News
Merck Serono: European Commission Approves Cetuximab® for First-Line Use in Head and Neck Cancer
Cetuximab® approved for first-line use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in Europe
Dipeptide blocks the formation of toxic amyloid β-peptide aggregates in mice
Israeli researchers have developed a novel approach for treatment of the Alzheimer’s disease (see report in the journal Angewandte Chemie - Nr. 47/2008): the new drug, a molecule made from two nonphysiological amino acids, improves the cognitive abilities of mice with Alzheimer’s and reduces the amyloid plaques in their brains.
COARTEM IS SAFE AND EFFECTIVE
Coartem would be the first ACT cleared in the U.S. for treating malaria
This treatment against malaria by Novartis, Coarten, is a combination drug, artemether–lumefantrine, more effective than its separate components.
New England Journal of Medicine: Two new studies show malaria vaccine candidate advancing in Africa
Results published online in the New England Journal of Medicine revealed that the world's most clinically advanced malaria vaccine candidate provides both infants and young children with significant protection against malaria. Two separate phase II trials reaffirmed earlier study results and support the ongoing efforts, pending regulatory approvals, to launch the phase III study of GlaxoSmithKline Biologicals' RTS,S/AS vaccine candidate across Africa.
Accordo Pfizer Inc. e sigma-tau Industrie Farmaceutiche Riunite SpA
The companies will market Eurartesim(R), a novel fixed dose artemisinin-based combination therapy (ACT), in Africa.
DHA + PQP: A WINNER COMBINATION FOR NEW TREATMENT OF MALARIA
Developed by the Italian pharmaceutical company Sigma-Tau a combination of dihydroartemisinin and piperaquine (DHA+PQP): New data confirm the absence of side effects and the benefit of the simpler treatment schedule. These notable results were presented today at the 57th Annual Meeting of the American Society of Tropical Medicine & Hygiene (ASTMH) held in New Orleans, Louisiana, USA, (December 7-11, 2008).
A NEW PILL FOR TRANSIENT INSOMNIA AFTER SLEEP-TIME SHIFT: JET LAG
A new melatonin agonist - tasimelteon - to help overcome problems of transient insomnia associated with jet lag and shift work: two randomised controlled multicentre trials.
LUMIGAN: A DRUG COULD HELP GROW EYELASHES
Using a medication called Lumigan, to treat glaucoma, patients observed as side effects, the grow of their eyelashes. Now this drug could be used in cosmetic to help grow eyelashes.
FATE AND EFFECTS OF TAMIFLU IN THE ENVIRONMENT
In many countries governments, corporations, and even some private individuals are stockpiling the drug Tamiflu. Unfortunately, increased resistance is being developed against this vital drug, partly because it is used too liberally for ordinary seasonal influenza.
Biocitech
The new french life science technology park
95% OF THE BODY'S SUPPLY OF SEROTONIN IS PRODUCED IN THE GUT
Now some experiments - conducted in mice - suggest that the serotonin plays a key role in regulating bone formation, opening the possibility of novel treatments for diseases such as osteoporosis
FDA Approves Banzel (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder
Eisai Corporation announced that the U.S. FDA approved Banzel (rufinamide) for the adjunctive treatment of a severe forms of childhood epilepsy (Lennox-Gastaut syndrome; LGS) in children 4 years and older and adults.
PURPLE TOMATOES AS POTENTIAL ANTICANCER
Scientists have expressed genes from snapdragon in tomatoes to grow purple tomatoes high in health-protecting anthocyanins.
FDA Approves Rapaflo® (Silodosin) for BPH
Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Rapaflo (silodosin), the company's new alpha blocker for the treatment of the signs and symptoms of BPH.
Cytheris Initiates Clinical Trial of Interleukin-7 (IL-7) as an Immunotherapy in HCV Patients
A study to evaluated the safety and tolerability of CYT107 recombinant human Interleukin-7 in combination with pegylated interferon and ribavirin has begun enrolment in Taiwan, France, Italy and Switzerland
EFSA calls for more scientists
Selected applicants will be offered a renewable three-year mandate and will join Europe’s network of leading food safety scientists from the summer of next year.
Pharmaceutical Research in Italy continuing to experience difficulties
The Istituto di Ricerca di Biologia Molecolare - IRBM P. Angeletti, italian research centre of Merck Research Laboratories will be closed by the end of 2009.
JASCO’s New European Headquarter’s Grand Opening Concludes its 50th Anniversary Celebration in 2008
This year JASCO celebrates its 50th anniversary in the analytical instrumentation market
Newly developed Geniom RT Analyzer form febit
The DKFZ (German Cancer Research Center) Investigates the Role of miRNAs in Carcinogenesis Using febit’s Geniom RT Analyzer
A Phase I clinical trial of ImmuFact IMP321 in pancreatic cancer will be carried out at Washington University in Saint Louis

Immutep S.A. announced yesterday, October 16, that the FDA, after review of the Investigational New Drug Application (IND), has allowed the administration of IMP321 in cancer patients in a Phase I trial conducted by Dr. William G. Hawkins at the Washington University School of Medicine in Saint Louis (MO).
Europe's largest and most influential antibody event.
