Performance-based managed entry agreements need to be made more effective, but this can only happen if countries relax their stance on confidentiality and share information on MEAs amongst themselves, says a working paper from the OECD.

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.

Progress is being made towards the implementation of the EU’s new patent system, but the UK’s insistence on severing all ties with the European Court could spell the end for its participation.

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

US FDA's advisors produce tie vote on bupivacaine extended-release solution for post-surgical analgesia; proponents valued its potential to to cut opioid use, while opponents questioned its efficacy.

However, the month may be losing its influence over the US FDA's annual submission total.

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.

Industry now needs to wait for a more appealing appeal or a revived legislative effort after the high court declines review of Athena Diagnostics v. Mayo Collaborative Services, which created a sharp divide in the Federal Circuit, and Hikma v. Vanda; biopharma and others contend eligibility issue is biggest problem in patent system.

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.