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Johnson & Johnson

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Latest From Johnson & Johnson

BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process

Janssen and Amgen suggest user fee agreement changes aimed at speeding review process for some biosimilar applications and supplements in comments to US FDA on biologic product competition and innovation, while Merck presses agency to clarify its current view on cross-product labeling.

Biosimilars Legislation

Clovis In Pole Position To Be First PARP For Prostate Cancer

Clovis is looking a steal a march on its rival PARP inhibitors and hopes to be the first drug in the class to get approval for prostate cancer following strong data seen in the TRITON trial.

Research & Development Clinical Trials

Shire’s Motegrity: US FDA Panel Nod On CV Safety Comes With Concern About Neuropsych Events

In unanimously endorsing prucalopride for chronic idiopathic constipation, advisory committee seems reassured by extensive data on 5-HT4 agonist’s cardiovascular safety, but some members called for an epidemiological study to assess possible suicidality signal.


Advisory Committees Drug Review

Acne Claims For Cosmetics Leave Blemish On UK Advertising Regs

Advertising Standards Authority issued decisions Oct. 17 on complaints against three cosmetics brands and an online beauty retailer for statements the independent regulator reads as acne-treatment claims, or the “spots” equivalent, calling them medicinal claims for unlicensed products.
Consumer United Kingdom
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