Page 27 - Usfda
Sun Pharma, Hikma ink pact for plaque psoriasis drug for MENA region
One of the company's wholly-owned subsidiaries and Hikma Pharmaceuticals have entered into the agreement for Ilumya, Sun Pharma said in a filing to BSE
 "Sun Pharma, Hikma ink pact for plaque psoriasis drug for MENA region")
Dr Reddy's inks pact with Gilead to manufacture, market Remdesivir in India
Dr Reddy's would need to scale up manufacturing and obtain regulatory approval for marketing of this drug in respective countries, the company said
 "Dr Reddy's inks pact with Gilead to manufacture, market Remdesivir in India")
Gilead finds fourth partner for manufacture of Remdesivir in Zydus Cadila
Indian drug maker to get know-how from Gilead Sciences Inc, to manufacture the API for Remdesivir, make the finished product and market it in 127 countries, including India
 "Gilead finds fourth partner for manufacture of Remdesivir in Zydus Cadila")
Biocon gets a shot in the arm with FDA approval for insulin glargine
The drug will be major contributor in the firm's bid to reach $1 billion revenue target by FY22, says biologics CEO Hamacher
 "Biocon gets a shot in the arm with FDA approval for insulin glargine")
US FDA grants orphan drug status to mexiletine hydrochloride: Lupin
The Mumbai-based company's drug NaMuscula (mexiletine hydrochloride) is the first and only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders
 "US FDA grants orphan drug status to mexiletine hydrochloride: Lupin")
Zydus Cadila gets USFDA nod for generic antiviral drug, Atazanavir capsules
Atazanavir, an antiretroviral drug, is used to treat Human Immunodeficiency Virus (HIV-1) infection incombination with other antiretroviral drugs
 "Zydus Cadila gets USFDA nod for generic antiviral drug, Atazanavir capsules")
Covid-19 crisis: Indian drug companies yet to get nod to market remdesivir
The USFDA granted remdesivir an emergency use authorization for the treatment of hospitalized patients with severe Covid-19
 "Covid-19 crisis: Indian drug companies yet to get nod to market remdesivir")
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
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")