Pharmaceuticals News and Research

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FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

Progenics Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA), along with the European Medicines Agency (EMA) of the European Union (E.U.) and Health Canada, the Canadian Regulatory Agency, have each approved single-use, pre-filled syringes of RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection for use in their respective territories. These pre-filled syringes provide a simplified dosing option for the treatment of opioid-induced constipation (OIC) in palliative-care patients with advanced illness.

30 Sep 2010

USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceutical's Crestor ® tablets 5 mg, 10 mg, 20 mg, 40 mg.

30 Sep 2010

New immunotherapy regimen improves survival rate in children with neuroblastoma: Research

Administering a new form of immunotherapy to children with neuroblastoma, a nervous system cancer, increased the percentage of those who were alive and free of disease progression after two years, according to researchers at the University of California, San Diego School of Medicine and fellow institutions.

30 Sep 2010

Austrian AGES approves Baxter's PREFLUCEL vaccine for seasonal influenza

Baxter International Inc. today announced the first approval of PREFLUCEL by the Austrian Agency for Health and Food Safety (AGES). The vaccine was shown to be effective in preventing seasonal influenza and is indicated for prophylaxis of influenza in adults and the elderly. PREFLUCEL is manufactured using Baxter's proprietary advanced Vero cell technology.

From Baxter International Inc. 30 Sep 2010

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Alnylam Pharmaceuticals, Inc. a leading RNAi therapeutics company announced today that it has published results in the American Journal of Respiratory and Critical Care Medicine from its double-blind, placebo-controlled, randomized Phase IIa study of ALN-RSV01 in lung transplant patients naturally infected with respiratory syncytial virus (RSV).

30 Sep 2010

Breakthrough neuroblastoma treatment

According to a new study the addition of an experimental immunotherapy drug to the standard regimen of care extended the lives and decreased the risk of a disease recurrence in children with high-risk neuroblastoma. This tumor most frequently originates in one of the adrenal glands, but can also develop in nerve tissues in the neck, chest, abdomen, or pelvis. It forms 12 percent of cancer-related deaths in children under the age of 15 and half of patients with this type of malignancy have the high-risk form.

29 Sep 2010

Starpharma expands partnership with Eli Lilly

Starpharma Holdings Limited (ASX:SPL,OTCQX:SPHRY) today announced the signing of a collaborative research agreement with leading US pharmaceutical corporation Eli Lilly and Company.

29 Sep 2010

Unique genetic markers point to patient response to SCV-07 treatment

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that researchers have identified two unique gene clusters that differentiated subjects who responded to treatment in the Company’s phase 2a proof of concept study of SCV-07 for the prevention of severe oral mucositis (OM; WHO grades 3-4) in patients with advanced head and neck cancer.

29 Sep 2010

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

Keryx Biopharmaceuticals, Inc. announced today the initiation of the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.

29 Sep 2010

NeurAxon closes convertible debenture financing

NeurAxon, Inc., a development-stage pharmaceutical company that is designing and developing next-generation pain therapeutics targeting neuronal nitric oxide synthase (nNOS), today announced that it has closed a convertible debenture financing in which the convertible debentures are convertible under specified circumstances into existing class B preferred shares for a total of approximately $14 million.

29 Sep 2010

Senesco fiscal 2010 revenue decreases to $140,000

Senesco Technologies, Inc. reported financial results for the 12 months ended June 30, 2010 ("Fiscal 2010").

29 Sep 2010

NIAID study utilizes Biojector B2000 system to explore syringe, needle benefits

Bioject Medical Technologies Inc., a leading developer of needle-free injection therapy systems, today announced that its unique Needle-Free Injection Therapy (NFIT) system, the Biojector 2000, is being utilized in a study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the U.S. National Institutes of Health (NIH).

29 Sep 2010

Rigel earns $25M milestone payment from Astrazeneca for clinical development of fostamatinib

Rigel Pharmaceuticals, Inc. today announced that it has earned $25 million from AstraZeneca for the fulfillment of two major milestones in the agreement the two companies have regarding the clinical development of fostamatinib (R788), a novel oral syk inhibitor. The first milestone is for initiation of the phase 3 clinical program with fostamatinib in patients with rheumatoid arthritis (RA) that was announced by AstraZeneca earlier today.

