Prescription Drug News and Research

RSS

Roundup: Ga. 'provider fee' defeat could mean $430M less for Medicaid; Minn. health programs in line for $37M cut over fiscal cliff; Calif. stem cell board criticized

Just weeks before the 2013 General Assembly convenes, the state's provider fee, called a "bed tax" by some, remains a high-profile wild card -- one that could deal Georgia's hospital industry a crippling blow. If the fee is not renewed -- and anti-tax forces will oppose it -- the Medicaid system may lose $430 million-plus that the assessment now generates. That loss would swell the state's Medicaid financial shortfall, which is already about $400 million (Miller, 12/6).

7 Dec 2012

Viewpoints: Considering baby boomers' future burden on Medicare; Holtz-Eakin endorses state exchanges; The value (or not) of mammograms

The Congressional Budget Office projects that if current policies continue, total federal spending will rise to 24 percent of gross domestic product in 2022. [Republicans and Washington deficit hawks'] proposed solution is a cap on government spending.

7 Dec 2012

FDA designates two of Cubist’s Phase 3 antibiotic candidates

Cubist Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated two of the company's Phase 3 antibiotic candidates, CXA-201 (ceftolozane/tazobactam) and CB-315, as Qualified Infectious Disease Products (QIDP).

6 Dec 2012

First Edition: December 6, 2012

Today's headlines include a report that some in the GOP are urging lawmakers to support the idea of trading tax breaks for changes in safety-net programs.

6 Dec 2012

Government announces fraud collections hit record $5 billion

The Justice Department's civil division recovered a record $5 billion in the past fiscal year from companies that defrauded taxpayers, with much of the abuse occurring in the health care and mortgage industries.

6 Dec 2012

Studies gauge health law's impact on consumer savings, Rx drug coverage

The Commonwealth Fund concluded that consumers saved $1.5 billion in 2011 as a result of a provision that limits how much insurers can spend on expenses not related to medical care. Meanwhile, Avalere Health found that drug coverage plans offered on health exchanges will vary by state.

6 Dec 2012

Prescribing opioids lead to admissions for substance abuse treatment and deaths

A Viewpoint article published recently in the Journal of the American Medical Association suggests that the clinical practice of prescribing amphetamines, opioids, and benzodiazepines to treat chronic pain may be contributing to the increase in fatal drug overdoses and the likelihood that those drugs will be diverted to the illegal market.

6 Dec 2012

HHS says health law changes to Medicare drug program saved seniors $5 billion

The administration announces that almost 2.8 million people have saved an average $677, because the law is closing the prescription drug doughnut hole.

5 Dec 2012

Appeals court reverses conviction of drug sales rep who talked about off-label uses

In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative's freedom of speech.

5 Dec 2012

Decoding Part D marketing and other news

Choosing a Medicare Prescription Drug plan is a tricky business. Most beneficiaries go for the cheapest monthly premium, but this can be a big mistake, especially for those with unusual or expensive medications.

1 Dec 2012

Negative perceptions about generic drugs are more widespread among ethnic minorities

Negative perceptions about generic drugs are more widespread among ethnic minorities than among whites, finds a new study in Ethnicity & Disease.

1 Dec 2012

Sucampo receives supplement approval from FDA for AMITIZA

Sucampo Pharmaceuticals, Inc. today announced that the Company received a supplement approval from the U.S. Food and Drug Administration (FDA) that removes pregnancy "warnings and precautions" and clarifies information regarding the use of AMITIZA (lubiprostone) by pregnant and/or nursing women. In addition, the FDA expanded the labeling text of the Mechanism of Action section in the prescribing information for AMITIZA.

30 Nov 2012

Eisai announces FDA acceptance of AcipHex NDA for priority review

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review Eisai's New Drug Application (NDA) for AcipHex Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of Gastroesophageal Reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age.

30 Nov 2012

DARA BioSciences submits KRN5500 Orphan Drug Application with FDA

DARA BioSciences, Inc., a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for KRN5500, a compound in development to treat a painful form of chronic chemotherapy-induced peripheral neuropathy (CCIPN).

30 Nov 2012

Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved COMETRIQ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

30 Nov 2012

New rules for 'Obamacare' implementation released - scrutinized by insurers, employers, states, consumers

The Obama administration released new health care regulations Tuesday that preclude insurers from adjusting premiums based on pre-existing or chronic health conditions, tell states what benefits must be included in health exchange plans, and allow employers to reward employees who work to remain healthy.

22 Nov 2012

FDA accepts MAP Pharmaceuticals’ resubmission of NDA for LEVADEX

MAP Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) resubmission for LEVADEX orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA).

22 Nov 2012

What the health law's future holds

Even with the election in the rear view mirror, efforts to implement the healthcare law will continue to face challenges. Meanwhile, experts discuss what steps must be taken to control health care costs and to educate the public about the health overhaul.

20 Nov 2012

FDA accepts Orexo’s Zubsolv NDA for review

FDA has informed Orexo that the Zubsolv New Drug Application (NDA) has been accepted for review, and that the Prescription Drug User Fee Act (PDUFA) action date will be July 6, 2013.

19 Nov 2012

Summit looks at the growing problem of prescription drug abuse

Today, a not-for-profit organization presenting at the Delaware Prescription Drug Abuse Summit appealed to the event's host, Attorney General Beau Biden, for assistance in preventing medication overdoses.

17 Nov 2012