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Results For "submission"

300 News Found

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years
Biotech | April 29, 2022

Moderna files for authorization of its Covid-19 vaccine in young children six months to six years

Submission to regulators globally is based on phase 2/3 studies of mRNA-1273 in young children


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Sanofi continues to deliver strong business
News | April 28, 2022

Sanofi continues to deliver strong business

Business EPS of €1.94, up 20.5% on a reported basis and 16.1% at CER, also benefitting from an improved effective tax rate


Pharming gets positive review from UK MHRA for leniolisib
Biotech | April 26, 2022

Pharming gets positive review from UK MHRA for leniolisib

A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme


Erytech sells U.S. manufacturing facility and enters long-term supply agreement with Catalent
Biotech | April 25, 2022

Erytech sells U.S. manufacturing facility and enters long-term supply agreement with Catalent

Erytech is evaluating valuable strategic options to leverage its Erycaps platform and its development and manufacturing capabilities with complementary assets and/or a broader corporate transaction


Takeda announces approval of Nuvaxovid Covid-19 vaccine in Japan
Drug Approval | April 19, 2022

Takeda announces approval of Nuvaxovid Covid-19 vaccine in Japan

Approval for primary and booster immunization is based on efficacy and safety data from Japan and international clinical studies


GSK to acquire Sierra Oncology for US $1.9bn
Biotech | April 18, 2022

GSK to acquire Sierra Oncology for US $1.9bn

Momelotinib complements GSK’s existing expertise in haematology, with Sierra Oncology anticipating US regulatory submission in Q2 this year and EU submission in the second half of 2022


Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test
Biotech | April 08, 2022

Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test

If authorized by the USFDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for Covid-19 in as little as 18 minutes


Good business performance gives Boehringer Ingelheim tailwind for investment in R&D
Biotech | April 05, 2022

Good business performance gives Boehringer Ingelheim tailwind for investment in R&D

R&D investment up 11.7% to 4.1 billion EUR in 2021 (20.0% of net sales)


Intas and Axantia sign an exclusive agreement for Ranibizumab biosimilar
Biotech | April 04, 2022

Intas and Axantia sign an exclusive agreement for Ranibizumab biosimilar

Intas has developed a biosimilar of Lucentis, which is currently under Phase III global trial for submission in major countries including EMA & the US