Bayer HealthCare : FDA Grants Orphan Drug Status to Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis

March 11, 2010 – Bayer Schering Pharma AG, Germany, announced that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for the ciprofloxacin dry powder inhaler (DPI) for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency (EMA)... Bayer HealthCare's Press Release -

Syncrosome : Models for Therapeutic Research

nov 23, 2009 - Syncrosome will participate in the next Animal Models for Therapeutic Research in Basel from December 2nd to 3rd, 2009.
Animal Models for Therapeutic Research is a major international preclinical exhibition in Switzerland.
During this congress Mrs Sandra Robelet will present a conference on the HTAP (Pulmonary Artery Hypertension PAH – Models in rat)... Syncrosome's Press Release -

Oxagen : Completion of Recruitment in Phase IIb Dose Range-Finding Clinical Trial in New Oral Treatment for Asthma

9th December 2009 – Oxagen Limited, a drug discovery and development company specializing in inflammation, announced that the recruitment for its double blind, randomised, placebo controlled Phase IIb clinical trial in asthma with OC000459, its lead oral CRTH2 (DP2) antagonist, has now been completed.

The study, which was initiated in mid May 2009, is expected to complete by the end of Q2 2010. It involves 440 asthmatic patients with moderate persistent asthma who will be randomised to one of three possible dose levels of OC000459 or placebo by oral tablet for a 12 week dosing period, with lung function (improvement in clinic FEV1) being the primary end point.

The purpose of the study is to determine the magnitude of further improvement in lung function and asthma symptoms on longer term therapy and to define the optimal once daily oral dose of OC000459... Oxagen's Press Release -

Genta : to Support Initiation of New Clinical Trial using Ganite® as Treatment for Life-Threatening Infections in Patients with Cystic Fibrosis

December 2, 2009 - Genta Incorporated (OTCBB: GETA) announced that the Company will supply Ganite® (gallium nitrate injection) for a new clinical trial that will be initiated in patients with cystic fibrosis (CF) who may develop serious infections.

Infection is the most common cause of death in CF patients. Frequently, these infections are due to bacteria known as Pseudomonas aeruginosa, and patients are commonly treated with years of antibiotic therapy to control such infections. However, prolonged antibiotic use has greatly increased resistance due to genetic mutations. In addition, Pseudomonas has evolved protective mechanisms known as "biofilms" that encase colonies of bacteria and prevent antibiotics from reaching infection sites. Bacteria in biofilms are far more resistant to being killed. Recent information has suggested that gallium may be used as an anti-bacterial agent against Pseudomonas, in part due to its ability to disrupt biofilms... Genta's Press Release -

Eurand : ZENPEP(TM) (Pancrelipase) Delayed-Release Capsules

Nov 30, 2009 - First and Only FDA-Approved Pancreatic Enzyme Product Clinically Proven in Patients as Young as One Year Old - Eurand N.V. (NASDAQ: EURX), a global specialty pharmaceutical company, announced the commercial availability of ZENPEP(TM) (pancrelipase) Delayed-Release Capsules, a pancreatic enzyme product (PEP) indicated for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. The U.S. Food and Drug Administration (FDA) approved ZENPEP on August 27, 2009.

Eurand has also completed the hiring, training and deployment of its sales organization to promote ZENPEP, including a specialty CF sales force composed of 16 Eurand sales people targeting the 120 accredited cystic fibrosis centers, satellites and other specialists who treat CF. In addition, the Company has contracted with Innovex, a Quintiles company, to promote ZENPEP to PEP prescribers who commonly treat patients with EPI associated with other conditions such as chronic pancreatitis, pancreatic cancer and gastric surgery. These 49 Innovex sales professionals will call on key gastroenterologists, internal medicine specialists, family-practice physicians and oncologists... Eurand's Press Release -

