An ambitious action plan drawn by an EU task force, if implemented on a priority basis by the European Commission, could increase the EU’s capacity to advise on, assess and analyze big data.

A number of new products have been submitted for review at the European Medicines Agency. While marketing authorization applications from ViiV Healthcare and BioMarin Pharmaceutical are being fast-tracked, a submission from Incyte is not.

The Therapeutic Goods Administration says that its cost-recovery fees need to go up, mainly because of a fall in the number of medicines on the therapeutic products register. It is also seeing a rise in the cost of the fee-free services it provides.

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

Swissmedic will scale back its review procedure for certain anti-infectives if the indications for which approval is being sought are identical to those approved in the EU or the US.

The recruitment process for the new executive director of the European Medicines Agency seems to be running to schedule.

Emergence of the inter partes review process dramatically changed the patent dispute arena.  The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.

A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.

An interactive timeline shows the news of the past decade and the evolution of US FDA policies. Click on each year for a full list of events and see the accompanying article.

A novel Swedish payment scheme and transferable exclusivity vouchers for new antimicrobials are among mechanisms being examined by the European Commission for encouraging the development of new drugs to tackle the growing problem of antibiotic resistance. 

AstraZeneca's PARP inhibitor Lynparza becomes first US FDA-approved drug for pancreatic cancer based on progression-free survival endpoint, providing regulatory precedent for other sponsors to use that development approach; all other pancreatic cancer drugs had been approved based on an overall survival benefit.

Just two of six applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster were successful last month.

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. 

Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: AbbVie's Skyrizi takes psoriasis lead, Amarin goes it alone, Viatris debuts, BeiGene on US drug pricing and Roche think neuroscience is the new oncology.

Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: GSK's first-in-class oncology opportunity, Pfizer's Bourla on underappreciated pipeline, AstraZeneca's Enhertu pricing, Amgen's genomics push, Lilly filters through deals and Medicxi's de Rubertis teases big pharma CEOs about M&A. 

Another day, another report on how to tackle the ever-present problem of antimicrobial resistance and the dearth of new treatment. In its latest assessment of the state of play, the AMR Industry Alliance has come up with some alarming facts and figures – and some ideas for the next steps.

US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.

2019 saw Indian companies advance innovation efforts and build and expand their specialty portfolios and biosimilars businesses. But manufacturing compliance issues weighed down several firms while on another front charges against the Singh brothers of Ranbaxy escalated.