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Current and future players in the lupus market

Pharmaceutical Technology

The management of SLE and LN consists largely of treatment options that are based on highly efficacious steroids or immune-suppressive therapy with an undesirable safety profile, which includes accrued organ damage, infections and cancer. in 2018 across the 7MM despite being an off-label therapy for lupus.

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New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

The FDA Law Blog

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. And in December 2021, we saw FDA apply those factors in responding to a citizen petition (Docket No.

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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

pharmaphorum

Happy to announce that @EU_Commission has just approved a contract for guaranteed 900 million doses (+900 million options) with @BioNTech_Group @Pfizer for 2021-2023. — Ursula von der Leyen (@vonderleyen) May 8, 2021. Other contracts and other vaccine technologies will follow.

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Phase III trial shows tislelizumab improves outcomes for liver cancer patients

European Pharmaceutical Review

The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia. receptors on macrophages, helping the body’s immune cells to detect and fight tumours. The primary endpoint of non-inferiority of overall survival (OS) between the two groups of patients was met, BeiGene said.

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FDA awards full approval to Paxlovid amidst hazy coverage plans

Pharmaceutical Technology

The label is specified for the treatment of “mild-to-moderate Covid-19 in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death.” The FDA first granted the drug under an emergency use authorisation (EUA) during the pandemic in December 2021.

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Immunocore claims first-ever FDA approval for TCR cancer therapy

pharmaphorum

At the moment the only other BiTE to reach the US market is Amgen’s CD19-targeting Blincyto (blinatumomab), which has been approved for various types of leukaemia and made $340 million in sales in the first nine months of 2021.

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As cases rise, WHO says monkeypox risk is “moderate”

pharmaphorum

For comparison, there were just seven cases of monkeypox in the UK between 2018 and 2021, according to a just-published paper in The Lancet Infectious Diseases. No deaths have been reported from the infections.

Vaccines 105