Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 11

Results For "EMA"

2799 News Found

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site
Biotech | March 04, 2022

WuXi STA passes EMA drug product pre-approval inspection at its Wuxi City site

WuXi STA’s drug product site in Wuxi City offers a full range of services including formulation development and manufacturing for a broad range of oral and injectable dosage forms


Nirsevimab EMA regulatory submission accepted under accelerated assessment
Biotech | February 17, 2022

Nirsevimab EMA regulatory submission accepted under accelerated assessment

Nirsevimab is the first investigational long-acting antibody designed to protect all infants for the respiratory syncytial virus season with a single dose


EMA approves Pfizer’s 20-valent pneumococcal conjugate vaccine
Biotech | February 16, 2022

EMA approves Pfizer’s 20-valent pneumococcal conjugate vaccine

Apexxnar is the first pneumococcal conjugate vaccine to help protect adults ages 18 years and older against 20 serotypes responsible for the majority of invasive disease and pneumococcal pneumonia


Abbott announces world's first implant of dual-chamber leadless pacemaker in pivotal trial
Medical Device | February 08, 2022

Abbott announces world's first implant of dual-chamber leadless pacemaker in pivotal trial

Proprietary implant-to-implant (i2i) device technology is used for communication between two implanted leadless pacemakers to regulate the heart rate


Lonza partners with biotech firm HaemaLogiX on multiple myeloma drug candidate
Biotech | January 29, 2022

Lonza partners with biotech firm HaemaLogiX on multiple myeloma drug candidate

Company to manufacture drug substance for clinical supply of HaemaLogiX’s lead multiple myeloma drug candidate, KappaMab, at its new state-of-the-art facility in Guangzhou, China


Novo Nordisk India launches world’s first and only GLP-1 RA, oral semaglutide
Drug Approval | January 20, 2022

Novo Nordisk India launches world’s first and only GLP-1 RA, oral semaglutide

Oral semaglutide is a co-formulation of GLP-1RA semaglutide with an absorption enhancer SNAC which protects semaglutide from undergoing degradation in the stomach


Outlook for the Indian Pharma Industry remains stable for this year
Opinion | January 13, 2022

Outlook for the Indian Pharma Industry remains stable for this year

The stability is led by healthy demand in the domestic and emerging markets


Trastuzumab deruxtecan type II variation application validated by EMA
Biotech | December 28, 2021

Trastuzumab deruxtecan type II variation application validated by EMA

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)


Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease