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FTC’s Rahul Rao On Why Agency Targeted Drug-Device Orange Book Patents

 
• By Brenda Sandburg

Deputy director of the Bureau of Competition notes in an interview that the FTC focused on older products it felt should have more generic competition in its letters to companies citing improper patent listings. He says it is clear which drug-device combo patents should not be listed.

FTC orange book Rao
• Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

The US Federal Trade Commission took on a new mission when it issued letters to drug manufactures claiming they improperly listed patents pertaining to drug-device combination products in the US Food and Drug Administration’s Orange Book. Lawyers have questioned why the FTC did so without guidance from FDA on what device patents can be listed.

Rahul Rao, deputy director of FTC’s Bureau of Competition, who wrote the letters, talked to the Pink Sheet about why the agency focused on these specific

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EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
• By Eliza Slawther

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.