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NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA).

18 Aug 2011

Endo terminates collaboration and axomadol development program with Grunenthal

Endo Pharmaceuticals announced today that it is terminating its research program and collaboration related to the development of axomadol.

18 Aug 2011

Syndax receives European patent allowance for entinostat to treat metastatic breast cancer

Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, today announced allowance by the European Patent Office for the patent application titled "N-(2-AMINOPHENYL)-4[N-(PYRIDINE-3-YL) - METHOXYCARBONYL - AMINOMETHYL]-BENZAMINE (MS-275) POLYMORPH B."

18 Aug 2011

New gout drug may help severely affected: Study

A new drug for gout could help very sick gout patients who don't get better with usual treatment, according to a new study. The research was designed and funded by the pharmaceutical company Savient, which markets the drug, called Krystexxa (pegloticase).

17 Aug 2011

Pegloticase can improve clinical outcomes of patients with chronic gout

Injections of pegloticase, a modified porcine enzyme, can produce significant and sustained clinical improvements in 2 out of 5 patients with chronic gout that is resistant to conventional therapies, researchers report in the August 17, 2011, issue of JAMA.

17 Aug 2011

Zinc lozenges might reduce duration of common cold episodes by 40%

Depending on the total dosage of zinc and the composition of lozenges, zinc lozenges may shorten the duration of common cold episodes by up to 40%, says Dr. Harri Hemila from the University of Helsinki.

16 Aug 2011

AVI BioPharma, MDA to initiate exon-51 Phase 2 trial in Duchenne muscular dystrophy

More than a decade of targeted Muscular Dystrophy Association-funded research, made possible as a result of generous public support of the MDA Labor Day Telethon and thousands of grass-roots special events, has today culminated in MDA providing financial assistance for the start of the first Phase 2 placebo-controlled, multiple dose efficacy, safety, tolerability and pharmacokinetics clinical trial of an exon-51 skipping drug, eteplirsen, as a potential therapy for Duchenne muscular dystrophy.

16 Aug 2011

Enrollment commences in Omthera's Epanova Phase III trial for hypertriglyceridemia

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been enrolled in its ESPRIT Phase III clinical trial of Epanova, in patients with hypertriglyceridemia (TG level greater than or equal to 200 and < 500 mg/dL) despite treatment with a statin.

16 Aug 2011

Enrollment commences in RegeneRx RGN-259 Phase 2 trial for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. has announced that the first patients have been enrolled and randomized to receive RGN-259 or placebo in its 72-patient, Phase 2 clinical trial in patients with dry eye syndrome.

16 Aug 2011

Toclizumab for juvenile rheumatoid arthritis

The arthritis drug Toclizumab could be a boon for hundreds of children suffering from severe arthritis. It has been re-launched in children after being already licensed for the treatment of adults. At least two thirds of children taking tocizilumab have been able to return to a normal life, after many were bedridden or forced into wheelchairs by the disease, the clinical studies reveal.

16 Aug 2011

Starpharma starts bacterial vaginosis prevention study of VivaGel

Starpharma Holdings Limited today announced the commencement of its Phase 2 study of VivaGel for the prevention of bacterial vaginosis (BV), following receipt of ethics approval.

15 Aug 2011

Sinovac second quarter sales increase 52.5% to $15.7 million

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today its unaudited second quarter financial results for the period ended June 30, 2011.

12 Aug 2011

Pacira second quarter total revenues increase to $3.6 million

Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, today announced financial results for the second quarter ended June 30, 2011, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL, and updated its 2011 financial guidance.

11 Aug 2011

Higher protein intake helps postmenopausal obese women lose more weight

Dieting postmenopausal women who want to avoid losing muscle as they lose fat should pay attention to a new University of Illinois study. Adding protein throughout the day not only holds hunger pangs at bay so that dieters lose more weight, it keeps body composition-the amount of fat relative to muscle-in better proportion.

11 Aug 2011

Caffeine can treat postdural puncture headaches

People who suffer headaches after a spinal tap might have a relatively simple way to ease the painful throb: a caffeine tablet.

11 Aug 2011

Study: AAKG supplementation has no significant impact on increased blood flow

A Baylor University study has found that a popular nutritional supplement that is marketed to lead to greater muscle strength through increasing blood flow to the muscle does not increase blood flow as claimed on the bottle.

11 Aug 2011

Positive results from two ADL5945 Phase 2 studies for opioid-induced constipation

Adolor Corporation today announced positive, statistically significant top line results from its two Phase 2 studies of ADL5945 in chronic non-cancer pain patients with opioid-induced constipation.

11 Aug 2011

Protox reports net loss of $3.2 million for second quarter 2011

Protox Therapeutics Inc., a developer of innovative products for the treatment of urological diseases, today announced financial results and achievements for the quarter ended June 30, 2011.

10 Aug 2011

Glenmark commences Revamilast Phase IIb trial in chronic inflammatory disorders

Glenmark Pharmaceuticals today announced that its Novel Chemical Entity "Revamilast" (GRC 4039) has initiated Phase IIb human dose range finding trials globally. Revamilast is an orally active, potent and selective inhibitor of phosphodiesterase 4 (PDE 4) that is currently being developed by Glenmark for the treatment of chronic inflammatory disorders such as Asthma, Rheumatoid Arthritis (RA) and other inflammatory diseases.

10 Aug 2011

Acorda Therapeutics receives U.S. patent allowance for aminopyridine compositions

Acorda Therapeutics, Inc. today announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 11/102,559 entitled "Method of Using Sustained Release Aminopyridine Compositions."

10 Aug 2011