Category Archives: Pharmaceuticals

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 »

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 »

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 »

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 »

Humdrum, stodgy Pfizer suddenly turns heads with partial drug-pipeline spinoff; old dog apparently can learn new tricks.

The News: Pfizer Inc. (NYC) on Monday (September 25, 2017) announced that it is spinning off a new company, SpringWorks Therapeutics LLC, to develop several drugs for rare diseases that… Read more »

Alnylam soars on RNAi success as Phase 3 patisiran study hits all goals; market overreacts as pipeline unproven and competition lurks.

The News: Alnylam Pharmaceuticals Inc.’s (Cambridge MA) RNAi-based drug that targets a rare genetic disease cleared a key study, in a breakthrough for the new class of medicines that works… Read more »

Zai Lab’s U.S. IPO marks another white-hot Chinese offering that begs the question: why are these Asian offerings so special?

The News: Shang­hai-based biotech Zai Lab Ltd. raised $150 mil­lion from its up­sized IPO last Wednes­day (September 20, 2017), sell­ing 8.3 mil­lion shares at $18 each. After trad­ing began, the… Read more »