Tag Archives: U.S. Food and Drug Administration

FDA warns against unproven medical claims for marijuana. “Prohibition” didn’t work, remember?

The News: Four companies selling dozens of various marijuana-derived dietary supplements have been officially warned by the US Food and Drug Administration to stop plugging their products as cures for… Read more »

John McCain in Phase 1 trial of Bexion’s solid cancer tumor candidate; Bexion who?

The News: In late September, the University of New Mexico Comprehensive Cancer Center (UNMCC) announced that the first clinical trials of a new drug that targets solid cancer tumors have… Read more »

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 »

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 »

Amgen, Allergan get nod for Avastin biosim; FDA’s Gottlieb making good on vow to hasten generic approvals, catch the EU.

The News: Amgen Inc. (Thousand Oaks CA) and Allergan PLC (Dublin IRL) said Thursday (September 14, 2017) that the Food and Drug Administration has approved their biosimilar version of Roche… Read more »

Slumbering giant Lilly to cut more jobs, take a $1.2-billion hit to bolster R&D pipeline.

The News: Eli Lilly & Co. (Indianapolis IN) last week said it would lay off about 8% of its employees as the drugmaker, which has suffered setbacks over the past… Read more »

Novartis CEO Jimenez is stepping down; does successor Narasimhan have the right stuff to take the reins in 2018?

The News: Swiss pharmaceuticals titan Novartis AG (Basel) will get a new chief executive in 2018–Dr. Vasant Narasimhan (pdf)–after Joseph Jimenez proclaimed his upcoming retirement effective in February. Jimenez has… Read more »

Novartis gets FDA nod for breakthrough leukemia treatment Kymriah; with a cost of $450,000, who’s going to get it?

The News: Novartis AG (Basel CHE) has obtained approval from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel or CTL019) to treat children and young adults with… Read more »