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1785 News Found

CEPI and SK bioscience partner to advance mRNA vaccine technology
News | October 26, 2022

CEPI and SK bioscience partner to advance mRNA vaccine technology

CEPI will provide up to US$40 million in initial funding to support the development of mRNA-vaccine candidates against Lassa Fever virus


Inceptua Early Access and Sentynl Therapeutics launch early access program for Nulibry for pediatric patients
News | October 19, 2022

Inceptua Early Access and Sentynl Therapeutics launch early access program for Nulibry for pediatric patients

MoCD Type A is a rapidly progressive autosomal recessive inborn error of metabolism resulting in toxic sulfite levels causing neurologic sequelae


Merck announces positive top-line results from Phase 3 Stellar Trail evaluating Sotatercept for the treatment of PAH
Clinical Trials | October 11, 2022

Merck announces positive top-line results from Phase 3 Stellar Trail evaluating Sotatercept for the treatment of PAH

Sotatercept demonstrated significant improvement in exercise capacity and key secondary outcome measures compared to placebo when added to background therapy


EDQM grants CEP certificate to Supriya Lifescience for Diphenhydramine Hydrochloride
Drug Approval | September 28, 2022

EDQM grants CEP certificate to Supriya Lifescience for Diphenhydramine Hydrochloride

This will be an added advantage for Supriya Lifescience Limited in the European market.


European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


CEPI funds consortium led by CPI to advance Caltech’s new all-in-one coronavirus vaccine
News | July 15, 2022

CEPI funds consortium led by CPI to advance Caltech’s new all-in-one coronavirus vaccine

Up to $30m funding will be provided to advance an innovative vaccine technology that could protect against current and future SARS-CoV-2 variants and other SARS-like Betacoronaviruses.


USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from the excepted products list
Drug Approval | July 14, 2022

USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from the excepted products list

Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.


CEPI and Codiak BioSciences partner to develop protective Betacoronavirus vaccine
News | July 06, 2022

CEPI and Codiak BioSciences partner to develop protective Betacoronavirus vaccine

CEPI will provide seed funding of up to US$2.5 million to Codiak BioSciences.


FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Drug Approval | June 14, 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial