Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.

Trends Affecting Biopharmaceutical Manufacturing

How to apply ALCOA+ to a laboratory building management system.

Data Integrity Compliance in a GLP Test Facility

Data sharing facilitates traceability and boosts quality of APIs.

Digital Supply Chain Ensures API Quality

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Articles

European Commission Approves Lumykras (Sotorasib) to Treat KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

NICE Recommends Darzalex in Combination with Velcade to Treat Multiple Myeloma

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

FDA Grants Oncolyze Orphan Drug Designation for Leukemia Treatment

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine  booster dose interval from six to five months.

FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

FDA Accepts IND for Poseida Therapeutics’ Allogeneic CAR-T Cell Therapy Candidate

Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.

Pharming Gains Nod from EMA on PIP for Leniolisib

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

FDA Keeps New Drugs Coming

Editor of Pharmaceutical Technology Europe

Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.

Without a Particle of Doubt

Feliza Mirasol is the science editor for 

Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.

Quality Systems

Trends Affecting Biopharmaceutical Manufacturing

Data Integrity Compliance in a GLP Test Facility

Digital Supply Chain Ensures API Quality