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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

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