29 Sep 2010

Bayer Schering collaborates with Ligon to apply SMM technology for first-in-class drug discovery

Ligon Discovery, the innovator of Small Molecule Microarray technology, today announced that it has partnered with Bayer Schering Pharma AG, Germany, to apply its proprietary Small Molecule Microarray screening platform (SMM) to discover potential first-in-class drug candidates for new disease targets.

29 Sep 2010

NIH trial selects Inovio's PENNVAX-G DNA vaccine candidate to evaluate HIV-1 prevalent

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that a Phase I study, called RV262, recently began to evaluate a combination DNA prime/MVA vector boost regimen that was developed to protect against diverse subtypes of HIV-1 prevalent in North America, Europe, Africa, and South America.

29 Sep 2010

CAP cells produce high virus titers upon influenza strain infection

CEVEC Pharmaceuticals, the developer of an extremely potent protein expression system based on human CAP cells, announced today that CAP cells produce high virus titers upon infection with influenza strains. The virus titers are as good as or even higher than with MDCK and Vero cells, host cells currently used for influenza vaccine production.

29 Sep 2010

Florida likely to seek waiver on medical loss ratio; Ariz. cuts back Medicaid benefits

The Hill Healthwatch: "Florida's 14-member insurance advisory board has unanimously passed a resolution to seek a waiver from the health law's medical loss ratio. An official with the Florida Office of Insurance Regulation tells The Hill that the board's vote means it's a 'done deal' that the state will formally seek some kind of waiver but the board is gathering public input through Oct. 8.

29 Sep 2010

New RTCA Cardio Instrument monitors real-time cardiomyocyte beating and cellular events

Roche announced today that it had launched the RTCA Cardio Instrument, the latest member of the xCELLigence product family. The RTCA Cardio Instrument is a medium throughput cell analyzer that utilizes impedance readings to monitor cardiac beating and cellular events in real time.

From Roche Sequencing and Life Science 29 Sep 2010

Researchers identify biomarker to predict tivozanib drug resistance

Researchers believe there may be a way to predict, based on individual tumors, those patients that are more likely to respond to the investigational new drug tivozanib.

29 Sep 2010

Pieris enters multi-year collaboration with Sanofi-Aventis and Sanofi Pasteur for Anticalin technology

Pieris AG announced today the signature of a collaboration and license agreement with both Sanofi-Aventis and Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, under which Pieris will apply its proprietary Anticalin technology to discover novel Anticalin drugs against multiple targets, with further development undertaken by Sanofi-Aventis and Sanofi-Pasteur. The collaboration will initially involve two targets nominated by Sanofi-Aventis and Sanofi-Pasteur, and includes the option for four additional targets.

29 Sep 2010

Pharmaceuticals News and Research

FDA, EMA and Health Canada approve Progenics' RELISTOR in pre-filled syringes

USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

New immunotherapy regimen improves survival rate in children with neuroblastoma: Research

Austrian AGES approves Baxter's PREFLUCEL vaccine for seasonal influenza

Alnylam Pharmaceuticals publishes ALN-RSV01 Phase IIa study results

Breakthrough neuroblastoma treatment

Starpharma expands partnership with Eli Lilly

Unique genetic markers point to patient response to SCV-07 treatment

Keryx commences Zerenex Phase 3 study for hyperphosphatemia in patients with ESRD on dialysis

NeurAxon closes convertible debenture financing

Senesco fiscal 2010 revenue decreases to $140,000

NIAID study utilizes Biojector B2000 system to explore syringe, needle benefits

Rigel earns $25M milestone payment from Astrazeneca for clinical development of fostamatinib

Bayer Schering collaborates with Ligon to apply SMM technology for first-in-class drug discovery

NIH trial selects Inovio's PENNVAX-G DNA vaccine candidate to evaluate HIV-1 prevalent

CAP cells produce high virus titers upon influenza strain infection

Florida likely to seek waiver on medical loss ratio; Ariz. cuts back Medicaid benefits

New RTCA Cardio Instrument monitors real-time cardiomyocyte beating and cellular events

Researchers identify biomarker to predict tivozanib drug resistance

Pieris enters multi-year collaboration with Sanofi-Aventis and Sanofi Pasteur for Anticalin technology

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