Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.

The sponsors of Alsitek and quizartinib are hoping that new data generated for the drugs will resolve the concerns raised by the European Medicines Agency when it previously rejected the products for marketing in the EU.

A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection. 

A Pink Sheet timeline shows the regulatory highs and lows of AMX0035's path to US approval for treatment of amyotrophic lateral sclerosis.

Launched in part to help resurrect AMX0035’s regulatory prospects, the multiregional PHOENIX study is winding down in the US. There still may be some risk of potential dropouts, however.

Hundreds of videos have been sent in by people interested in contributing to the future pandemic treaty proposed by the World Health Organization.

But premiums in future years made need to keep pace with accelerating Medicare spending on Alzheimer’s drugs.

Brazil’s health technology assessment institute is to incorporate cost-effectiveness thresholds into its decision making.

Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.

Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.

Investigational products from Ultragenyx and MinervaX secured a place on the European Medicines Agency’s priority medicines scheme this month.

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

Excellence, innovation, deal-making and individual achievement across the Japanese biopharma sector were celebrated at the inaugural Pharma Intelligence Japan Awards 2022 in Tokyo on 1 September.

Moderna seeks damages for sales of Comirnaty in US and other wealthy countries from 8 March onward, a timeframe driven by Moderna's accessibility pledge. Suit claims Pfizer and BioNTech copied two key features of its mRNA technology for their rival COVID vaccine.

Amgen says contracts it submitted to district court show Otezla rebates were not conditioned on customers covering its cholesterol-lowering drug Repatha instead of Regeneron’s Praluent. It requests stay of the litigation until Supreme Court acts on Amgen’s cert petition on the patent case between the two competitors.

A senior Parexel executive and ex-FDA pharmaceutical quality assessor emphasizes at a conclave why “first impressions matter now more than ever” as the agency  deploys complex alternate inspections tools which the pandemic provided, and that companies need to ensure that they get things right the first time.

Responses to US FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.

Memo outlines how US agency ensured sufficient delivery of updated COVID-19 vaccine doses even as it navigated unresolved inspection findings of the Catalent plant where the additional doses had been manufactured.