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Protein-restricted diet supplemented with IGF-I may protect from Alzheimer's

Mice with many of the pathologies of Alzheimer's Disease showed fewer signs of the disease when given a protein-restricted diet supplemented with specific amino acids every other week for four months.

15 Feb 2013

Patient-specific cancer cell lines designed to predict chemotherapy sensitivity

In laboratory studies, scientists at the Johns Hopkins Kimmel Cancer Center have developed a way to personalize chemotherapy drug selection for cancer patients by using cell lines created from their own tumors.

15 Feb 2013

Oramed to submit new oral insulin IND with FDA

Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that it has been in communication with the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application for oral insulin.

15 Feb 2013

Treasury pick says he will work to reduce Medicare spending, but offers few specifics

Meanwhile, President Barack Obama's references in his State of the Union address to modest changes to Medicare continue to generate examination.

15 Feb 2013

IOM report offers recommendations to combat distribution of fake, substandard medicines

The Institute of Medicine of the National Academies "is urging stronger regulation of pharmaceuticals around the world to combat the growing problem of fake and poor-quality medicines," NPR's "Shots" blog reports.

15 Feb 2013

FDA committee recommends approval of Guerbet’s Dotarem NDA for adults and children

Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older.

15 Feb 2013

Third Rock Ventures announces formation of Jounce Therapeutics

Third Rock Ventures, LLC today announced the formation of Jounce Therapeutics, Inc. with a $47 million Series A financing of the company. Jounce is focused on the discovery and development of first-in-class cancer immunotherapies designed to harness the patient's immune system to seek out and attack cancerous cells and tumors.

15 Feb 2013

University of Granada’s melatonin gel effective against mucositis

Mucositis is one of the most frequent side effects of chemotherapy and radiotherapy in cancer patients and currently cannot be treated. Investigators at the University of Granada have patented a melatonin gel that is 100% effective against this inflammatory reaction.

15 Feb 2013

SPI Pharma launches Actimask Ibuprofen 92S

SPI Pharma, Inc., a global leader in providing pharmaceutical ingredients and technologies for patient-friendly dosage forms, announces the launch of Actimask Ibuprofen 92S, a taste-masked Ibuprofen.

15 Feb 2013

Viewpoints: FDA needs more power to regulate compounding pharmacies; Time to revamp military benefits, including health

Traditionally, the licensing and control of pharmacies has been left to the states, but their performance has been uneven. The federal role has been thrown into question in recent years by lawsuits. ... compounding pharmacies are not generally required to inform the FDA that they are in business nor to register with the FDA or disclose what products they are making.

15 Feb 2013

Cambrex, Dow partner to manufacture HPMCAS for drug solubility enhancement

Cambrex and The Dow Chemical Company have executed an agreement for Cambrex to contract manufacture Dow Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) for Drug Solubility Enhancement.

15 Feb 2013

Mallinckrodt, Actavis enter settlement agreement to resolve Exalgo patent litigation

Actavis, Inc. today announced that it has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Actavis' generic version of the 32 mg dosage strength of Mallinckrodt's Exalgo (Hydromorphone Hydrochloride Extended-Release) tablets.

15 Feb 2013

FDA approves Teva’s generic Adderall XR ANDA for treatment of ADHD

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shire's Adderall XR Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder.

14 Feb 2013

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

Santarus, Inc. announced today the U.S. commercial launch of UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

14 Feb 2013

FDA acknowledges United Therapeutics’ oral treprostinil NDA to treat PAH

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension.

14 Feb 2013

Blocking C5a protein prevents low birth weight in babies born to pregnant women with malaria

An international team of tropical medicine researchers have discovered a potential method for preventing low birth weight in babies born to pregnant women who are exposed to malaria. Low birth weight is the leading cause of infant death globally.

14 Feb 2013

New study reveals racial disparities in chronic pain management

Opioids are frequently prescribed for pain management in noncancer patients, but recommended clinical guidelines for monitoring effectiveness and signs of drug abuse are often not implemented. Alongside well-documented racial disparities in prescribing opioid medications for pain, researchers report racial differences in the use of recommended opioid monitoring and follow-up treatment practices.

14 Feb 2013

Combination of Methotrexat and Tofacitinib shows promise against rheumatoid arthritis

Together with colleagues from the international rheumatic diseases research community, scientists of the Charité - Universitätsmedizin Berlin have presented a new therapy approach for the treatment of rheumatoid arthritis (RA), a chronic form of joint inflammation.

14 Feb 2013

FOXC2 vital to epithelial-mesenchymal transition in breast cancer

Researchers have identified a pivotal protein in a cellular transformation that makes a cancer cell more resistant to treatment and more capable of growing and spreading, making it an inviting new target for drug development.

14 Feb 2013

Traumatic brain injury investigational treatment from BHR Pharma receives EMA orphan medicinal product designation

BHR Pharma, LLC announced today the European Medicines Agency (EMA), responsible for evaluating medicines developed for use in the European Union, granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its proprietary intravenous progesterone infusion agent, BHR-100. The agent currently is being evaluated as a neuroprotective treatment for severe traumatic brain injury (TBI) in the global, Phase III SyNAPSe® clinical trial.

14 Feb 2013

Pharmaceutical News

Protein-restricted diet supplemented with IGF-I may protect from Alzheimer's

Patient-specific cancer cell lines designed to predict chemotherapy sensitivity

Oramed to submit new oral insulin IND with FDA

Treasury pick says he will work to reduce Medicare spending, but offers few specifics

IOM report offers recommendations to combat distribution of fake, substandard medicines

FDA committee recommends approval of Guerbet’s Dotarem NDA for adults and children

Third Rock Ventures announces formation of Jounce Therapeutics

University of Granada’s melatonin gel effective against mucositis

SPI Pharma launches Actimask Ibuprofen 92S

Viewpoints: FDA needs more power to regulate compounding pharmacies; Time to revamp military benefits, including health

Cambrex, Dow partner to manufacture HPMCAS for drug solubility enhancement

Mallinckrodt, Actavis enter settlement agreement to resolve Exalgo patent litigation

FDA approves Teva’s generic Adderall XR ANDA for treatment of ADHD

Santarus launches UCERIS for induction of remission in patients with ulcerative colitis

FDA acknowledges United Therapeutics’ oral treprostinil NDA to treat PAH

Blocking C5a protein prevents low birth weight in babies born to pregnant women with malaria

New study reveals racial disparities in chronic pain management

Combination of Methotrexat and Tofacitinib shows promise against rheumatoid arthritis

FOXC2 vital to epithelial-mesenchymal transition in breast cancer

Traumatic brain injury investigational treatment from BHR Pharma receives EMA orphan medicinal product designation

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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