News

Further Complete Response Letter for Aveed (Endo Pharma)

Endo Pharmaceuticals has received a third Complete Response Letter (CRL) from the FDA, asking for tighter safety measures before it can approve the application to market its long-acting testosterone injection Aveed (testosterone undecanoate) for the treatment of Hypogonadism.

The Complete Response Letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps ...

FDA approves Xofigo (Bayer HealthCare) for Prostate Cancer

The FDA has approved Xofigo (radium Ra 223 dichloride), from Bayer HealthCare, for the treatment of patients with castration-resistant Prostate Cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo (formerly Alpharadin) is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to ...

CHMP recommends Spedra (avanafil) as a treatment for Erectile Dysfunction in adult men

Vivus, the USA-based pharmaceutical company has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval for Spedra (Avanafil) for the treatment of erectile dysfunction in adult men.

Avanafil is a selective phosphodiesterase type 5 inhibitor which increased the percentage of sexual attempts resulting in successful intercourse by roughly 20%-30% over placebo ...

CHMP recommends Xtandi (enzalutamide) as a treatment for Prostate Cancer

Astellas Pharma Europe Ltd., the European Headquarters of Astellas Pharma Inc. and Medivation, Inc.have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending European Commission approval for Xtandi (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant Prostate Cancer whose disease has progressed on or after docetaxel therapy.

Enzalutamide is ...

Phase III success for Androxal (Repros Therapeutics) for Hypogonadism

Repros Therapeutics Inc. reported top-line results for the first pivotal study of Androxal, ZA-301, in the treatment of secondary Hypogonadism. Results for the Intent-to-Treat population met both co-primary endpoints mandated by the FDA. The Intent-to-Treat population included all men randomized in the study whether or not they completed the study. 151 subjects were randomized into the study, 38 on ...

Phase III study shows Cialis (Eli Lilly) plus finasteride provides benefits for Benign Prostatic Hyperplasia

A new Phase III study showed Cialis (tadalafil), from Eli Lilly and Co, co-administered with finasteride significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of Benign Prostatic Hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride also improved erectile function scores versus placebo/finasteride in those men ...

Firmagon (Ferring)shows lower CV risks in treatment of Prostate Cancer

Data presented at the European Association of Urology 2013 annual meeting in Milan, indicate that the gonadotropin releasing hormone (GnRH) antagonist Firmagon (degarelix) from Ferring, may be associated with lower risk of a cardiovascular (CV) event or death compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists.

These data are based on a pooled analysis of 2,328 ...

MRI-guided focal laser ablation system (Visualase) shows promise in patients with Prostate Cancer

A small Phase I trial of an MRI-guided focal laser ablation system, from Visualase, designed to treat the diseased portion of the Prostate in patients with Prostate Cancer, suggests the technique is safe and can be performed without the troubling complications associated with more aggressive therapies. This study enrolled nine men with biopsy-confirmed, low-risk Prostate Cancers with an MRI of ...

New meta-analysis shows benefits of Xiaflex (Auxilium Pharmaceuticals) for Peyronie's disease

A meta-analysis of Phase III results assessing Xiaflex (clostridial collangase for injection), from Auxilium Pharmaceuticals, for the treatment of Peyronie's disease provides new results on previous IMPRESS studies' co-primary and secondary endpoints. Post-hoc meta-analysis from a combination of identical IMPRESS I and II studies indicates that the co-primary endpoints maintain statistical significance. In addition, the % of global responders, the ...

Results of REDUCE study show benefits from Avodart/Avolve (Glaxo Smith Kline) for Prostate Cancer Risk

New results from the four-year REDUCE clinical study evaluating Prostate Cancer Risk reduction in men taking Avodart/Avolve (dutasteride), from Glaxo Smith Kline, have been announced. REDUCE results showed that dutasteride decreased the risk of biopsy detectable Prostate Cancer by 22.8 percent compared to a placebo group, but concerns remained about the drug’s effectiveness. Nearly 2,800 men from the REDUCE study ...

Abraxane(Celgene) success in MPACT trial for combination treatment of Pancreatic Cancer

Celgene International Sàrl,has announced that its phase III clinical trial of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with metastatic Pancreatic Cancer demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone [(median of 8.5 vs. 6.7 months) (HR 0.72, P=0.000015)].

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical ...

