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2023 Pipeline Report: Testing the Limits

PharmExec

Our annual report spotlighting notable investments in new drug development captures a mix of gradual gains and giant leaps—both equally as promising—in five expanding and diverse therapeutic areas: spinal muscular atrophy, hemophilia A, intranasal and inhaled vaccines, gene-targeted therapy, and RNA therapeutics.

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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4DMT has stated that it will examine the 12 months of data from the Phase I/II trial on six patients in H2 2023 with the clinical hold not expected to have any additional impact on the company’s Phase III plans.

FDA 105
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FDA panel turns down Acadia’s Nuplazid for Alzheimer’s psychosis

pharmaphorum

Other questions focused on the durability of Nuplazid’s antipsychotic effect and the design of Acadia’s 019 trial – and whether a failure to show a significant effect in Alzheimer’s in the 045 study was down to its limited statistical power or lower activity in that patient cohort.

FDA 52
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Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

PharmaShots has prepared a list of the top 20 drugs with patent expiry in 2023 Company: Eisai Generic Name: Rufinamide First Approval Date: Nov 17, 2008 Patent Expiration: Apr 2023 2022 Sales: $52M Indication: Lennox-Gastaut syndrome (LGS) Banzel is a prescription add-on drug for the treatment of seizures linked with LGS.

FDA 49
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Top 20 IPOs in Healthcare by Total Fund Value

PharmaShots

Bausch + Lomb efficaciously emerged as a top-grade performer with a total IPO value of $711M, followed by HilleVax and Third Harmonic Bio With the invaluable insights of DealForma, PharmaShots has prepared a detailed report on the Top 20 IPOs in the Healthcare industry of the year 2022 Funding Value: $6.3M Founded Year: 2007 No. of Shares: 1.5M

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The benefits of mass spectrometry for expediting biologics to patients

European Pharmaceutical Review

The presence of novel and increasingly complex molecules in today’s pipelines requires analytical methods with higher resolution, throughput and sensitivity. Development paths have been reported to be further accelerated in response to the COVID-19 pandemic, with the potential to reduce gene to IND timelines to only six months.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.