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AffaMed Therapeutics, a global clinical stage biopharmaceutical company, announced during the recent "China International Trade in Services Fair 2021" a strategic cooperation partnership with Beijing Tiantan Hospital of Capital Medical University and Beijing Infinite Brain Technologies (IBT)
Hetero gets emergency use nod to make Roche's COVID-19 drug
Hetero expects to make the treatment, tocilizumab, available in India by the end of the month under the brand name Tocira. Tocilizumab has been facing a global shortage as the highly contagious COVID-19 Delta variant drives up cases in several countries
TB Alliance and Lupin partner to manufacture anti-TB drug pretomanid
The TB Alliance has granted Lupin a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug BPaL regimen. Lupin intends to commercialise the anti-tuberculosis (TB) medicine in approximately 140 countries and territories
DCGI gives nod to phase-I clinical trial of COVID-19 vaccine by Reliance Life Sciences
The Drugs Controller General of India (DCGI) recently granted permission to Reliance Life Sciences for conducting phase-I clinical trial of its indigenous COVID-19 vaccine with certain conditions, sources said
DCGI: India has digital friendly and competent GRP-driven regulatory system
India is having one of the best, easiest, very digital friendly and most competent Good Regulatory Practices (GRP)-driven regulatory systems in place and is striving towards a better ecosystem by reducing the compliance burden or redundant procedures
US FDA updates its March 2020 norms to conduct human studies
The global regulator which noted the Covid-19 as a public health emergency now insists that the clinical trial industry, investigators, and institutional Review Boards need to maintain compliance with good clinical practice (GCP), minimize risks to trial during the ongoing pandemic
No price regulation on medical devices other than those under NLEM and TMR: DoP official
The pricing regulations on medical devices are restricted to a few products and the industry is free to fix the maximum retail price for their products. The listed products should not increase the prices above 10 per cent as per the pricing regulations, said a senior official from the Department of Pharmaceuticals (DoP)
RIL arm acquires stake in Strand Life Sciences
Reliance Strategic Business Ventures Limited, a wholly owned subsidiary of Reliance Industries Limited has acquired stake in Strand Life Sciences for a cash consideration of Rs. 393 crore
The Drugs Controller General (India) has directed the State drug controllers to restrict the fixed dose combination (FDC) tolperisone HCI 150 mg+ paracetamol IP 500 mg tablet only for symptomatic treatment of post-stroke spasticity associated with pain in adults, and direct the manufacturers to submit phase IV clinical trial data on revised indication
Dr Reddy's launches Reddy-Lenalidomide in Canada
Dr Reddy's Laboratories yesterday launched Reddy-Lenalidomide, a generic equivalent to Revlimid (lenalidomide) capsules in the Canadian market. The product is approved by Health Canada, the company notified in a statement
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