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1387 News Found

UAE to recognise Indian pharma products within three months
News | February 19, 2022

UAE to recognise Indian pharma products within three months

The agreement also had a permanent safeguard mechanism which can be resorted to in a situation of sudden surge in imports.


US FDA to review Amylyx new drug application for AMX0035
Drug Approval | February 19, 2022

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).


ITM receives investment of EUR 25 mn from Grand Pharma
News | February 18, 2022

ITM receives investment of EUR 25 mn from Grand Pharma

Equity investment follows recent EUR 520 m licensing agreement providing Grand Pharma (GP) access to three of ITM’s targeted radionuclide therapeutic and diagnostic candidates for Greater China


Bayer raises peak sales for Nubeqa to exceed €3 billion
News | February 18, 2022

Bayer raises peak sales for Nubeqa to exceed €3 billion

Darolutamide is developed jointly by Bayer and Orion Corporation


Ligand posts strong 2021 performance
News | February 18, 2022

Ligand posts strong 2021 performance

Ligand expects 2022 royalties of $55 million to $60 million, material sales of $40 million to $50 million, and contract revenue of $52 million to $62 million.


Kato wins USFDA approval for studies in retinal disorder
Biotech | February 17, 2022

Kato wins USFDA approval for studies in retinal disorder

Resolv ER may remedy leading causes of blindness in adults


Jubilant Ingrevia commissions Diketene derivatives facility
Biotech | February 17, 2022

Jubilant Ingrevia commissions Diketene derivatives facility

The commissioned facility has a capacity of 7,000 TPA to produce various Esters (Mono Methyl Acetoacetamide, Methyl Acetoacetate, Ethyl Acetoacetate, and Ter-Butyl Acetoacetate)


USFDA approves Lupin’s Supplemental New Drug Application for Solosec
Drug Approval | February 17, 2022

USFDA approves Lupin’s Supplemental New Drug Application for Solosec

The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV


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


Angus completes expansion of Louisiana site to include hydrochloride production
News | February 16, 2022

Angus completes expansion of Louisiana site to include hydrochloride production

TRIS AMINO HCl is widely used as a diagnostic reagent and as a downstream processing buffer in the purification of commercial biopharmaceuticals