Tag Archives: GlaxoSmithKline PLC

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 »

Senate confirms Gottlieb as FDA chief; former FDA tour, industry ties signal solid choice despite Dems’ jabs

The News: The US Senate voted 57 to 42 on Tuesday (May 9, 2017) to confirm Scott Gottlieb, MD, as Food and Drug Administration (FDA) Commissioner. Gottlieb, who was nominated by… Read more »

Pernix soars on absolutely no news; naturally, rumors of a takeout flourish

The News: Pernix Therapeutics Holdings Inc. (Nasdaq:PTX) was one of the week’s top gainers, rocketing $2.02, or 50%, to $6.33 Monday (May 8, 2017)–without a press release being issued, or other… Read more »

Wall Street cheers as Axovant snags biotech star David Hung; failed Alzheimer’s drug not impressed

The News: Axovant Sciences Ltd. (Hamilton Bermuda) announced that former Medivation Inc. (San Francisco) chief executive and founder David Hung has been selected as its next CEO effective April 7, 2017 sending… Read more »

China’s FDA approves AstraZeneca’s lung-cancer drug in new “fast-track” program; European drugmakers beating US to world’s biggest drug market

The News: AstraZeneca PLC (London) has won approval for its lung-cancer pill Tagrisso in China, a key market for the potential blockbuster medicine. Tagrisso is designed to help cancer patients… Read more »