Tag Archives: Pfizer Inc.

Top Stories for Week of June 8, 2020

White House picks five COVID-19 vaccine candidates for Warp Speed initiative. The Trump administration has chosen five companies as the most likely contenders to produce a vaccine for the coronavirus, senior officials… Read more »

In a seeming role-reversal, FDA steps up action over Thanksgiving week while EMA goes on holiday.

Although usually thought of as a well-deserved respite from governmental rulings, the US Food and Drug Administration seized on Thanksgiving week as a demonstration of its zeal to pump out… Read more »

FDA goes on a rulings binge

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FDA ROUNDUP: In one of the busiest rulings binges of the year, the US Food and Drug Administration last week approved an assortment of pharmaceuticals, medical devices, an AI algorithm… Read more »

All three of the world’s major drug regulators have busy week despite heat waves, political chaos. You know; the usual.

Last week was a rare case where the world’s leading drugs and devices regulators were all in action simultaneously. The US Food and Drug Administration (FDA), the European Medicines Agency… Read more »

European drug regulator comes out of hibernation in new Dutch headquarters, rivaling the FDA with rulings; well, just for one week.

It may have taken nearly 6 months and perhaps a Fourth of July holiday-shortened work week here in the US, but the European Medicines Agency (EMA) finally issued some new… Read more »

Wondering why some of your Pharma shares keep going up? Thank Trump’s tax “reform;” no, really.

The News: The drug industry has taken heat from patient advocates and a US senator for handing out its tax savings to shareholders instead of using its windfall to help patients… Read more »

Pfizer, Merck’s Bavencio flop illustrative of shattered Pharma model. Is industry’s collapse just around the corner?

The News: Pfizer Inc. (NYC) and its German part­ner Merck KGaA (Darmstadt) have run into a brick wall in their race to ex­pand the mar­ket for their PD-L1 check­point inhibitor Baven­cio… 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 »