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tenofovir alafenamide

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EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

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BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin lymphoma

This type of cancer is the most common one diagnosed in teenagers

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Lilly announces plan for new $3bn facility to boost manufacturing in Europe

The facility will be built in the Netherlands and will increase capacity for the company's oral medicines portfolio

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EU medicine shortages hit record highs in 2023 and 2024

Even with countermeasures in place, European auditors warn that the risks remain elevated

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Lilly’s early Alzheimer’s disease treatment approved in the EU

Marketing authorisation follows positive late-stage trial results

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ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs

On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation...

Genesis Research Group

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Gilead Sciences’ Biktarvy granted FDA approval for expanded HIV use

An estimated 1.2 million people in the US are currently living with the virus

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Sanofi’s Sarclisa approved by EC to treat newly diagnosed multiple myeloma

The drug is already approved in the EU across three other multiple myeloma indications

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J&J announces EC approval of Imbruvica in previously untreated mantle cell lymphoma

The drug is already approved in the EU to treat relapsed or refractory cases of the blood cancer

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Johnson & Johnson’s Darzalex approved by EC as first treatment for high-risk SMM

The early precursor of active multiple myeloma accounts for around 15% of all new multiple myeloma cases

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Roche’s Itovebi granted EC approval to treat advanced breast cancer patients

Hormone receptor-positive breast cancer accounts for around 70% of all breast cancer cases

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EC approves SpringWorks Therapeutics’ Ezmekly to treat rare genetic disorder NF1

Neurofibromatosis type 1 affects an estimated 135,000 people in the EU

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