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European regulators issue guidance on regulatory requirements in the context of COVID-19 pandemic
The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients
Roche provides regulatory update on risdiplam for the treatment of spinal muscular atrophy (SMA)
Roche, announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam with a decision expected by August 24, 2020
Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries
Sanofi has committed to donating 100 million doses of hydroxychloroquine to 50 countries around the world, and has begun to progressively deliver the medicine to authorities that have requested it
Lupin's Nagpur Facility Receives EIR from U.S. FDA
Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) after closure of the U.S. FDA inspection of its Nagpur, India facility. The inspection for the facility was carried out by the U.S. FDA between January 6, 2020 and January 10, 2020
ICMR approves Molbio Diagnostics' testing kit for COVID-19
Molbio Diagnostics supported by India Health Fund, through the Centre for Health Research and Innovations (CHRI), has recently obtained approval from Indian Council of Medical Research (ICMR) for its testing kit -- the Truenat Beta CoV test -- to be used by patients to test for COVID-19
Indira IVF adapts IoT technique in its embryology labs to record data and transmit in real time
Indira IVF, a leading fertility chain in India, uses Internet of Things (IoT) technique in their embryology labs to record data and also transmits in real time. With the help of IoT, sophisticated sensors and chips are embedded in equipment which monitors and records data
Lincoln Pharma continues to invest in upgrading manufacturing capacity
Lincoln Pharmaceuticals Ltd continues to invest in upgrading manufacturing capacity, new product development and expand global footprints
Meddo Health partners with ICMR approved labs to launch rapid test kits by next week
Meddo, India's largest out-patient care network in partnership with Indian Council of Medical Research (ICMR) approved labs has started booking for COVID-19 (RT-PCR) testing in Delhi NCR
Lupin's Aurangabad Facility Receives EIR from U.S. FDA
Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Aurangabad, India facility. The inspection for the facility was carried out by the U.S. FDA between February 10, 2020 and February 14, 2020 and concluded with no observations
COVID-19 Testing Kits: Mylab Signs Deal With Serum
Mylab Discovery Solutions, the first Indian company whose testing kit was approved by the Indian Council of Medical Research (ICMR), has tied up with Serum Institute of India, world's largest vaccine manufacturer by number of doses produced, to scale up the operations and escalate faster delivery of testing kits
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