A ruling by Europe's top court has clarified the respective roles of member state agencies and courts in cases where the starting date for the data exclusivity period is called into question.

Plans from the European Commission that would oblige all EU member states to consider joint clinical assessments have come under fire from Germany, France, Poland and the Czech Republic.

In an interview with the Pink Sheet, Delaware District Judge Sleet discusses patent reform fallout and major issues facing district courts.

The message is unmistakably clear: new policies are putting China first to make drugs more accessible and affordable, including widely prescribed products for cancer. Tactics including compulsory licensing, tax incentives, and substitution to support the use of domestic generics should ring alarm bells for multinationals, observers say.

No big policy implementation expected to be announced during president's speech planned for next week. HHS will continue to gather feedback on various approaches to lowering drug pricing.

Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.

A new US drug spending report from IQVIA parses out how rebates impact drug spending and explores affordability for patients. The data show drug makers offset about 28% of drug spending and provide some support to industry's arguments on drug pricing. 

Regulators in the US and the EU urged manufacturers to follow the general principles set in International Conference on Harmonization guidelines in developing new oligonucleotides and peptide drugs. They say that in the absence of tailored guidance, sponsors should take a science- and risk-based approach in developing these products, which have flooded the development pipeline.

'Knowledge management platform' will identify agency's scientific precedents; Commissioner Gottlieb says it is one of FDA's top three initiatives, along with continuous manufacturing and real-time safety monitoring.

Regulators report that an international collaboration on GMP inspections of API sites has bolstered the exchange of information between participating health authorities, yet the information technology system that supports the system could use some improvement.

Analysts say firm’s consumer health division is showing signs of a comeback, with worldwide sales up 5.3% to $3.4bn, boosted 3.7% from currency exchange on strong beauty segment sales, driven by increased online marketing, and strengthening OTC drug sales.

FDA agrees with Breckenridge Pharmaceutical, Nexgen Pharma, Lannett Co. and Paddock Labs that ending availability of their Rx PEG 3350 products on May 2 would cause a shortage of the drug available to consumers. Saying "it likely would be difficult for manufacturers of OTC PEG 3350 products to compensate for the removal" of the Rx drugs by that date, FDA extends the deadline to Nov. 2.