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Biopharma sees strong Q2 2023 market cap growth

European Pharmaceutical Review

Submission for US FDA regulatory approval, anticipated to be received by the end of 2023, further drove this progress, GlobalData noted. billion sales globally by 2029, this could offset Keytruda’s decline sales expected after its loss of exclusivity in 2028, GlobalData highlighted.

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Oncology biosimilar case studies: rituximab biosimilars

Pharmaceutical Technology

Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. However, in the second year of biosimilar competition, Rituxan sales started to significantly erode. Rituxan’s success made it a prime target for biosimilar developers.

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Merck defends blockbuster Januvia franchise from patent challenge

pharmaphorum

Merck & Co has been fighting to defend its blockbuster type 2 diabetes therapy Januvia from generic competition for years, and a new judgment looks set to protect its third biggest-selling drug for another few years. Viatris is seeking FDA approval to market generic versions of both Januvia and Janumet in the US. The US patent (No.

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EHA 2023: Kura Oncology’s menin inhibitor ziftomenib shows impressive Phase I results

Pharmaceutical Technology

According to GlobalData’s analyst consensus forecast, global sales for ziftomenib will reach $255m by 2029. Kura faces competition in the menin inhibitor market as the therapy is being developed to treat various indications. It received fast track and breakthrough designation from the FDA and is poised to be first to market.

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NICE recommends AbbVie’s/J&J’s Imbruvica for combo use in untreated CLL

Pharmaceutical Technology

While Imbruvica maintained a previously strong position on the market, competition has chipped away at the inhibitor’s market share. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31 billion in 2029.

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Key Developments from AMCP 2023 on Blockbuster Generics, Diabetes Drugs, PBM Legislation, and More

PM360

Attention deficit hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) , manufactured by Takeda, also is facing generic competition. In the respiratory area with inhalers, it’s tough to get drugs approved, so the competition comes slowly,” he said. Starting in 2026, the provision will affect 10 Part D drugs.

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Emerging Trends in Orthopedic Medical Device Industry

Medico Reach

billion by 2029. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. The potential increase in industry competition could also spell trouble for some.

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