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Biocon says probe on Malaysia manufacturing unit ends

“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.

21-day lock-down needed from scientific perspective: Kiran Mazumdar Shaw

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.

With DNA data, biotech cos can build diagnostics: Kiran Mazumdar-Shaw

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.

Covid-19: India needs to get into vaccine production in a big way, says Kiran Mazumdar-Shaw

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.

Biocon gets 3 USFDA observations for insulin facility in Malaysia

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.

India needs to curb illegal seed technology, strengthen IPR regime to boost farm investments, says Bayer CropScience COO

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.

Why gene data will put India on the map

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.

USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility

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.

GST profiteering: Rs 230-crore penalty on Johnson & Johnson

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%.

Biocon extends licensing pact with Equillium for itolizumab

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.

SPV Foundation posts Rs 3 cr grant for bioscience research; TIFR scientist Vidita Vaidya bags research grant

SPV Foundation posts Rs 3 cr grant for bioscience research; TIFR scientist Vidita Vaidya bags research grant

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.

Biocon, Mylan get USFDA nod for pegfilgrastim drug substance licence

Biocon, Mylan get USFDA nod for pegfilgrastim drug substance licence

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.

NCLAT gives 30 days more to Sterling Biotech promoters to settle dues

NCLAT gives 30 days more to Sterling Biotech promoters to settle dues

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.

Advent set to buy controlling stake in Bharat Serum

Advent set to buy controlling stake in Bharat Serum

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.

Processes must be robust; merely being better no longer an option: Siddharth Mittal, Managing Director, Biocon

Processes must be robust; merely being better no longer an option: Siddharth Mittal, Managing Director, Biocon

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 number six in top 10 Global Biotech Employers ranking for 2019

Biocon number six in top 10 Global Biotech Employers ranking for 2019

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.

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