Bharat Biotech begins clinical trials of TB vaccine on adults in India
PTI / Updated: Mar 24, 2024, 16:55 IST
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(Representative image: IANS)
HYDERABAD:
Bharat Biotech International Ltd on Sunday said it started clinical
trials of the Tuberculosis vaccine Mtbvac on adults in India.
This
is the first vaccine against Tuberculosis derived from a human source by
the Spanish biopharmaceutical company, Biofabri, a press release from
Bharat Biotech said.
The release said that Mtbvac is being developed
for two purposes; firstly, as a more effective and potentially
longer-lasting vaccine than BCG ( Bacillus Calmette Guerin) for newborns
and secondly, for the prevention of TB in adults and adolescents, for
whom there is currently no effective vaccine.
The trials are carried out by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety and immunogenicity of Mtbvac have started with a pivotal safety, immunogenicity and efficacy trial which has been planned to start in 2025, the release said.
It is a giant step to test in adults and adolescents in the country where 28 per cent of the world's TB cases accumulate.
TB
remains one of the world's leading infectious causes of death,
especially in India, Esteban Rodriguez, CEO of Biofabri said. Krishna
Ella, Executive Chairman Bharat Biotech said "Our quest for a more
effective vaccine against Tuberculosis received a big boost today, with
clinical trials in India. Our goal to develop TB vaccines to prevent
disease in adults and adolescents has taken a big step today."
The
Mtbvac vaccine has passed several milestones before entering clinical
trials in India. After the recent completion of a Phase-2 dose finding
trial, a double-blind controlled Phase-3 clinical trial in newborns has
been started in 2023 to compare the vaccine with the current BCG
vaccine.
As many as 7,000 newborns from South Africa, 60 from
Madagascar and 60 from Senegal will be vaccinated. To date, more than
1,900 babies have been vaccinated, the release added.
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RBI to conduct special audit for regulatory breaches by IIFL Finance, JM Financial Products
PTI / Updated: Mar 24, 2024, 16:53 IST
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NEW DELHI: IIFL Finance Ltd and JM Financial Products Ltd (JMFPL) will undergo a special audit to further probe their regulatory breaches, as the Reserve Bank has initiated the process for the appointment of auditors. The Reserve Bank has floated two separate tenders for the appointment of auditors for special audits of these two non-banking finance companies.
Audit firms empanelled by the Securities and
Exchange Board of India (Sebi) for forensic audit can participate in the
tendering process, and the last date for submission of bids is April 8,
as per the tender document published by the Reserve Bank of India.
The selected firms will be awarded work on April 12, 2024, as per the bid documents.
Earlier this month, the Reserve Bank put a curb on these two entities for non-compliance of regulatory guidelines.
The
central bank barred IIFL Finance from sanctioning or disbursing gold
loans after certain material supervisory concerns were observed in its
gold loan portfolio.
The RBI had said an inspection of the company
was carried out by it with reference to IIFL's financial position as of
March 31, 2023.
"Certain material supervisory concerns were observed
in the gold loan portfolio of the company, including serious deviations
in assaying and certifying purity and net weight of the gold at the
time of sanction of loans and at the time of auction upon default," the
RBI had said in a statement.
These practices, apart from being
regulatory violations, also significantly and adversely impact the
interest of the customers, the central bank added.
A day after, the
Reserve Bank imposed restrictions on JM Financial Products Ltd following
the finding that the company indulged in various manipulations,
including repeatedly helping a group of its own customers to bid for
various IPOs by using loaned funds.
The central bank barred the
systemically important non-deposit-taking NBFC from providing any kind
of financing against shares and debentures, including sanction and
disbursal of loans against initial public offering (IPO) of shares and
subscription to debentures.
In a statement, the RBI said the actions
were "necessitated due to certain serious deficiencies observed in
respect of loans sanctioned by the company for IPO financing as well as
NCD (non-convertible debentures) subscriptions".
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