tag regulatory-approval 
PM360
NOVEMBER 27, 2023
The first solution, developed by EVERSANA leveraging AWS and AWS Partner TensorIoT , addresses a time-consuming and error-prone process in the industry—medical and regulatory content approvals. As we came together with AWS, it became clear we could make a real impact in the medical and regulatory review process for branded materials.
World of DTC Marketing
JUNE 23, 2021
One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39 Not to mention the $56,000 annual price tag. government.
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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
AUGUST 21, 2022
Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. Auvelity is the first drug Axsome has taken through to regulatory approval, but could be the first of a string of new products for the company, according to Tabuteau.
Pharmaceutical Technology
NOVEMBER 9, 2022
An approval decision on the gene therapy, also known as EtranaDez, is expected by the end of this month. On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application.
PM360
JUNE 26, 2023
In commercial, issues related to Medical, Legal, and Regulatory (MLR) review compliance will need to be carefully managed as well. Auto-tagging, a laborious task, is another area where generative AI/LLMs can assist. Auto-tagging helps the right content get delivered to the appropriate customers.
pharmaphorum
JULY 25, 2022
The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer. In the MagnetisMM-3 trial, elranatamab was associated with an ORR of 60.6%
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