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ThromboGenics submits ocriplasmin BLA with FDA to treat symptomatic VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that it has submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ocriplasmin Intravitreal Injection, 2.5 mg/mL, for the treatment of symptomatic VMA including macular hole.

23 Dec 2011

New way to awaken paternal Ube3a allele linked with Angelman syndrome

Results of a new study from the University of North Carolina at Chapel Hill may help pave the way to a treatment for a neurogenetic disorder often misdiagnosed as cerebral palsy or autism.

22 Dec 2011

Effects of allopregnanolone in women with severe pre-menstrual syndrome

Sensitivity to allopregnanolone, a hormone that occurs naturally in the body after ovulation and during pregnancy, changes during the course of the menstrual cycle and is different in women with severe pre-menstrual syndrome (PMS) compared with women without PMS complaints. This has been shown by Erika Timby in her doctoral dissertation recently defended at Umeå University, Sweden.

22 Dec 2011

Drugmaker Merck to pay $24M to settle Medicaid case

Drugmaker Merck & Co. will pay Massachusetts $24 million to settle a civil lawsuit accusing a former subsidiary of causing the state to overpay pharmacists for a widely used asthma medication. Attorney General Martha Coakley said Tuesday that the deal with Merck and 12 other drugmakers who settled previously enables the state to recover more than $47 million for its Medicaid program.

22 Dec 2011

HPV vaccine support by GAVI example of 'equity in health'

Noting that human papillomavirus (HPV) causes 70 percent of cervical cancer cases worldwide, Mary Robinson, former president of Ireland and former GAVI Alliance Board chair, writes in this BMJ Group Blogs post that the GAVI Alliance's decision to support the introduction of HPV vaccine among women in developing countries "is an important example of how we must continue to strive for equity in health. And it will help ensure that the world's less-privileged women remain the strength behind their children, their families, and their communities."

22 Dec 2011

New silk-based microneedle system for controlled-release drug delivery

Bioengineers at Tufts University School of Engineering have developed a new silk-based microneedle system able to deliver precise amounts of drugs over time and without need for refrigeration. The tiny needles can be fabricated under normal temperature and pressure and from water, so they can be loaded with sensitive biochemical compounds and maintain their activity prior to use. They are also biodegradable and biocompatible.

22 Dec 2011

JAMA commentary argues that vitamin therapy still plays a role in reducing stroke

A commentary by Dr. David Spence of The University of Western Ontario and Dr. Meir Stampfer of the Harvard School of Public Health in today's Journal of the American Medical Association (JAMA) argues that vitamin therapy still has a role to play in reducing stroke.

22 Dec 2011

FDA approves Merck's Isentress to treat HIV-1 infection in children, adolescents

Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.

22 Dec 2011

ACTF, Merck announce new HIV initiatives

Today, Merck, known as MSD outside the United States and Canada, and the ADAP Crisis Task Force (ACTF) announced a number of new initiatives to help struggling state AIDS Drug Assistance Programs (ADAPs) continue to provide access to medicines to people living with HIV.

22 Dec 2011

Impax submits IPX066 NDA to FDA for treatment of Parkinson's

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. today announced the submission of Impax's New Drug Application (NDA) for IPX066 to the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic Parkinson's disease (PD). IPX066 is a patented extended release capsule formulation of carbidopa-levodopa.

22 Dec 2011

Leishmania parasite develops combined resistance against drug, human immune system

Scientists of the Institute of Tropical Medicine (ITG) discovered a parasite that not only had developed resistance against a common medicine, but at the same time had become better in withstanding the human immune system.

22 Dec 2011

Malaria vaccine shows early success

An experimental vaccine for malaria has been developed by British scientists. It has shown early potential to neutralize many, perhaps all, strains of the deadliest malaria parasite.

21 Dec 2011

CutisPharma introduces FIRST - Mouthwash Kits

CutisPharma, Inc. announced the introduction of FIRST - Mouthwash BLM 4oz and FIRST - Mouthwash BLM 6oz compounding kits. These products expand the FIRST Magic Mouthwash line for CutisPharma.

21 Dec 2011

Actavis enters LOI with QRxPharma to commercialize MoxDuo IR in the U.S.

Actavis Group, the international generic pharmaceuticals company, today announced that its US subsidiary, Actavis Inc, has entered into a binding letter of intent (LOI) with QRxPharma Limited to commercialize MoxDuo IR in the United States.

21 Dec 2011

Optical imaging can visualize cultured cancer cells' response to particular drug

Many cancer therapies target specific proteins that proliferate on the outside of some cancer cells, but the therapies are imperfect and the cancer does not always respond. Since it is beneficial for doctors to know as soon as possible how a cancer is affected by treatment, researchers from Vanderbilt University are striving to design tests that assess treatment response rapidly, accurately, and cost-effectively.

21 Dec 2011

Low-income neighborhoods often misinformed about emergency contraception access

Researchers from Boston Medical Center (BMC) and Boston University School of Medicine (BUSM) have found that in low-income neighborhoods, misinformation about access to emergency contraception is a common occurrence.

21 Dec 2011

Ranbaxy signs consent decree with U.S. FDA

Ranbaxy Laboratories Ltd. today announced that it has signed a consent decree with the U.S. Food and Drug Administration.

21 Dec 2011

FDA accepts Pfizer's tofacitinib NDA for review

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

21 Dec 2011

University of Oxford scientists develop new candidate malaria vaccine

A new candidate malaria vaccine with the potential to neutralise all strains of the most deadly species of malaria parasite has been developed by a team led by scientists at the University of Oxford.

21 Dec 2011

Takeda receives FDA approval for EDARBYCLOR to treat hypertension

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced that the U.S. Food and Drug Administration (FDA) approved EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.

21 Dec 2011