Pharmaxis, Aridol, first Asian Approval

Jan. 16, 2008 — Pharmaxis (ASX: PXS; Nasdaq: PXSL) announced the Korean regulatory agency has granted marketing approval for its asthma management product, Aridol... [PDF] Pharmaxis' Press Release-

Nycomed, ALVESCO , FDA approval for the U.S. market

15.01.2008 - Nycomed announced today that the Food and Drug Administration (FDA) approved ALVESCO (ciclesonide) Inhalation Aerosol in the United States for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older. ALVESCO is an inhaled corticosteroid with novel release and distribution properties...
...ALVESCO is based on the active ingredient ciclesonide which is Nycomed’s patented corticosteroid with a novel principle of action. Ciclesonide is a prodrug that is activated by intracellular esterases following oral inhalation. ALVESCO has wide inhibitory activities against multiple inflammatory cell types and chemicals involved in the asthmatic response... Nycomed's Press Release-

Aeras and Crucell, Start of a Tuberculosis Vaccine Clinical Trial

December 21, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) announced it will receive up to USD 5 million from Rockville, Maryland-headquartered Aeras Global TB Vaccine Foundation to support the advanced development of the candidate AdVac- and PER.C6-based tuberculosis vaccine...
Crucell and Aeras also announced the launch of a new Phase I BCG-Ad35 prime boost clinical trial of the unique AdVac-based tuberculosis vaccine, weeks sooner than expected...
Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004 using Crucell's AdVac vaccine technology and PER.C6 manufacturing technology... Crucell's Press Release-

Exelixis, Phase 1/2 Trial of XL184 in Patients With Non-Small Cell Lung Cancer

Jan 07, 2008 - Exelixis, Inc. (Nasdaq: EXEL) announced that it has initiated a phase 1/2 trial of XL184 in patients with non-small cell lung cancer (NSCLC) who have had progressive disease while on a regimen containing erlotinib.XL184 is a small molecule that simultaneously inhibits the MET, RET and VEGFR receptor tyrosine kinases. In the initial phase 1 part of the study, safety and pharmacokinetics of combining XL184 with erlotinib will be evaluated. The primary endpoint of the phase 2 part of the study is overall response rate. Secondary endpoints include progression-free survival, overall survival and pharmacodynamics... Exelixis' Press Release-

Genzyme, License Agreement with Moffitt Cancer Center for Exclusive Rights to Lung Cancer Diagnostic

January 15, 2008 - Genzyme Corp. (Nasdaq: GENZ) announced that it has entered into a license agreement with Moffitt Cancer Center to obtain exclusive worldwide diagnostic testing rights to the discovery of the relationship of two proteins to patient response to non-small cell lung cancer (NSCLC) treatment...The expression levels of the two proteins, RRM1 and ERCC1, have been shown by Dr. Gerold Bepler, M.D., and his team from Moffitt, to correlate with patient response to platinum drugs and gemcitabine, both of which are commonly used in treating NSCLC... Genzyme's press Release-

Luminex , FDA Clearance for xTAG Respiratory Viral Panel

Jan. 3, 2008 -Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its xTAG(TM) Respiratory Viral Panel (RVP). xTAG RVP is the first FDA-cleared assay to simultaneously detect and identify 12 viruses and viral subtypes that together are responsible for more than 85 percent of respiratory viral infections... Luminex' Press Release -

GlaxoSmithKline and Theravance, 642444 and 685698 advance in clinical development for the treatment of asthma

Jan. 03, 2008 - GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced the start of large Phase 2b asthma dose-optimisation studies with both the lead inhaled corticosteroid (ICS) GW685698 ('698) and the lead long-acting beta agonist (LABA) GW642444 ('444) assets in the 'Horizon' programme to develop a next-generation combination product. GSK began enrolling patients with mild to severe asthma in the '698 Phase 2b clinical programme on 21st December 2007 and began enrolling patients with persistent asthma in the '444 Phase 2b clinical programme on 29th December 2007. These clinical programmes will determine the most effective doses to be taken into Phase 3 combination studies. The Phase 2b COPD programme with '444 is also on schedule to commence in 1H 2008... GSK's Press Release - Theravance's Press Release-

Alnylam, Progress in Clinical Development of ALN-RSV01 for the Treatment of Respiratory Syncytial Virus (RSV) Infection