The 4th annual European Antibody Congress hits Geneva on 1-3 December
New Safinamide patent granted by European Patent Office (EPO)
Safinamide for the treatment of Restless Legs Syndrome
protected up to 2025
SILODOSIN FOR SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
The FDA has approved silodosin (Rapaflo), an alpha-1 adrenergic receptor blocker, for symptoms of Benign Prostatic Hyperplasia (BPH)
Alzheimer’s Disease
Eu-Pharmagate has selected some lectures available on the web to help those who wants to know more
DIABETES
EU-Pharmagate has selected these lectures from web
Awarded the Nobel Prize in Chemistry for 2008
The Royal Swedish Academy of Sciences has decided to award the Nobel Prize in Chemistry for 2008 jointly to
Osamu Shimomura, Martin Chalfie Roger Y. Tsien, "for the discovery and development of the green fluorescent protein, GFP"
Nobel Prize in Physiology or Medicine, 2008
The winners of the 2008 Nobel Prize in Physiology or Medicine have been announced. This year's prize recognizes the significance of discovering viruses that cause severe human diseases.
REDUCTION OF OSTEOPOROSIS BY AN INVESTIGATIONAL MONOCLONAL ANTIBODY: DENOSUMAB
The risk of fractures in women with osteoporosis was significantly reduced by denosumab, an investigational monoclonal antibody, found a phase III study.
Scandal in China: milk contaminated with melamina
It has been found in about 10% of the milk from the three leading companies, which account for about 60% of the market. The substance could be carcinogenic. Requests for "explanations" from the United States and the European Union. Thousands of parents are asking for compensation.
Nice Approves Pradaxa(R) - 1st New Oral Anticoagulant In UK For Over 50 Years
NICE (National Institute of Health and Clinical Excellence) recommending Pradaxa(R) (dabigatran etexilate) as an option for the primary prevention of venous thrombembolic events in adults who have undergone elective total hip or total knee replacement surger
FOCUS AND PERSPECTIVE ON THE ITALIAN BIOTECH PIPELINE.
An interesting note on Italian’s biotech sector by Sergio Dompé on Zangani.com Blogs
Class Of Diabetes Drugs Carries Significant Cardiovascular Risks
A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.
Black raspberries slow cancer by altering hundreds of genes
New research strongly suggests that a mix of preventative agents, such as those found in concentrated black raspberries, may more effectively inhibit cancer development than single agents aimed at shutting down a particular gene.
Honokiol, a natural compound from magnolia cones, blocks a pathway for cancer growth
Honokiol, a biphenolic compound present in the cones, bark, and leaves of Magnolia grandifloris used in the traditional Japanese medicine as an anxiolytic, anti-thrombotic, anti-depressant, anti-emetic, and anti-bacterial, now recognized also as potential antitumor compound.
THE FIRST LUNG CANCER VACCINE TO BE APPROVED BY CUBAN AUTHORITIES
According to Cuban scientists (conference at Cuba’s Center of Molecular Immunology) .the first vaccine to extend lives of lung cancer patients has been approved by Cuban authorities for use and is available in the island’s hospitals
Start of Phase II Clinical Study for Italian AIDS Vaccine
Programme of phase II studies presented yesterday at The Istituto Superiore di Sanità (ISS) by the president Enrico Garaci and Barbara Ensoli director of The Italian National AIDS Center of ISS.
HTI-286, A NEW POTENT TUBULIN INHIBITOR ACTIVE IN THE PROSTATE CANCER
HTI-286, a synthetic analogue of the marine sponge product hemiasterlin, is active against prostate cancer in vitro and in animal models, according to a report in the May 15th International Journal of Cancer.
ARENEGYR: A new agent for the treatment of cancer
ARENEGYR is a new anticancer agent, currently under clinical trials, Phase I and II, with a selective activity on tumour vascular (vascular targeting agent, VTA).
ORAL AGENT SHOWS PROMISE AGAINST MULTIPLE SCLEROSIS
Laquinimod is an immunomodulator developed by Active Biotech and produced by Teva Pharmaceutical Industries. It is currently under development in phase III trials for treatment of multiple sclerosis as an oral therapy
Zoledronic Acid Significantly Reduced Relapse in Early Breast Cancer
Zoledronic acid, a bisphosphonate used for bone metastases and osteoporosis, has shown a significant benefit in early breast cancer in an Austrian trial of 1803 premenopausal women.
ASA404: A SMALL-MOLECULE TUMOR-VASCULAR DISRUPTING AGENT
Novartis’ non-small cell lung cancer (NSLC) drug ASA404, which is designed to selectively reduce blood supply to tumors, has entered a Phase III trial.
A “SERENDIPITOUS” APPROACH UNCOVERED A NEUROGENIC SMALL MOLECULE
147,000 compounds were screened to see which could stimulate stem cells cultivated from rodent embryos to become heart cells. Unexpectedly, five molecules stimulated the cells to transform into forms resembling nerve cells.
BRISTOL-MYERS SQUIBB AND ASTRA ZENECA DEMONSTRED SIGNIFICANT REDUCTION IN KEY MEASURES OF GLUCOSE CONTROL IN TREATMENT WITH ONGLYZA(TM) OF NAÏVE PEOPLE WITH TYPE 2 DIABETS.
