Public Company Edition: The usual mid-January surge in public offerings hasn't happened this year, since the SEC can't process new filings, but Alnylam, Acceleron and others apparently were prepared for a lengthy shutdown. Also, ARM reports cell and gene therapy financing data.

Valneva’s 2019 guidance has been boosted by the US Army’s Ixiaro vaccine order, as other products flourish in the pipeline.

Digital health represents a set of opportunities that can transform all parts of the pharma landscape. Speaking on the sidelines of Biotech Showcase 2019, Stephanie Bova, managing partner at Hatch@Takeda, tells Scrip how the Japanese pharma has established a new group to support the creation and financing of digital health businesses in the US and Europe.

SVP/CSO Daniel Skovronsky says the company has invested in technology and biotech-like teams to speed up the process of translating targets identified in house into human data for novel drugs.

Annual payment plans for gene therapies appear closer to becoming reality now that bluebird bio detailed plans at J.P. Morgan. Novartis, Sarepta and others are also talking to payers about alternative payment models. Harvard Pilgrim's Michael Sherman applauded the effort in an interview.

With a focus on innovative early stage European biotechs, Novo Seeds senior partner Stephan Christgau explains to Scrip how the investor picks opportunities and creates companies.

A worst-case Brexit scenario – a disorderly one – has become more likely, making an already white-knuckled life sciences industry step up its preparations.

How much therapies should cost and how they should be reimbursed are questions that are expected to dominate in 2019, according to industry experts and participants surveyed by Scrip on their expectations for the coming year. This is the focus for the final installment of our three-part Scrip Asks series.

Roche’s subcutaneous (SC) Herceptin (trastuzumab) has been declined a trial waiver in India, at least for now, stretching potential launch timelines for the product significantly. The company emphasizes that a harmonized regulatory approach could best serve patient interests for therapies like Herceptin that come with a ‘long history of proven efficacy’.

It's early days yet and Alzheimer's is a field littered with failures, but the latest results for the vaccine UB-311 support advancing development.

Investors reacted negatively when Aptinyx’s lead candidate missed its primary endpoint in diabetic peripheral neuropathy, but CEO Riedel tries to emphasize the positives from the study while awaiting fibromyalgia data with NYX-2925.

R&D head John Tsai spoke with Scrip about culture change at Novartis as it moves toward advanced therapy platforms and embraces digital technologies, and offered a peek into what’s in store for R&D in 2019 and beyond.