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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

Approaching the cliff: What's at stake for Medicare and Medicaid?

Medicare and other entitlement programs are in the mix as deficit deal-making takes center stage.

17 Nov 2012

Obama pledges 'substantive changes' to Medicare as part of budget deal

President Barack Obama told the nation's top CEOs Wednesday that he was committed to "substantive changes" to Medicare and other entitlement programs, but Senate Democrats are warning him not to cave on entitlements as negotiations with congressional leaders move forward. Also in the mix, health care providers lobby to counter possible Medicare cuts.

16 Nov 2012

Viewpoints: Obama must tell allies that entitlements can't be excluded from fiscal deal; Medical device tax will thwart innovation

As bipartisan negotiations over avoiding the "fiscal cliff" draw nearer, many of President Obama's core Democratic supporters are urging him to fix the debt through defense cuts and tax increases rather than by tackling Social Security, Medicare and other federal entitlement programs. It's a reprise of progressive resistance to the entitlement trims Mr. Obama contemplated during the abortive debt-reduction negotiations with House Speaker John A. Boehner (R-Ohio) last year.

15 Nov 2012

LA Times investigates doctors' connection to prescription drug abuse

Prescription overdoses kill more people than heroin and cocaine. An L.A. Times review of coroners' records finds that drugs prescribed by a small number of doctors caused or contributed to a disproportionate number of deaths.

14 Nov 2012

FDA accepts Navidea’s resubmitted NDA for Lymphoseek

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the Company's October 30, 2012 resubmission of its New Drug Application (NDA) for Lymphoseek (Technetium Tc 99m Tilmanocept) Injection.

14 Nov 2012

FDA grants Priority Review to ImmunoGen’s trastuzumab emtansine BLA

ImmunoGen, Inc., a biopharmaceutical company that develops anticancer products using its Targeted Antibody Payload (TAP) technology and antibody expertise, today announced that Genentech, a member of the Roche Group, has disclosed that the U.S. Food and Drug Administration (FDA) has officially accepted the Biologics License Application (BLA) for trastuzumab emtansine and granted it Priority Review.

7 Nov 2012

Pfizer receives FDA approval for Xeljanz to treat rheumatoid arthritis

The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.

6 Nov 2012