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Intellect Neurosciences receives patent for Alzheimer's disease vaccine

Intellect Neurosciences, Inc a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has received a Notice of Allowance from the United States Patent and Trademark Office related to RV01 and RV02, the Company's two lead vaccine candidates. The Notice of Allowance is a written communication stating that the patent application has been allowed and will be granted as a new patent. RV01 and RV02, generated using the Company's RECALL-VAX technology, have the potential to delay the onset of or prevent Alzheimer's disease in individuals susceptible by age, genetic or other risk factor.

11 Aug 2010

Advanced Life Sciences reaches SPA agreement with FDA for Restanza Phase 3 study

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study of its novel once-daily oral antibiotic Restanza to treat community acquired bacterial pneumonia (CABP). The trial is the first prospectively designed superiority study to be conducted in CABP.

11 Aug 2010

NovoSeven RT in 8 mg vial for hemophilia A or B with inhibitors receives FDA approval

Novo Nordisk announced today that the U.S. Food and Drug Administration has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8 mg vial size, making the hemophilia A or B with inhibitors treatment available in 1, 2, 5 and 8 mg vials. The 8 mg vial allows a rapid initiation and administration of this medication for those patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).

11 Aug 2010

Study shows physicians reluctant to use finasteride for prostate cancer

Despite the dramatic results of the Prostate Cancer Prevention Trial (PCPT), which showed a significant reduction in prostate cancer among those taking finasteride, physicians have not increased its use, according to a study published in the September issue of Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

11 Aug 2010

Education, changes in reimbursement practices can reduce inappropriate antibiotic usage: Study

Improved drug coverage under Medicare Part D has led to an increase in the use of antibiotics by seniors, particularly of brand-name and more expensive drugs, according to a University of Pittsburgh Graduate School of Public Health study. Published in the Aug. 23 issue of Archives of Internal Medicine and the first to explore spending on antibiotics under Medicare Part D, the study suggests recent changes in drug coverage improved the use of antibiotics for pneumonia, but could lead to unnecessary spending on expensive broad-spectrum antibiotics and the overuse of inappropriate antibiotics.

11 Aug 2010

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

11 Aug 2010

Labopharm launches antidepressant OLEPTRO for major depressive disorder in U.S.

Labopharm Inc. today announced that OLEPTRO(TM) (trazodone hydrochloride extended-release tablets), a novel once-daily formulation of the antidepressant trazodone, has been launched in the United States by its joint venture with Gruppo Angelini, Angelini Labopharm. OLEPTRO(TM) is indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of OLEPTRO(TM) has been established in a trial of outpatients with MDD as well as in trials with the immediate release formulation of trazodone.

11 Aug 2010

Noven enters agreement to acquire global rights to ADHD drug Daytrana from Shire

Noven Pharmaceuticals, Inc. today announced that it has entered into a Product and Trademark Acquisition Agreement with affiliates of Shire plc pursuant to which Noven will acquire global rights to Daytrana® (methylphenidate transdermal system) from Shire.

11 Aug 2010

Study reveals no evidence of link between bisphosphonates to esophageal cancer risk

Although some reports have suggested a link between the use of oral bisphosphonates (drugs that prevent the loss of bone mass) and esophageal cancer, analysis of medical data from more than 80,000 patients in the United Kingdom found that use of these drugs was not significantly associated with new cases of esophageal or gastric cancer, according to a study in the August 11 issue of JAMA.

11 Aug 2010

CADTH Review Panel releases recommendations for Biologic Response Modifier Agents for Adults with RA

The Canadian Agency for Drugs and Technologies in Health's (CADTH) Therapeutic Review Panel released last week their recommendations for Biologic Response Modifier Agents for Adults with Rheumatoid Arthritis (RA).

10 Aug 2010

FDA grants Orphan Drug Designation to YM BioSciences' JAK1/2 inhibitor

YM BioSciences Inc., announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medical need, in which a patient's bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.

