Showing posts with label Biocon. Show all posts
Showing posts with label Biocon. Show all posts

Thursday, July 16, 2020

Remdesivir to Itolizumab: How effective are the drugs for Covid treatment?


Remdesivir costs around Rs 5,000 per vial with a total treatment cost in the range of Rs 35,000-50,000.


The Central Drugs Standard Control Organisation (CDSCO) has approved five drugs in the last month for Covid-19 treatment – two antiviral: Remdesivir and Favipiravir – and three for easing the symptoms: Dexamethasone, Tocilizumab and Itolizumab. These drugs’ use is bound to birth complications considering there are doubts about the evidence the government has furnished – or not – to approve their use.

Remdesivir costs around Rs 5,000 per vial with a total treatment cost in the range of Rs 35,000-50,000. Favipiravir costs Rs 103 per 200 mg tablet; the total treatment cost ranges from Rs 12,000 to Rs 15,000. A vial of Itolizumab costs around Rs 8,000 and the total treatment cost could be between Rs 32,000 and Rs 50,000. Tocilizumab costs Rs 40,000 to Rs 50,000 per vial.

Remdesivir
Remdesivir was approved for clinical use for both children and adults by the CDSCO as an injection on June 1, amid controversies surrounding its efficacy. This drug is manufactured by Gilead Sciences Inc. The first randomised double-blind study showed no statistically significant treatment efficacy in severe Covid-19 patients. Gilead’s own study reported that no fewer people died when on the drug. However, while the study also reported patients on Remdesivir recovered four days earlier on average, independent experts aren’t convinced.

A press release by the US National Institute of Arthritis and Infectious Disease (NIAID), the study’s sponsor, nonetheless said hospitalised patients with Covid-19 recovered faster when they were on Remdesivir compared to placebo. There was also a controversy surrounding the changing of end points of the study, to get a favourable outcome. Gilead’s quest to secure approval for the drug were also shadowed by reports of lobbying to influence the FDA and other authorities.

Thursday, March 19, 2020

Biocon receives EIR from USFDA for good manufacturing practice inspection


"We remain committed to global standards of quality and compliance," company spokesperson said.


Biocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good manufacturing practice (GMP) inspection of its small molecules manufacturing facility in Bengaluru.

"The EIR has been closed with a voluntary action indicated (VAI) classification for the observations, the company spokesperson said in a filing to BSE.

"Biocon has received the EIR from the US Food and Drug Administration (FDA) for the post-approval and GMP inspection of its small molecules active pharmaceutical ingredient (API) manufacturing facility at 20th KM, Biocon Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020," as per the filing.

At the conclusion of the inspection last month, the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company, the filing said.

"We remain committed to global standards of quality and compliance," company spokesperson added.

The shares of Biocon were trading at Rs 257.00 apiece on the BSE, up 1.76 from the previous close.