Humira Approved for Pediatric Patients with AU

AbbVie receives CHMP positive opinion for Humira for pediatric patients with AU

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AbbVie (ABBV) said that the European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for #HUMIRA for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

The #CHMP opinion is based on results from the SYCAMORE clinical trial, a randomized controlled study of the clinical effectiveness and safety of HUMIRA combined with methotrexate versus methotrexate plus placebo for the treatment of active JIA-associated uveitis.

It was sponsored by the University Hospitals Bristol NHS Foundation Trust and coordinated by the Clinical Trials Research Centre at the University of Liverpool.

The Independent Data Safety and Monitoring Committee recommended unmasking the trial early after 90 randomized patients with active JIA-associated uveitis showed that HUMIRA combined with methotrexate controlled ocular inflammation better and was associated with a significantly lower rate of treatment failure than placebo.

The review of the marketing authorization application is being conducted under the centralized licensing procedure.

A marketing authorization decision is anticipated by September.

If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

HUMIRA was approved by the European Medicines Agency for the treatment of non-infectious intermediate, posterior and panuveitis in adults in June 2016.

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Amazon Investigated by FTC for Deceptive Pricing

FTC exploring possible deceptive discounting by Amazon

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The FTC is exploring allegations of potential deceptive discounting by Amazon (AMZN), Reuters reports, citing a source close to the investigation.

The FTC is investigating a complaint brought by Consumer Watchdog, an advocacy group which looked at around 1,000 products on Amazon’s website last month and found that Amazon put reference prices on about 46% of them; an analysis by Consumer Watchdog found that in more than half of products with reference prices, Amazon’s reference prices were higher than it had sold the same product in the previous three months, Reuters says.

The FTC is looking into the allegations as part of its review of Amazon’s proposed acquisition of Whole Foods (WFM).

Amazon said in a statement that Consumer Watchdog’s study was “deeply flawed,” calling the conclusions “flat out wrong.”

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RLJ Lodging Trust Says No to $3 Billion Purchase Offer

Blackstone made $3B offer to buy RLJ Lodging Trust, WSJ says

Blackstone Group (BX) made an approximately $3B offer to purchase RLJ Lodging Trust (RLH), which if successful would end the real estate investment trust’s plans to acquire FelCor Lodging Trust (FCH), the Wall Street Journal reports, citing people familiar with the matter.

RLJ disclosed that it had received an unsolicited proposal on June 12 from a private-equity firm but the company rejected the offer as “not reasonably likely” to be superior to its acquisition of FelCor, resulting in the private-equity firm twice raising its offer, which reached $25.50 a share on June 23, but then dropping its offer on July 6 to the original price of $24 following a review of RLJ, which rejected that offer.

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