FDA goes on a rulings binge
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 »
Tag Archives: GlaxoSmithKline PLC
England’s biotech startup Sitryx out of the blocks with new I/O program. Stakes are high as Europe’s science contending with US for top global developers.
The News: Sitryx Therapeutics Ltd. (London) has launched with the goal of treating cancer and inflammatory conditions by targeting the metabolism of immune cells, a promising new area of research…. Read more »
India’s huge pharma/consumer health market in crosshairs of world’s biggest drugmakers. China, Japan, Korea lurking as Asia joins fray with West.
The News: GlaxoSmithKline PLC‘s (London) Indian consumer health unit is drawing the attention of more big-name suitors as the magnitude of the potential there is coming into clearer focus. After… Read more »
ViiV Healthcare’s success with monthly combo HIV med making Gilead sweat over its HIV franchise. After World Cup fiasco, England chasing California in $$$$/rep race.
The News: GlaxoSmithKline PLC’s (London) ViiV Healthcare unit now has results to support a two-drug monthly injection co-developed with Johnson & Johnson (New Brunswick NJ) as it pushes ahead with its ambition… 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 »
Germany’s Merck puts consumer drugs business up for sale; does this signal a last-ditch shot at M&A or just shoring up existing pipeline?
The News: Merck KGaA (Darmstadt DEU) put its consumer-health unit on the block Tuesday (September 5, 2017) in a move that will focus its healthcare activities on the riskier business… Read more »
Pfizer granted Prevnar patent from India; drugmaker draws quick fire for pricing, access.
The News: India has granted Pfizer Inc. (NYC) a patent for its powerful pneumonia vaccine Prevenar 13, in a blow to some health groups that said this would put the… Read more »
Update: CDC data say docs still making billions from Pharma, med device companies; my personal take.
The News: It’s been a few years since the US government unveiled its Open Payments (OP) database, a collection of drug and device makers’ payments to healthcare providers. The data-collection… Read more »
Glaxo dodges another Advair punch as second generic attempt crashes; Big Pharma’s plight highlights new world order for competition and innovation
The News: GlaxoSmithKline PLC is likely to escape generic competition to its blockbuster lung drug Advair in the US this year, after a second application for a cut-price equivalent form… Read more »