As the number of biosimilar approvals continues to rise in the US, the number of biosimilar launches continues to lag, but experts explained how this is more of a legal issue than a problem with the FDA.

Chad Landmon, partner at Axinn, Veltrop & Harkrider LLP, offered an overview on Monday at the Association of Accessible Medicines’ conference in Bethesda, MD, of the biosimilar “patent dance,” which is the convoluted and often uncertain process by which the patent issues are resolved ahead of a biosimilar’s launch.

Stephen Hahn’s nomination as the new commissioner of the FDA was delivered right on schedule Friday, with the clock ticking down on the November 1 deadline President Donald Trump faced in finding a permanent replacement for Scott Gottlieb. The pending news had become the worst kept secret in Washington. But the full meaning of the move is still undetermined.

The Chief Medical Executive at MD Anderson had a rep for steering straight into confrontation, when the future of the institution was at stake. More problematic, perhaps, will be his role in dismissing Chinese researchers at a time the Trump administration has been bearing down on the Asian giant. Just how Hahn will manage drug development, which is my primary arena of interest, is going to take some time to figure out.

As another UK election beckons, prime minister Boris Johnson and opposition leader Jeremy Corbyn engaged in yet another dustup about the state of the National Health Service (NHS) in the last round of Prime Minister’s Questions presided by legendary outgoing speaker John Bercow.

Corbyn accused Johnson and his government of conducting ‘secret meetings’ with US pharmaceutical executives as part of a post-Brexit trade deal, citing reports including Channel 4 dispatches that reported on Tuesday that the price the NHS pays for US medicines could soar under a future trade deal.

Months after Firdapse maker Catalyst Pharmaceuticals filed a lawsuit against the FDA, the Florida company on Wednesday said the drug had failed a pivotal trial in patients afflicted with congenital myasthenic syndromes (CMS), an umbrella term for rare neuromuscular disorders comprising a spectrum of more than 50 genetic defects.

The drug, known chemically as amifampridine, was sanctioned for use in adult Lambert-Eaton myasthenic syndrome (LEMS) patients in November 2018. The company is working on expanding the label to include patients with CMS, MuSK-positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA).