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India Panel No-Go For Lilly’s Antibody In COVID-19

More Data Required?

 
• By Anju Ghangurde

India expert panel decides not to back Lilly’s bamlanivimab as a COVID-19 therapy, at least for now, under the accelerated approval route and without local trials, but the US firm is still pursuing an authorization request. Physicians underscore the need for more data on important patient outcomes for the antibody product.

YES and NO acceptance and rejection symbols vector for vote, election choice. Brush painted symbolic approval icons in square frames. Tick and cross signs, check marks graphic design. - Vector
Lilly Pursues Regulatory Approval For Bamlanivimab In India • Source: Shutterstock

Eli Lilly and Company’s investigational neutralizing antibody bamlanivimab has not been endorsed, at least not immediately, by an Indian expert panel as a treatment for COVID-19 via the expedited trial waiver route.

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More from India

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 
• By Urtė Fultinavičiūtė

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

More from Asia

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.