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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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PharmaShots Weekly Snapshots (February 13 - 17, 2023)

PharmaShots

Iveric Bio Reports the US FDA Acceptance of NDA and Granted Priority Review of Avacincaptad Pegol for Geographic Atrophy Date: Feb 17, 2023 | Tags: Iveric Bio, Avacincaptad Pegol, Geographic Atrophy, Regulatory, US, FDA, NDA, Priority Review ALX Oncology Reports the First Patient Dosing of Evorpacept in the P-I Study (ASPEN-07) for the Treatment of (..)

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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.

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Benefits of blockchain in limiting counterfeit drug distribution

European Pharmaceutical Review

Smart contracts, which are essential for easing international trade and logistics operations, can enable the user to track fake returns to the producer and supplier using RFID tags. In conclusion, Kordestani et al. Blockchain offers the possibility of non-modifiable data uploading with traceability and low-cost data storage.

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HP&M Attorneys Receive Accolades: Top Lawyer Under 40 and WWL: Life Sciences 2023 Global Elite Thought Leader

FDA Law Blog: Biosimilars

Duchenne, Friederichs’s Ataxia, Sickle Cell Disease, Chagas, ALS). In addition to Mr. Karst, ten other HP&M Directors were tagged as “Recommended” by WWL: Life Sciences 2023: Ricardo Carvajal Robert A. Dormer Jeffrey N. Gibbs Paul M. Hyman Alan M. Kirschenbaum Allyson B. Mullen Frank J. Sasinowski Jeffrey K.

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Actualising the power of antibody-drug conjugates as cancer therapeutics

European Pharmaceutical Review

tag ® , inspired by the unique features of microtubule biology and perfectly suited for DAR 2 and DAR 4 ADCs. Fu Z, Li S, Han S, et al. Zacharias N, Podust V, Kajihara K, et al. Modi S, Saura C, Yamashita T, et al. Kasper M, Lassak L, Vogl A, et al. Schumacher D, Helma J, Mann F, et al. 2021;18(6):327-344.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

This is in addition to its considerable price tag. Grupp SA, Kalos M, Barrett D, et al. Mirza A-S, Hosing C, Foss FM, et al. Zhang H, Liu M, Li Q, et al. Asghar N, et al. Rejeski K, Perez A, Sesques P, et al. Schultz LM, Baggott C, Prabhu S, et al. Hayden PJ et al. Cytotherapy.