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Quality by design with a focus on biosimilars

Pharmaceutical Technology

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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The drug industry continues to dare regulation

World of DTC Marketing

Pfizer expects to make as much as $22bn from its new Covid pill this year, on top of $37bn it made in 2021 from the vaccine. Reportedly, the cost of production for molnupiravir stands at about $17.74. Pfizer’s Paxlovid currently costs about $530 for a five-day course of the treatment. costs about $700.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

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Biogen Announces FDA Approval of Plegridy (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

The Pharma Data

The addition of the IM administration of Plegridy to Biogen’s MS portfolio offers another important option at a time when MS patients are being encouraged to discuss their MS treatment and considerations around COVID-19 vaccination with their physicians.1,2 or visit your respective country’s product website. percent vs. 32.1

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Clinical Catch-Up: December 21-25 | BioSpace

The Pharma Data

CureVac and the University Medical Center of Mainz launched a Phase III trial of CVnCoV, their COVID-19 vaccine candidate, in healthcare workers. The study will evaluate the safety and immunogenicity of the vaccine in a two-dose schedule of 12 micrograms. The drug is an autologous IL13Ralpha2-CAR-T cell product.

Trials 52
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SKYRIZI® (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis

The Pharma Data

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. .” The U.S. are pregnant or plan to become pregnant.