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FDA approves Analog and Dipharma’s ANDA for nitisinone capsules

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted clearance to Analog Pharma and Dipharma’s abbreviated new drug application (ANDA) for 20mg nitisinone capsules. Nitisinone capsules are indicated for the treatment of adult and paediatric patients with HT-1 in combination with dietary restriction of tyrosine and phenylalanine.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

Second, the production and delivery of CAR T cells necessitates close collaboration between the pharma industry and academic (usually transplant) departments. Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks.

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Pharma coming to moral crossroads

World of DTC Marketing

As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.