European Commission extends Zytiga(Janssen Cilag) indication in Prostate Cancer

Janssen-Cilag has announced that the European Commission has approved an extension to the licence of Zytiga (abiraterone acetate), to include its use in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant Prostate Cancer (mCRPC) in men who have failed on androgen deprivation therapy in whom chemotherapy is not yet indicated. The oral, once-daily drug, with prednisone ...

FDA approves Skyla (Bayer)levonorgestrel-releasing intrauterine system for use as a Contraceptive

The FDA has approved a new low-dose hormone intrauterine device designed to prevent pregnancy, the first new device of its type in 12 years, according to Bayer AG.

The T-shaped polyethylene device, known as Skyla, is designed to prevent pregnancy for 3 years, during which time it releases a diminishing dosage of progestin. The proportion of women using long-acting reversible ...

FDA reviews Xiaflex (Auxilium Pharmaceuticals) for patients with Peyronie's disease

The FDA has accepted for filing and granted standard review status to its supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH), from Auxilium Pharmaceuticals, for treatment of Peyronie's disease (PD). The FDA is expected to take action on the application by September 6, 2013. Xiaflex for the treatment of PD was granted orphan designation in the ...

BayerHealthCare submits Alpharadin to FDA for treatment of castration-resistant Prostate Cancer

Bayer HealthCare has submitted a New Drug Application to the FDA seeking approval for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases. The treatment has been granted fast track designation by the FDA.

The submission was based on data from the ALSYMPCA trial, a Phase III, randomized, double-blind, placebo-controlled international study ...

BayerHealthCare submits Alpharadin to EMA for treatment of castration-resistant Prostate Cancer

Algeta ASA announces that Bayer HealthCare has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Alpharadin (radium-223 dichloride (radium-223)) for the treatment of castration-resistant Prostate Cancer in patients with bone metastases.

The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. ...

FDA expands Zytiga (Janssen Biotech) indication in Prostate Cancer

The FDA has expanded the approved use of Zytiga (abiraterone acetate) from Janssen Biotech, to treat men with late-stage (metastatic) castration-resistant Prostate Cancer prior to receiving chemotherapy. The FDA initially approved Zytiga in April 2011 for use in patients whose Prostate Cancer progressed after treatment with docetaxel, a chemotherapy drug. Zytiga is a pill that decreases the production of male ...

Phase II study of XL 184 (Exelixis) shows significant improvement in patients with castration-resistant Prostate Cancer

About two-thirds of patients with castration-resistant Prostate Cancer treated with XL 184 (cabozantinib), from Exelixis, had improvements on their bone scans, with 12 percent seeing complete resolution of uptake on bone scan, according to results of a Phase II study. The trial enrolled 171 men with castration-resistant Prostate Cancer, and began as a randomized trial in which all patients received ...

CHMP recommends approval of Cialis (Eli Lilly) for Benign Prostatic Hyperplasia

The CHMP in the EU has recommended approval of Cialis (tadalafil), from Eli Lilly and Co, for once daily use for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH). The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on ...

FDA approves Prolia(Amgen) for treatment of Male Osteoporosis

Amgen announced the FDA has approved a new indication for Prolia (denosumab) as a treatment to increase bone mass in men with Osteoporosis at high risk for fracture. Prolia, the first FDA approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months. According to the National Osteoporosis Foundation,two million men in the U.S. ...

Positive results of Phase III study of Zytiga (Janssen Biotech) in metastatic Prostate Cancer

Results of a Phase III trial of Zytiga (abiraterone acetate), from Janssen Biotech, confirm it offers a significant survival benefit to patients with castration-resistant metastatic Prostate Cancer. The study, the first Phase III trial to show a significant survival benefit for this kind of drug, involved 1195 patients in thirteen countries, and compared the effects of prescribing Zytiga and the ...

FDA approves Xtandi(Astellas/Medivation)to treat castration- resistant Prostate Cancer

The FDA has on 31 August 2012 approved Xtandi (enzalutamide) from Astellas/Medivation to treat men with late-stage (metastatic) castration-resistant Prostate Cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for ...

Architect Testosterone assay(Abbott) 2nd Generation receives CE Mark

Abbott has received CE Marking (Conformite Europeenne) for a testosterone assay with improved sensitivity and clinical utility. With a simple blood test, the ARCHITECT 2nd Generation Testosterone Assay can accurately measure the wide range of testosterone levels seen in a number of different patient populations and clinical settings.Testosterone assays play an important role in the diagnosis and management of many ...