Results from a 24-week Phase III study presented at the 68th American Diabetes Association Annual Scientific Sessions demonstrated that saxagliptin produced significant reductions in key measures of glucose control
Synthetic molecules developed by Hebrew University researchers hold promise for new family of anti-cancer drugs
The new molecules may be precursors to the development of a new generation of anti-cancer drugs highly effective while having no toxic effects on normal tissue.
TARGETED CANCER TERAPY: FROM TRIAL TO CLINICAL
This week we highlight an important webcam education on Targeted Therapy, from www.madpagetoday.com
First EU licence granted for pre- pandemic bird flu vaccine
The European Commission has granted the first licence to market a vaccine in preparation for a pandemic of H5N1 bird flu in Europe, British pharmaceutical firm GlaxoSmithKline said on Monday. The ruling from the European Medicines Agency (EMEA) allows GSK to sell Prepandrix, which targets the most virulent strain of the virus that can be fatal to humans, in all 27 European Union member states.
NEW CANCER VACCINES IN DEVELOPMENT
Recent discoveries in the understanding of the immune system as well as in cancer biology, are allowing the development of a new approach to treating cancer - therapeutic cancer vaccines.
Prana Announces Completion of Phase IIa Trial of PBT2 in Alzheimer's Disease Patients
Prana Biotechnology Limited, a biopharmaceutical company focused on the research and development of treatments for neurodegenerative disorders, announced it has completed its Phase IIa clinical trial of PBT2 in patients with early Alzheimer's disease.
DEBIOPHARM SIGNS LICENSE AGREEMENT FOR MARKETING OF SALVACYL®/MOAPAR 3-MONTH FOR SEXUAL DEVIATIONS
An unmet medical and social need for the treatment of sexual deviations.
INNOCENTIVE ANNOUNCED THE TOP SOLVERS 2007
Eleven individuals in 2007 earned $50,000 or more
The U.S. FDA ACCEPTS ORITAVANCIN NDA (New Drug Application)
Oritavancin, also known as LY333328, is a novel semi-synthetic glycopeptide antibiotic developed for the treatment of serious Gram-positive infections. Originally discovered and developed by Eli Lilly, oritavancin was acquired by InterMune in 2001 and then by Targanta Therapeutics in late 2005[
AN EXTRAORDINARY STORY FROM DAILYMAIL
A “special dust”, actually a collagen powder derived from pigs' bladders, appeared to provide a suitable "matrix" or framework, stimulating regrowth of the tissues and division of the cells, to enable Mr Spievack's finger to grow back - in just a month. And not just a stump - flesh, tendon, skin, fingernail, fingerprints and all.
ALBERT HOFMANN, FATHER OF LSD, DEAD AT 102
Albert Hofmann was born in Baden, Switzerland (January 11, 1906) was a Swiss scientist best known for synthesizing lysergic acid diethylamide (LSD). Hofmann authored more than 100 scientific articles and wrote a number of books, including LSD: My Problem Child. Dr. Hofmann died of a heart attack April 29,2008, in the morning at his home in Basel, Switzerland.
FDA Approves Cimzia® to Treat Crohn's Disease
Cimzia® is an investigational agent, now approved: it is the first and only PEGylated anti-TNF (Tumor Necrosis Factor) biologic therapy available for the treatment of rheumatoid arthritis.
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION
Taro Pharmaceutical Industries Ltd. reported that it has received final approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for cetirizine hydrochloride oral solution, 1 mg / 1 mL (“Cetirizine Oral Solution”).
Winners for 2008 EFMC Awards announced
The Awards will be presented to the winners during the opening ceremony of the XXth EFMC-ISMC Symposium
NEW VACCINE TO PREVENT GASTROENTERITIS CAUSED BY ROTAVIRUS
FDA approves Rotarix, a new vaccine for children
NEW DRUG APPLICATION FOR TREANDA(R) BY CEPHALON
FDA Accepts TREANDA(R) New Drug Application (NDA) For The Treatment Of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) who have progressed during or following treatment with rituximab or a rituximab-containing regimen.
POSITIVE RESULTS OF AN2728 IN PSORIASIS PATIENTS
Anacor Pharmaceuticals announced results from a Phase 2a clinical trial of AN2728, an investigational topical anti-inflammatory drug, in patients with psoriasis.
FIRST THERAPY APPROVED FOR TREATMENT OF CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES (CAPS) A RARE, HEREDITARY, INFLAMMATORY DISEASE
Regeneron Pharmaceuticals, Inc. has received marketing approval from the U.S. Food and Drug Administration (FDA) for ARCALYST™ (rilonacept) Injection for Subcutaneous Use, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).
EMEA: STRONG PERFORMANCE IN 2007
EMEA (European Medicines Agency) reports strong performance in regulatory and public-health activities in 2007; the outlook for 2008 is even higher application numbers and a focus on advanced-therapy medic
MULTIVITAMINS DO NOT REDUCE RISK FOR LUNG CANCER, AND VITAMIN E MAY RAISE IT
Can multivitamins reduce risk for lung cancer? A recent study by C.G. Slatore, and colleagues, from the University of Washington in Seattle, Washington, reported in the March 1 issue of the American Journal of Respiratory and Critical Care Medicine and highlighted by Z. Chustecka and C. Vega on medscape.com showed that a long-term use of supplemental multivitamins does not reduce the risk of developing lung cancer, and high doses of vitamin E may even raise the risk, particularly in smokers.
