Draft legislation has been published by the UK’s Intellectual Property Office to ensure that the EU’s supplementary certificate protection manufacturing waiver will continue to function in the case of a no-deal Brexit outcome.

HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.

US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.

The rebate rule is dead, but we should pay tribute to the failed endeavor.

Sponsors should realize that only a very few people – think 4, not 50 – will be permitted to be unblinded, CDER's Laura Lee Johnson tells the DIA annual meeting.

Former US FDA Commissioner Robert Califf remains eager to encourage broader use of real-world evidence – but his blunt, pessimistic read on the state of biopharma innovation is remarkable coming from a former FDA head.

The Council of the EU has published its conclusions on making the EU a “best practice region” in combatting antimicrobial resistance. While there are plenty of recommendations, little concrete action is proposed.

White House will not move forward with a rebate proposal the drug industry supported as a way to lower patient drug spending.

News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

Even after the US FDA warns Strides on uncontrolled records destruction and poor OOS investigations at its Puducherry plant, firm remains confident in its US market growth projections.

Product pre-approval inspections, vaccines and plasma-derived products are on the discussion agenda as the US-EU mutual recognition agreement takes full effect.

HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.