Progress is being made with redistributing UK rapporteurships for non-centrally approved medicines, but companies need to keep up the momentum if all procedures are to be reallocated to other EU countries by the Brexit date of March 29, 2019.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Boehringer stands out in its decision to litigate rather than settle, and the firm has obtained AbbVie's settlement agreements with other biosimilar makers.

Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.

Developing advanced therapy medicinal products is not easy, but the head of regulatory affairs at Swedish cell therapy company Immunicum has some useful tips for SMEs that could help them navigate their development more easily.

The drug value assessment organization said it is considering whether or not to move forward with a program to consult pharmaceutical manufacturers on early research, a move that could raise questions about the group's independence.

Prestige Consumer's sales in its latest quarter were lifted by gas relief and ear wax products, but the gains were offset "revenue recognition" accounting changes and slower sales of BC and Goody's as supplies of the analgesics transitioned to new packaging.

AstraZeneca’s Lokelma and Vifor’s Veltassa will be subject to a final review by the England and Wales health technology appraisal body in December following draft guidance not recommending their use in the National Health Service to treat hyperkalemia.

Company says 75% of Medicare Part D patients who aren't eligible for low income subsidies abandon the PCSK9 inhibitor at the pharmacy counter due to $370 co-pay, which may now range from $25-$150 per dose.

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

Draft guidance soon will help the world’s leading pharmaceutical inspectorates align views on which drug GMP deficiencies are considered major – and which are truly critical.

Providing self-care products "opens this organization up to massive opportunity" which Perrigo will identify in early 2019, says new CEO Murray Kessler. It remains committed to selling or spinning off its Rx unit, though it's "just a few FDA approvals away from significantly" growing, he says as firm reports $68m net loss in its latest quarter.

Big pharmas' recent third-quarter results and commentaries point to sales drivers for consumer health divisions coming from markets outside their established primary markets of US and Europe. Consumer unit lines include oral care and topicals as well as nutritional products.