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The U.K.’s National Institute for Health and Care Excellence published guidances for three drugs in four indications, recommending their use by the NHS as long as the sponsors comply with patient access programs and agreed-upon discounts. Read More
FDA advisory committee members recommended approval for some versions of Braeburn’s modified-release reformulation of buprenorphine but balked at endorsing higher dosages of the medication, which is indicated for weekly or monthly treatment of opioid abuse. Read More
The number of “pay-for-delay” patent settlements agreed to by pharmaceutical companies in fiscal 2015 declined from the year before, according to a report from the Federal Trade Commission. Read More
The IV drug was approved for use in combination with other antiemetics to treat adults experiencing delayed nausea and vomiting after chemotherapy. Read More
Gilead is defending a suite of patents for its profitable hepatitis C antivirals from challenges by a non-profit group petitioning the PTO’s Patent Trial and Appeal Board. Read More
The PTO’s Patent Trials and Appeals Board reversed course last week, granting inter partes review of a Herceptin patent that it previously refused, following challenges from Hospira. Read More
A worker benefits fund filed a lawsuit against Johnson & Johnson this week for allegedly maintaining an illegal monopoly for its Crohn’s disease drug Remicade. Read More
The European Medicines Agency is already changing its procedures in advance of the UK’s departure from the European Union in 2019, with the pending withdrawal affecting which experts the agency appoints to investigate applications for new drug approvals, the agency said. Read More