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Gilead commences GS-1101 Phase 3 trial in CLL

Gilead Sciences, Inc. today announced that the first patient has been dosed in a Phase 3 clinical trial evaluating the efficacy and safety of GS-1101.

2 May 2012

ACE inhibitors or ARBs could treat and prevent PTSD

Traumatized people who take a class of common blood pressure medications tend to have less severe post-traumatic stress symptoms, researchers have found.

2 May 2012

FDA approves Levaquin for plague

The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.

30 Apr 2012

JCO publishes Syndax erlotinib-entinostat Phase 2 study for advanced non-small cell lung cancer

Syndax Pharmaceuticals, Inc., a late-stage oncology company focused on the clinical development of epigenetic therapies in solid tumors, announced that previously reported results from ENCORE 401, a randomized, placebo controlled Phase 2 study of erlotinib with or without entinostat in advanced non-small cell lung cancer patients were published in the Journal of Clinical Oncology (JCO).

30 Apr 2012

Enrollment complete in Zalicus Synavive Phase 2b clinical trial for rheumatoid arthritis

Zalicus Inc., a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced it has completed enrollment with 292 patients enrolled in the SYNERGY trial, a Phase 2b clinical trial designed to evaluate the safety and efficacy of Synavive, a low-dose glucocorticoid with the potential for amplified immuno-inflammatory benefits, in patients with rheumatoid arthritis (RA).

30 Apr 2012

VIVUS receives FDA approval for Stendra to treat erectile dysfunction

The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

30 Apr 2012

FDA approves VIVUS’ STENDRA for treatment of erectile dysfunction

VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.

30 Apr 2012

FDA approves Novartis’ Afinitor for treatment of renal angiomyolipomas and TSC

Novartis Pharmaceuticals Corporation announced today that the US Food and Drug Administration (FDA) approved Afinitor (everolimus) tablets for the treatment of adult patients with kidney tumors known as renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery.

27 Apr 2012

GSK receives FDA approval for Votrient to treat advanced soft tissue sarcoma

The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.

27 Apr 2012

Positive top-line results from Shire’s Vyvanse Phase 2 study on binge eating disorder

Shire plc, the global specialty biopharmaceutical company, today announced positive top-line results from a Phase 2 study to evaluate the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) in adults with binge eating disorder.

27 Apr 2012

Novartis receives FDA approval for Afinitor to treat renal angiomyolipomas caused by TSC

The U.S. Food and Drug Administration approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex.

27 Apr 2012

CytRx commences INNO-206 Phase 2 clinical trial for pancreatic cancer

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced the initiation of a Phase 2 clinical trial evaluating the preliminary efficacy and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have progressed after receiving two prior therapies.

26 Apr 2012

First-ever study to evaluate effects of interaction between metamphetamines and Ibudilast

John W. Tsuang, M.D., principal investigator at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed), in conjunction with Steven J. Shoptaw, Ph.D., from the UCLA Department of Family Medicine, is spearheading a Phase I clinical safety trial that for the first time examines the effects of Ibudilast when administered with metamphetamine (MA), an addictive stimulant that is closely related to amphetamine.

26 Apr 2012

FDA issues complete response letter to Takeda’s NDAs for type 2 diabetes investigational therapies

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. today announced that the company received a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone.

26 Apr 2012

Botox effect modest in migraine prevention: Study

Botox injections have been used in prevention of migraines but new research shows that its effect is only modest. Among chronic sufferers who had at least 15 migraines a month, the treatment prevented, on average, about two headaches a month. Botox was no more effective than some of the most widely prescribed drugs used for migraines when the treatments were compared.

25 Apr 2012

Vitamin D supplementation in winter can help lower blood pressure in hypertensive patients

A new study, presented at the European Society of Hypertension meeting in London, shows that vitamin D supplementation in winter can help lower blood pressure in patients with hypertension.

25 Apr 2012

S-equol effective in reducing menopausal hot flashes, muscle and joint pain among U.S. women

A dose of 10 milligrams (mg) daily of S-equol delivered via a newly developed fermented soy germ-based nutritional supplement is as effective as a standard dose of soy isoflavones at reducing hot flash frequency significantly and is even more effective for relieving muscle and joint pain, according to a peer-reviewed study in US postmenopausal women published in the June Journal of Women's Health, available now as a Fast Track article online ahead of print.

25 Apr 2012

Clinical trial to evaluate IGF-1 in children with SHANK3 deficiency

In an important test of one of the first drugs to target core symptoms of autism, researchers at Mount Sinai School of Medicine are undertaking a pilot clinical trial to evaluate insulin-like growth factor (IGF-1) in children who have SHANK3 deficiency (also known as 22q13 Deletion Syndrome or Phelan-McDermid Syndrome), a known cause of autism spectrum disorder (ASD).

25 Apr 2012

Biogen Idec announces positive data from oral BG-12 second Phase 3 trial on RRMS

Today Biogen Idec announced that detailed positive data from CONFIRM, the second Phase 3 clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS), will be presented in three platform presentations at the 64th Annual Meeting of the American Academy of Neurology (AAN) in New Orleans.

25 Apr 2012

Gabapentin drug helps people to quit cannabis

Scientists at The Scripps Research Institute have found clinical evidence that the drug gabapentin, currently on the market to treat neuropathic pain and epilepsy, helps people to quit smoking marijuana.

24 Apr 2012

Placebo News and Research

Gilead commences GS-1101 Phase 3 trial in CLL

ACE inhibitors or ARBs could treat and prevent PTSD

FDA approves Levaquin for plague

JCO publishes Syndax erlotinib-entinostat Phase 2 study for advanced non-small cell lung cancer

Enrollment complete in Zalicus Synavive Phase 2b clinical trial for rheumatoid arthritis

VIVUS receives FDA approval for Stendra to treat erectile dysfunction

FDA approves VIVUS’ STENDRA for treatment of erectile dysfunction

FDA approves Novartis’ Afinitor for treatment of renal angiomyolipomas and TSC

GSK receives FDA approval for Votrient to treat advanced soft tissue sarcoma

Positive top-line results from Shire’s Vyvanse Phase 2 study on binge eating disorder

Novartis receives FDA approval for Afinitor to treat renal angiomyolipomas caused by TSC

CytRx commences INNO-206 Phase 2 clinical trial for pancreatic cancer

First-ever study to evaluate effects of interaction between metamphetamines and Ibudilast

FDA issues complete response letter to Takeda’s NDAs for type 2 diabetes investigational therapies

Botox effect modest in migraine prevention: Study

Vitamin D supplementation in winter can help lower blood pressure in hypertensive patients

S-equol effective in reducing menopausal hot flashes, muscle and joint pain among U.S. women

Clinical trial to evaluate IGF-1 in children with SHANK3 deficiency

Biogen Idec announces positive data from oral BG-12 second Phase 3 trial on RRMS

Gabapentin drug helps people to quit cannabis

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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