
European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME
By IPP Bureau - June 28, 2025
Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
FDA approves removal of REMS programs within Bristol Myers Squibb’s cell therapy labels
By IPP Bureau - June 28, 2025
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
EMA starts review of sodium oxybate in alcohol dependence
By IPP Bureau - June 28, 2025
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
Biocon Biologics receives Health Canada approval for Yesafili
By IPP Bureau - June 27, 2025
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
Star Health Insurance partners with Medi Assist to transform claims through AI and Digital Innovation
By IPP Bureau - June 27, 2025
Star Health Insurance is modernising its claims ecosystem to be future-ready
SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
By IPP Bureau - June 27, 2025
The inspection concluded with zero Form 483 observations
Lupin launches Prucalopride tablets in US
By IPP Bureau - June 27, 2025
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
Philogen withdraws marketing authorization application for Nidlegy in EU
By IPP Bureau - June 26, 2025
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Dr. Lal PathLabs strengthens its genomics capabilities with Illumina's NovaSeq X Series
By IPP Bureau - June 26, 2025
The NovaSeq X system features Illumina's cutting-edge XLEAP-SBS chemistry, offering unmatched throughput, accuracy, and sustainability
Ashland expands viatel bioresorbable polymers offering for medical devices
By IPP Bureau - June 26, 2025
Viatel bioresorbable polymers are increasingly used in dental and orthopedic implants
Covestro launches localized production of medical-grade TPU in Asia Pacific
By IPP Bureau - June 25, 2025
Changhua site meets international regulatory standards for global medical applications
Glenmark Pharmaceuticals launches TEVIMBRA in India
By IPP Bureau - June 25, 2025
TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)
Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
By IPP Bureau - June 25, 2025
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
Bachem expands multi-site production capacities to meet rising demand
By IPP Bureau - June 25, 2025
The Swiss peptide and oligonucleotide manufacturers roll out major investments across site networks in US, UK and Switzerland
