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Focus on Regulation

Tag Archives: Pharma

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers
On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding “Competition enforcement in the pharmaceutical sector (2009-2017)” (“Report”). The Report summarizes the impressive enforcement activity of EU competition law enforcers in the pharmaceutical sector in the last decade while emphasizing at the same time the scope for continued enforcement action.

FDA launches Biosimilars Action Plan to spur biologics competition, finalizes labeling guidance

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives for innovators to invest in further research.  On July 19, FDA also published the guidance “Labeling for Biosimilar Products,” finalizing an April

Italy approves new provisions on informed consent and advance decision of medical treatments – Why it matters for clinical trials in emergency situations

On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the future (so-called advanced decision, sometimes also referred to as living will, and translated as “Biotestamento” in Italian ). Advanced decision of