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Bend Research expands hot-melt extrusion pharmaceutical manufacturing capabilities

Bend Research Inc., a leading independent drug-formulation development and manufacturing company, announced today that it is expanding its pharmaceutical manufacturing capabilities for hot-melt extrusion.

7 Sep 2010

DSM Pharma launches InnoSyn route scouting services for pharmaceutical customers

DSM Pharma Chemicals, a business unit of DSM Pharmaceutical Products, today announced the launch of InnoSyn™ route scouting services. In response to the increasing interest of pharmaceutical customers to outsource the development of robust low-cost manufacturing routes, DSM is offering focused and flexible stand alone route scouting services.

7 Sep 2010

Scientists urge government to set target effectiveness for newly approved antibiotics

The United States must focus on conserving the use of antibacterial drugs, or face a public health crisis from rapidly rising rates of antibiotic-resistant infections, according to an analysis out today.

7 Sep 2010

Almost half of all Americans use prescription drugs each month

Nearly half of all Americans used at least one prescription drug per month in 2008, according to a study by the Centers for Disease Control and Prevention, Bloomberg reports. That's a 10 percent increase over the preceding decade. Over that time, yearly spending by Americans on drugs doubled to $234 billion. "The two biggest-sellers last year were Pfizer Inc.'s Lipitor for high cholesterol and Bristol-Myers Squibb Co.'s clot-buster, Plavix.

4 Sep 2010

FDA approves IDE study to evaluate HeartWare Ventricular Assist System

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a second allotment of 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

4 Sep 2010

Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.

3 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Celldex Therapeutics regains worldwide rights to commercialize rindopepimut therapeutic cancer vaccine

Celldex Therapeutics, Inc. announced today it will regain full worldwide rights to develop and commercialize rindopepimut (CDX-110), effective November 1, 2010.

3 Sep 2010

Regional Director of WHO Africa warns of impact global financial situation will have on health systems, MDGs

Regional Director of WHO for Africa Luis Sambo discussed during the 60th session of the Africa Committee of the WHO how the global economic situation could impact funding for health programs in Africa and the ability for countries to reach U.N. Millennium Development Goal targets, PANA/Afrique en ligne reports.

3 Sep 2010

EQP program helps healthcare professionals identify quality of dietary supplements

Not all supplements are created equally but Emerson Ecologics, the largest provider of dietary supplements and services to healthcare professionals, is taking aggressive steps to make it more clear to healthcare professionals and their patients which manufacturers to trust when it comes to a supplement's purity, identity and potency.

3 Sep 2010

New peer-reviewed study on chemopreventive effects of Protandim

LifeVantage Corporation, the maker of Protandim®, a clinically proven, science-based therapy for oxidative stress, announced today that a new peer-reviewed study involving Protandim® was published in the scientific journal PLoS ONE. The study, conducted by researchers at Louisiana State University, examined the biochemical mechanisms that underlie the ability of Protandim® to suppress tumors in mice. That ability was previously demonstrated by the authors in a study involving a mouse two-stage model of chemically-induced skin cancer.

3 Sep 2010

Dilemmas created for healthcare professionals by medicinal use of cannabis

Nurses have a responsibility to respect and support patients who use cannabis for medicinal purposes, but must stay within the law and follow professional guidance at all times, according to a research review in the September issue of the Journal of Clinical Nursing.

3 Sep 2010

'Gateway effect' of marijuana overblown

New research from the University of New Hampshire shows that the "gateway effect" of marijuana - that teenagers who use marijuana are more likely to move on to harder illicit drugs as young adults - is overblown.

3 Sep 2010

'Aspartame danger' myths

Heard the one about how aspartame single-handedly caused the Gulf War syndrome? In recent years, outlandish allegations – often spread via the Internet by individuals who have little scientific or medical expertise – have tried to link the low-calorie sweetener to every ailment ranging from Multiple Sclerosis and Parkinson's disease to cancer and weight gain. However, the overwhelming body of scientific evidence via more than three decades of research and over 200 studies demonstrate that aspartame is safe.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

3 Sep 2010

BDSI announces positive meeting with FDA, Meda on REMS program for ONSOLIS

BioDelivery Sciences International, Inc. today announced a positive meeting with the U.S. Food and Drug Administration (FDA), Meda and BDSI that occurred on Wednesday, July 21, 2010 to discuss significant modifications to the existing Risk Evaluation and Mitigation Strategy (REMS) program for ONSOLIS (fentanyl buccal soluble film).

3 Sep 2010

Study finds high content of aluminium in infant formulas

The aluminium content of a range of the most popular brands of infant formulas remains high, and particularly so for a product designed for preterm infants and a soya-based product designed for infants with cow's milk intolerances and allergies, researchers have found.

3 Sep 2010

Botox maker agrees to pay $600 million for misbranding

The Associated Press: "Allergan Inc., the maker of wrinkle-smoothing Botox, has agreed to pay $600 million to settle a yearslong federal investigation into its marketing of the top-selling, botulin-based drug. The Justice Department and the company said Wednesday in a statement it will plead guilty to one misdemeanor charge of 'misbranding,' in which the company's marketing led physicians to use Botox for unapproved uses. Those included the treatment of headache, pain, spasticity and cerebral palsy in children.

3 Sep 2010

Diabetes drug metformin exhibits potential against tobacco-induced lung tumors

Metformin, a drug commonly used to treat type 2 diabetes, shows potential in the prevention of tobacco-induced lung tumors, according to early research conducted at the National Cancer Institute (NCI).

3 Sep 2010

Pharmaceutical News

Bend Research expands hot-melt extrusion pharmaceutical manufacturing capabilities

DSM Pharma launches InnoSyn route scouting services for pharmaceutical customers

Scientists urge government to set target effectiveness for newly approved antibiotics

Almost half of all Americans use prescription drugs each month

FDA approves IDE study to evaluate HeartWare Ventricular Assist System

Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celldex Therapeutics regains worldwide rights to commercialize rindopepimut therapeutic cancer vaccine

Regional Director of WHO Africa warns of impact global financial situation will have on health systems, MDGs

EQP program helps healthcare professionals identify quality of dietary supplements

New peer-reviewed study on chemopreventive effects of Protandim

Dilemmas created for healthcare professionals by medicinal use of cannabis

'Gateway effect' of marijuana overblown

'Aspartame danger' myths

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

BDSI announces positive meeting with FDA, Meda on REMS program for ONSOLIS

Study finds high content of aluminium in infant formulas

Botox maker agrees to pay $600 million for misbranding

Diabetes drug metformin exhibits potential against tobacco-induced lung tumors

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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