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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

Theradiag’s new biotherapy monitoring kits receive CE mark approval

Theradiag, a company specializing in theranostic and in vitro diagnostics, today announced it has obtained a CE mark for two new biotherapy monitoring kits; Tocilizumab (anti-IL6R) and Rituximab (anti-CD20) that further expand the Lisa Tracker range.

14 Feb 2013

Study demonstrates how CN2097 works to restore neural functions impaired by Angelman syndrome

In a new study in mice, a scientific collaboration centered at Brown University lays out in unprecedented detail a neurological signaling breakdown in Angelman syndrome, a disorder that affects thousands of children each year, characterized by developmental delay, seizures, and other problems.

14 Feb 2013

FDA grants orphan drug status to Lentigen’s LG631-CD34 for treatment of glioblastoma multiforme

Lentigen Corporation, a biotechnology company specializing in the development and manufacture of lentiviral gene delivery products, announced today that that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to P140K methylguanine methyltransferase (MGMT) transduced human CD34 cells for bone marrow protection in the treatment of glioblastoma multiforme.

14 Feb 2013

FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Pioglitazone Hydrochloride Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Synthon Pharmaceuticals, Inc., and will be available in 15 mg, 30 mg, and 45 mg strengths.

14 Feb 2013

Periconceptional folic acid intake may reduce risk of autistic disorder in children

In a study that included approximately 85,000 Norwegian children, maternal use of supplemental folic acid from 4 weeks before to 8 weeks after the start of pregnancy was associated with a lower risk of autistic disorder in children, according to a study appearing in the February 13 issue of JAMA.

13 Feb 2013

African-American and Caucasian women absorb, metabolize vitamin D at same rate

African-American women battling vitamin D deficiencies need the same dose as Caucasian women to treat the condition, according to a recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).

13 Feb 2013

Antibody therapeutics targeting GPCRs to be developed by alliance between MorphoSys and Heptares

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and UK-based Heptares Therapeutics, the leading GPCR drug discovery and development company, have signed an agreement to discover novel antibody therapeutics targeting G protein-coupled receptors (GPCRs), which are membrane proteins involved in a broad range of biological processes and diseases.

13 Feb 2013

State Medicaid drug selection panels' conflict-of-interest policies vary widely

State policies to ensure drug selection in Medicaid programs is free from outside influence vary widely, according to a new study.

13 Feb 2013

Scopolamine may also be possible treatment for anxiety disorders

However, scopolamine is re-emerging as an antidepressant, with recent studies showing that scopolamine can rapidly improve mood in depressed patients. In addition, in a new study published in Biological Psychiatry this month by Dr. Moriel Zelikowsky and colleagues at the University of California, Los Angeles, it may also be a possible treatment for anxiety disorders.

13 Feb 2013

Pharmaceutical News

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

Theradiag’s new biotherapy monitoring kits receive CE mark approval

Study demonstrates how CN2097 works to restore neural functions impaired by Angelman syndrome

FDA grants orphan drug status to Lentigen’s LG631-CD34 for treatment of glioblastoma multiforme

FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

Periconceptional folic acid intake may reduce risk of autistic disorder in children

African-American and Caucasian women absorb, metabolize vitamin D at same rate

Antibody therapeutics targeting GPCRs to be developed by alliance between MorphoSys and Heptares

State Medicaid drug selection panels' conflict-of-interest policies vary widely

Scopolamine may also be possible treatment for anxiety disorders

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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