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Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

pharmaphorum

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog: Biosimilars

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

These 4 letters related to 5 different communications vehicles, 4 of which involved digital forms of communications – 2 were videos, 1 was a web page and 1 was an Instagram posting, one of the rare letters involving a social media platform.

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Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. 2017; 55(7):1998-2008. The study included 92 adult patients with confirmed CDI. Peng Z, Jin D, Kim HB, et al. J Clin Microbiol. About the author Dr Olaia Aurtenetxe is the Head of Clinical Research at Mikrobiomik.

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Regulatory Agencies Worldwide Are Partnering to Combat Illegal Online Pharmacies

National Association of Boards of Pharmacy

Established in 2008 by INTERPOL and the Permanent Forum on International Pharmaceutical Crime in response to the growing prevalence of illegal online pharmacies, Operation Pangea aims to improve global cooperation and enforcement capabilities to disrupt the illegal pharmaceutical trade. History of Operation Pangea.

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Ministry of Health Medicines Formulary (MOHMF)

RX Note

Medicines Special Approval Form is subdivided into Named-patient basis Registered with Drug Control Authority but medicine is not listed in MOHMF Registered with Drug Control Authority and medicine is listed in MOHMF but off label use from MOHMF.

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Japan’s M&A Boom

Pharmaceutical Technology

Daiichi Sankyo’s move to acquire Ranbaxy is, according to Dealogic’s research, the second-biggest outbound M&A so far in 2008, with a deal worth $5,326m. Like in many other sectors, China and India are the ones labelled as those which will lead the expansion. % increase over the previous year. % increase).