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Rare Disease Spotlight – tracing the rise of orphan drug designations over almost 40 years

Pharmaceutical Technology

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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You can’t afford to get cancer

World of DTC Marketing

Among adults 65 and older with Medicare coverage, average annual out-of-pocket costs for medical services and prescription drugs were highest in the initial phase of care (first 12 months after diagnosis) — $2,200 and $243, respectively — and the end-of-life phase (12 months before death) — $3,823 and $448, respectively. ScienceNews.com.

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The future of pain medication: are cannabinoids the solution to the opioid epidemic?

Pharmaceutical Technology

In 2022, the FDA awarded VX-548 breakthrough therapy and fast-track designations for post-operative pain, and the drug is forecast to reach sales of $416m by 2029. Currently, Jazz Pharmaceuticals’s nabiximols is the only cannabinoid approved for pain, receiving approval in Israel, in August 2010.

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs. Of those 131 approved FDCs, 98 were oral dosage forms.

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The Witty Answer to GSK’s Future

Pharmaceutical Technology

Important elements within this expectation are the build up of strong contributions from Rotarix, Cervarix and Tykerb, while the outlook for GSK’s important asthma franchise becomes less clear beyond 2010. PT: Glaxo shares have fallen 17% in the past year. .

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Biosimilars with this designation are beneficial to payers as they eliminate the need for another prescription, she explains An interchangeable biosimilar can be automatically substituted for Humira at a pharmacy, Bhat adds.

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