Category Archives: Government

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 »

McConnell scraps Graham-Cassidy bill; but be mindful of Yogi Berra’s quip back in 1973.

The Latest: Senate Republican leaders on Tuesday (September 26, 2017) officially pulled the plug on the latest plan to repeal the Affordable Care Act, abandoning a planned vote on the… Read more »

Latest ACA repeal bill returns for one more Senate audition; will McConnell, other GOP leadership put it to a vote?

The News: Powerful healthcare groups continued to denounce the Graham-Cassidy bill Wednesday (September 20, 2017), including AARP and the American Hospital Association, both of which urged a “no” vote. But… 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 »

GOP Sen. Alexander’s plucky, bipartisan bill to fix Obamacare headed to Senate vote this week; does this dark horse have a chance in such a crowded field?

The News: The month of September has been blitzed with healthcare bills. Last week alone, Democrat and Republican senators introduced both a single-payer plan and an Affordable Care Act (ACA) repeal and replacement… 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 »

Obamacare fails to implode as Ohio’s CareSource fills last “bare” US county.

The News: Obamacare plans will be sold in every part of the US next year after an insurer agreed to do business in a small Ohio county, overcoming predictions that… Read more »