The continued availability of medicines, in particular those used for patients with COVID-19, is of critical concern for EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic.
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In a dedicated COVID-19 workshop, organised by the European Medicines Agency (EMA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed how data generated during clinical practice could complement evidence from clinical trials with potential therapeutics or vaccines against COVID-19. Participants from more than 25 countries, representing 28 medicines regulatory authorities globally and experts from the World Health Organization and the European Commission acknowledged the importance of observational studies of real world data for increasing the effectiveness and efficiency of regulatory processes and decision-making in the development, authorisation and monitoring of medicines and vaccines to prevent and treat COVID-19 and to address knowledge gaps that cannot be addressed by clinical trials.
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HLL has introduced rapid diagnostic kit under the brand name Make Sure for the quick detection of Corona virus. The test result will be available within 15 to 20 minutes. The test kit is being manufactured at HLL Manesar Factory, Gurgaon.
The kit is one-step novel coronavirus IgM/IgG antibody detection from the human serum, plasma and/or whole blood obtained from the patient with signs and symptoms of respiratory infection.
This device is designed to aid in the rapid differential diagnosis of COVID-19 virus infection in large population screening in our country during the current pandemic situation and this shall support in the management of control and treatment of coronavirus disease
This kit is validated and approved by the NIV, Pune and the ICMR for use in India.
The principle of 'MakeSure' COVID-19 IgM/IgG antibody test kit is based on antibody capture immunochromatographic assay for the simultaneous detection of IgM and IgG antibodies to COVID-19 virus in human serum, plasma and/or whole blood samples.
HLL is planning to manufacture two lakh kits for supplying to various government units within the next 10 days. Along with that HLL has also started manufacturing of hand sanitizers under the brand name "Medigard" at their Peroorkada Factory, Thiruvananthapuram and Kanagala Factory, Belgaum.
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The Council of Scientific and Industrial Research (CSIR) has adopted a five-tier strategy to fight Covid-19, which is also getting wide support from the industry to implement it. This information was provided by Dr. Shekhar C. Mande, Director General of CSIR. He was addressing an online zoom meeting with directors of 38 laboratories of CSIR to discuss the strategy related to Covid-19.
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A lawsuit is filed against Aurobindo Pharma and Emcure Pharma by MSP Recovery Claims in Florida, USA which claims that these pharmaceutical companies hide details about presence of carcinogenic element in anti-diabetic medicines reported by law360.
On 2nd March 2020, Valisure has tested and detected high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes.
Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA levels were detected above the 96 nanograms (ng) daily acceptable intake limit.
The Defendants knowingly and with an intent to defraud, concealed from Plaintiff and Class Members the material facts concerning their pervasive cGMP violations, and made express and implied representations to Plaintiff’s assignors and Class Members that their Metformin drugs conformed to applicable standards of quality, purity, identity and strength, were not adulterated, and were merchantable, fit for human consumption and fit for their intended purpose when, in truth and in fact, the Metformin drugs were contaminated with a probable human carcinogen.
MSP recovery claimed in petition that, "each package of Metformin drugs sold in the United States contained a printed insert, which represented that the drug in the package had the specified properties, conformed to the specified description, and carried a guarantee of quality assurance. The Defendants knowingly or extremely recklessly made these representations with actual knowledge, or reason to know, that they were false."
Florida class action seeking to recover USd 124 million that health insurers paid for the popular diabetes drug.
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Our research institutions are increasingly translating their knowledge into challenging and useful applications. This product from JNCASR is a compelling example of that”- Prof Ashutosh Sharma, Secretary, DST
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Supply lines from abroad opened up today with the receipt of 1.70 lakh Personal Protection Equipment (PPE) coveralls from China which have been donated to the Government of India. Along with domestic supplies of 20,000 coveralls, a total of 1.90 lakh coveralls will now be distributed to hospitals and will add to the 3,87,473 PPEs already available in the country as of now. A total of 2.94 lakh PPE coveralls have been arranged and supplied by Government of India now.
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During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating coronavirus disease (COVID-19) in compassionate use programmes in the European Union.
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A new study in Neuron offers clues to why autism spectrum disorder (ASD) is more common in boys than in girls. National Institutes of Health scientists found that a single amino acid change in the NLGN4 gene, which has been linked to autism symptoms, may drive this difference in some cases. The study was conducted at NIH’s National Institute of Neurological Disorders and Stroke (NINDS).
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