Direct Thrombin Inhibitors: Alternatives to Heparin
A Medscape article on alternative to heparin by LEILA MUREEBE. This article reviews current viable options and barriers to the use of heparin.
THE FDA APPROVED PRISTIQ FOR ANTIDEPRESSANT USE
Pristiq (Desvenlafaxine succinate), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD).
Cholesterol lowering mechanism of soybean protein hydrolysate identified
An interesting study helps in understanding how soy protein may lower blood fat levels
U.S. REGULATORS IDENTIFIED CONTAMINANT IN BAXTER’S HEPARIN
The US FDA has detected a "contaminant" in many samples of Chinese-supplied heparin that may be the cause of hundreds of severe and sometimes deadly allergic reactions to the blood-thinning drug.
XELODA (CAPECITABINE) FOR TREATING METASTATIC COLORECTAL CANCER
The European Commission has approved Roche Holding AG's oral chemotherapy Xeloda (capecitabine) for treating metastatic colorectal cancer.
FROM INDUSTRY TO ACADEMIA
On Nature Review – Issue February, 2008, the experience of two researchers who have recently moved from Pharma to Academia
INTELENCE™, A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR, AGAINST HIV-1 INFECTION
INTELENCE™ is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI)
Indicated - in combination with other antiretroviral agents - for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents.
APPROUVED IN EUROPE THE NOVEL NOVARTIS’ ANTIDIABETES
EMEA has approved vildagliptin (Galvus) by Novartis, for treatment of type 2 diabetes mellitus (non-insulin-dependent diabetes).
NEW RESEARCH: ALZHEIMERS PATIENTS IMPROVE DRAMATICALLY WITH ENBREL
An extraordinary new scientific study, which for the first time documents marked improvement in Alzheimer’s disease within minutes of administration of a therapeutic molecule, has just been published in the Journal of Neuroinflammation.
PHASE I STUDY OF AFP-464 IN PATIENTS WITH SOLID TUMORS
AFP-464 is an aminoflavone pro-drug, a first-in-class molecule, with the potential to fill a large unmet medical need in the treatment of cancer
NEW FDA ORPHAN DRUG FOR ORAL FLUDARABINE AGAINST CHRONIC LYMPHOCYTIC LEUKEMIA
The US Food and Drug Administration (FDA) has granted orphan drug designation to oral fludarabine phosphate for the treatment of chronic lymphocytic leukemia (CLL), the most common cancer affecting the bone marrow and blood.
“THE GOLDEN PILL 2007” TO AN ORPHAN DRUG
The prestigious French review Prescrire since 27 years awarded drugs which represent a major therapeutic advancement in areas where there is an unmet medical need, that is where patients and doctors are devoid of treatments. Prescrire is a totally independent medical review which has no links whatsoever with the healthcare industry
DR. JUDAH FOLKMAN, M.D., U.S. CANCER PIONEER, DIES (1933-2008)
Judah Folkman, M.D., director of the vascular biology program at Children’s Hospital Boston and the Andrus professor of pediatric surgery and professor of cell biology at Harvard Medical School, died suddenly January 14, 2008. He was 74.
HIGHER INTAKE OF CAROTENOIDS AND VITAMIN E COULD REDUCE THE RISK OF DEVELOPING CATARACT
A new study recently published on Archives of Ophthalmology, reports that dietary carotenoids such as lutein and zeaxanthin as well as vitamin E, could reduce the risk of cataracts in women
ONLY 19 NEW DRUGS APPROVED BY FDA IN 2007
The U.S. Food and Drug Administration approved 19 new drugs in 2007, the fewest in 24 years
SUPER RED WINE MIGHT BOOST LIFESPAN
A novel stilbene synthase gene (STS), cloned from Chinese wild Vitis pseudoreticulata and responsible for synthesis of the phytoalexin resveratrol in grapevine, was successfully transferred into V. vinifera L. cv. Thompson Seedless via Agrobacterium tumefaciens-mediated transformation.
Expression of the STS gene was detected by high performance liquid chromatography (HPLC), which showed that the resveratrol concentration in the transgenic plants was about 6 times higher than that in non-transformed control plants.
THE NEW ANTI-FUNGAL DRUG ANIDULAFUNGIN NOW IN EU-COUNTRIES
Approval in February 2006 by the FDA, and now, in September 2007, approved by EMEA. In 2008 available in many EU countries (UK, France, Spain, Germany).
FAVORABLES RESULTS FROM FIRST CLINICAL TRIAL OF FV-100, AN ORAL DRUG FOR THE TREATMENT OF SHINGLES.
Inhibitex, Inc, announced that it has completed its initial Phase I clinical trial of FV-100, a nucleoside analogue being developed to treat shingles.
TELBIVUDINE FOUND BETTER AT SUPPRESSING HEPATITIS B VIRUS.
