Page 14 - Glenmark Pharmaceuticals

Govt mulls faster drug approval process, regulatory system overhaul

The industry, which has been lobbying for faster approvals for quite some time now, says the current pandemic should help expedite the reforms process

Strides Pharma to conduct trials for potential Covid-19 drug Favipiravir

Favipiravir is manufactured under the brand name Avigan by a unit of Japan's Fujifilm Holdings Corp and was approved for use as an anti-flu drug in the country in 2014

Mumbai docs want key drugs made available fast as hospital wards swell up

If patients recover faster, they needn't stay in hospital for 14 days and this could free up beds; Remdesivir and Favipiravir are in the process of being made available in India

Covid-19: Pune-based drug firm to export favipiravir to 18 countries

Favipiravir is under trial in many countries as a potential treatment for Covid-19

Top 10 biz headlines: RIL results, FMCG mkt to see 'slowest' growth & more

Here are the top 10 business headlines this morning

In race to stop Covid-19, Indian drugmakers to conduct clinical trials

Glenmark, Zydus Cadila to start trials in May

Glenmark gets DCGI nod for clinical trials of potential Covid-19 drug

As per the clinical trial protocol approved, 150 subjects with mild to moderate Covid-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care

Strong outlook, attractive valuations driving Glenmark's bounce back

US growth remains crucial for earnings upgrades, while licensing deals can help reduce both, costs and debt

Street positive in Hindustan Unilever's ability to scale up VWash

Strong distribution network and company's cost efficiency would help increase sales of the acquired high-margin portfolio

HUL zooms 10% after announcing acquisition of Vwash from Glenmark

Glenmark will manufacture VWash for HUL over the next one year after which the production arrangement would be reviewed

Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

The product is a generic version of AstraZeneca AB's Farxiga tablets

More drug licensing deals will play a big part in paring Glenmark's debt

The company's US sales growth has remained subdued due to intense competition for its dermatology range.

Glenmark Pharma shines as September quarter marks rebound in earnings

Analysts are upgrading their ratings as they expect sales momentum in the US and domestic markets to improve

Glenmark Pharma net declines 38% to Rs 255.54 cr in September quarter

Glenmark's total expenses was at Rs 2,548.56 crore during the period as against Rs 2,308.80 crore, up 10.38%

New FDA warning letters show Indian drug makers' quality concerns persist

The latest regulatory crackdown shows US regulator's stance is hardening toward lapses in quality control even as it seeks cheaper drugs to contain health care costs

Glenmark Pharma gets USFDA approval for prostate cancer treatment drug

Drug firm Glenmark Pharmaceuticals on Thursday said it has received final approval from the US health regulator for Abiraterone Acetate tablets, used to treat prostate cancer. The approved product is a generic version of Zytiga tablets, 250 mg, of Janssen Biotech. "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Abiraterone Acetate tablets USP, 250 mg," the company said in a regulatory filing. Quoting IQVIA sales data for the 12 month period ending August 2019, Glenmark said the Zytiga tablets, 250 mg market achieved annual sales of approximately USD 794.1 million. Glenmark's current portfolio consists of 162 products authorised for distribution in the US marketplace and 46 ANDA's pending approval with the USFDA. Shares of Glenmark Pharma were trading 0.15 per cent higher at Rs 286.00 apiece on the BSE.

Glenmark Pharma gets tentative nod from USFDA for multiple sclerosis drug

Glenmark Pharmaceuticals on Wednesday said it has received tentative nod from the US health regulator for dimethyl fumarate delayed-release capsules used for treating multiple sclerosis. The tentative nod granted by US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for multiple strengths of dimethyl fumarate delayed-release capsules of 120 mg and 240 mg. These are generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc, Glenmark Pharmaceuticals said in a statement. Citing IQVIATM sales data for the 12 month period ending August 2019, the company said Tecfidera Capsules, 120 mg and 240 mg achieved annual sales of approximately USD 3.7 billion. Glenmark's said its current portfolio consists of 161 products authorised for distribution in the US market and 49 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

Glenmark stock tumbles to 52-week low on USFDA warning letter to Baddi unit

Plant accounts for 7 per cent of company's US sales; firm says no major pending approvals from unit in the next 12 months

USFDA warning letter for Glenmark's Baddi unit, reason classified

The United States Food and Drug Administration (USFDA) had inspected the facility between April 15 and April 20 and earlier classified the inspection as an official action indicated

Glenmark Pharma shareholders approve raising $200 mn via debt securities

The proposal was approved at the company's annual general meeting held on September 27