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US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates

 
• By Michael McCaughan

Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.

Large US American flag on sailboat off the coast of California

The US Food & Drug Administration’s new “public health” framework for considering opioid analgesic applications made its debut in a series of advisory committee meetings in mid-January – and it did not go well for the sponsors.

Two of the three opioid formulations reviewed – Nektar Therapeutics’s new molecular entity oxycodegol and Intellipharmaceutics International Inc.’ proposed abuse-deterrent formulation of oxycodone – were overwhelmingly rejected. In...

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Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 
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Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
• By Lisa Takagi

Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.