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New drug test promises to yield quick and effective response for cancer therapy

A group of scientists from Hamburg may have taken a big step towards more effective cancer drug development, Europe's largest cancer congress, ECCO 15 - ESMO 34 [1], heard today (Wednesday 23 September). Dr Ilona Schonn, Director of Cell Culture Research at Indivumed GmbH, told the conference that they had developed a preclinical drug test platform that would enable researchers to analyse tumour tissue for individual patient drug responses on the molecular level.

23 Sep 2009

Second annual study of FDA drug review released

PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released its second annual study on the state of the U.S. Food and Drug Administration (FDA) drug review process.

From Parexel 23 Sep 2009

Bioelectronics files for pre-marketing clearance for its ActiPatch® Therapy products

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, announced that it filed today with the U.S. Government's Food and Drug Administration for 510(K) pre-marketing clearance for its ActiPatch® Therapy products.

23 Sep 2009

Top 20 pharma companies seek out new partnering opportunities at BIO-Europe 2009

In order to seek out new partnering opportunities, the top 20 big pharma companies will be in attendance on November 2–4 in Vienna, Austria for BIO-Europe 2009, the largest dedicated partnering conference in Europe.

23 Sep 2009

UBC acquires Gigamoto Technology Partners to implement risk management programs

United BioSource Corporation (UBC) today announced the acquisition of Gigamoto Technology Partners, Inc. (Gigamoto), a Pennsylvania-based software development company providing leading-edge technology solutions in support of drug safety and risk management programs for the life sciences industry.

23 Sep 2009

Preclinical data on Protalix Biotherapeutics' antiTNF released

Protalix Biotherapeutics, Inc., reported today preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the Company’s proprietary ProCellEx technology, pr-antiTNF is a plant cell expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid sequence to Enbrel.

23 Sep 2009

EGFR-targeted therapy improves survival rates in metastatic colorectal cancer patients

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) demonstrated a significant improvement in overall survival (OS) when added to standard 1st-line chemotherapy for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors.

23 Sep 2009

FDA committees to review Neuromed’s NDA for Exalgo

CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals, Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the September 23, 2009 joint meeting of its Anesthetics and Life Support Advisory Committee and its Drug Safety and Risk Management Advisory Committee.

23 Sep 2009

Results of IES presented at ECCO

Pfizer Inc today announced new, longer-term data from the Intergroup Exemestane Study (IES) showing that women who switched to AROMASIN® (exemestane tablets) after taking tamoxifen for two to three years experienced a significant reduction (18%) in the risk of disease-free survival (DFS) events. In addition, IES showed that AROMASIN prolonged overall survival (OS) in the ER+/unknown population with a 14% reduction in the risk of dying. These results demonstrate that the benefits of treatment are maintained in long term follow-up. These results were presented at the joint ECCO 15/ESMO 34 meeting in Berlin, Germany.

23 Sep 2009

Update from Advanced Cell on pre-clinical activities for its RPE cell program

Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) provided an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases.

23 Sep 2009

Chan calls for additional H1N1 vaccines for poor countries during WHO Asia-Pacific regional meeting

During the WHO Asia-Pacific regional meeting Monday, WHO Director-General Margaret Chan discussed the organization's efforts to ensure that poor nations have access to H1N1 vaccines, VOA News reports (Bayron, 9/21).

23 Sep 2009

Government orders additional H1N1 vaccine

Associated Press/Boston Globe reports that on Monday, "the United States ordered more swine flu vaccine, bringing its eventual total to 251 million doses, up from the long-planned 195 million doses.

23 Sep 2009

Sanofi Pasteur receives additional order H1N1 vaccine

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the company has received an additional order from the U.S. Department of Health and Human Services (HHS) to produce vaccine to help protect against the Influenza A (H1N1) 2009 virus. The new order is for the production of bulk antigen equivalent to 27.3 million doses based on 15 mcg of antigen per dose.

22 Sep 2009

China SFDA awards Jiangsu Yanshen a new drug certificate and production license for its H1N1 vaccine

Simcere Pharmaceutical Group (NYSE: SCR) ("Simcere" or the "Company"), a leading manufacturer and supplier of branded generic and innovative pharmaceuticals in China, today announced that Jiangsu Yanshen Biological Technology Stock Co., Ltd ("Jiangsu Yanshen"), in which Simcere holds a 37.5% stake, was awarded a new drug certificate and production license from China's State Food and Drug Administration (SFDA) on September 18 for Jiangsu Yanshen's H1N1 vaccine.

22 Sep 2009

Emissary Capital begins investment research coverage on Sinobiopharma

Emissary Capital Group, Inc. has initiated investment research coverage on Sinobiopharma, Inc. (OTC Bulletin Board: SNBP) with a Buy rating and target price of $1.00-$1.25.

22 Sep 2009

Gerresheimer opens new R&D and production centers in USA and Europe

The Gerresheimer Group expands its activities in the pharmaceutical plastic business with two strategically significant investments in the USA and Europe. This week the company is almost simultaneously opening a new research and development center for medical plastic systems in the USA as well as a new production center for pharmaceutical plastic packaging in Spain.

22 Sep 2009

Drug registration process for Nutra Pharma's pain reliever begins

Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it plans to begin the drug registration process in Canada and Europe for its over-the-counter (OTC) pain reliever. The company is currently marketing a similar drug in the United States under the brand name Cobroxin for the treatment of moderate to severe (Stage 2) chronic pain.

22 Sep 2009

FemSoft from Rochester Medical included in the UK Drug Tariff

Rochester Medical Corporation (Nasdaq: ROCM) today announced that the Company's FemSoft(R) Insert has been approved for inclusion in Part IX of the UK Drug Tariff as a prescription product which is reimbursable.

22 Sep 2009

Gerresheimer opens new R&D and production centers in USA and Europe

The Gerresheimer Group expands its activities in the pharmaceutical plastic business with two strategically significant investments in the USA and Europe.

22 Sep 2009

CSL Behring offers new dosage strength of Helixate FS in U.S.

Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS.

22 Sep 2009