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Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.
Experts at the International Council for Harmonisation have nearly completed the first draft of a guideline that explains in which situations nonclinical juvenile animal testing is considered informative and necessary to support pediatric drug development. The guideline is expected to address the "discordant advice" that different regulatory agencies currently offer companies in relation to such studies.
US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.
An M.D. is preferred for position that would run CDER in director's absence and oversee 'major programs' at the Center.
At inconveniently timed NORD conference, the former CDER deputy center director finds himself unable to speak for either FDA or the Pharmaceutical Research and Manufacturers of America.
Hybrid approach to pharmacy benefit management expected to save insurer $4bn annually after Anthem ends its relationship with Express Scripts in 2020. Integration of medical and Rx benefit data could lead to more value-based contracting.
Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.
J&J’s worldwide OTC drug division sales rose 4.4% to $1bn, driven by the Tylenol and Nicorette brands, the firm reports Oct. 17. Those revenues helped offset softness in the firm’s Listerine and other oral care products due to more competition online from start-ups selling straight to consumers.
The European Commission has launched a consultation on proposals to “recalibrate” supplementary protection certificates and patent research exemptions.
Regulators in India routinely face flak over lengthy approval timelines, but drug firms failing to show up at pre-scheduled regulatory meetings does little to improve the situation. The reason for the no-shows is open to speculation. Absenteeism appears to be significant in areas such as oncology and hematology.
Research centers are collaborating on projects to find causes of disease; Ampligen, Rituxan and KPAX-002 are only drugs in clinical trials.
Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.
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