tag prime-patient 
Pharmaceutical Technology
SEPTEMBER 30, 2022
Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. These approvals represent crucial milestones for bluebird bio, the gene therapy field, and patients with rare genetic diseases.
Rethinking Clinical Trials
DECEMBER 12, 2023
The Jumpstart intervention is a communication-priming intervention. The research question Jumpstart set out to answer is can a patient-specific, clinician-facing communication priming intervention with discussion prompts effectively promote goals of care discussions between clinicians and hospitalized older adults with serious illness?
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pharmaphorum
AUGUST 25, 2022
Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.
pharmaphorum
JULY 25, 2022
J&J filed for approval of the bispecific in the US in December based on the results of the phase 1b MajesTEC-1 study in myeloma patients who had been treated with a median of five lines of prior therapy. Most patients diagnosed with myeloma will relapse over the course of their disease, so the disease is still considered incurable.
XTalks
JUNE 9, 2021
The historic and highly anticipated approval created a flurry of excitement in the Alzheimer’s disease space for patients, healthcare practitioners, advocacy groups and Biogen shareholders alike, as shares of the company jumped more than 50 percent after the announcement. Aducanumab Controversy and Price Tag.
pharmaphorum
DECEMBER 17, 2021
Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.
XTalks
AUGUST 23, 2021
This is not a debate on approval,” said Stacie Weninger, PhD, president of the F-Prime Biomedical Research Initiative, in a focused topic session on the impact of drug approval on future clinical trials held on Tuesday July 27. “Now Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.
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