10 Aug 2010

Weifang Shengtai to supply Kelun with 10,000 tons of dextrose monohydrate injection grade

Shengtai Pharmaceutical, Inc. announced on August 6, 2010 that Weifang Shengtai Pharmaceutical Co., Ltd ("Weifang Shengtai"), its operating subsidiary in China, entered into an agreement with Kelun Pharmaceutical ("Kelun") to supply Kelun with 10 thousand tons of dextrose monohydrate injection grade: Kelun Guizhou will be supplied with 7 hundred tons and Kelun Sichuan with 9.3 thousand tons. The agreement is entered into at reasonable prices and will be carried out by prepayments.

10 Aug 2010

Transcept Pharmaceuticals second-quarter net loss decreases to $2.06 million

Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced financial results for the three and six months ended June 30, 2010.

10 Aug 2010

Unigene second-quarter revenue decreases to $3.03 million

Unigene Laboratories, Inc. has reported its financial results for the quarter ended June 30, 2010.

10 Aug 2010

Systemic lupus erythematosus drug market to quadruple from $400 million in 2009 to over $1.6 billion in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, driven primarily by the launch and uptake of Human Genome Sciences/GlaxoSmithKline's Benlysta, the systemic lupus erythematosus (SLE) drug market will quadruple from about $400 million in 2009 to more than $1.6 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

10 Aug 2010

Anika second-quarter product revenue increases 56% to $13.7 million

Anika Therapeutics, Inc., a leader in products for tissue protection, healing, and repair, based on hyaluronic acid technology, today reported financial results for the quarter ended June 30, 2010.

10 Aug 2010

Endo to acquire Penwest for $5.00 per share

Endo Pharmaceuticals today announced actions designed to advance the company's leadership and growth in pain management, including an agreement to acquire all outstanding shares of Penwest Pharmaceuticals for $5.00 in cash per share, or an estimated enterprise value of approximately $144 million at the time of deal close. Penwest has been working with Endo since 1997 on the development and commercialization of OPANA® ER and receives a royalty stream on net sales of the product.

10 Aug 2010

Psoriasis drug market to double from $3.4 billion in 2009 to $6.8 billion in 2019: Pharmacor 2010

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the continued uptake of marketed and emerging interleukin and TNF-alpha inhibitors and a twofold increase in the penetration of biologics in the moderate-to-severe population will drive the psoriasis drug market to double from $3.4 billion in 2009 to $6.8 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

10 Aug 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the use of a Prefilled Dual-Chamber Syringe for administration of XYNTHA® Antihemophilic Factor (Recombinant) Plasma/Albumin-Free to hemophilia A patients. XYNTHA is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.

9 Aug 2010

Progenics second-quarter total revenue decreases to $2.3 million

Progenics Pharmaceuticals, Inc. today announced its results of operations for the second quarter and six months ended June 30, 2010.

9 Aug 2010

Pharmaceutical News

Intellect Neurosciences receives patent for Alzheimer's disease vaccine

Advanced Life Sciences reaches SPA agreement with FDA for Restanza Phase 3 study

NovoSeven RT in 8 mg vial for hemophilia A or B with inhibitors receives FDA approval

Study shows physicians reluctant to use finasteride for prostate cancer

Education, changes in reimbursement practices can reduce inappropriate antibiotic usage: Study

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Labopharm launches antidepressant OLEPTRO for major depressive disorder in U.S.

Noven enters agreement to acquire global rights to ADHD drug Daytrana from Shire

Study reveals no evidence of link between bisphosphonates to esophageal cancer risk

CADTH Review Panel releases recommendations for Biologic Response Modifier Agents for Adults with RA

FDA grants Orphan Drug Designation to YM BioSciences' JAK1/2 inhibitor

Weifang Shengtai to supply Kelun with 10,000 tons of dextrose monohydrate injection grade

Transcept Pharmaceuticals second-quarter net loss decreases to $2.06 million

Unigene second-quarter revenue decreases to $3.03 million

Systemic lupus erythematosus drug market to quadruple from $400 million in 2009 to over $1.6 billion in 2019

Anika second-quarter product revenue increases 56% to $13.7 million

Endo to acquire Penwest for $5.00 per share

Psoriasis drug market to double from $3.4 billion in 2009 to $6.8 billion in 2019: Pharmacor 2010

FDA approves Pfizer's Prefilled Dual-Chamber Syringe for XYNTHA administration in hemophilia A patients

Progenics second-quarter total revenue decreases to $2.3 million

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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