AstraZeneca gained a crucial accelerated FDA approval for its targeted lung cancer drug AZD9291 today, offering tangible evidence of the R&D turnaround CEO Pascal Soriot had promised investors several years ago. And now the drug, to be marketed as Tagrisso, will be put to the market test to see if it can live up to Soriot's $3 billion peak sales estimate while staring down a strong rival in late-stage development at Clovis Oncology.
Throughout the tough times faced by the British biopharma industry, the country could always point to its scientific excellence as a source of pride. Now, with more money swilling around, the sector should be enjoying better days, yet as financial woes have receded another resource shortage has come into view: The United Kingdom appears to be running low on scientists.
A U.S. court has barred Dr Reddy's Laboratories from selling its generic of AstraZeneca's heartburn drug Nexium after AstraZeneca objected to the Indian drugmaker's use of the color purple for the pills, according to reports.
Last week, AstraZeneca petitioned a Delaware district court to bar Dr. Reddy's Laboratories copies of its purple heartburn med, Nexium, contending that the pill's distinctive hue should protect it from copycat competitors. At least for now, the court agrees.
In the second bit of bad news for Dr. Reddy's Laboratories in days, the company said on Tuesday that a U.S. federal court had temporarily barred sales of its generic of AstraZeneca's blockbuster heartburn drug Nexium in the U.S., Reuters reports.
AstraZeneca says it has a prime late-stage drug contender in the clinic that has the potential to compete for the lupus market. But it is lining up against GlaxoSmithKline, which has been touting promising Phase III data this week for a new subcutaneous formulation of Benlysta, a drug that has frequently disappointed analysts who have been tracking its sales over the years.
U.K.-based AstraZeneca continued a nice run in emerging markets and China in the third quarter as respiratory pulled it to double-digit growth.
AstraZeneca agreed to buy ZS Pharma and its pending-approval kidney drug, one-upping rival bidder Actelion to get its hands on what it believes is a blockbuster in the making.
AstraZeneca has so far weathered the Nexium patent cliff well enough to actually raise its full-year sales forecast for 2015. Its Brilinta growth strategy appears to be paying off. But the U.K.-based company faces another big hurdle in the advent of Crestor generics--and investors aren't letting up on the pressure.
AstraZeneca, working to catch up with Merck and Bristol-Myers Squibb in the growing field of immuno-oncology, said its treatment is unlikely to win speedy approval in lung cancer due to the presence of more advanced agents.