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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. Covid-19 vaccines stay in the spotlight.

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ESG Top Trends: Technology trends

Pharmaceutical Technology

Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData. AI also speeds up the drug development process, which could translate into cheaper drugs for patients. 3D bioprinting offers an alternative to animal testing in drug development.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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High biologics demand spurs need for greater contract manufacturing

Pharmaceutical Technology

Having steadily risen over the last two decades, 2020 saw more approvals for biopharmaceuticals, often termed as biologics, than any other year in the last decade, according to GlobalData analysis. Biologics are costly to produce and sell, and the more recent modalities, such as cell and gene therapies, can be difficult to manufacture.

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Development and Manufacturing of Primary Packaging and Medical Devices

Pharmaceutical Technology

The conceptualisation, development and manufacturing of primary packaging in the pharmaceutical industry require a meticulous and multi-disciplinary approach to ensure that the products meet the highest standards of safety and efficacy.

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Pathbreakers: The journey of first generics

Pharmaceutical Technology

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

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Illegal online pharmacies gain traction as regulators lag behind

Pharmaceutical Technology

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”