Two international studies of a new drug, telbivudine, show that it suppresses the virus that damages the liver faster and better than other treatments.
HYDROXYUREA CHEMOTHERAPY AGAINST MENINGIOMAS
Hydroxyurea, an inhibitor of ribonucleotide reductase, is one of the most active agents and is known to induce apoptosis in meningioma cells in vitro and in mouse xenografts. Results of preliminary clinical studies suggest that hydroxyurea has modest activity against recurrent and inoperable meningiomas, and can induce long term stabilization in some patients. However, the results are conflicting and a few clinical trials did not show positive results. Further clinical trials with larger patient cohorts and longer follow-up periods will be necessary to confirm the activity of hydroxyurea.
CORRELATION BETWEEN OF A NOVEL SMALL HEAT SHOCK PROTEIN (HSP16.2) AND MALIGNANCY IN BRAIN TUMORS
Hsp16.2 expression was directly correlated with the histological grade of brain tumors, therefore Hsp16.2 may have relevance as becoming a possible tumor marker
Phase III Clinical Trial Program for ALTROPANE®
ALTROPANE® is a diagnostic molecular imaging agent being developed to aid in the differentiation of Parkinsonian Syndromes from non-Parkinsonian tremor.
SIGNAL TRANSDUCTION INHIBITORS IN CANCER THERAPY
Concise and practical information on molecular targeted therapies
FDA APPROVED KUVAN™ AGAINST HIGH LEVEL OF BLOOD PHENYLALANINE
Kuvan™ (sapropterin dihydrochloride) Tablets is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).
NEW COMPOUNDS FOR PAIN TREATMENT
Pfizer Inc and Adolor Corporation have announced a collaboration to develop a new class of opioids for delivering analgesia without some of the complicating side effects of traditional mu agonists.
HEPARANASE EXPRESSION CORRELATES WITH THE PROGRESSION OF TONGUE CANCER AND WITH TUMOR SIZE
According to the results of a study published in the December 15 issue of Cancer, higher levels of heparanase were detected in the saliva of patients with tongue cancer, raising the possibility that heparanase testing can be used to monitor disease progression and response to treatment.
SBIO INITIATES CLINICAL TRIAL OF NOVEL ANTI-CANCER DRUG
SB939 belongs to a new class of targeted anti-cancer therapeutics called histone deacetylase (HDAC) inhibitors. SB939 is designed to be a "best-in-class" therapeutic amongst HDAC inhibitors being developed worldwide, and has demonstrated the potential to bring additional therapeutic benefits due to its high potency, superior oral availability and good tolerability.
MONEY FOR BIOMEDICAL RESEARCH
Italian Ministero della Salute set aside money for research
NEW ORPHAN DRUGS: AVI-4658, SQ109, ATIR
The FDA granted recently orphan drug designation to three new drugs
Overcoming adversity, one drug at a time
Students in Purdue University's Department of Computer and Information Technology are working to develop an information-management tool that could give pharmacists instant access to patients' genetic profile, making it possible to quickly determine the proper medicine dosage or if the drug cannot be tolerated by the patient.
TREATMENT OF SCHIZOPHRENIA WITH SEROQUEL XR(TM) ADMINISTERED ONCE DAILY
Seroquel XR® (quetiapine fumarate) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
GALENO 2007: THE WINNER IS TIGECYCLINE
It is a new generation antibiotic the winner of the Galeno Prize 2007
TOPOTECAN HYDROCHLORIDE (HYCAMTIN®) FOR ORAL USE.
After GlaxoSmithKline received final FDA approval for Hycamtin Capsules on October 15, 2007, Topotecan is the first topoisomerase inhibitor for oral use.
APPROVED BY THE US FDA TASIGNA® (NILOTINIB) FOR THE TREATMENT OF CML
The FDA has approved Tasigna® (nilotinib), a Novartis Pharma’s for treatment of Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients whose disease has progressed on or who cannot tolerate other therapies that included imatinib. Imatinib (Gleevec) is approved for the treatment of new diagnosed patients with Philadelphia chromosome positive CML
COMBIGAN, A WINNER COMBINATION FOR REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR HYPERTENSION
Allergan has announced that the FDA has approved an ophthalmic solution that combines brimonidine and timolol (Combigan) for reduction of intraocular pressure in patients with glaucoma or ocular hypertension
FDA APPROVES IXEMPRA (IXABEPILONE), FOR ADVANCED BREAST CANCER PATIENTS
Ixempra is a new anti-cancer treatment, a semi-synthetic analog of epothilone B, for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs.
ISENTRESS® (RALTEGRAVIR) FOR THE TREATMENT OF HIV-1 STRAINS RESISTENT INFECTIONS
ISENTRESS™ is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
DORIBAX(R) (DORIPENEM), A NOVEL PENEM ANTIBACTERIAL
DORIBAX® is a penem antibacterial indicated in the treatment of the complicated intra-abdominal infections and urinary tract infections.
