Page 7 - Us Fda
US Health Secy tells docs to prescribe HCQ as FDA withdraws use in Covid-19
During a White House media appearance with President Donald Trump, Azar asserted that HCQ was approved in the United States
 "US Health Secy tells docs to prescribe HCQ as FDA withdraws use in Covid-19")
UK begins trial of latest virus vaccine this week with 300 candidates
The British government said 300 healthy people will be immunized with two doses of the Covid-19 vaccine candidate developed at Imperial, which has been backed by 41 million pounds
 "UK begins trial of latest virus vaccine this week with 300 candidates")
US FDA ends emergency use of hydroxychloroquine to treat Covid-19
The decision on the so-called 'wonder drug' as touted by the US President Donald Trump is taken in the wake of recent clinical trials
 "US FDA ends emergency use of hydroxychloroquine to treat Covid-19")
Lupin steps up production of key drugs in potential use for Covid-19
Expects US approval for Albuterol soon
 "Lupin steps up production of key drugs in potential use for Covid-19")
Opportunity in crisis: 5 sectors that may gain from coronavirus pandemic
As India moves to open up the country, investors look at sectors that have been resilient. Puneet Wadhwa charts sectors that are expected to do well in the next few months
 "Opportunity in crisis: 5 sectors that may gain from coronavirus pandemic")
Investors should stick to stocks of firms focused on domestic market
Pharma firms can build brands and enjoy higher margins here
 "Investors should stick to stocks of firms focused on domestic market")
India growth crucial for Torrent Pharma's health amid steep fall in volume
The country accounts for 44% of overall revenues
 "India growth crucial for Torrent Pharma's health amid steep fall in volume")
Malaysia plant boosts Biocon prospects in US and other key markets
Firm seen benefiting from operating leverage, biologic sales by FY22
 "Malaysia plant boosts Biocon prospects in US and other key markets")
Covid-19 throws up drug supply opportunity for Ipca, other pharma firms
Sun Pharma, Dr Reddy's, Torrent Pharma, Cipla, Cadila Healthcare and Natco Pharma would also benefit from malaria drug supplies, Alembic Pharma from azithromycin sales
 "Covid-19 throws up drug supply opportunity for Ipca, other pharma firms")
Glenmark gets US FDA nod for tablet used to treat high levels of iron
Glenmark Pharmaceuticals on Tuesday said it has got final approval from the US health regulator for Deferasirox tablets for oral suspension. "Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Deferasirox tablets for oral suspension, 125 mg, 250 mg and 500 mg, the generic version of exjade1 tablets for oral suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation," the company said in a filing to the BSE. The tablet is used to treat high levels of iron in the body caused by multiple blood transfusions. According to IQVIA sales data for the 12-month period ending November 2019, exjade tablets for oral suspension -- 125 mg, 250 mg and 500 mg -- had annual sales of approximately USD 106.4 million (about Rs 750 crore). Glenmark's current portfolio consists of 165 products authorised for distribution in the US market and 43 ANDAs pending approval with the US FDA. In addition
 "Glenmark gets US FDA nod for tablet used to treat high levels of iron")
US health regulator sends stern letter to GPT Pharma about Hyderabad plant
The company has 15 working days to explain to the Food and Drug Administration how it has improved manufacturing standards.
 "US health regulator sends stern letter to GPT Pharma about Hyderabad plant")
Over-prescribing antibiotics hurting children in poor countries: Lancet
The researchers, including those from Harvard University in the US, said one major factor contributing to this global health crisis is the excessive use of antibiotics worldwide
 "Over-prescribing antibiotics hurting children in poor countries: Lancet")
Expansions, clean track record helping Divi's Labs tap new opportunities
The current margin pressure will also get mitigated by tax benefits and operational efficiencies
 "Expansions, clean track record helping Divi's Labs tap new opportunities")
Aurobindo recalls heartburn drug ranitidine, two others from US market
Development follows regulatory compliance issues being faced by several of its plants back home; Ranitidine taken off due to the presence of carcinogenic compound
Caplin Steriles gets US FDA approval for generic blood pressure drug
The company has so far developed and filed 13 ANDAs on its own and with partners, and received six approvals
 "Caplin Steriles gets US FDA approval for generic blood pressure drug")
Zydus Cadila gets US FDA approval for generic muscle relaxing injection
The approval is for single-dose vials of Cisatracurium Besylate Injection USP with strengths of 10 mg/5 ml and 200 mg/20 ml
 "Zydus Cadila gets US FDA approval for generic muscle relaxing injection")
Cadila Healthcare receives US FDA approval for schizophrenia drug
The product will be manufactured at Liva Pharma's manufacturing facility at Vadodara
Regulatory woes resurface for Indian pharma companies as stocks fall
Concerns over US sales are diluting positives of strong domestic growth, and have led to a 10 per cent fall in the Nifty Pharma index in one month
 "Regulatory woes resurface for Indian pharma companies as stocks fall")
Rupee fall gives leg up to IT, pharma funds, may help ease margin pressure
IT and pharma funds have returned 4.4% and 1.77% in the past month, respectively
 "Rupee fall gives leg up to IT, pharma funds, may help ease margin pressure")
Tide turns for pharma as US FDA concerns get addressed
This indicates turn-of-the-tide of regulatory concerns raised by the US FDA in the last three years
 "Tide turns for pharma as US FDA concerns get addressed")
