Page 15 - Usfda
Gilead's remdesivir shows modest improvement in moderate Covid-19 patients
At day 11, around 76% of the patients in the 5-day treatment group showed improvement in clinical status versus 66% for standard care alone, Gilead said
 "Gilead's remdesivir shows modest improvement in moderate Covid-19 patients")
Trump says he has been taking Hydroxychloroquine despite FDA warning
The President, according to The Hill report, said he consulted with the White House doctor about taking the drug, but it was not explicitly recommended for him
 "Trump says he has been taking Hydroxychloroquine despite FDA warning")
Huge scope for Indian pharma as FDA eases drug scrutiny over shortage in US
Injectibles account for 60% of crunch; most plants under American regulator's lens the past two months have now received positive outcomes
 "Huge scope for Indian pharma as FDA eases drug scrutiny over shortage in US")
Tech Mahindra arm leverages AI for potential Covid-19 therapeutic drugs
Makers Lab does molecular docking studies of 19 FDA approved ligands and anti-virals. technique enables search for therapeutically potent drugs and molecules in real-time
 "Tech Mahindra arm leverages AI for potential Covid-19 therapeutic drugs")
Gilead enters licensing pact with 5 drug firms in India, Pak for remdesivir
According to the agreement the companies Cipla, Hetero Labs, Jubilant Life Sciences, Mylan, and Pakistan based Ferozsons Labs, to manufacture and sell remdesivir in 127 countries
 "Gilead enters licensing pact with 5 drug firms in India, Pak for remdesivir")
Jubilant Life inks non-exclusive licensing pact with Gilead for Remdesivir
The drug, which is an injectable, got emergency approval from the US drug regulator recently.
 "Jubilant Life inks non-exclusive licensing pact with Gilead for Remdesivir")
Centre keen on testing Gilead's remdesivir to combat coronavirus
The USFDA has recently given an emergency approval to the drug for use on coronavirus patients
 "Centre keen on testing Gilead's remdesivir to combat coronavirus")
USFDA authorises emergency use of antigen test to diagnose, treat Covid-19
According to Johns Hopkins University, the United States has over 1.3 million confirmed cases, with the death toll at 78,320
 "USFDA authorises emergency use of antigen test to diagnose, treat Covid-19")
Dr Reddy's gets USFDA inspection closure report fo Srikakulam unit
The plant is one of the company's three units that were served a warning letter in November 2015 for not following the prescribed operational and manufacturing quality standards
 "Dr Reddy's gets USFDA inspection closure report fo Srikakulam unit")
Blood thinners may boost survival rates of coronavirus patients: Study
The Washington Post reported that the results of the analysis, conducted over 2,733 patients, were published on Wednesday in the Journal of the American College of Cardiology
 "Blood thinners may boost survival rates of coronavirus patients: Study")
US targets fraud in coronavirus antibody test market with tighter rules
The FDA said it would share information on its website and with potential buyers of these tests
 "US targets fraud in coronavirus antibody test market with tighter rules")
Not just bigwigs, Mid-rung local players join coronavirus vaccine race
With vaccines of some firms already in animal trial phase, developers say that if all goes well, India could have a vaccine by next year
 "Not just bigwigs, Mid-rung local players join coronavirus vaccine race")
How remdesivir, new hope for Covid-19 patients, was resurrected
The drug failed as a treatment for hepatitis and Ebola. With federal funding, scientists trained it on the coronavirus.
 "How remdesivir, new hope for Covid-19 patients, was resurrected")
USFDA okays emergency use of Gilead drug for hospitalised Covid-19 patients
Gilead CEO Daniel O'Day has announced that the company is donating 1.5 million vials of the medicine
 "USFDA okays emergency use of Gilead drug for hospitalised Covid-19 patients")
FDA's lax blood test rules open US market to dubious vendors: Report
The rush to obtain test kits follows the FDA's unprecedented decision last month to allow any company to sell antibody tests in the US without prior review by the agency
 "FDA's lax blood test rules open US market to dubious vendors: Report")
Lupin gets inspection closure report from USFDA for Pithampur plant
Lupin Managing Director Nilesh Gupta, said the company has received the EIR for the plant with Voluntary Action Indicated (VAI) status
 "Lupin gets inspection closure report from USFDA for Pithampur plant")
Diversified model, US outlook to help Dr Reddy's stock trade better
The company has multiple growth engines given its focus on India/emerging markets and limited competition products in the US
 "Diversified model, US outlook to help Dr Reddy's stock trade better")
Battling Covid-19: Start-ups chip in to resolve India's ventilator crisis
Domestic firms are also sourcing ventilator parts from within the country to manufacture ventilators at a much lower cost
 "Battling Covid-19: Start-ups chip in to resolve India's ventilator crisis")
Covid-19: US FDA warns against use of hydroxychloroquine outside hospitals
Among some of side effects, heart rhythm abnormalities developed in most of the 84 coronavirus patients treated with hydroxychloroquine
 "Covid-19: US FDA warns against use of hydroxychloroquine outside hospitals")
US FDA clears Aurobindo Pharma Unit IV, reverts classification to VAI
The latest classification, VAI, suggests that though certain objectionable conditions were found during the review, they did not warrant any further regulatory action
 "US FDA clears Aurobindo Pharma Unit IV, reverts classification to VAI")
