Author Archives: Steve Walker

MannKind’s 10-year quest for insulin product Afrezza gets last-ditch chance; time to buy, or run?

The News: Last week, MannKind Corp. (Nasdaq:MNKD) led advancing stocks in the healthcare sector, soaring 151% to $5.03, after saying it won a labeling concession from the FDA on its Afrezza inhalable… Read more »

Trump does end-run around Congress, scraps Obamacare insurer subsidies via executive order; what’s really happening?

The News: An alliance of US states joined ranks on Friday (October 13, 2017) to sue to block President Donald Trump’s move to dump a key component of Obamacare–subsidies to… Read more »

China’s FDA to accept foreign trial data for accelerated approvals; sounds great, but future enforcement of IP rights poses threat to US Pharma.

The News: For decades, patients in China have fought to gain access to cutting-edge medicines thanks to bureaucratic delays that have thwarted drug development. Now a sweeping government overhaul of… Read more »

Innovio’s DNA-based Zika vaccine is safe and effective at inducing immune response; where has this breakthrough vaccine technique been hiding?

The News: A DNA-based Zika vaccine from Inovio Pharmaceuticals Inc. (Plymouth Meeting PA) and South Korea’s GeneOne Life Science Inc. induced anti-Zika immune responses in an early stage human trial,… Read more »

Alarming study concludes most new, pricey cancer drugs don’t work; why are we just hearing about this?

The News: Researchers said only half of the cancer drugs approved by European regulators in the past few years have shown to help patients. Many of the drugs were approved… Read more »

Catabasis soars on fresh Duchenne trial data, proving biotech melt-up still in progress; but for how much longer?

The News: Recuperating from a trial flop involving its lead drug for Duchenne muscular dystrophy, Catabasis Pharmaceuticals Inc. (Cambridge MA) is charging ahead with a late-stage study, hyping new data… Read more »

FDA’s Gottlieb continues to amaze, turning agency into pharma-friendly ally.

The News: The US Food and Drug Administration on Monday (October 2, 2017) announced a series of measures designed to speed to market generic versions of complex drugs such as… Read more »

Senators seek probe of Allergan’s patent sale to Mohawk Tribe; could Tesla do the same with its battery patents?

The News: Four senators are demanding an investigation of Allergan PLC’s (Dublin IRL) first-of-a-kind patent deal with the Saint Regis Mohawk Tribe, alleging the move to protect Restasis is another… Read more »

Patients lose, lawyers win, as AbbVie does deal with Amgen to delay Humira biosim.

The News: Amgen Inc. (Thousand Oaks CA) has agreed to delay the US launch of its FDA-approved biosimilar version of AbbVie Inc.’s (North Chicago) Humira (adalimumab) until 2023, under a… Read more »