Drug Approval | January 19, 2023
USFDA completes inspection at APL HealthCare
The company has been issued ‘Form 483’ with two observations
The company has been issued ‘Form 483’ with two observations
India's G20 Presidency will focus on three main priorities: Health Emergencies Prevention, Preparedness and Response (One Health & AMR); Access and Availability to Affordable Medical Countermeasures (Vaccines, Therapeutics, and Diagnostics); and Digital Health
The top 15 Indian pharma players have continued to experience anaemic growth in the US market over the five years ended FY22
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company will respond to these observations within the stipulated time period.
Under the soon to be launched Heal in India initiative, India aims to provide its health infrastructure for patients abroad and make it a global hub for medical and value-based healthcare for patients from across the world
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Merck intends to complete today the acquisition of Imago through a merger of Merck’s wholly owned subsidiary with and into Imago
Moderna and Merck announced mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a 44% reduction in the risk of disease recurrence or death in melanoma patients
Acquisitions have the potential to add at least $1 billion in sales by 2028
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