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CytRx Notes Topline Data From Trial of Arimoclomol in Amyotrophic Lateral Sclerosis

Press release content from Business Wire. The AP news staff was not involved in its creation. CytRx Notes Topline Data From Trial of Arimoclomol in Amyotrophic Lateral Sclerosis May 7, 2021 GMT LOS ANGELES (BUSINESS WIRE) May 7, 2021 CytRx Corporation (OTCQB: CYTR) (“CytRx”), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today noted that Orphazyme A/S (NASDAQ: ORPH) (“Orphazyme”) announced that the ORARIALS-01 pivotal trial for arimoclomol in Amyotrophic Lateral Sclerosis (“ALS”) did not meet primary and secondary endpoints to show benefit in people living with the disease. According to Orphazyme, no important safety signals were reported in the trial. Topline data will be presented at the upcoming virtual European Network to Cure ALS meeting and complete data from the study will be published later this year.

United statesGreg marose bela kirpalaniEuropean network to cureCommittee for medicinal products humanCytrx corporationEuropean medicines agencyDrug administrationAmyotrophic lateral sclerosisEuropean networkNorth americaRating scale revisedMedicinal productsHuman useNasdaq copenhagenGreg maroseBusiness wire

Guidance on the licensing of biosimilar products

Guidance on the licensing of biosimilar products This guideline is to provide developers of biosimilar products with a clear outline of the requirements in Great Britain. From: Details The purpose of this guideline is to provide developers of similar biological medicinal products (also known as biosimilars) with a clear outline of the requirements for biosimilar products in Northern Ireland/Great Britain/UK. Applicants should also take into account principles contained within the Committee for Medicinal Products for Human Use ( CHMP) guidelines. This MHRA guidance contains further clarifications and some revisions to these CHMP guidance documents, which take into account the scientific and regulatory experience gained since the first biosimilar product was licensed in 2006, including biosimilar monoclonal antibodies and fusion proteins licensed from 2013.

Committee for medicinal products humanMedicinal productsHuman useகுழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன்மருத்துவ ப்ராடக்ட்ஸ்மனிதன் பயன்பாடு

India approves antibody cocktail to treat COVID-19

© Getty Images India on Wednesday granted emergency use authorization for an antibody cocktail used to treat COVID-19 as the country battles a devastating surge in coronavirus cases. The approval for the drug, developed by Roche and Regeneron, was based on data filed by the U.S. and the “scientific opinion” of the Committee for Medicinal Products for Human Use, a European Union medical agency, according to a press release from Indian pharmaceutical company Cipla. The drug is meant for high-risk patients who fall ill with mild to moderate cases of COVID-19. It has been shown to reduce the risk of hospitalization or death by 70 percent, compared to a placebo, according to Cipla.

Committee for medicinal products humanEuropean unionMedicinal productsHuman useDrug administrationCovid 19 vaccineCoronavirus vaccineMonoclonal antibody treatmentAntiviral drugsCovid 19 drug developmentDonald trumpகுழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன்ஐரோப்பிய தொழிற்சங்கம்மருத்துவ ப்ராடக்ட்ஸ்மனிதன் பயன்பாடுடொனால்ட் துருப்பு

(RHHBF), ROCHE HLDG LTD SPONS (RHHBY) - India Gives Emergency Use Nod To Roche-Regeneron s COVID-19 Antibody Cocktail

(RHHBF), ROCHE HLDG LTD SPONS (RHHBY) - India Gives Emergency Use Nod To Roche-Regeneron s COVID-19 Antibody Cocktail
benzinga.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from benzinga.com Daily Mail and Mail on Sunday newspapers.

Roche holdingsRegeneron pharmaceuticals incCommittee for medicinal products humanEuropean unionEmergency use authorizationMedicinal productsHuman useUse authorizationரோச் ஹோல்டிங்ஸ்குழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன்ஐரோப்பிய தொழிற்சங்கம்அவசரம் பயன்பாடு அங்கீகாரம்மருத்துவ ப்ராடக்ட்ஸ்மனிதன் பயன்பாடுபயன்பாடு அங்கீகாரம்

Covid-19: évaluation du vaccin Pfizer/BioNTech pour les 12-15 ans - LINFO re - Monde, Europe

Covid-19: évaluation du vaccin Pfizer/BioNTech pour les 12-15 ans - LINFO re - Monde, Europe
linfo.re - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from linfo.re Daily Mail and Mail on Sunday newspapers.

United statesCommittee for medicinal products humanEuropean medicinesMedicinal productsHuman useஒன்றுபட்டது மாநிலங்களில்குழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன்ஐரோப்பிய மருந்துகள்மருத்துவ ப்ராடக்ட்ஸ்மனிதன் பயன்பாடு