The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
The agency's Oncologic Drugs Advisory Committee voted unanimously to recommend approval of tazemetostat for epithelioid sarcoma. The company has said it would likely use drugs like Bristol-Myers Squibb's Revlimid as a benchmark for pricing.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The FDA’s Allergenic Products Advisory Committee voted 7-2 in favor of supporting the efficacy profile of Palforzia, or AR101. Some committee members expressed concerns about a lack of diversity in the Phase III clinical trial.
Although the study of AR101 met its primary endpoint, patients on the drug had more allergic reactions than those on placebo. An allergy expert explained that the disparity reflects time needed to build up tolerance to peanut allergen.
Although the agency goes against about one-fifth of AdCom recommendations, a study published Sunday only found one reliable variable predicting when that would happen.
A company spokesperson said the company was working to address the agency's concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Shares of the company were down more than 12 percent in premarket trading on the Nasdaq Wednesday. They had already fallen 46 percent Friday after the release of AdCom briefing documents.
The company's shares were down more than 4 percent in Monday morning trading after the agency's decision, which itself followed a negative AdCom vote in November.
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
The Psychopharmacologic Drugs Advisory Committee will meet on Thursday to vote on whether to recommend the FDA approve the drug, ALKS 5461, an opioid for major depressive disorder.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.