Positive results in Phase III study of MDV 3100 (Medivation Inc) in Prostate Cancer patients

Results of a Phase III clinical trial of the drug MDV 3100 (enzalutamide), from Medivation Inc, show the drug extends life by an average five months in the most advanced stages of Prostate Cancer.

The study, AFFIRM, followed 1199 patients whose cancer that had progressed despite both hormonal and chemotherapy treatments, with 2/3 of patients receiving the drug MDV 3100 ...

Quartette (Teva) is FDA filed for Contraception

Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd, has announced that the FDA has accepted for filing its New Drug Application (NDA) for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for Contraception....

Eeva System (Auxogyn) shows positive results in trial for IVF

A new study shows that the Early Embryo Viability Assessment (Eeva) Test from Auxogyn is able to predict embryo advancement in IVF (In vitro fertilisation) treatment with a new level of accuracy. In a prospective multi-center cohort study of 160 patients and close to 1,800 embryos, the Eeva Test was able to predict blastocyst formation at the cleavage stage with ...

AG200-15 (Agile Therapeutics) contraceptive patch filed at FDA

Agile Therapeutics has made a new drug application for its once-weekly, low-dose contraceptive patch, AG200-15,(ethinyl estradiol plus levonorgestrel) and the application was accepted for a standard 10-month review by the FDA. The FDA may make a decision by the first quarter of next year....

NICE recommends Zytiga (Janssen Cilag) for metastatic Prostate Cancer

The National Institute for Health and Clinical Excellence (NICE) has published final guidance endorsing Zytiga (abiraterone acetate) from Janssen Cilag as an NHS treatment option for patients in England and Wales with metastatic castration resistant Prostate Cancer (mCRPC), if their disease has progressed despite having received a docetaxel-containing chemotherapy regimen....

FDA give premarket approval for the Prostate Health Index (Beckman Coulter) to test for Prostate Cancer

The FDA has given Premarket Approval (PMA) for the Prostate Health Index (PHI), from Beckman Coulter. The PHI test is a non-invasive blood test that is 2.5-times more specific in detecting Prostate Cancer than PSA (prostate-specific antigen) in patients with PSA values in the 4-10 ng/mL range. Typically, physicians recommend that men with a PSA in that range consider a ...

MDV 3100 (Astellas) for Prostate Cancer submitted to EMA for marketing authorisation

Astellas has submitted a European marketing authorisation application to the EMA for MDV 3100 (enzalutamide) for the treatment of men with metastatic castration-resistant Prostate Cancer who have been previously treated with docetaxel-based chemotherapy. The submission follows positive results from the pivotal Phase III AFFIRM study, which confirmed that enzalutamide demonstrated a statistically significant improvement (p<0.0001) in overall survival with a ...

FDA announces guidance for licensing Zertane (Ampio Pharma) for Premature Ejaculation

Ampio Pharma has announced the outcome of its pre-IND meeting with the FDA to discuss the licensing of Zertane (oral rapidly dissolving tramadol) for Premature Ejaculation. The FDA provided guidance on the design of two Phase III pivotal clinical trials of approximately 15 weeks duration. Successful completion of these trials will allow for FDA clearance to market Zertane as a ...

Plethora/Schiele files PSD 502 at EMA for treatment of Premature Ejaculation

Plethora Solutions (a subsidiary of Sciele Pharma, a Shionogi company) has submitted a dossier to the European Medicines Agency (EMA) for the approval of PSD 502 for the treatment of Premature Ejaculation...

J&J Janssen Cilag submits supplemental applications to extend use of Zytiga in Prostate Cancer

J&J Janssen Cilag International has submitted a type II variation to the EMA for Zytiga (abiraterone acetate). Simultaneously, Janssen Research & Development submitted a supplemental New Drug Application to the FDA. Both applications are intended to extend the use of Zytiga administered with prednisone for patients with metastatic castration resistant Prostate Cancer (mCRPC) who are asymptomatic or mildly symptomatic after ...

Positive results for Phase III study of enzalutamide (Medivation) for Prostate Cancer treatment

Results from a Phase III clinical trial show that enzalutamide (formerly MDV 3100), from Medivation, prolongs lives of patients with Prostate Cancer. Patients in the AFFIRM trial who had stopped responding to chemotherapy evaluated 27 factors, including pain and energy levels and ability to work while taking MDV 3100. Results showed that around 43% of men taking the drug experienced ...

