is clinical dead?

is it true everyone good in clinops quit. studies arebeing halted or canceled left and right but not disclosed to the street until raj and his relatives can sell. are millions being siphoned off to relatives in india through oncorx or defending raj from sec ask avi. is joe looking for new cmo. Total shitshow. raj has gone postal with offlabel promoting on sales calls and giving wrong information on earnings call ask tom r. is it it true stability of melphalan is less than the 24 hours promised last year and closer to 1 hour ask jt or la. cant make 2012 till next year really. namaste.

 

Big Trouble. . . More DOG drugs get worse

 

Re: is clinical dead? VP of medical resigned

VP of medical resigned last week.

Another sign this place not interested in R & D.

 

Everyone has the same thinking. . . .so much for SPI2012

WASHINGTON, D.C. (AP) -- The Food and Drug Administration is reviewing research data on what could become the first U.S.-approved "biosimilar" drug, a cheaper, sort-of generic version of a biologic drug.

Nearly five years after Congress passed a law enabling future approval of biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.

The FDA is evaluating Swiss drugmaker Novartis AG's application to sell a biosimilar version of Neupogen, which brought maker Amgen Inc. $1.4 billion in sales last year. Neupogen, known chemically as filgrastim, treats a dangerous decrease in infection-fighting white blood cells, common in cancer patients getting certain treatments.

Sandoz, the generic division of Novartis, already sells three biosimilar drugs, including filgrastim, in about 60 other countries.

The FDA should make its decision after a standard 10-month review, a spokeswoman said.

"Biosimilars have been successfully used in Europe and other markets for years," Ralph Neas, CEO of the Generic Pharmaceutical Association, said in a statement. "Filgrastim's filing acceptance moves us closer to the day when U.S. patients that currently must rely on costly brand biologics for treatment will have more choices."

Biologic drugs are powerful, injected medicines produced in living cells. They are much more expensive to produce than traditional pills made by mixing chemicals. Some newer ones cost more than $100,000 per treatment course, making copayments unaffordable for many patients.

That also adds up to billions in annual costs for insurance companies and government health programs, which are trying to rein in spending. Thus the Affordable Care Act, which President Obama signed into law early in 2010, includes the Biologics Price Competition and Innovation Act's requirements for approval of cheaper biosimilars.

When a traditional drug loses patent protection, multiple companies start selling copycat pills at up to 90 percent less than the brand-name medicine. That's why nearly 85 percent of prescriptions dispensed in the U.S. are generic pills.

To gain approval, generic drugmakers need only prove to the FDA that their pills are chemically identical to the original drug.

 

We don't care, we have the Amgen folks.

 

when are the layoffs. when will joe replace lee? who will they bring in?

 

Tis true that the good people in the clinical dept have left. Some were fired. All leads back to Lee Allen, the CMO. Sad to say, it shows a total lack of leadership.

 

Joes talking more openly about replacing Lee so its only a matter of time now before all of clinical is gone

 

Even if true, it would not be "gone" but "UPGRADED" and replaced to enhance the Pipeline going forward.

 

Re: is clinical dead? VP of medical resigned

Huge hole now. He ran medical and half if dev.If he and the COO quit so close together what does it say of pipeline? Ken at least knew something but quit after last 2012 meeting. I wonder......joe is joe sales

 

everything is fine. you are working way way too hard to throw sppi under the bus. It is tough being a disgruntled fired underperforming former employee.

 

When joe tells Riga how horrible lee is he shouldn't tell everyone because words spreads like fire

 

Lee is the best cmo we've had amongst the last six the past couple years

 

These clowns don't even know what's wrong with clinical like running all studies with 1 study manager. Everythings on hold. They worry about personality over function. They think what's said in the locker room stays in the old boys lockerroom. It brings morale down in the entire clinical group since JT is a commercial person and now COO

 

If you call having no novel pipeline, study managers and a depressed demotivated team, then we are beyond dead. Everyone knows what Joe says about Lee. What life is there when management sucks it out

 

Everyone in development wouldn't be depressed if Joe wound't rag on Lee so openly. We've had so many CMOs and to have yet another is a tragedy.

 

Re: is clinical dead? VP of medical resigned

No doubt this place is a joke. Raj likes Joe because Joe is an American version of Raj. Both full of hot air and in over their heads.

 

Re: is clinical dead? VP of medical resigned

No ctms, no MDs, no studies.

 

Re: is clinical dead? VP of medical resigned

When is Lee's last day? Heard he resigned

 

Why did he resign?