“This is to inform you that Biocon Sdn Bhd, a subsidiary of Biocon, has received the EIR from the USFDA for the pre-approval inspection of its insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between Feb 10 and 21, 2020,” said the company spokesperson in a statement.
Biotech entrepreneur Kiran Mazumdar Shaw said the 21-day nation-wide lockdown in the wake of the coronavirus outbreak, announced by PM Modi, is needed from the scientific point of view to collect required testing data to fully understand the severity of the disease.
Primers are short pieces of the DNA of a virus that is used for polymerase chain reaction (PCR) tests that help in reducing the time to diagnose a disease. Scientists have sequenced the genome of the novel coronavirus. The rapid screening diagnostic here means taking the Covid-19 virus sequence and creating a PCR-based test to match against the sequence.
The CMD of Biocon also the government to rope in the private sector to boost diagnostic capacity to deal with the COVID-19 cases. "Now we realise that it cannot be contained so easily," she said on the WHO's assessment that COVID-19 can be characterised as a pandemic. According to her, the response of the US and Europe has been very slow in containing it.
USFDA had conducted a pre-approval inspection of Biocon's subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for Insulin Glargine between February 10 and 21. "At the conclusion of the inspection, the agency issued a Form 483 with three observations which we believe are procedural in nature," a Biocon spokesperson said in a regulatory filing.
Major cotton producing countries like USA, Brazil and African countries are moving ahead of India with new technology, and competitiveness of Indian cotton in global trade is eroding, Wiebusch said. “By 2028, we anticipate India to account for 65% of area increase but only 33% of production increase,” he said.
India’s plan to focus on two national-level programmes to build genomic data of the population and crops is expected to help the country in developing per- sonalised drugs, tackle disease and increase yield in crops, experts said.
As per the USFDA, a Form 483 is issued to Biocon's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts. At the conclusion of the inspection of the Bengaluru facility, USFDA issued a Form 483, with 5 observations.
The authority said it found it ‘surprising’ that the FMCG major had not added the tax cost and losses to prices of products between July 1 and November 14, 2017, but had chosen to do so from November 15, when it was supposed to have reduced prices due to the rate reduction to 18% from 28%.
Itolizumab, a first-in-class humanized anti-CD6 monoclonal antibody, is developed by Biocon and launched in 2013 in India under the brand name ALZUMAb to treat moderate to severe plaque psoriasis, a skin disease.
Vidita’s Neurobiology lab at TIFR currently studies the molecular, epigenetic and cellular changes that contribute to persistent alterations in human behaviour. It also focusses on molecular and cellular adaptations that arise from sustained antidepressant treatment.
This additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable the biotechnology major to enable its arm Biocon Biologics and Mylan to scale up capacity multi-fold and address the growing market opportunities in US and other global markets.
A three-member bench headed by Chairperson Justice S J Mukhopadhaya also said the Enforcement Directorate will probe and ascertain whether the money paid by the promoters is not from proceeds of crime. The promoters of the company include absconding Nitin Jayantilal Sandesara and Chetankumar Jayantilal Sandesara.
Kotak PE and OrbiMed together that hold 23% stake in Mumbai-based biopharma company Bharat Serums and Vaccines (BSV) are exiting through this sale. The rest of the stake is with the Daftary family who are relinquishing control but will stay on as a minority partner, said people in the know. Advent will become the largest shareholder in the company.
We have a very good track record on GMP compliance. We are taking a digital journey in strengthening our quality system, which will help us be dependent on systems and processes and less on people, says Siddharth Mittal, MD, Biocon.
Biocon continues to be the only company from Asia to feature on the prestigious US-based 'Science' magazine's annual 'Science Careers Top 20 Employers' list, since its debut in 2012.
Copyright © 2020 Bennett, Coleman & Co. Ltd. All rights reserved. For reprint rights: Times Syndication Service