AZ News from the Street 2018

Not much news so far this year from AZ but here is a crumb:


AstraZeneca, plc AZN announced that the European Commission (“EC”) has granted approval to its asthma disease candidate, benralizumab. It is approved as an add-on maintenance treatment for severe eosinophilic asthma in adult patients. It will be marketed by the trade name of Fasenra." AstraZeneca, plc AZN announced that the European Commission (“EC”) has granted approval to its asthma disease candidate, benralizumab. It is approved as an add-on maintenance treatment for severe eosinophilic asthma in adult patients. It will be marketed by the trade name of Fasenra.

With this approval, Fasenra is the first respiratory biologic drug to have an 8-week maintenance dosing schedule. The drug will be available in a fixed-dose subcutaneous injection via a prefilled syringe.

We remind investors that Fasenra received approval in the same indication in the United States in November last year. It is also under review in Japan

AstraZeneca’s shares have gained 25.1% in the past year, comparing favorably with the industry’s growth of 18.4% in that period.

The EC approved Fasenra based on data from the WINDWARD program, which included three phase III studies – SIROCCO, CALIMA and ZONDA.

Data from SIROCCO and CALIMA showed that Fasenra achieved significant reductions in exacerbations and improvements in lung function. Meanwhile, data from ZONDA study showed that Fasenra alone or in combination with standard of care (glucocorticoid) led to statistically-significant and clinically relevant reduction in daily maintenance oral corticosteroid (“OCS”) compared with placebo.

Severe asthma patients whose disease is driven by inflammation of eosinophils, a type of white blood cell, have until now had only limited treatment options, mostly oral steroids. Fasenra, which distinctively targets and rapidly depletes eosinophils, has shown potential to reduce oral steroid use in such patients

 

Its almost too quiet.

 

As the stock works its way up to 40, lol.......

 

U.S. FDA approves expanded use of AstraZeneca cancer drug
January 12, 2018
By Toni Clarke

(Reuters) - The U.S. Food and Drug Administration said on Friday it has approved expanded use of AstraZeneca Plc's cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene.

The drug belongs to a class of drug known as PARP inhibitors that has already been used to treat advanced BRCA-mutated ovarian cancer, the FDA said.

This is the first time a PARP inhibitor has been approved to treat breast cancer and the first time any drug has been approved to treat certain patients with metastatic breast cancer associated with the same genetic mutation.

"This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types," said Dr. Richard Pazdur, head of the FDA's oncology products division. Between 5-10 percent of patients with breast cancer have a BRCA mutation.

Patients are selected for treatment based on a diagnostic test made by Myriad Genetics Inc known as BRACAnalysis CDx. In 2014 Myriad won FDA approval for the test to help identify patients with advanced ovarian cancer considered eligible for treatment with the drug after others have failed.

 

Of course, almost every other stock is way up too in this bubble market, so who knows if it even has anything to do with AZ value?

 

Its a buy because of the pipeline........not a bubble market!! You people who are so fucking negative have NO clue! Just shows your ignorance and stupidity....

 

Wait till Pacific is FDA approved in February!!!

 

It looks very promising for sure. I wonder which REAL oncology biotech company will scoop us up after this success of this trial.

 

unlike a stable genius like you I suppose

 

Just called common sense

 

What uneducated part of the world are you from?

 

Austin TX

 

Here is how you know its a bubble market. People are shocked if the market doesn't go up even for one day.
However, while this clearly is irrational exuberance going on now, people can remain irrational longer than you think!

 

Trump University

 

Huh????? You just sexually aroused me!

 

animal spirits are roaring again today!! On no news it seems.

 

The moving goal post and brinkmanship on reaching an agreement for passing the spending resolution has the markets nervous today. An 11th hour agreement kicking the can down the road another few weeks is now looking like a best case scenario. A government shutdown cuts real spending and cash flowing into the economy and could trigger a sea change in the market optimism. Or not, in this irrational market environment!

 

I say shut the entire government down except for the military. But make sure it means that none of these ass clowns get paid a dime while it is shut down. Turn off the lights and the heat and let those huge palaces of ridiculousness remain empty. And please can we fire the entire WH press core. What a big waste of oxygen.
Does anybody really give a shit is Trump is over weight, eats McDonalds or has dentures? Holy Shit I couldn't believe it.

 

Unfortunately the system doesn't work like that. They will all get paid in full. And as GOP Senator Jeff Flake pointed out just yesterday, trying to silence the press is right out of Joseph Stalin's playbook. Are you sure that is the direction that you want to go in? That didn't work out very well for the people in the end did it?

And no one really does care if the moron in chief is obese, lots of people are, what is worrisome is that he feels compelled to lie about it, and everything else, because he is such an egomaniac