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French guy says Parkinson’s drug induced gambling and gay sex addiction, tries to sue GSK for $610,000

GlaxoSmithKline is being sued this week by a French father-of-two, alleging the British pharmaceutical firm’s drug – Reqip (Ropirnirole) to treat Parkinson’s disease turned him into a gay sex and gambling addict. Parkinson’s disease is a seriously and progressively debilitating disease that leads to tremors, slowing of movements and ultimately total immobility.

1 Feb 2011

King Pharmaceuticals awards payment to Pain Therapeutics for abuse-resistant medications

Pain Therapeutics, today announced that it had received a $5,000,000 milestone payment from King Pharmaceuticals, its exclusive commercial partner for abuse-resistant prescription pain medications.

29 Jan 2011

FDA accepts Pain Therapeutics NDA resubmission for REMOXY

Pain Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) resubmission for REMOXY (controlled-release oxycodone) and has classified it as a Class 2 resubmission.

27 Jan 2011

Medisafe to develop barcoded system to confirm origin of prescription medications

Medisafe 1 Technologies Corp., a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company intends to begin development of a barcoded system to confirm the origin and authenticity of prescription medications. The product is aimed at reducing ingestion of counterfeit medications.

27 Jan 2011

FDA accepts Optimer's fidaxomicin NDA for filing

Optimer Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI.

24 Jan 2011

R-Tech Ueno announces completion of RK-023 Phase 2a study for androgenetic alopecia

R-Tech Ueno, is pleased to announce that the Phase 2a clinical study of RK-023 to treat androgenetic alopecia was completed by January 21, 2011.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

Three million Medicare beneficiaries receive prescription drug cost relief through Affordable Care Act

U.S. Department of Health and Human Services Secretary Kathleen Sebelius today announced that three million Medicare beneficiaries nationwide have received prescription drug cost relief through the Affordable Care Act. To date, three million eligible beneficiaries who fell into the drug coverage gap known as the donut hole during 2010 have been mailed a one-time, tax-free $250 rebate check.

21 Jan 2011

AARP opposes health law repeal, writes letter to Congress

AARP CEO A. Barry Rand sent a letter to Members of Congress yesterday in advance of a scheduled vote on legislation to repeal the Affordable Care Act. In his letter, Rand said, "While we respect that there are those who do not support the ACA, AARP opposes repeal because the new law includes many vital provisions important to older Americans and their children."

21 Jan 2011

Viewpoints: Endorsing - and repudiating - health law repeal; Gov. Brewer on Ariz. Medicaid; Medical devices 'red tape'

The reason the GOP never got around to proposing a serious plan to expand coverage and control costs is because doing that is excruciatingly hard and politically dangerous. Look how long Democrats struggled to craft a measure and what happened to them after they passed it.

21 Jan 2011

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C.

20 Jan 2011

UnitedHealth Group reports net earnings of $4.10 per share for 2010

UnitedHealth Group today reported fourth quarter and full year 2010 financial results, including strong revenue growth from both its Health Benefits and Health Services business platforms. Full year and fourth quarter 2010 net earnings were $4.10 per share and $0.94 per share, respectively.

20 Jan 2011

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

ADVENTRX Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA).

20 Jan 2011

FDA announces consent decree of permanent injunction against Deltex

The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.

19 Jan 2011

Roundup: Calif., Fla. differ on health law; Texas Gov. on Medicaid 'flexibility'; Ariz. mental health

While Republicans open debate Tuesday on repealing health reform, leaders in California are sitting down to a completely different discussion: how they can most aggressively implement the new law and remain among the Obama administration's model states on the reform — without stumbling over the significant challenges that stand in their way (Kliff, 1/18).

18 Jan 2011

FDA calls for cuts in Acetaminophen in painkillers

The US FDA has asked for a limit on the amount of acetaminophen in prescription pain medicines in an effort to reduce the risk of liver damage. The announcement yesterday asked manufacturers to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and asked them to carry a “black box” warning about potential liver failure. At present these combinations carry up to 750 milligrams of acetaminophen.

13 Jan 2011

Study supports use of PRX as an anti-cataract agent

Scientists are reporting a scientific basis for the long-standing belief that a widely used non-prescription drug in China and certain other countries can prevent and treat cataracts, a clouding of the lens of the eye that is a leading cause of vision loss worldwide. Their study appears in Inorganic Chemistry, an ACS journal.

13 Jan 2011

FDA accepts to review Fibrocell Science's azficel-T drug

Fibrocell Science, a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that the U.S. Food & Drug Administration has accepted for review the Company's complete response submission for azficel-T, proposed brand name laViv, for the treatment of moderate to severe nasolabial folds and wrinkles.

12 Jan 2011

K-V Pharmaceutical provides update on FDA review of NDA for Gestiva

K-V Pharmaceutical Company today issued an update on the status of the U.S. Food and Drug Administration's review of Hologic, Inc.'s New Drug Application for Gestiva as a treatment for the prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

12 Jan 2011

US most susceptible to brand erosion post patent expiry

On average, small molecule brands in the US experienced the greatest degree of brand erosion following patent expiry and exposure to direct generic competition, according to a new report from independent market analyst, Datamonitor.

12 Jan 2011