Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 28

Results For "submission"

315 News Found

Covaxin receives approval for Emergency Use in Children 12-18 years
Drug Approval | December 27, 2021

Covaxin receives approval for Emergency Use in Children 12-18 years

Covaxin is formulated uniquely such that the same dosage can be administered to adults and children


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


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


ICMR invites EOI for Omicron detection kits
News | December 20, 2021

ICMR invites EOI for Omicron detection kits

The Indian Council of Medical Research (ICMR), intends to enter into non-exclusive agreements with companies


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


Pfizer’s Covid-19 drug 90 % effective
News | December 15, 2021

Pfizer’s Covid-19 drug 90 % effective

The data has been shared with the U.S.FDA as part of an ongoing rolling submission for Emergency Use Authorisation


Aragen Life Sciences acquires Intox
Biotech | December 15, 2021

Aragen Life Sciences acquires Intox

Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune


Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan
Biotech | December 14, 2021

Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan

In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020


Medicago and GSK’s plant based Covid-19 vaccine candidate show promise in Phase 3 trials
Biotech | December 10, 2021

Medicago and GSK’s plant based Covid-19 vaccine candidate show promise in Phase 3 trials

Primary endpoints and secondary endpoints for which data are available were met in trial dominated by Covid-19 variants


Cytel and Pulse Infoframe to transform rare disease research landscape
Biotech | December 10, 2021

Cytel and Pulse Infoframe to transform rare disease research landscape

Both companies will combine their expertise to channel real-world evidence toward ground-breaking new treatments in rare diseases