Chart's CAIRE : Acquisition of Covidien's Oxygen Therapy Business

Nov. 30, 2009 - Chart Industries, Inc. (Nasdaq:GTLS) announced that CAIRE, which operates under Chart's BioMedical segment, has completed the previously announced acquisition of Covidien's (NYSE:COV) oxygen therapy business, including the design, manufacturing, and sales and service functions worldwide. The acquisition includes products sold under the leading Companion(TM) and HELiOS(TM) brands. Financial terms of the transaction were not disclosed... Chart Industries' Press Release - Covidien's Press Release -

ZaBeCor Pharmaceuticals : Phase II Clinical Trial In Asthma Patients Following Positive Phase I Results

September 14, 2009 - ZaBeCor Pharmaceuticals announced the initiation of a Phase II clinical trial for its asthma drug candidate ExcellairTM, following the successful results of the Company’s Phase I clinical trials. ZaBeCor is one of the first companies to deliver siRNA to the lung and one of the first to target asthma with siRNA.

“The advancement of ExcellairTM into a Phase II clinical trial for asthma is a significant milestone for our company... ZaBeCor Pharmaceuticals' Press Release -

SuperGen : MP-470 Demonstrates Clinical Benefit in Small Cell Lung Cancer and Neuroendocrine Tumor Patients

Aug. 3, 2009 - SuperGen Inc., (NASDAQ: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that preliminary results from Phase Ib data of MP-470, its multi-targeted, tyrosine kinase inhibitor and RAD51 suppressor, demonstrated an overall clinical benefit rate of 54 percent when the drug is given in combination with standard of care (SOC) carboplatin containing doublet chemotherapy in patients with small cell lung cancer (SCLC) and neuroendocrine malignancies (NE). The data was presented on August 2, at the International Association for the Study of Lung Cancer (IASLC), 13th World Conference on Lung Cancer in San Francisco, CA.

The Phase I dose titration study enrolled four patients with SCLC and nine patients with NE as of February 28, 2009. As measured by the Response Evaluation Criteria in Solid Tumors (RECIST), five of thirteen patients achieved a confirmed partial response and two additional patients demonstrated stable disease greater than twelve weeks for an overall clinical benefit rate of 7/13 patients or 54% (95% CI, 25% - 81%). There were no clinically significant adverse events attributable to the addition of MP-470 to SOC. "We continue to be encouraged by the clinical data resulting from our MP-470 trials and the potential benefit of its addition to standard of care treatment regimens... SuperGen's Press Release -

Entest BioMedical : Treatment of Chronic Obstructive Pulmonary Disease

Nov. 5, 2009 – David Koos, Chairman and CEO of Entest BioMedical, Inc. (OTCBB: ENTB), stated that the Company's unique treatments for Chronic Obstructive Pulmonary Disease (COPD), currently in development, can lead to substantial revenue opportunities. According to Koos, "Current treatment for COPD is aimed at improving quality of life, not curing the illness. It is Entest's goal to reverse the damage from COPD. If successful, Entest stands to profit substantially from the money currently spent on maintenance treatments that are not cures."

The Company stated that over the next 5 years over $170 billion will be spent on treating COPD in the United States. Currently COPD is the 4th leading cause of death in the United States and is projected to become the 3rd leading cause of death in the US by 2020. It is estimated that COPD medical related costs will be in excess of $800 billion during the next 20 years... Entest BioMedical's Press Release -

NovaRx : FDA Approval of Protocol Amendment to Special Protocol Assessment (SPA) for Phase III Lucanix® Study

Nov. 4 - 2009 -- NovaRx Corporation announced that the Company has successfully negotiated and received FDA approval for a Special Protocol Assessment (SPA) Protocol Amendment to the pivotal Lucanix® Phase III clinical trial in patients with Non-Small Cell Lung Cancer (NSCLC). The amendment will expand patient eligibility and enable study investigators to treat patients with stable brain metastases. As many as one in three NSCLC patients have such metastases, thus the amendment will make significantly more patients eligible for the trial. Other approved protocol changes include expanded stratification criteria and the ability for investigators to treat patients with decreased serum albumin levels... NovaRx's Press Releases -

Sagent Pharmaceuticals launches VINORELBINE INJECTION, USP

30 September 2009 - Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that it has launched vinorelbine injection, USP, an anti-mitotic chemotherapy drug. According to IMS, 2008 sales of vinorelbine injection, USP in the United States approximated $17 million. Sagent will begin marketing and shipping vinorelbine injection immediately.

