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Some experts question early release of RTS,S malaria vaccine trial data

Nature News reports on last week's announcement of preliminary results from a large clinical trial testing the efficacy of GlaxoSmithKline's (GSK) RTS,S malaria vaccine, writing that while media coverage of the announcement touted it as a "big breakthrough in the long campaign to create a malaria vaccine," "several leading vaccine researchers, who are critical of the unusual decision to publish partial trial data, argue that the results raise questions about whether the RTS,S/AS01 candidate vaccine can actually win approval."

29 Oct 2011

BZL and ATLAB Pharma partner to develop 177Lu-J591 for metastatic prostate cancer treatment

ATLAB Pharma SAS and BZL Biologics LLC have entered into a sublicense agreement to develop 177Lu-J591 for cancer treatment. It includes exclusive rights to manufacture, develop and commercialize this radiopharmaceutical product worldwide as well as a joint Phase IIB/III clinical validation program.

29 Oct 2011

Reasons for caution about experimental malaria vaccine

Writing in KPLU's "Humanosphere" blog, Tom Paulson responds to last week's announcement of results from an ongoing clinical trial of an experimental malaria vaccine, saying, "Despite the hype and fanfare, many experts at the Seattle meeting said this experimental vaccine actually so far represents only incremental progress -- a scientific achievement which may still turn out to have little practical utility in the real world."

28 Oct 2011

Sulodexide drug fails to benefit diabetes patients with kidney disease

What was hoped to be a promising new drug to protect the kidneys has failed to benefit diabetes patients with kidney disease, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology.

28 Oct 2011

Lenvatinib may achieve partial response in thyroid, endometrial, and renal cancers

Phase 1 clinical studies of the experimental anticancer drug lenvatinib indicate that it may achieve at least a partial response in thyroid, endometrial, and renal cancers and melanoma.

28 Oct 2011

Diabetic patients with mild kidney disease may benefit from vitamin B6 derivative

A vitamin B6 derivative may help slow or prevent the progression of mild kidney disease in patients with diabetes, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology.

28 Oct 2011

Regeneron announces positive results from sarilumab Phase 2b trial on RA

Regeneron Pharmaceuticals, Inc. today announced that detailed clinical data from the positive Phase 2b portion of the seamless Phase 2/3 MOBILITY trial of sarilumab in rheumatoid arthritis (RA) will be presented at a late-breaking poster session at the upcoming American College of Rheumatology (ACR) Annual Scientific Meeting, which will take place from November 5-9 in Chicago.

28 Oct 2011

Bayer's regorafenib Phase 3 trial on metastatic colorectal cancer meets primary endpoint

Onyx Pharmaceuticals, Inc. today announced results from a Bayer HealthCare Pharmaceuticals Phase 3 trial evaluating the investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

27 Oct 2011

Gardasil vaccine safe and effective against anal cancer

A large, international clinical trial led by doctors at the University of California, San Francisco indicates that a vaccine to prevent anal cancer is safe and effective, according to a study reported in the Oct. 27, 2011 issue of New England Journal of Medicine.

27 Oct 2011

Biogen’s Multiple Sclerosis pill succeeds at a late phase clinical trial

Biogen Idec Inc. has reported success in a late stage clinical trial of its oral multiple sclerosis drug BG-12, a competitor's of Teva Pharmaceutical Industries’ Laquinimod. A 240-milligram dose of BG-12 administered two or three times a day significantly reduced the proportion of patients who relapsed by 49% and 50%, respectively, after two years compared with a placebo.

24 Oct 2011

external Trigeminal Nerve Stimulation pediatric clinical trial for ADHD receives NeuroSigma funding

NeuroSigma, Inc., a Los Angeles-based medical technology company, announced today that it has signed a contract with the University of California, Los Angeles (UCLA) to fund a Phase I pediatric clinical trial to study the use of non-invasive, external Trigeminal Nerve Stimulation (TNS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

24 Oct 2011

Sustained 'vigilance and money' necessary to fight malaria

With the RTS,S malaria vaccine trial results showing "moderate" success, helping to reignite "optimism about eradicating malaria entirely," "there are other big hurdles still to surmount," a New York Times editorial states.