Positive results from IMPRESS trial of Xiaflex (Auxilium Pharma) for Peyronie's Disease

The phase III IMPRESS studies of Xiaflex (clostridial collangase for injection), from Auxilium Pharma, for treatment of Peyronie's Disease (PD) annouce positive topline results. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for Xiaflex subjects and a 3.3 point improvement in the Peyronie's Disease Questionnaire bother domain. ...

Positive Phase III data for Zytiga (J&J Janssen Cilag) plus prednisone for Prostate Cancer

Analysis of the Phase III study, COU-AA-302, demonstrated that patients with metastatic castration-resistant Prostate Cancer (mCRPC) treated with Zytiga (abiraterone acetate), from J&J Janssen Cilag, plus prednisone, showed a statistically significant improvement in radiographic progression-free survival (rPFS) and all secondary endpoints compared to patients treated with placebo plus prednisone. The median rPFS in the control arm was 8.3 months but ...

Carbozantinib (Exelixis) enters Phase III for metastatic castration resistant Prostate Cancer

COMET-1 trial is initiated for cabozantinib from Exelixis Inc., and is a double-blind, placebo-controlled Phase III study that will include up to 240 international sites. The trial is designed to enroll 960 patients with metastatic castration-resistant Prostate Cancer (mCRPC) who have previously been treated with docetaxel, and abiraterone acetate and/or MDV3100. All patients will have bone metastases and there is ...

Enzalutamide is filed at FDA by Medivation for Prostate Cancer

Medivation has submitted a New Drug Application (NDA) to the FDA for enzalutamide (formerly MDV3100). The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits 1) testosterone binding to androgen ...

GSK to co pomote Testim (Auxilium Pharma) in USA

Auxilium Pharmaceuticals, and Glaxo Smith Kline have entered into an agreement to co-promote Testim (testosterone gel) testosterone replacement therapy product used in adult males. Under the terms of the agreement, Auxilium has granted GSK the exclusive right to co-promote Testim in the United States through Sept.30, 2015. GSK will promote Testim using a sizeable established field sales force which has ...

Menarini acquires rights to Priligy for Premature Ejaculation treatment

Janssen Pharmaceutica and ALZA have returned the rights to the premature ejaculation treatment Priligy (dapoxetine) to Furiex Pharmaceuticals. FuriexPharmaceuticals has licensed to Menarini rights to commercialise Priligy in Europe, most of Asia, Africa, Latin America and the Middle East. Furiex will retain development and commercialisation rights in the US, Japan and Canada. Priligy is marketed for on-demand treatment of premature ...

NICE draft guidance now approves Zytiga (J&J Janssen Cilag) for Prostate Cancer

NICE has issued new draft guidance recommending the use by the NHS of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with Prostate Cancer. After additional information about the drug was submitted to NICE by the company, the treatment will now be made routinely available for patients on the NHS. NICE had previously rejected the drug because it did ...

FDA approves Stendra (Vivus Inc) for Erectile Dysfunction

The FDA has approved Stendra (avanafil) tablets, from Vivus Inc, for the treatment of Erectile Dysfunction (ED). The approval is based on a study of more than 1,200 men with ED which evaluated the efficacy and safety of Stendra. At all doses tested (50mg, 100mg and 200mg), the drug met all primary efficacy endpoints. Significant improvement in erectile function was ...

BIND-014 first nanomedicine to enter clinical studies

BIND-014 is the first targeted and programmed nanomedicine to enter human clinical studies. The Phase 1 study has been electronically published in Science Translational Medicine. BIND-014 is a programmable nanomedicine that combines a targeting ligand and a therapeutic nanoparticle. BIND-014 contains docetaxel, a proven cancer drug which is approved in major cancer indications including breast, prostate and lung, encapsulated in ...

Ampio Pharma to discuss filing with FDA of Zertane for Premature Ejaculation treatment

Ampio Pharma has submitted to the FDA a pre IND package on Zertane (oral rapidly dissolving tramadol), its on-demand Premature Ejaculation drug, for a meeting and discussion on the way forward. Zertane has successfully completed two phase II and two phase III studies in Europe that met all end points including efficacy and safety. A follow on 12 weeks open ...

IMPACT study for Provenge (Dendreon) effect in Prostate Cancer questioned

Marie Huber in a paper in the Journal of the National Cancer Institute argues that Provenge (sipuleucel-T)from Dendreon extended survival because older men in the IMPACT study who did not receive Provenge died months sooner than similar patients in other studies possibly due to leukapheresis. She argues that the placebo they received was actually harmful making the Provenge effect appear ...

