Remove tag clinical-trial-data
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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. In a statement, Biogen and Eisai said that the FDA has agreed that Clarity AD “can serve as the confirmatory study to verify the clinical benefit of lecanemab.”

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PharmaShots Weekly Snapshots (January 23 - 27, 2023)

PharmaShots

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

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Benefits of blockchain in limiting counterfeit drug distribution

European Pharmaceutical Review

Benefits of blockchain technology in the pharma supply chain Blockchain technology can address these issues in the pharmaceutical supply chain by providing timely data and increase shared data’s authenticity, integrity , and invariability. This can reduce the willingness for counterfeit and less accurate data, according to the review.

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Oligonucleotide synthesis market to reach $16.7 billion by 2027

European Pharmaceutical Review

billion by 2027 during the forecast period, due to the rise in ongoing clinical trials for oligonucleotide-based therapies in key therapeutic sectors such as oncology. According to the report data, in 2021, antisense oligos accounted for the largest share of this segment, since many of these therapies are currently in clinical trials.

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Amylyx ALS drug draws criticism over $158,000 price tag

pharmaphorum

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.

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BD partners with Biocorp on connected self-injection devices

pharmaphorum

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.