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 is studying the Complete Response Letter and it is not related to the safety of gefapixant
The company has been manufacturing masks since the Covid-19 outbreak in 2020
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
UCB plans to submit regulatory applications in Q3 2022
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Go-ahead for pivotal clinical trial which is expected to commence by March
The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list
The company will receive an upfront payment as well as regulatory and sales based milestone payments from Lotus
The extended collaboration will provide services relating to small molecules for both Forbion and BGV portfolio companies active in the biopharmaceutical space
Industry Report highlights the opportunities and need for multiple sectoral collaboration through 12 actionable recommendations under 6 thematic areas
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