EC 906 filed by Astellas foe EU approval for LUTS associated with BPH

Astellas Pharma Europe has filed EC 905 its fixed dose combination of Flomaxtra XL (tamsulosin) and Vesicare(solifenacin)in the Netherlands under the EU Mutual Recognition Scheme for lower urinary tract symptoms associated with Benign Prostatic Hyperplasia....

Phase III study of Zytiga (Janssen) for Prostate Cancer unblinded

A Phase III study of Zytiga (abiraterone acetate), from Janssen, plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant Prostate Cancer (CRPC) has been unblinded. Study COU-AA-302 is an international, placebo controlled study that included 1,088 patients randomised to receive Zytiga (1,000 milligrams) once daily plus prednisone 5 mg twice daily or placebo plus prednisone ...

Aegerion Pharma files lomitapide for HoFH at EMA and FDA

Aegerion Pharmaceuticals a company focused on the development of novel therapeutics to treat severe lipid disorders, has announced that it has submitted a New Drug Application (NDA) to the FDA, and a Marketing Authorization Application (MAA) to the EMA seeking approval of its lead investigational therapeutic, lomitapide, as an adjunct to a low fat diet and other lipid-lowering therapies to ...

NX 1207 (Recordati/Nymox) starts Phase III trial for BPH

Recordati and Nymox Pharmaceutical Corporation announced the start of activities aimed to the preparation of a European Phase III clinical trial for NX-1207, following the successful completion of a Scientific Advice meeting with the European Medicines Agency. NX-1207, is a Phase III investigational drug from Nymox and is currently in clinical development in the United States for the treatment of ...

Vitaros(Apricus BioScience) for Erectile Dysfunction rights update

Apricus BioScience has licensed, via subsidiary NextMed, the German rights to its erectile dysfunction drug,Vitaros,to Sandoz AG. The drug is approved in Canada where it is marketed by Abbott Labs and has a Complete Response Letter from the FDA where the drug is to be marketed by Warner Chilcott. The drug is filed in the EU and will be marketed ...

Phase III Trial of MDV 3100 (Medivation/Astellas) in Prostate Cancer patients shows positive results

Researchers have presented positive results on all efficacy endpoints from the Phase III AFFIRM trial of the investigational drug MDV 3100, from Medivation and Astellas, in men with Prostate Cancer previously treated with chemotherapy. The results, presented at the 2012 Genitourinary Cancers Symposium, show that men taking MDV 3100 lived for a median of 18.4 months, compared with 13.6 months ...

Zytiga (J&J Janssen Cilag) offers benefits for Prostate Cancer patients who are not eligible for docetaxel therapy

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has noted a considerable added benefit of Zytiga (abiraterone acetate), from J&J Janssen Cilag, in patients with metastatic hormone-refractory Prostate Cancer who are not eligible for further treatment with docetaxel. Zytiga has been approved since September 2011 for men with metastatic Prostate Cancer that ...

LibiGel (BioSante Pharma) fails two Phase III trials for Female Sexual Dysfunction

Results from two Phase III studies of LibiGel (testosterone gel)from BioSante Pharmaceuticals, being BLOOM-1 and BLOOM-2 studies for Hypoactive Sexual Desire Disorder in postmenopausal women did not meet the co-primary or secondary endpoints. BioSante continues to conduct the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that has completed enrollment of 3,656 ...

FDA review of Yaz/Yasmin (Bayer) risk benefit

FDA advisers agreed that the benefits of Bayer Healthcare's drospirenone-containing oral contraceptives, such as Yaz and Yasmin, in preventing pregnancy outweigh the drugs' risks of potentially fatal blood clots. But the Advisory Committees,voted 21-5 that the labelling for the drugs fails to adequately reflect the risk-benefit profile for the products and should contain more graphic language....

FDA assesses evidence for risk of Thrombosis with drospirenone-containing drugs

As part of its ongoing review, the FDA reports that evidence shows conflicting data on a link between pills containing drospirenone (such as Safyral from Bayer) and blood clots, some of which appears to show a slight elevation of venous thromboembolism risk. Since the FDA reports it can not rule out the risk, it suggests this may warrant a new ...

Nomac/E2 is rejected by FDA as a contraceptive

Zoely/Nomac/E2 is a combined contraceptive pill (nomegestrol acetate (a progestogen) and estradiol (an oestrogen) which was approved by EMA for Teva Pharma on 17 July 2011 to be launched by year end and rejected by the FDA for Merck Inc. some days ago....

