Tag Archives: Breakthrough Therapy

Business, Finance, Occupation & Industry

The Dow's Top Stocks on a Record-Setting Day

Leave a comment

By Matt Thalman, The Motley Fool

Filed under:

Thanks to a few top stocks, the Dow Jones Industrial Average managed to once again set a new all-time closing high at 14,865. Today, the index rose 62 points, or 0.42%, after investors received a better-than-expected jobless claims report, despite a few technology stocks plummeting. The Labor Department reported that initial jobless claims for last week fell by 42,000, to 346,000. Economists were only expecting a decline of 23,000 from the 388,000 claims which were reported two weeks ago.  

With the jobless numbers moving in a positive direction, the markets, as a whole, ended the session on a high note. While the Dow was the top index, the S&P 500 managed to rise 0.36%, as the Nasdaq lagged behind, only gaining 0.09%.

The Nasdaq was likely pulled lower by the IDC report, which indicated that PC sales declined 14% during the first quarter of 2013. This report pulled a number of technology stocks lower, but shares of Cisco slipped away from the downward pressure, and managed to become one of the index’s top stocks. Shares of the networking giant rose 1% during today’s trading session after climbing 2.4% yesterday, and 2% on Tuesday. Today’s move came on very little news, but Cisco certainly is gaining momentum. The company also recently announced a joint project with Microsoft, in which the two will work together to provide data center customers with more functionality and lower complexity. In addition, the two will work together to improve and grow data center operations.  

Another top stock today was Chevron , which saw its shares rise 1.09%. One likely catalyst for the rise was the recent Morgan Stanley report that claimed Chevron would outperform its fellow Dow component and competitor ExxonMobil by 55% over the next few years. Morgan Stanley believes Chevron could experience higher production growth and realize better returns in the coming years. The firm also raised Chevron’s price target to $135 per share, while reducing Exxon’s to $85 per share.  

Not only does Morgan Stanley believe Chevron is cheap, but my Fool Colleague Brian Pacampara also feels that way. To read what Brian has to say about the company, click here.

Shares of Pfizer rose 2.41%, making it the true “top stock” of the Dow today. The increase came after Pfizer announced that its palbociclib, an experimental treatment for breast cancer, received the Breakthrough Therapy designation by the FDA. This is a great development for the company, as it will now have the drug expedited through the regulatory process. Currently, the drug is in the later stages of testing, and this news should help it hit the market sooner rather than later.  

More top stocks

The Motley Fool’s chief investment officer has selected his No. 1 stock for this year. Find out which stock it is in the brand-new free report, “The Motley Fool’s Top Stock for 2013.” Just click here to access

From: http://www.dailyfinance.com/2013/04/11/the-dows-top-stocks-on-a-record-setting-day/

Health

FDA Step Closer To Approving Breast Cancer Drug "Palbociclib"

Leave a comment

The pharmaceutical giant Pfizer has just announced that their drug “Palbociclib”, a selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has just received Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for breast cancer treatment. Breast cancer is the most common cancer among women worldwide…

From: http://www.medicalnewstoday.com/articles/258934.php

Business, Finance, Occupation & Industry

Pfizer's Palbociclib (PD-0332991) Receives Food And Drug Administration Breakthrough Therapy Designa

Leave a comment

By Business Wirevia The Motley Fool

Filed under:

Pfizer’s Palbociclib (PD-0332991) Receives Food And Drug Administration Breakthrough Therapy Designation For Potential Treatment Of Patients With Breast Cancer

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. announced today its investigational compound palbociclib (PD-0332991), an oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6, has received Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for the potential treatment of patients with breast cancer.

Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is “intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.” 1 The Breakthrough Therapy designation is distinct from the FDA‘s other mechanisms to expedite drug development and review.2

“We appreciate the opportunity that Breakthrough Therapy designation provides to work closely with the FDA on the development of palbociclib,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer’s Oncology business unit. “Palbociclib is one example of Pfizer’s commitment to identifying and translating innovative science into meaningful new treatment options for cancer patients.”

Pfizer will continue to work with the FDA to better understand the implications of Breakthrough Therapy designation on the palbociclib development program and to generate evidence needed to support a potential regulatory submission. The FDA‘s requirements for a potential submission have not yet been defined.

Pfizer has initiated a randomized, multi-center, double-blind Phase 3 study (known as Study 1008) evaluating palbociclib in combination with letrozole versus letrozole alone as a first-line treatment for post-menopausal patients with ER+, HER2- locally advanced or metastatic breast cancer. Study 1008 is currently open and enrolling.3

The Breakthrough Therapy designation was based on preliminary Phase 2 data in this patient population. Interim data presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium showed that women treated with the combination of palbociclib plus letrozole achieved a statistically significant improvement in median progression free survival (PFS) compared to women who received letrozole alone (26.1 months and 7.5 months, respectively).4

Breast cancer is the most commonly diagnosed cancer in women5 and the leading cause of cancer death among women worldwide.6 Among post-menopausal patients with advanced or metastatic breast cancer, ER+, HER2- is the largest molecular subgroup, representing approximately 60 percent …read more

Source: FULL ARTICLE at DailyFinance