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STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions

STAT

Such decisions are based on myriad factors, starting with the average $26,500 price tag. But there are other considerations, including the quality of the clinical trial data, side effect concerns, the patient population for which the medicine is approved, and budgetary constraints.

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Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA

pharmaphorum

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

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Advanced therapies and the high-profile pricing dilemma

pharmaphorum

The advancements made in drug development over the last decade have seen the arrival of a number of treatments that offer one-time cures and more effective therapies for conditions in smaller patient populations. However, with a price tag of €1.58 At more than $2.1

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After a slow start for expensive CAR-T therapies, drug developers revisit oral therapies for blood cancer

pharmaphorum

But along with strong efficacy come some considerable risks and costs: cytokine release syndrome (CRS), where a patient’s immune system becomes dangerously over-stimulated, and neurotoxicity are potential side effects that need to be managed. Side effects and cost implications.

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Scientists and medics turn to TikTok to reassure public on vaccine safety

pharmaphorum

Her videos cover a host of topics from the science behind the immune system, side effects caused by the shots and vaccine hesitancy and the clinical and regulatory path to approval. If we instead acknowledge that there are risks just like anything else in medicine and life, it’s a more effective message.”. Dr Austin Chiang.

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Free access to Zolgensma curbed, says Novartis

pharmaphorum

” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1 million in the US and just under €2 million in Europe, which the company says is justified by its dramatic benefits when given as a one-shot therapy to patients with SMA.

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Drug-resistant epilepsy drug Ontozry backed by NICE

pharmaphorum

The cost-effectiveness agency has backed Ontozry (cenobamate) as an option for treating focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least two prior antiseizure medicines.