AGREEMENT BETWEEN GLAXOSMITHKLINE AND SYNTA PHARMA FOR A NOVEL ANTIMELANOMA DRUG STA-4783
The agreement brings synta $ 80 million up front and up to $ 1.01 billion in total payments
NEW FDA ORPHAN DRUG MB07133 FOR THE TREATMENT OF LIVER CANCER
The US Food and Drug Administration (FDA) has granted orphan drug designation to MB07133, araCMP prodrug (Metabasis therapheutics Inc.) for the treatment of liver cancer
NEW FDA ORPHAN DRUG: IPI-504 FOR GASTROINTESTINAL STROMAL TUMORS
The FDA granted orphan drug designation to IPI-504 (Infinity Pharmaceuticals, Inc, and MedImmune) for the treatment of gastrointestinal stromal tumors (GISTs).
THE NOBEL PRIZE IN CHEMISTRY 2007
The Nobel Prize in Chemistry for 2007 has been awarded to Gerhard Ertl of Fritz-Haber-Institut der Max-Planck-Gesellschaft, Berlin, "for his studies of chemical processes on solid surfaces".
TANESPIMYCIN, THE FIRST HSP90 INHIBITOR TO ENTER A REGISTRATION PROGRAM.
Kosan Opens Registration Program For Lead Hsp90 Inhibitor, Tanespimycin, In Multiple Myeloma
THE NOBEL PRIZE IN PHYSIOLOGY OR MEDICINE 2007
The Nobel Prize in Physiology or Medicine for 2007 has been awarded jointly to Mario Capecchi Martin Evans and Oliver Smithies
FDA APPROVES NEW DRUG TO TREAT RARE DISEASE, ACROMEGALY
FDA APPROVES NEW DRUG TO TREAT RARE DISEASE, ACROMEGALY
The U.S. Food and Drug Administration has approved Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly, a rare and potentially life threatening disease in adults caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland located in the brain.
FDA FAST TRACKS ANTI-CANCER PROGEN’S PI-88
The FDA granted Progen’s PI-88 fast-track status for the treatment of post-resection liver cancer.
RECORDATI COMPLETES THE SILODOSIN PHASE III CLINICAL TRIALS
Recordati announced that it has successfully completed the double-blind portion of the phase III study of silodosin, an alpha-blocker for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) licensed from Kissei. The trial was conducted in 11 European countries with 1128 patients (977 randomized) enrolled in 70 clinical centres.
OSTEOPOROSIS DRUG SUCCEEDS IN 3 YEARS STUDY
Wyeth Pharmaceuticals presented the first Phase 3 data for bazedoxifene, a selective estrogen receptor modulator. Bazedoxifene Significantly Reduced the Risk of New Vertebral Fracture.
FDA APPROVES LILLY'S OSTEOPOROSIS DRUG EVISTA(TM)
Eli Lilly and Company announced that the U.S. FDA has approved its osteoporosis drug EVISTATM (raloxifene HCl) for a new use to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer
POSITIVE REPORTS FROM PHASE II CLINICAL TRIALS ON ANTIFLAMMATORY TPI-1020
Positive reports from phase ii clinical trials on antiflammatory tpi-1020 (NCX 1020), developed by NicOx in collaboration with Topigen.
LOOK AT JUICE
Grapefruit juice and drugs not always are arranged. Isolated the compounds responsible of the side effects
ISENTRESS : A NOVEL ANTI-HIV APPROVED BY THE FDA
Isentress is an integrase inhibitor being developed by Merck & Company. After reviewing the safety and effectiveness, it has been approved by FDA.
PIXANTRONE, A NOVEL ANTHRACYCLINE
A novel agent with activity in non-Hodgking’s lymphoma, in Phase III clinical trials.
EARLY DIAGNOSIS OF METASTASIS
For the cancer patients, prognosis correlates mainly with the size of the lesion /stage of tumor at the time of diagnosis, therefore early detection of small, stage-1 cancer can reduce mortality and morbidity. A new noninvasively approach could help patient in the mnext future.
ELI LILLY OPENS DOOR FOR NEXT-GENERATION ANTIPSYCHOTICS
Positive results from a Phase II trial have shown that Eli Lilly's latest antipsychotic drug acts on a new target and avoids key adverse effects caused by other antipsychotics.
CLOBUTINOL: AFTER 46 YEARS BANNED THE USE OF COUGH MEDICINES BECAUSE OF A POTENTIAL RISK OF IRREGULAR HEART BEAT
The decision came after new findings from a clinical study by unlisted Boehringer Ingelheim suggested that a potential risk of cardiac arrhythmia could not be excluded.
BIOLOGICAL SCIENCES ON LINE
A new web site is born, where the researchers will be able to share the movies of the experiments of laboratory in the field of bio-medical activities and to follow in direct the medical conferences: www.scivee.tv.
TOTAL SYNTHESIS OF AZADIRACHTIN ACHIEVED
After 22 years of research Professor Steven Ley of Cambridge University and his group solved the problem of the synthesis of this complex molecule
THE FUTURE OF THE NOVEL DRUG FOR THE TREATMENT OF MALIGNANT MESOTELIOMA
ONCONASE(R) is a potential chemopreventive agent, enhancer of the radiation effect and anti-oxidative agent.
