Pharmaceutical News

RSS

EVISTA improves bone quality as measured by HRpQCT: IIT

Interim data from a prospective Investigator Initiated Trial presented today at the ECTS, the 37th European Symposium on Calcified Tissues, in Glasgow, demonstrates that EVISTA (raloxifene 60mg; once-daily, distributed in 34 countries by DAIICHI SANKYO), indicated for the treatment and prevention of osteoporosis in postmenopausal women, improves bone quality as measured by the high-resolution peripheral quantitative computed tomography.

28 Jun 2010

WellPoint research leads to limits on use of Boniva; FDA spars with tobacco company

"WellPoint Inc. (WLP), the largest U.S. managed-care concern by membership, made it harder last year for its members to gain approval for use of the Boniva osteoporosis drug after internal research linked it to higher fracture rates, lower patient compliance and higher total costs of care than two other drugs, a WellPoint executive said Thursday," Dow Jones Newswires/The Wall Street Journal reports.

28 Jun 2010

Combination MMRV vaccine associated with increased risk of febrile seizures

The combination vaccine for measles, mumps, rubella and chickenpox (MMRV) is associated with double the risk of febrile seizures for 1- to 2-year-old children compared with same-day administration of the separate vaccine for MMR (measles, mumps, rubella) and the varicella (V) vaccine for chicken pox, according to a Kaiser Permanente Division of Research study appearing online in the journal Pediatrics. A febrile seizure is a brief, fever-related convulsion but it does not lead to epilepsy or seizure disorders, researchers explained.

28 Jun 2010

Poster presentation at MASCC Conference summarizes MuGard clinical experience

ACCESS PHARMACEUTICALS, INC., a biopharmaceutical company specializing in products for cancer and supportive care, is presenting a scientific poster today at the Multinational Association of Supportive Care in Cancer Conference in Vancouver, B.C. The poster presentation, co-authored by Dr. David Nowotnik of Access Pharmaceuticals and Dr. Caroline Dumas of SpePharm Holdings, summarizes MuGard clinical experience from cancer patients globally undergoing radiotherapy and/or chemotherapy.

28 Jun 2010

FDA grants orphan drug designation for Chiasma's Octreolin

Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

28 Jun 2010

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

New data were presented at the American Diabetes Association 70th Annual Scientific Sessions from a study comparing JANUMET (sitagliptin/metformin) to pioglitazone. In this study, JANUMET resulted in significantly greater blood sugar reductions in patients with type 2 diabetes compared with pioglitazone.

28 Jun 2010

Antioxidant therapy may prevent long-lasting cognitive impairment in cerebral malaria: Research

Using an experimental mouse model for malaria, an international group of scientists has discovered that adding antioxidant therapy to traditional antimalarial treatment may prevent long-lasting cognitive impairment in cerebral malaria. Their findings were published online June 24, 2010, in the journal PLoS Pathogens.

28 Jun 2010

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced data on ZGN-201, a prototype methionine aminopeptidase 2 inhibitor, for the treatment of obesity. Preclinical studies demonstrate MetAP2 inhibition eliminates excess body weight through the regulation of fat metabolism and food intake, and normalizes glucose tolerance in animal models.

28 Jun 2010

WCO signs declaration, vows to crack down on counterfeit drug industry

World Customs Organization Secretary General Kunio Mikuriya on Thursday signed a declaration vowing his group's commitment to crack down on the counterfeit drug industry, PBS NewsHour's "The Rundown" blog reports. The piece examines the growing threat of counterfeit medications worldwide and efforts to clamp down on the distribution of such drugs (Miller, 6/24).

28 Jun 2010

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV (velaglucerase alfa), the company's enzyme replacement therapy for the treatment of type 1 Gaucher disease.

28 Jun 2010

New preclinical data of XOMA 052 in animal model of Type 2 diabetes to be presented at ADA 2010

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, will be presenting new preclinical data in an animal model of Type 2 diabetes in which its anti-inflammatory therapeutic antibody candidate, XOMA 052, was used as monotherapy and in combination with the marketed anti-diabetic drugs exendin-4 (Byetta) or sitagliptin (Januvia).

28 Jun 2010

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Late-breaking Novo Nordisk extension data presented today at the 70th Annual Scientific Sessions of the American Diabetes Association showed that once-daily Victoza in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose than Januvia plus metformin at 52 weeks.

28 Jun 2010

Bayer signs agreement to supply Adalat XL product to Teva Canada

Bayer Inc. and Teva Canada Limited today announced they have entered an agreement regarding Bayer's Adalat XL (nifedipine) 20, 30 and 60 mg product. Effective immediately, Bayer Inc. will supply Adalat XL exclusively to Teva Canada Limited and Teva Canada Limited will become the sole distributor in Canada of brand name Adalat XL product.

28 Jun 2010

Psychotropic medications associated with adverse drug reactions in Danish children: Researchers

Between 1998 and 2007, psychotropic medications were associated with 429 adverse drug reactions in Danish children under the age of 17. Researchers from the University of Copenhagen's Faculty of Pharmaceutical Studies have published an article in the open access journal BMC Research Notes concluding that more than half of the 429 cases were serious and several involved birth defects, such as birth deformities and severe withdrawal syndromes.

25 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

New method to synthesize drug candidates for testing

Some drugs may be more effective the longer they last inside the body. To prevent such drugs from being broken down too rapidly, pharmaceutical manufacturers often attach a fluorine-containing structure called a trifluoromethyl group. However, the processes now used require harsh reaction conditions or only work in a small number of cases, limiting their usefulness for synthesizing new drug candidates for testing.

25 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

PecFent receives Positive Opinion from CHMP for treatment of BTCP

Archimedes Pharma, a leading specialty pharma company, today announced that its lead product, PecFent, has received a Positive Opinion from the Committee for Human Medicinal Products, of the European Medicines Agency. The CHMP is recommending PecFent, an innovative fentanyl nasal spray, be authorised for marketing in European Union countries for the treatment of breakthrough cancer pain - sudden, unpredictable episodes of intense pain that occur despite background pain medication.

25 Jun 2010

PMPRB report: Brand-name drug companies in Canada spent only 7.5% of revenues on R&D in 2009

Research and development spending in Canada by brand-name drug companies has dropped to its lowest level in 20 years, according to the latest annual report of the Patented Medicine Prices Review Board.

25 Jun 2010

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

25 Jun 2010

Pharmaceutical News

EVISTA improves bone quality as measured by HRpQCT: IIT

WellPoint research leads to limits on use of Boniva; FDA spars with tobacco company

Combination MMRV vaccine associated with increased risk of febrile seizures

Poster presentation at MASCC Conference summarizes MuGard clinical experience

FDA grants orphan drug designation for Chiasma's Octreolin

JANUMET results in greater blood sugar reductions in patients with type 2 diabetes compared to pioglitazone

Antioxidant therapy may prevent long-lasting cognitive impairment in cerebral malaria: Research

Data on MetAP2 inhibitors for treatment of obesity presented at ADA 2010

WCO signs declaration, vows to crack down on counterfeit drug industry

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

New preclinical data of XOMA 052 in animal model of Type 2 diabetes to be presented at ADA 2010

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Bayer signs agreement to supply Adalat XL product to Teva Canada

Psychotropic medications associated with adverse drug reactions in Danish children: Researchers

Japan's MHLW grants full marketing authorization to REVLIMID

New method to synthesize drug candidates for testing

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

PecFent receives Positive Opinion from CHMP for treatment of BTCP

PMPRB report: Brand-name drug companies in Canada spent only 7.5% of revenues on R&D in 2009

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

Latest News