Challenges Bringing Drugs to All EU Member States Worry Pharma

May 9th, 2023|Categories: Featured, Industry News|Tags: , , , , |

As the European Commission prepares for a major revamp to drug legislation, pharma executives and thought leaders worry that even with the new laws, rolling out new drugs to all 27 member states in a short timeframe will be a difficult task to achieve. The proposed law would offer pharma companies an additional years of data protection if new drugs reach all EU markets within 2-3 years of launch, which will be complicated if reimbursement decisions must be made in that period.

European Commission Reveals Plans for Single Market

April 27th, 2023|Categories: Featured, Industry News|Tags: , , , |

Despite having region-level drug approval agencies like the European Medicines Agency (EMA), member states have their own approval agencies. This fragmented framework slows the rollout of new pharmaceuticals. To address this issue, the European Commission has released their plans to unify the approval process across all member states.

EU Preps for Drug Law Overhaul

April 3rd, 2023|Categories: Featured, Industry News|Tags: , , , |

The EU is preparing legislation that would overhaul the pharmaceutical industry with a series of reforms targeting drug prices, transparency, and intellectual property (IP). Under the legislation, drugmakers would have a reduced exclusivity period for new drugs, which can be ameliorated by launching a drug in all member states simultaneously. In addition, the laws would simplify the regulatory approval process.

Gilead Science’s Long-Acting HIV Drug Secures Win With EU Approval

August 22nd, 2022|Categories: Featured, Industry News|Tags: , , , , |

Gilead Science has received approval from the European Commission for its HIV drug lenacapavir. The medication is used to treat multi-drug resistant HIV and is injected once every six months. This approval marks a win for Gilead, as the drug was placed on a temporary clinical by the FDA over the risk of contamination from glass shards.

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