Prescription Drug News and Research

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First Edition: December 6, 2011

In today's headlines, a story detailing how the health law is helping Medicare beneficiaries save money on their prescription drug costs.

6 Dec 2011

FDA assigns CTIs' pixantrone NDA new PDUFA action date

Cell Therapeutics, Inc. today announced that the U.S. Food and Drug Administration's Division of Oncology Products 1 has notified CTI that CTI's October 2011 resubmitted New Drug Application is considered a complete, Class 2 response to the FDA's April 2010 complete response letter.

6 Dec 2011

Just a few days left for Medicare open enrollment

Seniors and persons with disabilities have only days left to enroll in or make changes to their Medicare coverage. Open enrollment, known as the Annual Election Period (AEP) began a month earlier this year, on October 15, and will end three weeks earlier than usual, on December 7. The open enrollment period is when recipients may change their Medicare health plan and/or make changes to Medicare Part D prescription drug coverage.

5 Dec 2011

The Lipitor story: Drug companies brace for losses as patents expire on this and other popular medications

News outlets analyze the impact that generic Lipitor could have on costs and the "era of 'blockbuster drugs'" as well as the strategies from Lipitor's maker to block its generic competitors. Meanwhile, some of these generics are already reaching the marketplace.

2 Dec 2011

Pfizer backs its highest grosser Lipitor

Pfizer’s Lipitor, a blood cholesterol lowering drug, is a popular one the among general population. However now that a generic competition for the drug has arrived in the market the company has devised discounts and incentives for patients, insurers and companies that process prescriptions that will, at least for the next six months, make the brand name drug about as cheap as or cheaper than the generics.

30 Nov 2011

FDA assigns priority-review designation for ELIQUIS NDA for stroke prevention in atrial fibrillation

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS® (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

29 Nov 2011

First Edition: November 28, 2011

In today's headlines, reports about President Barack Obama's pick to succeed Donald Berwick as chief of the Centers for Medicare and Medicaid Services, as well as news about the Supreme Court's consideration of the health law and more on the nation's budget.

28 Nov 2011

Drug for midnight waking gets FDA approval

Transcept Pharmaceuticals Inc. has received the Food and Drug Administration (FDA) approval for its drug Intermezzo - a drug that can help people get back to sleep after waking in the middle of the night. The treatment contains a low-dose of zolpidem tartrate, the active ingredient in Paris-based Sanofi’s sleeping pill Ambien.

27 Nov 2011

Viewpoints: Blame for super committee mess, Supreme Court recusal is the judges' call

What's clear is that committee Democrats moved awfully far in the name of compromise. They offered more in Medicare cuts than Simpson-Bowles did - or than Obama did with Boehner, for that matter - and accepted less in the way of tax increases than those two proposals. For their part, Republicans moved off their position of complete intransigence on taxes. Then they refused to budge.

24 Nov 2011

FDA accepts Regeneron's ARCALYST sBLA for review

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental Biologics License Application (sBLA) for ARCALYST Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy.

22 Nov 2011

UnitedHealthcare announces agreement to acquire XLHealth

UnitedHealthcare, a UnitedHealth Group company, has agreed to acquire XLHealth Corp., a sponsor of Medicare Advantage health plans with a primary focus on Medicare recipients with special needs, such as those with chronic illness, and those also eligible for Medicaid.

22 Nov 2011

Essence Healthcare, CompCare sign new multi-service agreement

Comprehensive Care Corporation announced today it has signed a new multi-service agreement with Essence Healthcare to provide managed behavioral health and pharmacy management services to the Medicare Advantage population serviced by Essence Healthcare in Missouri, Washington and Illinois.

22 Nov 2011

Cigna, HealthSpring receive early termination of waiting period under Hart-Scott-Rodino Act

Cigna Corporation and HealthSpring, Inc. today announced that they have received early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, in connection with Cigna's pending acquisition of HealthSpring. The early termination of the waiting period under the Hart-Scott-Rodino Act satisfies one of the conditions for consummation of the transaction.

21 Nov 2011

New website helps small business owners to review health insurance plans

A greatly expanded website to give small business owners an unprecedented detailed review of their health insurance plan choices was announced today by the U.S. Department of Health and Human Services.

19 Nov 2011

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed.

18 Nov 2011

Debt panel deliberations involve gloom, doom and blame

As indications continue to suggest the super committee stalemate continues, the panel members and other lawmakers are pointing fingers and assigning blame. Health programs -- including Medicare -- continue to be a sticking point. News outlets also examine how the threatened cuts that would kick in if the panel doesn't find success would impact the health sector.

18 Nov 2011

Amgen's XGEVA delays onset of bone metastases in men with prostate cancer

Amgen announced today the publication of results from a Phase 3 trial (the '147 study) that evaluated XGEVA (denosumab) for use in preventing or delaying the onset of bone metastases in men with nonmetastatic castration-resistant prostate cancer.

16 Nov 2011

HFHP now able to offer two stand-alone prescription drug plans statewide

It began in 1996 as a local, community-based alternative to out-of-state insurance mega-giants, but now it is venturing out beyond the Space Coast for the first time. In what has become a real Space Coast business success story, Health First Health Plans (HFHP), which prides itself on its reputation for being community oriented and 100% dedicated to serving the specific needs of Floridians, is now able to offer two stand-alone prescription drug (PDP) plans from the Panhandle to the Keys.

10 Nov 2011

State roundup: Alaska's dental problem; some Minn. health funding blocked

The need for dental care in rural Alaska is huge. According to a recent CDC report, the rate of cavities among rural Alaska Native children is four and a half times greater than the general population of U.S. children of the same age. ... But it's important to note the dental therapist program in Alaska is not without controversy.

10 Nov 2011

APS supports CDC's call for multifaceted approach to address prescription drug misuse

As reported by the U.S Centers for Disease Control, some 15,000 deaths occurred in the U.S. in 2008 from overdoses of prescription pain medications, and demand for treatment of prescription opioid addiction increased almost six fold between 1999 and 2009.

10 Nov 2011