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Results For "EMA"

2396 News Found

Eplontersen granted Orphan Drug Designation in the US
Biotech | January 24, 2022

Eplontersen granted Orphan Drug Designation in the US

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US


Omicron is now in community transmission in India: INSACOG
News | January 23, 2022

Omicron is now in community transmission in India: INSACOG

The country is sixth among the most affected countries by active cases


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


Medicines Patent Pool finalises 27 generic manufacturers to produce molnupiravir
Drug Approval | January 21, 2022

Medicines Patent Pool finalises 27 generic manufacturers to produce molnupiravir

The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list


Bristol Myers Squibb receives approval for Abecma in Japan
Drug Approval | January 21, 2022

Bristol Myers Squibb receives approval for Abecma in Japan

It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan


US FDA approves Idorsia’s insomnia drug
Drug Approval | January 21, 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain


Green chemistry approaches to synthesis could make a big difference to pharma product outputs
News | January 20, 2022

Green chemistry approaches to synthesis could make a big difference to pharma product outputs

Bio-catalysis and Electro-catalysis emerge as most preferred green chemistry technologies


Natco Pharma signs agreement with Medicines Patent Pool
News | January 20, 2022

Natco Pharma signs agreement with Medicines Patent Pool

This agreement allows Natco to expand access to Covid-19 medicines in 105 countries in generic name


Healthcare for seniors an opportunity for service providers
Public Health | January 19, 2022

Healthcare for seniors an opportunity for service providers

Industry Report highlights the opportunities and need for multiple sectoral collaboration through 12 actionable recommendations under 6 thematic areas