SANCTURA®, A MUSCARINIC RECEPTOR ANTAGONISTS FOR THE OVERACTIVE BLADDER
SANCTURA® XR (trospium chloride extended release capsules) has been approved by the FDA for the daily treatment of overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency, and urinary frequency
PIVOTAL PHASE II CLINICAL TRIAL WITH TAMIBAROTENE IN REFRACTORY ACUTE PROMYELOCYTIC LEUKEMIA
INNOVIVE Pharm. reaches agreement with FDA for a pivotal Phase II clinical trial to evaluate Tamibarotene, for the treatment of relapsed or refractory acute promyelocytic leukemia (APL).
PI-88 FOR THE TREATMENT OF HEPATOCELLULAR CARCINOMA
The Committee for Orphan Medical Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) recommended the granting of orphan medicinal product designation for PI-88 for the treatment of hepatocellular carcinoma, or primary liver cancer.
FDA APPROVES SELZENTRY™ FOR THE TREATMENT OF HIV
The U.S. Food and Drug Administration (FDA) has approved Selzentry™ (maraviroc), a CCR5 antagonist for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load).
ABIRATERONE SHOWS PROMISE IN HORMONE-REFRACTIVE PROSTATE CANCER
Presented in Lugano, Switzerland, July 8, 2007, at the Annual Meeting of the European Society for Medical Oncology (ESMO), two studies (Abstracts 50PD and 51PD) on a new Androgen Synthesis Inhibitor: the Abiraterone
SPECTRUM PHARMACEUTICALS ACQUIRES FROM INDENA WORLDWIDE RIGHTS TO ORTATAXEL
More Than 350 Patients Have Been Treated In Phase 1 & 2 Studies- Ortataxel Is Orally Bioavailable - May Have Activity In Taxane-Refractory Tumors
INITIATES PHASE I CLINICAL TRIAL A NOVEL HSP27 INHIBITOR
OncoGenex announced enrollment of the first patient in an open-label, dose-escalation, multicenter Phase I clinical study evaluating a new investigational drug (NID), OGX-427, in patients with breast, ovarian, bladder, prostate or lung cancer.
TARGACEPT INC. INITIATES PHASE I CLINICAL TRIAL OF TC-5619
TC-5619, IS a novel small molecule that plays a role in protecting neuronal cells from deterioration and death.
GENAERA CORP. PRESENTS NEW PRECLINICAL DATA FOR OBESITY COMPOUND TRODUSQUEMINE (MSI-1436) AT CBI CONFERENCE
The Vice President, Nonclinical Development,of the Genaera presented "Trodusquemine: A Novel Small Molecule for the Treatment of Obesity and Related Metabolic Disorders," during the CBI 3rd Annual Obesity Drug Development Summit, July 26-27 in Arlington, Va.
NEW TARGET FOR HIV/AIDS DRUGS AND VACCINE DISCOVERED
Article in The FASEB Journal (august 2007)
FDA APPROVES SCHWARZ PHARMA'S NEUPRO(R) - ROTIGONINE TRANSDERMAL SYSTEM - FOR THE TREATMENT OF EARLY-STAGE PARKINSON’S DISEASE IN USA.
Rotigotine transdermal system is approved in Europe for the treatment of patients with early and advanced Parkinson's disease in combination with levodopa.
IMI: EVERYTHING READY IN ORDER TO START AT BEGINNING 2008
Innovative Medicines Initiative (IMI), is a joint undertaking of the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). It will support the development of new knowledge, tools and methods so that better and safer medicines can be made available more quickly. The IMI seeks to overcome research bottlenecks in the drug discovery and development process.
EUROPEAN TRADITIONAL MEDICINES - INTERNAZIONAL CONGRESS
In Tuscan, October 2007, the first international conference on the traditional medicine in Europe (from the grass to the acupuncture, to the veterinary).
A SYNERGIC EFFECT OF A TLR9 AGONIST AND BEVACIZUMAB IN TUMOR RESISTANT TO ANTI-EGFR DRUGS
Novel anticancer drugs TLR9 agonists interfere with EGFR signalling and potently synergize with EGFR inhibitors and with bevacizumab in wild type and cetuximab-resistant colon cancer xenografts.
SUCCESS OF THE STRATEGIC US-ITALIAN COOPERATION TO FIGHT OVARIAN CANCER
Goodwin Biotechnology and Menarini Announce the Successful Completion of their Strategic US-Italian Cooperation to Fight Ovarian Cancer
EFSA AND FDA STRENGTHEN COOPERATION IN FOOD SAFETY SCIENCE
The international cooperation agreement signed
A NEW MOLECULE FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION
The U.S. Food and Drug Administration (FDA) gave marketing approval to Letairis (ambrisentan), as orphan drug, for the for the treatment of pulmonary arterial hypertension
FDA APPROVES ALISKIREN: FIRST NEW ANTIHYPERTENSIVE ON THE MARKET IN MORE THAN 10 YEARS
The drug is the first in a new class of agents known as oral renin inhibitors and is approved for the treatment of high blood pressure as monotherapy or in combination with other antihypertensive medications.
