Prescription Drug News and Research

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First Edition: March 1, 2012

Today's headlines set the stage for the Senate's scheduled vote on a measure sponsored by Sen. Roy Blunt, R-Mo., that would allow employers and insurers to opt out of provisions in Obama's health care law to which they object on religious or moral grounds.

1 Mar 2012

FDA extends action date for Bristol-Myers Squibb, Pfizer's Eliquis NDA

Bristol-Myers Squibb Company and Pfizer announced today that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the New Drug Application (NDA) for Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

1 Mar 2012

Mass. Senate race: Brown-Kennedy dust-up continues

Sen. Scott Brown, R-Mass., has refused a request from former Rep. Patrick Kennedy, D-R.I., to pull a campaign advertisement rejecting the federal birth control mandate that features Kennedy's father, the late Sen. Edward Kennedy, D-Mass.

29 Feb 2012

Abortion legislation making noise at state capitols

A host of abortion legislation proposals in state capitols around America - ranging from requiring Colorado doctors with religious objections give patients notice to mandated insurance coverage of abortion in Washington - are making news.

28 Feb 2012

Report identifies patterns in misuse of illicit and prescription drugs among young adults

A new report from researchers at the Drexel University School of Public Health identifies patterns in the misuse of illicit drugs among young adults who also misuse prescription drugs.

28 Feb 2012

FDA assigns Priority Review designation to JRD's XARELTO sNDA

Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

27 Feb 2012

EMA acceptance of peginesatide MAA triggers $5M milestone payment to Affymax

Affymax, Inc. today announced that it will receive a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide.

27 Feb 2012

Cost of NHS prescriptions set to rise

Mr. Burns outlined a number of changes in the amounts charged for NHS services in a written statement to MPs. He added that patients purchasing a three-month or annual prescription payment certificate (PPC) will not face any increase, with the costs remaining at £29.10 and £104, respectively. The health minister pointed out that PPCs “offer savings for those needing four or more items in three months or 14 or more items in one year”.

26 Feb 2012

Impax announces FDA acceptance of NDA filing for IPX066

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson's disease (PD) submitted to the Agency on December 21, 2011.

23 Feb 2012

GOP presidential hopefuls face off in two battleground states

Issues ranging from plans to cap or cut Medicaid spending to voting positions on the Medicare prescription drug program are among the policies being tossed about as candidates jockey for Tea Party votes and conservative credentials.

23 Feb 2012

Enrollment complete in Onyx Phase 3 ASPIRE trial for relapsed multiple myeloma

Onyx Pharmaceuticals, Inc. today announced that it has reached the target enrollment in the ASPIRE trial, a Phase 3 international clinical trial evaluating carfilzomib in combination with lenalidomide (Revlimid) and low dose dexamethasone in patients with relapsed multiple myeloma.

23 Feb 2012

Onyx reports total operating revenue of $237.0M for fourth quarter 2011

Onyx Pharmaceuticals, Inc. today reported its financial results for the full year and fourth quarter 2011. Onyx reported non-GAAP net income of $42.0 million, or $0.66 per diluted share, for the full year 2011 compared to non-GAAP net income of $39.2 million, or $0.63 per diluted share, for the same period in 2010.

23 Feb 2012

FDA EMDAC recommends approval of VIVUS' Qnexa for obesity

VIVUS, Inc. today announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults.

23 Feb 2012

Making a medicinewise choice between brands

Following reports the first generic version of atorvastatin will be hitting pharmacy shelves this week, NPS is urging consumers to be medicinewise when making a choice between medicine brands.

22 Feb 2012

FDA approves new supplies of drugs that are facing shortages

The United States Food and Drugs Administration (FDA) have approved new suppliers for two crucial cancer drugs, easing critical shortages that had been concerning patients and families particularly of the children with leukemia. But there are currently 283 separate prescription drugs in short supply or unavailable nationwide, and regulators and manufacturers say shortages are a long-term problem that will continue to scare patients and doctors.

22 Feb 2012

CMS unveils 2013 Medicare Advantage payment and policy guidelines

Federal officials said Friday that the trend toward relatively low premium charges and stable benefits will likely continue.

22 Feb 2012

First Edition: February 22, 2012

In today's health policy headlines, the Supreme Court added 30 minutes to the time allocation for next month's health law arguments. Also in the news, the federal government announced funding awards yesterday to help launch consumer-governed health plans in eight states.

22 Feb 2012

FDA to review rejected weight loss drug Qnexa

The weight loss pill Qnexa has been once rejected by the FDA over safety concerns. But this Wednesday it will get a second chance before an FDA advisory committee. Qnexa maker Vivus Inc. hopes something might come out of this second chance. The company will be submitting new safety data from patients who took Qnexa for a second year after completing a one-year clinical trial.

21 Feb 2012

FDA grants Priority Review for Repligen's SecreFlo NDA

Repligen Corporation announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the Company's new drug application (NDA) for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis.

21 Feb 2012

NPAF commends passage of bill for parity in insurance coverage for orally administered chemotherapy

Representatives of Virginia's patient advocacy community praised the State House of Representatives and State Senate today for voting strongly in support of legislation that, if enacted, will help thousands of Virginia's insured cancer patients who are currently unable to access their physician-prescribed chemotherapy treatment regimens of choice.

18 Feb 2012