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FDA Approves J&J’s Darzalex Faspro for Rare Light Chain Amyloidosis

The Pharma Data

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. Approval supported by one of the largest clinical trial programmes undertaken for this rare disease.

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Advances in Rare Disease Drug Development: Disease Biology, Regulatory Support, Building Relationships and the Patient Voice

XTalks

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

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Eli Lilly Scores Emergency Use Authorization for COVID-19 Antibody Drug

XTalks

Amidst all the COVID-19 vaccine news, Eli Lilly has gained an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for an investigational antibody drug to be used in the treatment of recently diagnosed COVID-19. The ongoing trial continues to evaluate the safety and efficacy of the experimental therapy.

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Darzalex Faspro (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

The Pharma Data

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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Leqembi (lecanemab) Granted Accelerated Approval by the FDA as Alzheimer’s Disease Treatment

XTalks

The approval is based on Phase II data that demonstrated a reduction in amyloid-beta plaques (the defining characteristic of Alzheimer’s disease) in patients with early Alzheimer’s disease treated with Leqembi. Patients at an early stage of the disease and their caregivers can now consider a new treatment option with their doctors.

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Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

It is also important to ask whether doctors are being paid fair market value and if they are providing the services for which they’re being compensated, he adds. In 2005, Biogen withdrew Tysabri from the market following a clinical trial that resulted in two participants contracting progressive multifocal leukoencephalopathy (PML).