PFIZER’S LYRICA RECEIVES FDA APPROVAL FOR FIBROMYALGIA
Lyrica® ( generic name: pregabalin) is the first drug approved by FDA for fibromyalgia
EXENATIDE: A NEW TYPE OF DRUG FOR TYPE 2 DIABETES NOW IN ITALY
Byetta® is the brand name for a new drug (scientific name is EXENATIDE). This drug is the first to market of a class of drugs known as incretin mimetics, they mimic a naturally occuring incretin hormone: glucagon-like peptide-1 (GLP-1).
MEDITERRANEAN DIET ENRICHED WITH WALNUTS ALSO PROTECTS AGAINST OXIDATIVE DAMAGE
The decrease of the oxidative damage to LDL cholesterol is one of the protective mechanisms by which the Mediterranean diet exerts a protective effect on coronary heart disease development
ADDING FOLIC ACID TO BREAD COULD HELP IN THE FIGHT OF DEPRESSION
Researchers at the University of York and Hull York Medical School has confirmed a link between depression and low levels of folate, a vitamin which comes from vegetables.
FDA APPROVES COMMERCIALIZATION OF DIFFERIN ® (ADAPALENE) GEL 0.3% FOR ACNE
Galderma Laboratories, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved Differin® (adapalene) Gel, 0.3%, a new, higher concentration formulation of Differin® (adapalene) 0.1%, a topical retinoid indicated for the treatment of acne.
ITALIAN EURAND’S ZENTASE™ EFFECTIVE IN TREATING EXOCRINE PANCREATIC INSUFFICIENCY, STUDIES SHOW
Zentase Improves Absorption of Fat, Protein and Other Nutrients in Patients with Mild, Moderate or Severe Malabsorptıon, While Controlling Symptoms of Exocrine Pancreatic Insufficiency
FDA GRANTS “PRIORITY REVIEW” FOR BRISTOL MAYER SQUIBB COMPANY INVESTIGATIONAL ONCOLOGY TREATMENT IXABEPILONE.
Bristol-Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the New Drug Application (NDA) for the investigational compound ixabepilone, Bristol-Myers Squibb also announced that the NDA has been granted priority review. The target action date is in late October.
SHIRE PHARMACEUTICAL IN-LICENSES JUVISTAR ® (HUMAN TGFbeta3) FROM RENOVO
Shire pharm has just signed an agreement with Renovo Group for the exclusive development and commercialization rights to JUVISTA®, a novel treatment in late phase 2 development for the prevention and reduction of scarring. The costs of this operation have been up to $825 Million
OMACOR®: THE FIRST AND ONLY FDA-APPROVED PRESCRIPTION OMEGA-3 FATTY ACID PRODUCT
This new drug contains omega-3-acid ethyl esters, comprising of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). OMACOR® is the only omega-3 that, along with diet, has been proven and approved to dramatically reduce very high triglycerides (TGs) (≥500 mg/dL) in adult patients. Omacor® also contains alpha-tocopherol, otherwise known as vitamin E.
ENCYCLOPEDIA OF DNA ELEMENTS (ENCODE) CONSORTIUM
Targeted 1%of the human genome as part of the pilot phase of the ENCODE Project.
These data have been published in June on Nature.
GENE THERAPY AND STEM CELLS: A MEETING FOR NEW CHANCES IN CLINICAL TRIALS
In the recent annual meeting of the American Society of Gene Therapy in Seattle there was a palpable buzz around efforts to correct diseases by targeting therapeutic genes to stem cells already resident in the body.
CANCER STEM CELLS: AN INTERESTING REVIEW
The recent concept of 'cancer stem cells' has directed scientific communities
towards a different wide new area of research field and possible potential future treatment
modalities for the cancer.
POINT OUT ON AN INTERESTING REVIEW BY E. Weisberg et al..
Second generation inhibitors of BCRABL for the treatment of Imatinib resistant chronic myeloid leukaemia (see Nature Review vol. 7 May, 2007)
SATISFIED OR REFUNDED
Satisfied or refunded: this is the proposal of NHS to the drug's manufacturer of Velcade (Bortezomib).
THE SEA SPONGES HIDE THE SECRET OF THE NERVOUS SYSTEM OF THE MAN
A group of scientists of the University of Barbara Saint, in California, studying the genome of a sponge, have discovered significant clues to the evolutionary origins of the nervous system by studying the genome of a sea sponge, a member of a group considered to be among the most ancient of all animals.
FDA Approves Torisel, an mTOR Inhibitor
Torisel, a Targeted First-in-Class mTOR Inhibitor for the Treatment of Advanced Kidney Cancer
POST-MARKETING STUDIES
In U.S. , due an increasing interest in the post-marketing studies (Phase IV clinical trials), which are conduct on newly-approved medicines over the past six years, drug developers / sponsors believe this work has contributed little to their understanding of the new products, according to a new survey carried out by the Tufts Center for the Study of Drug Development (Tufts CSDD).
TO ASSIST SMOKERS IN SMOKING CESSATION
In June in Italy the first (the sole) nicotinic receptor partial antagonist useful in smoking cessation.
NEW DRUG APPROVED BY FDA TO TREAT VAGINAL INFECTIONS<
Administration has approved Tindamax (tinidazole) to treat bacterial vaginosis (BV), the most common vaginal infection among women of childb