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Nine for 2023, part two: healthcare’s hard problem, the prognosis for diagnosis, and key new pharmacotherapy platforms

pharmaphorum

The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023. Innovation will power the market.

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STAT+: Pharmalittle: We’re reading about the FDA listing Novo drugs as ‘available,’ pharma layoffs, and more

STAT

With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward. This was also well below the 1,624 jobs the industry slashed in October 2023. The number of layoffs in the U.S.

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FDA grants rare paediatric drug status for IPS HEART’s stem cell drugs

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

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Humira generic availability, cost, and dosage

The Checkup by Singlecare

While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.

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AI to revolutionise drug development by 2026

European Pharmaceutical Review

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.