Dec. 13, 2007 -Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced the presentation of results from its Phase I trial with ALN-RSV01 delivered via inhalation at the 18th Annual Drug Delivery to the Lungs meeting being held in Edinburgh, U.K. These data represent an important milestone in the company's efforts to advance ALN-RSV01 as an anti-viral drug for the treatment of RSV infection in patients. The Phase I study represents the first-ever clinical study of an RNAi therapeutic administered via inhalation... Alnylam's Press Release -

Panacea Pharmaceuticals' Lung Cancer Diagnostic Test, LC Detect,

December 18, 2007 - Gaithersburg, Maryland - Panacea Pharmaceuticals' lung cancer diagnostic test, LC Detectsm, has been named one of Time Magazine's Ten Biggest Medical Breakthroughs of 2007. LC Detect^sm is a simple blood test to facilitate the identification of lung cancer, even among individuals with early-stage disease... LC Detect^sm measures levels of human aspartyl (asparaginyl) &#beta;-hydroxylase (HAAH), a cancer molecular marker, in blood. HAAH has been detected by immunohistochemical staining in a broad range of cancers, including lung cancer, and has been shown to be highly specific and absent in adjacent non-affected tissue as well as tissue from cancer-free individuals... Panacea's Press Release -

Infinity and Medimmune, Phase 2 Trial of IPI-504 to Assess the Hsp90 Inhibitor’s Potential Anti-Tumor Activity in Patients with Advanced NSCLC

December 19, 2007 – Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) and MedImmune, Inc. announced that the companies have initiated the Phase 2 portion of a Phase 1/2 clinical trial of IPI-504, their lead heat shock protein 90 (Hsp90) inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) ...The goal of this open-label, multi-center clinical trial is to evaluate the anti-tumor activity of IPI-504 in patients with NSCLC... Infinity 's Press Release - MedImmune's Press Release -

Theravance, GSK1160724, Phase 1 Clinical Study With Investigational Medicine For Respiratory Disease

December 12, 2007 - Theravance, Inc. (NASDAQ: THRX) announced that GlaxoSmithKline plc (GSK) initiated subject screening in a Phase 1 clinical study designed to assess the safety, tolerability, and pharmacokinetics of an investigational, inhaled bronchodilator, GSK1160724, for the treatment of chronic obstructive pulmonary disease (COPD)...GSK1160724 is an inhaled, long-acting muscarinic antagonist (LAMA) discovered by Theravance through the application of multivalent drug design in a drug discovery program dedicated to finding new medicines for respiratory diseases such as COPD and asthma... Theravance's Press Release -

Discovery Labs, Aerosurf Improves Lung Function and Reduces Inflammation in a Model of Respiratory Distress Syndrome

December 3, 2007 — ...Aerosurf is an aerosolized formulation of Discovery Lab’s novel KL4 surfactant technology that is delivered non-invasively via novel aerosol generating technology and employs nasal continuous positive airway pressure (nCPAP). Aerosurf, like Discovery’s lead product Surfaxin®, is a precisionengineered synthetic, peptide-containing surfactant which is designed to closely mimic the essential attributes of human lung surfactant.... Discovery Labs' PDF -

Rigel , Initiation of Phase 1 Clinical Trial of R343 for Allergic Asthma by its Partner Pfizer

Dec. 6 , 2007 - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that its corporate partner, Pfizer (NYSE: PFE), has begun a Phase 1 clinical trial of an inhaled formulation of Rigel's small molecule syk kinase inhibitor, R343, for the treatment of allergic asthma. R343 is the third product candidate in Rigel's clinical portfolio... Rigel's Press Release -

IDM Pharma, IDM-2101 Updated Phase 2 Results Show Treatment Well Tolerated With Positive Survival Trend in Lung Cancer Patients

Nov. 2 - IDM Pharma, Inc. (Nasdaq: IDMI) announced updated results from the Phase 2 study of its investigational agent IDM-2101 which showed the vaccine was well tolerated, induced broadly specific cytotoxic T lymphocyte (CTL) responses, and showed a positive survival trend in patients with non-small cell lung cancer (NSCLC) who were vaccinated with IDM-2101, compared to a parallel external control group of non-vaccinated patients... IDM Pharma's Press Release -