24 Oct 2011

Tenofovir gel confirmed to be effective against herpes in lab experiment, study shows

Data from lab experiments published online by the journal Cell Host and Microbes last week show that the gel form of the antiretroviral tenofovir, which is being investigated as an HIV prevention method, works to inhibit the reproduction of herpes virus in tonsil and cervical tissue, the New York Times reports.

24 Oct 2011

FDA approves intraspinal injections in spinal cord stem cell ALS trial

Neuralstem, Inc. updated the progress of its ongoing Phase I safety trial of the company's spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at Emory University in Atlanta, Georgia.

24 Oct 2011

Lundbeck's ONFI receives FDA approval for treating seizures associated with Lennox-Gastaut syndrome

Lundbeck Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark, announced today that the U.S. Food and Drug Administration (FDA) has approved ONFI as adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients two years and older.

24 Oct 2011

European CHMP adopts positive opinion for Pharmaxis Bronchitol Marketing Authorisation

Pharmaceutical company Pharmaxis today announced the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of a Marketing Authorisation for Bronchitol, clearing the way for the product to be used in Europe "for the treatment of cystic fibrosis in adults as an add-on therapy to best standard of care."

24 Oct 2011

Zeaxanthin reduces risk for AMD

St. Louis-based ZeaVision, LLC announced that three recent groundbreaking studies demonstrate that Zeaxanthin (zee-uh-zan-thin), the predominate protective pigment in the back of the eye, reduces the risk for Age-Related Macular Degeneration (AMD) and benefits the treatment of advanced AMD, a condition that destroys central vision and affects millions of Americans.

24 Oct 2011

Vertex initiates INCIVEK combination Phase 3b study for hepatitis C

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the 'CC' variation near the IL28B gene.

24 Oct 2011

Synergy commences plecanatide Phase II/III trial in chronic idiopathic constipation

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced initiation of dosing of patients in a major Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation.

24 Oct 2011

Top-line results from Exelixis' cabozantinib phase 3 trial on medullary thyroid cancer

Exelixis, Inc. today reported top-line results from the ongoing phase 3 clinical trial of cabozantinib in patients with advanced medullary thyroid cancer (MTC), known as the EXAM trial.

24 Oct 2011

Drug Trial News

Some experts question early release of RTS,S malaria vaccine trial data

BZL and ATLAB Pharma partner to develop 177Lu-J591 for metastatic prostate cancer treatment

Reasons for caution about experimental malaria vaccine

Sulodexide drug fails to benefit diabetes patients with kidney disease

Lenvatinib may achieve partial response in thyroid, endometrial, and renal cancers

Diabetic patients with mild kidney disease may benefit from vitamin B6 derivative

Regeneron announces positive results from sarilumab Phase 2b trial on RA

Bayer's regorafenib Phase 3 trial on metastatic colorectal cancer meets primary endpoint

Gardasil vaccine safe and effective against anal cancer

Biogen’s Multiple Sclerosis pill succeeds at a late phase clinical trial

external Trigeminal Nerve Stimulation pediatric clinical trial for ADHD receives NeuroSigma funding

Sustained 'vigilance and money' necessary to fight malaria

Tenofovir gel confirmed to be effective against herpes in lab experiment, study shows

FDA approves intraspinal injections in spinal cord stem cell ALS trial

Lundbeck's ONFI receives FDA approval for treating seizures associated with Lennox-Gastaut syndrome

European CHMP adopts positive opinion for Pharmaxis Bronchitol Marketing Authorisation

Zeaxanthin reduces risk for AMD

Vertex initiates INCIVEK combination Phase 3b study for hepatitis C

Synergy commences plecanatide Phase II/III trial in chronic idiopathic constipation

Top-line results from Exelixis' cabozantinib phase 3 trial on medullary thyroid cancer

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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