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Remaining stocks of Trasylol removed

On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.

15 May 2008

GenoMed offers its patented treatment to Chinese earthquake victims

GenoMed has announced that it has offered its treatment to physicians caring for victims of the recent earthquake in China.

14 May 2008

Lawmakers criticize agencies for lack of coordination of prescription drug benefits for federal retirees

A lack of coordination between CMS and the Office of Personnel Management on prescription drug benefits for federal retirees has cost those retirees and the federal government as much as $200 million annually, according to a letter sent to the agencies on Monday by two House Democrats, CQ HealthBeat reports.

13 May 2008

Hawaii Legislature overrides Gov. Lingle's veto of prescription drug importation program

Hawaii lawmakers last week overrode Gov. Linda Lingle's (R) veto of a bill that will enroll the state in I-SaveRx, a program that allows residents to purchase lower-cost prescription drugs from other countries, the AP/Honolulu Advertiser reports.

13 May 2008

Canadian drug company awarded Rwandan contract to provide combination antiretroviral

Rwanda recently accepted a bid from the Toronto-based generic drug company Apotex to supply its fixed-dose combination antiretroviral drug Apo-triAvir to the country, the Toronto Star reports (Toronto Star, 5/9).

13 May 2008

Barr announces approval of generic version of Yasmin (drospirenone and ethinyl estradiol)

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.

9 May 2008

PolyMedix receives clearance to initiate phase I clinical study of novel systemic antibiotic compound

PolyMedix, Inc. has received a notice of no objection from Health Canada for the Company's Clinical Trial Application ("CTA") for its defensin mimetic antibiotic compound, PMX-30063. This notice of no objection allows for the initiation of human clinical studies in Canada. PMX-30063 is the first defensin mimetic antibiotic compound cleared to enter human clinical trials for systemic use, representing an entirely new class of antibiotic drugs.

9 May 2008

FDA approves new formulation of genetically engineered version of Factor VIIa plasma protein

The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.

9 May 2008

FDA approves first generic versions of Requip (ropinirole hydrochloride)

The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

9 May 2008

New guidelines say botulinum toxin effective for many neurological disorders, but not headache

New guidelines developed by the American Academy of Neurology confirm that the drug botulinum toxin is safe and effective for treating a variety of neurological conditions. Surprisingly, the drug may not be effective for chronic headaches, accrding to Allison Brashear, M.D., professor and chairman of the Department of Neurology at Wake Forest University Baptist Medical Center, who helped develop the guidelines.

9 May 2008

Cytopia announces novel anti-cancer drug development collaboration

Cytopia Limited today announced that it has entered into an anti-cancer drug discovery and development collaboration with Cancer Therapeutics CRC Pty Ltd. This agreement leverages Cytopia's early stage drug discovery pipeline of kinase inhibitors, a class of targeted therapeutics that is one of the fastest growing segments of the cancer drug market.

9 May 2008

Hearing to focus on direct-to-consumer ads for prescription drugs

Officials for Pfizer, Johnson & Johnson, Merck and Schering-Plough on Thursday will testify at a House Energy and Commerce Oversight and Investigations Subcommittee hearing that Democrats hope will "lay the groundwork for future legislation to tighten controls on drug marketing," the Wall Street Journal reports.

8 May 2008

FDA approves Strattera for ADHD in children and adolescents

Eli Lilly and Company announced today that the United States Food and Drug Administration (FDA) has approved Strattera (atomoxetine HCI) for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults.

8 May 2008

Apotex receives final tender approval from Rwanda for vital AIDS drug

Apotex Inc., Canada's largest generic pharmaceutical company has successfully bid and been awarded a tender from the Rwandan Government for the life saving triple combination AIDS drug "Apo Triavir". Apotex is the first company to provide this medicine to Africa under the provisions of the Canadian Access to Medicines Regime (CAMR).

7 May 2008

NCPA statement on "sense of congress" resolution opposing FDA restrictions on Estriol use

Yesterday H. Con. Res. 342 was introduced by Rep. Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.) opposing the Food and Drug Administration’s (FDA) decision to restrict Estriol (a form of Estrogen), a compounded hormone preparation used by women to alleviate the symptoms of menopause.

7 May 2008

GenVec announces grant for respiratory syncytial virus vaccine program

GenVec, Inc. announced today that it has received an Advanced Technology Phase I Small Business Innovation and Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases, of the National Institutes of Health, to support the Company's efforts to develop vaccines for the prevention of respiratory syncytial virus (RSV).

7 May 2008

Wal-Mart generic drug program to begin offering 90-day supplies of more than 350 medications for $10 each

Wal-Mart officials on Monday announced the company will expand its discount program for generic drugs to offer three-month supplies for $10, the AP/Google.com reports (Harris, AP/Google.com, 5/5).

6 May 2008

Prana Biotechnology has discovered novel drug candidates for use in Parkinson's disease

Prana Biotechnology Limited has announced that it has identified novel therapeutic drug candidates from its Parkinson's disease program. Already, a lead candidate drug has demonstrated positive effects in pre-clinical studies, protecting the brain from damage to the substantia nigra, the area of the brain affected in Parkinson's disease.

6 May 2008

Forty-one percent of registered nurses find generics are less effective than name brand drugs say American Society of Registered Nurses

In a national online survey conducted by the American Society of Registered Nurses, 41% of the 781 Registered Nurses surveyed on April 28 reported that generic drugs are less effective than their equivalent brand-name counterparts.

5 May 2008

Drug candidate to treat smallpox scaled up by new partnership

Two American companies are teaming up for second-round test-phase production of a FDA-designated "fast track" drug candidate to treat smallpox, a deadly virus that is feared to be able to reach people through acts of bio-warfare or bio-terrorism.

5 May 2008

Pharmaceutical News

Remaining stocks of Trasylol removed

GenoMed offers its patented treatment to Chinese earthquake victims

Lawmakers criticize agencies for lack of coordination of prescription drug benefits for federal retirees

Hawaii Legislature overrides Gov. Lingle's veto of prescription drug importation program

Canadian drug company awarded Rwandan contract to provide combination antiretroviral

Barr announces approval of generic version of Yasmin (drospirenone and ethinyl estradiol)

PolyMedix receives clearance to initiate phase I clinical study of novel systemic antibiotic compound

FDA approves new formulation of genetically engineered version of Factor VIIa plasma protein

FDA approves first generic versions of Requip (ropinirole hydrochloride)

New guidelines say botulinum toxin effective for many neurological disorders, but not headache

Cytopia announces novel anti-cancer drug development collaboration

Hearing to focus on direct-to-consumer ads for prescription drugs

FDA approves Strattera for ADHD in children and adolescents

Apotex receives final tender approval from Rwanda for vital AIDS drug

NCPA statement on "sense of congress" resolution opposing FDA restrictions on Estriol use

GenVec announces grant for respiratory syncytial virus vaccine program

Wal-Mart generic drug program to begin offering 90-day supplies of more than 350 medications for $10 each

Prana Biotechnology has discovered novel drug candidates for use in Parkinson's disease

Forty-one percent of registered nurses find generics are less effective than name brand drugs say American Society of Registered Nurses

Drug candidate to treat smallpox scaled up by new partnership

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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