Agency officials determining needs using existing budgets before requesting more funds and will engage with tech investors for design advice.

Filing for clinical trial activities in the electronic common technical document format via the Common Electronic Submission Gateway is expected to help sponsors send their information in a secure manner, with reduced transmission times and cost.

The bedding-in period is ending for Europe’s one-year-old system for preventing the circulation of fake medicines, and the scheme is gearing up for a more fully operational stage. 

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

EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.

Senate Finance Committee’s approach to penalize companies for raising WAC list prices is not a ‘price control,’ but a reasonable approach to change the incentives that distort pricing in the supply chain, US HHS Secretary Alex Azar says.

Amid the ongoing spread of the coronavirus outbreak, China turns to novel and repurposed antiviral drugs but also courts traditional medicines to ease public fear over the largely unknown threat.

Sanofi follows Janssen in teaming up with HHS' BARDA to develop a COVID-19 vaccine; using technology platform of its Flublok vaccine, Sanofi expects to enter clinical trials in 1 to 1 ½ years.

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Only two of seven recent applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster made the grade.

Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.

Political worries aside, industry is confidently executing on focused strategies as it welcomes a new decade, even if a lack of deal news at the J.P. Morgan Healthcare Conference didn't excite investors.

Additional highlights from the J.P. Morgan Healthcare Conference, including Takeda’s partnering outlook, Sage’s guidance on Zulresso sales, Frequency’s next steps for its hearing loss drug and Revance’s preparations to take on the aesthetics market. 

The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.

After realizing some generics don’t work, academic medical center screens quality by manufacturer. Other providers protest: It’s not our job.

Agency agrees with those who prescribe and buy drugs on need to incentivize quality. Except providers want it yesterday.