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USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


Merck donates 1.5 billionth tablet of praziquantel to Africa
Public Health | January 25, 2022

Merck donates 1.5 billionth tablet of praziquantel to Africa

The tablet donations provided for the treatment of more than 600 million schoolchildren in affected countries in sub-Saharan Africa since 2007


Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation
News | January 25, 2022

Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation

The company has been manufacturing masks since the Covid-19 outbreak in 2020


FDC’s chooses UFlex’ Asepto holographic packaging for Electral
Packaging | January 25, 2022

FDC’s chooses UFlex’ Asepto holographic packaging for Electral

The six-layer packaging ensures that external media such as bacteria, light and air do not contaminate the liquid


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