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Sebelius overturns FDA on morning after pill access

The Health and Human Services Secretary Kathleen Sebelius this Wednesday has overturned the Food and Drug Administration's plan to remove the age limit on who can buy Teva Pharmaceutical Industries Ltd's Plan B One-Step pill – commonly known as the “morning after pill” without a prescription.

8 Dec 2011

Medicare enrollment deadline extended — for some

Kaiser Health News reports that federal officials are extending this Dec. 7 deadline for at least two days -- but only to those seniors who contact any of several sources of assistance.

8 Dec 2011

Senate hearing focuses on merger of two big drug benefit managers

Express Scripts and Medco Health Solutions are seeking to combine operations, but some senators have raised concerns about the effect on consumers.

7 Dec 2011

First Edition: December 7, 2011

In the news today, a status check on the work -- including the Medicare doc fix -- that Congress still needs to attend to before leaving Washington for the holidays.

7 Dec 2011

Medicare enrollment deadline is tomorrow

Seniors enrolled in Medicare have until Wednesday to select a medical and prescription-drug plan for 2012. Medicare moved up its enrollment deadline to Wednesday from the traditional Dec. 31 deadline. Consumers who have Medicare and have not selected a plan have until Wednesday to switch plans. Even those who decide to stick with existing plans are encouraged to review their options because plans can change from year to year.

7 Dec 2011

USA Today: Health law provision triggered $1.5 billion in prescription drug savings for beneficiaries

USA Today notes that the government is expected to announce today that the health law's Medicare doughnut hole provision triggered this savings. In other Medicare news, the federal government announced Monday that Medicare will allow its claims database to be used by employers, insurance companies and consumer groups.

7 Dec 2011

PDUFA goal date of NDA for Protalix's taliglucerase alfa extended

Protalix BioTherapeutics, Inc., announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

6 Dec 2011

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