“Sagent has launched six products in the third quarter of 2009, including vinorelbine, our third oncolytic product. Our innovative business model enables us to provide our customers with a broad range of products and delivery systems with features designed to help enhance safety and convenience,” said Michael Logerfo, corporate vice president of Sagent. “We continue to receive positive feedback from our customers who often consider the enhanced features of our products to be important factors when making their purchasing decisions.”

Sagent’s vinorelbine injection is offered in 10 mg per 1 mL and 50 mg per 5 mL, latex-free and preservative-free, single-dose vials that incorporate easy-to-read product and dosage information.

About Vinorelbine Injection, USP

Vinorelbine injection is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, vinorelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, vinorelbine is indicated in combination with cisplatin... Sagent Pharmaceuticals' Press Release -

Almac and Lilly Partner on Companion Diagnostic Development

15-SEP-09 - Almac and Lilly UK have entered into a partnership to develop a companion diagnostic for ALIMTA, with cisplatin, as a combination therapy for non-squamous non-small cell lung cancer.


The study focuses on evaluating Thymidylate Synthase (TS) as a predictive marker of response to Alimta in combination with cisplatin. A number of parallel exploratory analyses will be performed as alternative strategies to identify further potentially novel predictive biomarkers of response to the combination therapy. These include global gene expression profiling from FFPE tumour samples using the Almac Diagnostics Lung Cancer DSA™ research tool... Almac's Press Release -

Aerocrine and Panasonic Shikoku Electronics : asthma partnership

4 November 2009 – Aerocrine AB (OMX Nordic Exchange: AERO) announced that Aerocrine and Panasonic Shikoku Electronics, CO., LTD (PSEC) have entered into a long-term agreement to develop, manufacture and market new generation products for airway inflammation monitoring using exhaled nitric oxide.

PSEC, a wholly owned subsidiary of Panasonic Corporation, is a world class electronic development, manufacturing and marketing corporation with extensive experience in designing and manufacturing consumer and professional medical devices. Aerocrine is a clinically based medical technology corporation that discovered exhaled nitric oxide monitoring for clinical use in asthma care and leads the market with proprietary technology and products for airway inflammation measurement.



Under the agreement, Aerocrine and PSEC will collaborate to develop future generations of products for airway inflammation monitoring for both clinical and personal use. PSEC will be responsible for the worldwide manufacture and supply of the products and Aerocrine will be responsible for regulatory approvals, method development and global commercialization... Aerocrine's Press Release -

Pulmatrix : Company Developing Novel Therapies to Treat and Prevent Respiratory Diseases

November 2, 2009 – Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the treatment and prevention of infectious and progressive respiratory diseases, announced that it has secured $30.2 million in Series B financing. ARCH Venture Partners and Novartis Bioventures Fund co-led the round with participation from existing investors Polaris Venture Partners and 5AM Ventures.
Proceeds from the financing will be used to enhance Pulmatrix’s R&D capabilities in advancing a new class of host-targeted therapies that treat and prevent a full range of respiratory diseases by harnessing the airway and lungs own natural biophysical properties and host defense mechanisms. In particular, the financing will accelerate the development of Pulmatrix’s product pipeline, including multiple clinical trials in a number of respiratory diseases that will initiate in 2010 and 2011. Currently, Pulmatrix has a drug compound, PUR003, which is being evaluated in Phase 1B/2A trials in influenza, with results from this initial clinical study expected by the end of the year. The new and ongoing clinical trials build upon previous preclinical studies that have demonstrated the efficacy of the Pulmatrix approach in the treatment, prevention, and transmission control of both viral and bacterial diseases in multiple animal species... [PDF] Pulmatrix's Press Release -