Postmarket research
As Omicron continues to dominate globally, research is coming in every day on this highly contagious variant of SARS-CoV-2.
Gilead has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
Pazdur, along with the FDA’s R. Angelo de Claro and Gautam Mehta from the Center for Drug Evaluation and Research, penned an opinion piece published Thursday in JAMA Oncology.
The Centers for Medicare and Medicaid Services indicated it would cover the cost of these drugs and any necessary scans — but only “if they are enrolled in qualifying clinical trials.”
Another drug Vounatsos heralded was zuranolone, which Biogen is developing with Sage Therapeutics for multiple forms of depression.
On December 28, the U.S. Food and Drug Administration reported there had been 50 novel drug approvals for the year, and that was just for new chemical entities.
Biogen and Eisai released an update on the Phase IV post-marketing confirmatory study and plan to submit the final protocol to the FDA in March 2022 and launch patient screening in May 2022.
The study was momentous in that it was the first head-to-head comparison of two modalities. The Aimovig showed significantly good results and aced primary endpoints.
Eli Lilly and Company announced Tuesday the launch of a head-to-head study to compare once-monthly injectable Emgality® (galcanezumab-gnlm) with Nurtec® ODT (rimegepant) for the prevention of migraine.
The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.
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