Contraceptives containing Beyaz (Bayer Healthcare) show higher risk of blood clots

The use of oral Contraceptive pills that contain Beyaz (drospirenone), from Bayer Healthcare, is linked to a significantly higher risk of blood clots, both deep vein thrombosis and pulmonary embolism, according to an article in the Canadian Medical Association Journal. The study found that the use of Beyz-containing combined oral contraceptives was associated with a significantly increased risk of venous ...

Radiotherapy combined with androgen deprivation therapy improves survival in Prostate Cancer patients

Men with locally advanced Prostate Cancer and who receive radiotherapy (RT) on top of their androgen deprivation therapy (ADT) using treatments such as leuprolide acetate have greater overall survival compared with men on ADT alone. This trial followed 1205 patients were randomly assigned to either ADT and RT or ADT alone. The addition of RT to ADT improved overall survival ...

Phase III trial of MDV 3100 (Medivation/Astellas) shows significant benefits for patients with advanced Prostate Cancer

An analysis of a Phase III trial of men with advanced Prostate Cancer treated using MDV 3100, from Medivation and Astellas, shows the AFFIRM trial has met its interim efficacy stopping criteria by demonstrating a statistically significant improvement in survival. Those on the drug outlived those on placebo by an average of 4.8 months, and the trial has been stopped ...

Study backs findings that some newer contraceptive pills more likely to cause VTE

A new study confirms earlier findings that certain oral contraceptive pills including those with desogestrel, gestodene, or drospirenone, including Safyral, from Bayer HealthCare, are more likely to cause serious blood clots (venous thromboembolism - VTE ) than others. The authors, led by Dr Øjvind Lidegaard from the University of Copenhagen, say that women on pills containing one of the newer ...

SiMoA PSA test found a reliable predictor of Prostate Cancer recurrence

A clinical evaluation of the SiMoA Prostate Specific Antigen (PSA) test, from Quanterix, shows that this digital immunoassay is a reliable predictor of five–year biochemical recurrence (BCR)–free survival following radical prostatectomy (RP) in patients with Prostate Cancer. To determine the ability of this test to predict five–year BCR–free survival following RP, researchers utilized frozen serum specimens from men who had ...

FDA warns that Leukemia drug Sprycel can lead to PAH

The FDA has issued a warning that treatment with Sprycel (dasatinib), from BMS, may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs, called pulmonary arterial hypertension (PAH). With PAH, the heart must work harder to pump the blood into the lungs and the overworked heart ...

Cialis Phase III study in Benign Prostatic Hyperplasia is reported in Jo.Sexual Medicine

A pivotal Phase III study of Cialis (tadalafil) tablets 5 mg from Eli Lilly and Company for once daily use met its co-primary endpoints, significantly improving measures of both erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both conditions. The study is available online in The Journal of Sexual Medicine . It is ...

Cialis is FDA approved for Benign Prostatic Hyperplasia

The FDA has approved Cialis (tadalafil) tablets, the PDE 5 inhibitor marketed for erectile dysfunction ,from Eli Lilly Company, for once daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). The FDA also approved Cialis for once daily use for a separate indication for the treatment of ...

NICE rejects Jevtana for Prostate Cancer

NICE, the health technology appraisal institute for England and Wales, has issued draft guidance declining to recommend Jevtana (cabazitaxel) from Sanofi-Aventis for prostate cancer patients already treated with Taxotere ( docetaxel). Reasons given are the high cost of the new drug and concerns about adverse events. Sanofi is promoting Jevtana as a replacement for now generic Taxotere....

Provenge sales for Prostate Cancer disappoint Dendreon and lead to staff reduction

Dendreon will reduce its workforce by 500 employees( about one-quarter of its work force)as sales of its prostate cancer immunotherapy, Provenge(sipuleucel-T) have disappointed and are well short of its projections. The largest proposed job cuts are in manufacturing but the company is looking for a partner in Europe as its moves toward filing for approval of Provenge there by the ...

Ampio Pharma and Zertane for Premature Ejeculation

Ampio Pharma has developed an oral rapid-dissolving tablet form of the centrally acting opioid analgesic, tTramadol as a therapy for premature ejaculation. Tramadol is used in many countries for the treatment of moderate to severe pain.In a Phase III ,604 patient European trial Ampio Pharma reported positive summary results from in which the 62mg dose of Zertane (oral rapidly dissolving ...