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Anju Ghangurde

Executive Editor, APAC

Mumbai, India

Anju has been a journalist since 1993 including stints at India's leading financial dailies. She covers a range of topics across the pharma and biosimilar landscape. Drug pricing, policy and regulatory affairs, M&A and patents are areas of special interest to her. She is also a recipient of the British Chevening Scholarship for Young Indian Journalists (2000-01) awarded by the Foreign & Commonwealth Office.

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CAR-T To N-of-1 Studies: How Jeeva Is Helping Drive Trial Efficiencies

Jeeva’s founder and CEO talks to Scrip about how the firm’s clinical trial management platform does away with the need for numerous point solutions and vendors, enabling sponsors to undertake trials more effectively including in the complex and competitive oncology space.

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US FDA’s Cavazzoni To Manufacturers: Pay Attention To Data Received From CROs

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Compliance Quality

IGBA’s Almeida On Patent Quality, Single Data Package Globally For Off-Patent Drugs

IGBA's secretary general, in an interview with Scrip, bolsters the case for enabling single global development of off-patent medicines and the acceptance of foreign comparators in bioequivalence studies as complex and niche therapeutics increasingly dot pharma’s pipeline. The global off-patent industry association, she maintained, is also “paying attention” to patent quality in various regions.

Policy Regulation

US FDA’s Cavazzoni To Manufacturers: Pay Attention To Data Received From CROs

Manufacturers should keep a sharp eye on data from contract research organizations, looking for any irregularities amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Compliance Quality

India Pharma Chiefs On Supply Chain Learnings From Auto Sector, New ‘PAGE’ On Skilling

Leaders from India’s top drug makers discuss efforts to operationalize a world-class skilling institute, backed by tie-ups with organizations like the PDA, ISPE and also taking a leaf out of the automobile industry’s book to build supply chain resilience. They also exuded confidence on moving up the innovation value chain.

India Commercial

India’s Drug Regulatory Apparatus Set For ‘Big Ticket’ Changes

India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.

India Regulation
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