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Novel haemophilia B gene therapy approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. Pfizer licensed BEQVEZ from Spark Therapeutics in December 2014.

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Pharma is in acquisition mode but small biotechs hurting for money

World of DTC Marketing

It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 5 drugs) ranged from $765.9

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FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

Pharmaceutical Technology

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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The current pharma business model is unsustainable

World of DTC Marketing

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

Pharma 210
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Biogen and Eisai’s Alzheimer’s drug secures support in closely watched AdCom

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects.

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FDA accepts BLA for Pfizer’s haemophilia B gene therapy

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec. Pfizer obtained the licence for gene therapy from Spark Therapeutics in December 2014.

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$8 million grant awarded to new US stem cell clinic

European Pharmaceutical Review

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The organisation considers collaboration will advance scientific discovery, clinical advances and training.