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3136 News Found

Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results
Drug Approval | December 26, 2023

Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure


Astellas completes acquisition of Propella Therapeutics
News | December 26, 2023

Astellas completes acquisition of Propella Therapeutics

Astellas has acquired abiraterone decanoate being developed by Propella to treat prostate cancer


Eugia's East Windsor facility gets 10 observations from USFDA
Drug Approval | December 25, 2023

Eugia's East Windsor facility gets 10 observations from USFDA

The plant is yet to start commercial operations


Bristol Myers Squibb to buy Karuna Therapeutics for US$ 14 billion
News | December 24, 2023

Bristol Myers Squibb to buy Karuna Therapeutics for US$ 14 billion

Transaction delivers KarXT, a first-in-class M1/ M4 muscarinic receptor agonist with differentiated efficacy and safety


USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer
Drug Approval | December 23, 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients


Biocon Biologics signs distribution partnership with Sandoz for Adalimumab BS Subcutaneous Injection in Japan
Supply Chain | December 23, 2023

Biocon Biologics signs distribution partnership with Sandoz for Adalimumab BS Subcutaneous Injection in Japan

The transfer of the distribution rights will strengthen Sandoz's immunology and biosimilar portfolio


JB Pharma buys opthalmology brands from Novartis for Rs 964 Cr
News | December 22, 2023

JB Pharma buys opthalmology brands from Novartis for Rs 964 Cr

JB Chemicals will pay Rs 125 crore to Novartis to license the same drug portfolio for the Indian market


Piramal Pharma Solutions commissions ADC manufacturing expansion in Scotland
News | December 21, 2023

Piramal Pharma Solutions commissions ADC manufacturing expansion in Scotland

The commissioning of the facility represents the culmination of a £45m investment to address rapidly growing demand for ADC manufacturing, supported by a £2.4m Scottish Enterprise grant


Norms for fixing prices of medicines
Policy | December 20, 2023

Norms for fixing prices of medicines

NPPA fixes the ceiling price of scheduled formulations as per the extant provisions of DPCO, 201


FDA grants priority review to Merck’s new biologics license application for V116
Drug Approval | December 20, 2023

FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults