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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

Mesoblast cleared to begin first phase 2 clinical trial for wet AMD

Regenerative medicine company Mesoblast Limited (ASX: MSB) today announced that it has received regulatory clearance from the Singapore Health Sciences Authority (HSA) to commence the first Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult stem cell therapy for patients with proliferation of leaky blood vessels in the eyes – neovascular (“wet”) Age-related Macular Degeneration (AMD).

24 Oct 2011

Mirna, Silence enter agreement to assess delivery systems for novel microRNAs

Silence Therapeutics plc, a leading RNA interference (RNAi) therapeutics company, today announced that it has entered into an agreement with Mirna Therapeutics Inc., a biopharmaceutical company pioneering microRNA-based therapeutics for cancer, to assess the delivery capabilities of Silence's proprietary AtuPLEX and DBTC delivery systems for Mirna's novel microRNAs.

24 Oct 2011

Pivotal pediatric clinical study comparing Q/LAIV to FluMist meets primary endpoint

The pivotal pediatric clinical study compared Q/LAIV to two trivalent formulations of MedImmune's licensed seasonal influenza vaccine, FluMist (Influenza Vaccine Live, Intranasal) and met its primary endpoint.

22 Oct 2011

Abbott, Biogen Idec announce additional results from daclizumab HYP Phase 2b trial for RRMS

Today Biogen Idec and Abbott announced additional results from the SELECT Phase 2b trial, the first of two registrational studies designed to evaluate the investigational compound daclizumab high-yield process in people with relapsing-remitting multiple sclerosis.

22 Oct 2011

Sanofi announces new results from alemtuzumab-Rebif comparative CARE-MS I trial

Sanofi and its subsidiary Genzyme announced today new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab to Rebif (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis.

22 Oct 2011

Ferring reports on FDA approval of labeling supplement for EUFLEXXA to treat knee osteoarthritis

On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles.

22 Oct 2011

Pfizer's Prevnar 13: Additional data from adult clinical studies presented at 49th IDSA

Pfizer Inc. announced today that additional data from several clinical studies of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine) conducted in adults 50 years and older will be presented during the 49th Annual Meeting of the Infectious Diseases Society of America, which is being held Oct. 20-23, 2011, in Boston, Mass.

22 Oct 2011

Janssen announces FDA label update approval for PREZISTA HIV tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for PREZISTA (darunavir) tablets to include 192-week data from the ARTEMIS study.

22 Oct 2011

Additional data from Sanofi's quadrivalent inactivated influenza vaccine study

Sanofi Pasteur, the vaccines division of Sanofi, announced today the results of a new study evaluating the immunogenicity and safety of an investigational quadrivalent inactivated influenza vaccine (QIV) among adults 65 years of age and older.

22 Oct 2011

Merz presents XEOMIN clinical data on dystonia at IDS 2011

New data presented at recent neurological congresses and summarized at the IDS indicate that patients treated with XEOMIN for cervical dystonia or blepharospasm (involuntary closing of the eyelids) experienced long-term sustained efficacy with a favorable safety profile in studies of up to 121 and 88 weeks duration, respectively.

22 Oct 2011

Positive top line results from Shire's LDX phase III study on ADHD

Shire plc, the global specialty biopharmaceutical company, today presented positive top line results of the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX) in children and adolescents aged 6 to 17 years with Attention-Deficit/Hyperactivity Disorder.

22 Oct 2011

NIH stops triple-drug therapy clinical trial for idiopathic pulmonary fibrosis

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has stopped one arm of a three arm multi-center, clinical trial studying treatments for the lung-scarring disease idiopathic pulmonary fibrosis (IPF) for safety concerns.

22 Oct 2011

Much work remains to be done in fight against malaria

Positive results announced this week from a large clinical trial testing the efficacy of the RTS,S malaria vaccine are "encouraging," but they are also "a reminder of how much work remains to be done," an Economist editorial reports.

22 Oct 2011

Romark announces results from NT-300 Phase 2B-3 trial on influenza

Romark Laboratories announced that results of a large Phase 2B-3 US clinical trial of its new flu drug, NT-300 (nitazoxanide), will be presented as an oral late-breaking communication at the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) being held in Boston, October 20-23, 2011.

22 Oct 2011

Xencor commences XmAb5871 Phase 1 trial in autoimmune diseases

Xencor, Inc., a company using its proprietary Protein Design Automation (PDA) platform technology to engineer next-generation antibodies, announced today the initiation of a Phase 1 clinical trial of XmAb5871, the company's therapeutic antibody for the treatment of autoimmune diseases.

22 Oct 2011