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Anti-HIV NanoViricide drug candidate shows promise in animal trials

NanoViricides, Inc said that its anti-HIV drug candidates demonstrated significant therapeutic efficacy in the recently completed preliminary animal studies.

5 May 2008

Novavax opens new U.S. vaccine plant in Rockville, Maryland

Officials from Novavax, Inc., the State of Maryland and Montgomery County today celebrated the opening of Novavax's new state-of-the-art vaccine production facility at the company's headquarters in Rockville, Maryland.

1 May 2008

Breakthrough compound could lead to new class of antihypertensive drugs

University of Florida researchers have identified a drug compound that dramatically lowers blood pressure, improves heart function and - in a remarkable finding - prevents damage to the heart and kidneys in rats with persistent hypertension

1 May 2008

3M Drug Delivery System collaborates on vaccine adjuvants

3M Drug Delivery Systems announces the signing of a non-exclusive license agreement with the Infectious Disease Research Institute (IDRI) in support of vaccine research for humanitarian efforts in developing countries. Under the agreement, 3M will donate its patented toll-like receptor (TLR) immune response modifier compounds.

1 May 2008

FDA needs additional $225 million, new authority to inspect foreign facilities to protect U.S. residents from unsafe prescription drug imports, agency officials say

FDA officials on Tuesday said the agency would need at least $225 million in additional funding annually, along with other authoritative powers, to adequately inspect the safety of imported drug products, the Baltimore Sun reports.

30 Apr 2008

AstraZeneca submits sNDA for SYMBICORT in chronic obstructive pulmonary disease

AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.

30 Apr 2008

ISTA Pharmaceuticals announces new clinical findings to support Bepreve NDA

ISTA Pharmaceuticals, Inc. has announced positive results from the preliminary analysis of its second and final Bepreve (bepotastine ophthalmic solution) Phase III clinical study.

30 Apr 2008

FDA begins multi-year hiring initiative

Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the U.S. Food and Drug Administration begins a multi-year hiring initiative.

30 Apr 2008

Medical schools should implement bans on pharmaceutical, medical device industry gifts, editorial states

A report released on Sunday by a task force of the Association of American Medical Colleges that recommends new restrictions on what physicians, staff members and students at U.S. medical schools can accept from drug companies and medical device makers is "encouraging," but it "flinched" on some important issues, a New York Times editorial states (New York Times, 4/29).

29 Apr 2008

Humana reports Q1 revenue increase driven by Medicare Advantage plan performance

Humana on Monday announced that first-quarter revenue increased by 12% to $6.96 billion from $6.20 billion in the period last year, driven by higher-than-average enrollment in the company's Medicare Advantage plans, the Wall Street Journal reports.

29 Apr 2008

Clinton Foundation, UNITAID announce new antiretroviral discounts

The Clinton Foundation HIV/AIDS Initiative and UNITAID on Monday announced that they have negotiated agreements with generic drug companies that will reduce the cost of some antiretroviral drugs and provide new pediatric formulations, the Wall Street Journal reports.

29 Apr 2008

FDA approves Amitiza for irritable bowel syndrome with constipation

The U.S. Food and Drug Administration today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.

29 Apr 2008

CQ's Carey looks at genetic anti-discrimination measure, legislation to block Medicaid rules implementation, FDA hearings

Mary Agnes Carey, associate editor of CQ HealthBeat, examines Senate approval of genetic nondiscrimination legislation, House passage of a measure to block implementation of new Medicaid rules and hearings about FDA's need for increased inspection resources in this week's "Health on the Hill from kaisernetwork.org and CQ."

28 Apr 2008

Association of American Medical Colleges proposes ban on 'pharma' gifts to physicians, staff, medical students

All 129 U.S. medical schools should not allow pharmaceutical and medical device companies to provide food, gifts and travel to physicians, faculty members and students, according to a report released on Sunday by the Association of American Medical Colleges, the New York Times reports.

28 Apr 2008

FDA official says agency cannot ensure safety of all medications sold in U.S.

Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, on Thursday at a Senate hearing said that the number of medication ingredients manufactured abroad limits the ability of the agency to ensure the safety of all treatments sold in the U.S., CQ HealthBeat reports (Carey, CQ HealthBeat, 4/24).

26 Apr 2008

FDA approves Actonel (risedronate sodium) for postmenopausal osteoporosis

The U.S. Food and Drug Administration (FDA) approved a new once-a-month dose (150 mg) of Actonel (risedronate sodium) tablets for the treatment and prevention of postmenopausal osteoporosis. Actonel is approved to reduce the risk of fractures in postmenopausal women with osteoporosis.

24 Apr 2008

Amneal Pharmaceuticals to acquire assets of Interpharm Holdings

Amneal Pharmaceuticals, LLC has announced the execution of an Asset Purchase Agreement for Amneal's wholly-owned subsidiary, Amneal Pharmaceuticals of New York, LLC, to acquire the assets, facilities and business of Interpharm. The acquisition includes Interpharm's facilities on Long Island, New York as well as the intellectual property including ANDA's, technology and processes.

24 Apr 2008

Newark Star-Ledger examines effect of Wal-Mart generic drug discount program on pharmaceutical industry

The Newark Star-Ledger on Tuesday examined how analysts say the "overall impact" of Wal-Mart Stores' generic prescription drug program on the pharmaceutical industry "has been relatively small" (Cohen/Fitzgerald, Newark Star-Ledger, 4/22).

24 Apr 2008

DNA vaccines may offer hope in multiple sclerosis

Authors from the VA North Texas Health Care System Neurology Section and the Department of Neurology at the University of Texas Southwestern Medical Center at Dallas have highlighted the potential benefits for DNA-based vaccine administration in patients with multiple sclerosis (MS).

24 Apr 2008

Tredaptive and Janumet recommended for approval in European Union

Food and Drug Administration (FDA) is currently reviewing the combination of extended release (ER) niacin and laropiprant under the trademark Cordaptive (ER niacin/laropiprant). The CHMP recommendation does not apply to regulatory decisions by the FDA and no inferences should be made about pending FDA regulatory actions based on the recommendation of the CHMP.

24 Apr 2008