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Pfizer seeks early approval for breast cancer drug

By WTOP Staff

LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) — Pfizer Inc. said Friday that the Food and Drug Administration will let the drugmaker apply for approval of its heavily touted experimental breast cancer medicine based on midstage patient testing results.

That means New York-based Pfizer won’t have to do bigger, and very expensive, late-stage patient studies to apply for approval of palbociclib, as company executives and investors had hoped.

Having to run those additional studies could have delayed Pfizer’s application by up to a couple of years, keeping patients and doctors waiting and ultimately reducing how much money the drug could bring Pfizer before its 20-year patent expires.

Pfizer, the world’s second-biggest drugmaker by revenue, said that after discussions with the FDA, the final results of a study called PALOMA-1 will be sufficient for review.

Pfizer said that by the third quarter of this year, it will apply for approval to use palbociclib with a drug called Femara, or letrozole, as an initial treatment for postmenopausal women with a certain type of advanced breast cancer.

The FDA last year named palbociclib a breakthrough therapy, a designation given to medicines for diseases with no or inadequate treatments. It’s meant to speed up the testing and approval process. The designation was based on interim results from the PALOMA-1 study.

Those showed that by combining palbociclib with letrozole, patients on average survived 20.2 months before their tumors worsened. That was about twice as long as the benefit for women in a comparison group who only received letrozole.

Pfizer has already begun two late-stage studies of palbociclib, and breast cancer researchers in Spain and Germany are doing their own studies testing it in combination with other treatments.

BernsteinResearch analyst Dr. Timothy Anderson wrote to investors that Pfizer’s discussions with the FDA “should not be viewed as an implicit approval of sorts,” but that he does expect approval.

“We currently forecast a launch of palbociclib in 2015 with sales reaching $1.9 (billion) in 2020,” Anderson wrote, noting that rivals Novartis AG and Eli Lilly and Co. aren’t far behind Pfizer in their development of similar drugs.

Pfizer shares initially jumped 1.7 percent on the news and were up 15 cents at $29.21 in midafternoon trading.

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Follow Linda A. Johnson at www.twitter.com/LindaJ_onPharma

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Don’t Settle for Student Loans to Pay for Online Education

By WTOP Staff
Online college programs are becoming a more popular choice for prospective students, with one study finding that more than 6 million students enrolled in at least one online course in fall 2015. The popularity of these courses can be attributed in part to their flexibility with working adults' schedules, students' ability to progress more quickly through online programs and, oftentimes, cheaper tuition. [See 10 low-cost online bachelor's programs for out-of-state students.]Online degrees can be beneficial to many college students, but some studies have shown online learners complete their programs at lower rates than students at traditional brick-and-mortar campuses. Individuals with student loans but no degree comprise two-thirds of defaulted borrowers. Though these numbers are not encouraging, just like for traditional programs, there are ways to reduce how much you'll need to borrow for an online program to ensure you won't become one of these statistics. Don't just settle on borrowing student loans to cover the whole cost of your program and living expenses. Instead, start thinking about how to cut costs and cover your balance in different ways, such as the following. -- Grants and scholarships: Even though you are taking an online course, you can still apply and receive grants and scholarships. But your first step should be to complete the Free Application for Federal Student Aid, commonly referred to as the FAFSA, which will allow you to receive a Pell Grant if your expected family contribution is low enough. The EFC criteria and award amounts are adjusted annually, but the 2017-2018 academic year awards range from $606 to $5,920, which could significantly lower the amount you borrow annually. Your next step is to apply for scholarships. You can start by checking online scholarship search engines, such as the Salt Scholarship Search, College Board's BigFuture and Peterson's. But don't forget to take advantage of local organizations and your school's financial aid office. Both may offer scholarships that you can't find with a national scholarship search. [Review these 10 sites to kick off your scholarship search.]For instance, organizations like the Elks Club, Knights of Columbus or the Rotary Club typically offer scholarships annually to local students. Just because you're going to school online doesn't mean you're ineligible. Visit your local library for scholarship listings, and ask around town. You might be surprised how many local organizations offer scholarships. While these scholarships typically aren't large, every little bit counts. Each dollar you receive in a scholarship is a dollar you don't have to borrow and pay interest on. -- Work-study: Another option for online students may be work-study awards. Not all students enrolled in online programs are eligible, but students at some schools -- including, for example, SUNY Empire State College and Liberty University -- are. Work-study awards are not given upfront like scholarships and grants. In most cases, they are an offer to earn up to the awarded amount if you secure an eligible work-study job. While there is a misconception that all work-study jobs must be on campus, students can work for off-campus, nonprofit or public employers as long as the work is in the public's interest. You may be able to work for a for-profit employer if the job is relevant to your course of study. No matter who the outside employer is, it will need to have an established agreement with your college for you to receive work-study funds. Remember, to be eligible for federal financial aid, you must be enrolled and pursuing a degree or certificate. If you're not working toward a credential, Pell Grants and work-study won't be option, but you may still be able to take advantage of private scholarships -- just be sure to read the eligibility criteria carefully. [Explore what to know about financial aid in online programs.]-- Pay as you go: One of the great benefits to enrolling online is the flexible schedule, which can allow you to complete your college coursework around your responsibilities. But prospective students often overlook using their part- or full-time job earnings as an option for paying for college. Almost 80 percent of college students in 2015 worked at least part time while attending classes, according to the National Center for Education Statistics. By budgeting and thinking strategically about your college costs, you can likely reduce your dependence on student loans by paying a portion out of pocket. Many -- but not all -- online programs are less expensive than traditional programs and often have shorter payment periods. Six, eight or 10 weeks are common course durations. Because of the frequency of payments in an online setting, you may be well-placed to pay as you go and possibly avoid borrowing altogether. Attending college online and avoiding student loans may be challenging, but if you are willing to put in the effort, you can limit the amount you need to borrow. More from U.S. News Q&A: Understanding Student Loan Discharge Eligibility Student Loan Refinancing Isn't Right for All Borrowers
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