New Drugs and Clinical Trial Rules, 2019, which brought about significant changes to the regulatory framework that oversees clinical trials in India, were put into effect by the Central Drugs Standard Control Organisation (CDSCO).
Cadila Pharmaceuticals has introduced generic versions of sitagliptin in India under the trade names Jankey and Sitenali to treat type 2 diabetes, a first-of-its-kind drug for the treatment of excessive blood glucose levels.
Domestic pharmaceutical companies are preparing plans to produce antivirals and other drugs that could treat monkeypox. Monkeypox has just recently been deemed an international public health emergency by the WHO.
Due to a large increase in other income, Dr Reddy’s Laboratories, a pharmaceutical behemoth with annual sales of over Rs. 20,500 crore, reported net profit of Rs. 1,459 crore for the first quarter ended June 2022 as opposed to Rs. 539 crore in the same time last year.
Bangladesh’s pharmaceutical industry has been one of the biggest beneficiaries of the LDC patent waiver. Bangladesh shipped the most pharmaceutical items among LDCs, accounting for approximately 55.4% of overall LDC pharmaceutical product exports.
The Marketing Authorization Application for leniolisib has been given an accelerated examination by the Committee for Medicinal Products for Human Use of the European Medicines Agency to treat rare immunodeficiency, APDS.
Sarepta Therapeutics announced that it
plans to apply for regulatory clearance of
its gene therapy to treat Duchenne muscular
dystrophy earlier than anticipated. This is
a risky decision, but it could enable the
business get to market much more quickly.
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