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Kamada reports positive data with inhaled Alpha-1 Antitrypsin in cystic fibrosis

Kamada has announced today positive data from its Phase II study evaluating inhaled Alpha-1 Antitrypsin (AAT) delivered via an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in the treatment of cystic fibrosis. The results demonstrate the product has an excellent safety profile and shows promising signs of efficacy, as indicated by a reduction in lung inflammation.

12 Oct 2008

FDA continues review of Takeda's NDA for Alogliptin

Takeda Pharmaceutical Company Limited has announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

12 Oct 2008

FDA approves Rapaflo for treatment of symptoms due to benign prostatic hyperplasia

The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

12 Oct 2008

Cheap 'Polypill' deals with heart disease and stroke

The 'Polypill' is a single pill which combines a range of drugs that protect against heart disease and stroke and was first considered a number of years ago as a cost effective way to significantly reduce the death toll from cardiovascular disease. But progress has been hampered by the reluctance of pharmaceutical companies to embark on a project involving inexpensive drugs which offered little financial incentive.

7 Oct 2008

Studies examine ability of antiretroviral Maraviroc to control HIV viral loads

According to two studies sponsored by drugmaker Pfizer and published in the New England Journal of Medicine on Wednesday, the antiretroviral drug maraviroc, which is sold as Selzentry by Pfizer, might help control viral loads among HIV-positive people who have shown resistance to other treatments, Reuters reports.

5 Oct 2008

Eli Lilly starts second global phase III trial of investigational Alzheimer's disease compound

Eli Lilly and Company today announced it will begin enrolling patients in a second Phase III study of LY450139, a gamma-secretase inhibitor being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease.

2 Oct 2008

Plethora Solutions completes European trial of PSD502 for premature ejaculation

Sciele Pharma, Inc. today announced that Plethora Solutions Holdings PLC has completed its European Phase III study of PSD502 for the treatment of premature ejaculation (PE) in Europe. The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008.

30 Sep 2008

Arthritis treatments glucosamine and chondroitin shown to be no better than placebo

According to the latest research, the popular supplements glucosamine and chondroitin sulfate, used to fight arthritis and joint pain, do not seem to work any better than a placebo in slowing the loss of knee cartilage in osteoarthritis.

30 Sep 2008

Arana files U.S. IND for lead anti-Inflammatory

Biotechnology company Arana Therapeutics Limited today announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug Administration) for the anti-inflammatory product ART621 in a rheumatoid arthritis (RA) indication.

29 Sep 2008

Statins shown not to increase the risk of Lou Gehrig's disease

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

29 Sep 2008

Popular COPD treatment increases risk for cardiac events, cardiac death

New research out of Wake Forest University School of Medicine shows that use of the most commonly prescribed once-a-day treatment for chronic obstructive pulmonary disease (COPD) for longer than one month increases the risk of cardiovascular death, heart attack or stroke by more than 50 percent

24 Sep 2008

Isoflavone dietary supplement improves the functioning of the arteries in stroke patients

A dietary supplement containing isoflavone - a chemical found in soybeans, chickpeas, legumes and clovers - can improve artery function in stroke patients according to new research published online in Europe's leading cardiology journal, the European Heart Journal today.

23 Sep 2008

Combo of flu shot and COLD-FX cuts cold and flu by a third

A new study has shown the benefit of annual flu vaccinations for seniors along with Canada's top cold and flu-fighting product COLD-FX.

17 Sep 2008

GlaxoSmithKline and XenoPort submit NDA for Solzira for restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

16 Sep 2008

FDA approves Gamunex for chronic inflammatory demyelinating polyneuropathy

The U.S. Food and Drug Administration has announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

14 Sep 2008

Trial demonstrates safety and efficacy of neurally acting anti-migraine agent for treatment of acute migraine

CoLucid Pharmaceuticals, Inc., an innovative biotechnology company focusing on therapies for central nervous system disorders, announced Phase II results of its lead compound COL-144 in the treatment of acute migraine. Results demonstrated that COL-144 was safe and effective in relieving migraine headaches.

7 Sep 2008

FDA 'fast track' granted to BioMS Medical for lead drug, dirucotide for the treatment of multiple sclerosis

BioMS Medical Corp has announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

4 Sep 2008

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Anadis announced today its commercialization of a new product, BioGard, intended to maintain gastrointestinal and immune system health. The specific formulation may be of particular clinical benefit in persons undergoing antiretroviral therapy for HIV/AIDS.

4 Sep 2008

Diffusion Pharmaceuticals initiates phase I/II clinical trial in patients with peripheral arterial disease

Diffusion Pharmaceuticals LLC, a clinical-stage drug-development company commercializing new drugs for the treatment of unmet medical needs, announced today that it has begun to enroll patients in a Phase I/II clinical trial of its lead drug candidate trans sodium crocetinate (TSC).

3 Sep 2008

Vimpat (lacosamide) approved in Europe

UCB announced today that the European Commission (EC) has approved Vimpat (lacosamide) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Vimpat is the first new antiepileptic drug (AED) for partial-onset seizures in three years and offers a new treatment option for European patients living with uncontrolled partial-onset epilepsy.

3 Sep 2008

Placebo News and Research

Kamada reports positive data with inhaled Alpha-1 Antitrypsin in cystic fibrosis

FDA continues review of Takeda's NDA for Alogliptin

FDA approves Rapaflo for treatment of symptoms due to benign prostatic hyperplasia

Cheap 'Polypill' deals with heart disease and stroke

Studies examine ability of antiretroviral Maraviroc to control HIV viral loads

Eli Lilly starts second global phase III trial of investigational Alzheimer's disease compound

Plethora Solutions completes European trial of PSD502 for premature ejaculation

Arthritis treatments glucosamine and chondroitin shown to be no better than placebo

Arana files U.S. IND for lead anti-Inflammatory

Statins shown not to increase the risk of Lou Gehrig's disease

Popular COPD treatment increases risk for cardiac events, cardiac death

Isoflavone dietary supplement improves the functioning of the arteries in stroke patients

Combo of flu shot and COLD-FX cuts cold and flu by a third

GlaxoSmithKline and XenoPort submit NDA for Solzira for restless legs syndrome

FDA approves Gamunex for chronic inflammatory demyelinating polyneuropathy

Trial demonstrates safety and efficacy of neurally acting anti-migraine agent for treatment of acute migraine

FDA 'fast track' granted to BioMS Medical for lead drug, dirucotide for the treatment of multiple sclerosis

Anadis to commercialise "BioGard" adjunctive therapy for HIV/AIDS

Diffusion Pharmaceuticals initiates phase I/II clinical trial in patients with peripheral arterial disease

Vimpat (lacosamide) approved in Europe

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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