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FDA panel favors continued research on novel pain medicine

A panel of experts for the U.S. Food and Drugs Administration (FDA) this Monday recommended that the federal government should allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure.

13 Mar 2012

Agennix, DSM sign new contract to manufacture talactoferrin for NSCLC

DSM Pharmaceutical Products, the custom manufacturing business of Royal DSM N.V., and Agennix AG have signed a new contract under which DSM will continue to manufacture talactoferrin for Agennix at commercial levels.

13 Mar 2012

Feds reject J & J's $1 billion drug settlement

Prosecutors in Washington, D.C., have rejected a roughly $1 billion proposed settlement to resolve allegations that Johnson & Johnson promoted the antipsychotic drug Risperdal for unapproved uses, according to people familiar with the matter.

13 Mar 2012

FTY720 improves locomotor recovery in mice with SCI

A new study suggests that administering FTY720, an oral drug that has shown promise in trials for human multiple sclerosis, significantly improves locomotor recovery in mice with spinal cord injury.

13 Mar 2012

Scientists at Seattle conference discuss progress, obstacles in fight against HIV/AIDS

"Scientists, stymied for decades by the complexity of the human immunodeficiency virus, are making progress on several fronts in the search for a cure for HIV infections," but "a major stumbling block is the fact that HIV lies low in pools or reservoirs of latent infection that even powerful drugs cannot reach, scientists told the Conference on Retroviruses and Opportunistic Infections, one of the world's largest scientific meetings on HIV/AIDS," in Seattle last week, Reuters reports.

13 Mar 2012

JAK-STAT inhibitors reverse MS-like disease in mice

A new class of drugs completing clinical trials soon for rheumatoid arthritis should be examined as a treatment for multiple sclerosis, according to the authors of a University of Alabama at Birmingham study published today in the Proceedings of the National Academy of Sciences.

13 Mar 2012

Cancer Research UK disappointed over SMC ruling against advanced prostate cancer drug

Cancer Research UK is extremely disappointed that the advanced prostate cancer drug, abiraterone, has been ruled too expensive for routine use by the Scottish Medicines Consortium (SMC).

12 Mar 2012

Pfizer’s Prevnar 13 Phase 3 study for pneumococcal disease meets all study endpoints

Pfizer Inc. announced today that data from a Phase 3 study of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) met all study endpoints, showing immunogenicity and establishing a safety profile in children and adolescents aged 5 through 17 years.

12 Mar 2012

BDSI announces postponement of ONSOLIS U.S. relaunch

BioDelivery Sciences International, Inc. today announced that the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two appearance issues raised by the U.S. Food and Drug Administration (FDA) following a recent inspection of the Aveva manufacturing facility where ONSOLIS is produced.

12 Mar 2012

FDA approves Organogenesis oral soft tissue regeneration product, GINTUIT

Today Organogenesis Inc., a business leader in the regenerative medicine field, announced that the United States Food and Drug Administration (FDA) has approved GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), a cell-based product that has been shown to predictably generate new and aesthetically appealing oral soft tissue (gum tissue).

12 Mar 2012

Over 71% of all rogue online pharmacies clustered with just ten Registrars

In the wake of news regarding counterfeit Avastin hitting the US market, a new analysis released by LegitScript.com estimates that out of roughly 450 companies with ICANN accreditations to sell domain names, over 71% of all rogue online pharmacies are clustered with just ten Registrars, with over 50% of all rogue online pharmacies at just two Registrars.

12 Mar 2012

Former 'legal high' even more popular after UK ban

The former 'legal high' mephedrone is even more popular than it was shortly after it was banned by the UK government, according to a survey of London club-goers published in the Journal of Substance Use today.

12 Mar 2012

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

12 Mar 2012

ITQB, REQUIMTE convert solid antibiotic ampicilin into an ionic liquid form

In a daring move into the biomedical arena, ITQB chemists from the Molecular Thermodynamics Lab and collaborators from REQUIMTE have managed to convert the solid antibiotic ampicilin into an ionic liquid form, a method that may be extended to other pharmaceutical compounds with benefits for their administration. The work is now published in Medicinal Chemistry Communications.

12 Mar 2012

TSRI, OPKO Health to develop and commercialize SR 3306 for Parkinson's

OPKO Health, Inc. and The Scripps Research Institute today announced a global agreement for the development and commercialization of SR 3306, a novel compound discovered by scientists from the Florida campus of The Scripps Research Institute that blocks the destruction of brains cells in animal models of Parkinson's disease.

12 Mar 2012

FDA may allow many chronic ailment drugs to be available over-the-counter

The U.S. Food and Drug Administration (FDA) is deciding on a proposal to waive prescription requirements for commonly used drugs that treat conditions like diabetes, asthma, and migraines.

11 Mar 2012

Methylphenidate may affect learning and memory in children with ADHD

New research with monkeys sheds light on how the drug methylphenidate may affect learning and memory in children with attention deficit hyperactivity disorder.

11 Mar 2012

FDA approves Boca Pharmacal's generic Tapazole Methimazole tablets ANDA

Boca Pharmacal, Inc., today announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Methimazole Tablets USP, 5mg and 10mg, the generic version of King Pharmaceuticals' Tapazole® Methimazole tablets, indicated to treat hyperthyroidism.

10 Mar 2012

Blood vessels that form within brain cancers predominantly not made up of cancer cells

Johns Hopkins scientists have published laboratory data refuting studies that suggest blood vessels that form within brain cancers are largely made up of cancer cells. The theory of cancer-based blood vessels calls into question the use and value of anticancer drugs that target these blood vessels, including bevacizumab (Avastin).

10 Mar 2012

Consumer coalition sues drugmakers over coupon programs

The lawsuit claims that these popular programs, which appear to save money for patients, actually increase costs and conceal information about the discounts from health plans.

9 Mar 2012