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Six new drugs in clinical development stage: Dr Reddy’s
Hyderabad: Country’s second largest drug maker Dr Reddy’s Laboratories has said it is working on six new drugs in different areas, including metabolic disorders and cardiovascular diseases, psoriasis and migraine.
According to a filing with US Securities Exchange Commission, the drug maker said as of March 31, 2013, DRL had 21 active products in the proprietary products pipeline, of which six are in clinical development stage.
including metabolic disorders and cardiovascular diseases, psoriasis and migraine.
read all at
Sihuan Pharma Receives OK from CFDA for Trials of Novel PPI Drug
http://www.telegraphindia.com/pressrelease/prnw/prna_086_1306033.html
Sihuan Pharma Receives OK from CFDA for Trials of Novel PPI Drug
HONG KONG, July 18, 2013 Sihuan Pharmaceutical Holdings Group Ltd. (“Sihuan Pharmaceutical” or the “Company”), a leading pharmaceutical company with the largest cardio-cerebral vascular (“CCV”) drug franchise in China’s prescription market, today announced that Anaprazole Sodium, a Category 1.1 new drug received the Approval for Clinical Studies from the State Food and Drug Administration (“SFDA”) of the People’s Republic of China. Anaprazole Sodium is the fifth Category 1 innovative drug in respect of which the Company has received approval for Clinical Studies, applications for patents have been made in China, the United States, Japan and Europe.
Anaprazole Sodium is a new generation of proton pump inhibitors (“PPIs”) which treats ulcers quickly and efficiently by inhibiting gastric acid secretion and eradicating Helicobacter pylori. Preclinical studies have shown that the new drug covalently binds to proton pump, thus providing substantially stronger and longer inhibitory effects when compared to other PPI drugs, traditional H2-receptor antagonists and antacids currently available in the market. Therefore, it can effectively treat various gastric acid diseases
The clinical benefit of high-dose toremifene for metastatic breast cancer
http://www.ncbi.nlm.nih.gov/pubmed/23863727
Source
Dept. of Surgery, Saga University Faculty of Medicine.
Abstract
Introduction: Toremifene(TOR)is a selective estrogen receptor modulator(SERM). A high dose of 120 mg TOR(HD-TOR) has been used for recurrent breast cancer in Japan, but there is still insufficient evidence regarding the efficacy of HD-TOR. Patients and methods: HD-TOR was administered for recurrent or metastatic breast cancer between January 2003 and May 2012. The primary end point of the study was the tumor response rate. Bone metastasis cases were excluded from the efficacy analysis, but were included in the safety population. Results: A total of 21 patients registered in the study and the 2 patients with bone metastasis only were excluded from the efficacy analysis. The median follow-up period was 8. 3 months. None of the patients in the study had a CR, 4 had a PR(21. 1%), 9 had SD(47. 4%), and 6 had PD(31. 6%). Eight of the 9 SD cases had a long-term SD. The ORR was 21. 1% and the CB rate was 63. 2%. The median TTP of CB cases was 18. 3 months. None of the patients discontinued treatment because of a grade 3 or grade 4 adverse effects. Conclusion: In summary, the current study showed that HD-TOR may lead to a CB for recurrent breast cancer in first- or second-line treatment rather than thirdline. In particular, HD-TOR may give a benefit in highly endocrine-sensitive cases.
toremifene
Toremifene citrate is an oral selective estrogen receptor modulator (SERM) which helps oppose the actions of estrogen in the body. Licensed in the United States under the brand name Fareston, toremifene citrate is FDA-approved for use in advanced (metastatic)breast cancer. It is also being evaluated for prevention of prostate cancer under the brand name Acapodene.[1]
In 2007 the pharmaceutical company GTx, Inc was conducting two different phase 3clinical trials; First, a pivotal Phase clinical trial for the treatment of serious side effects ofandrogen deprivation therapy (ADT) (especially vertebral/spine fractures and hot flashes, lipid profile, and gynecomastia) for advanced prostate cancer, and second, a pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high gradeprostatic intraepithelial neoplasia, or PIN. Results of these trials are expected by first quarter of 2008[2]
An NDA for the first application (relief of prostate cancer ADT side effects) was submitted in Feb 2009,[3] and in Oct 2009 the FDA said they would need more clinical data, e.g. another phase III trial.[4]
- Price N, Sartor O, Hutson T, Mariani S. Role of 5a-reductase inhibitors and selective estrogen receptor modulators as potential chemopreventive agents for prostate cancer.Clin Prostate Cancer 2005;3:211-4. PMID 15882476
- “GTx’s Phase III Clinical Development of ACAPODENE on Course Following Planned Safety Review” (Press release). GTx Inc. 2007-07-12. Retrieved 2006-07-14.
- “GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA” (Press release).
- “GTx and Ipsen End Prostate Cancer Collaboration due to Costs of FDA-Requested Phase III Study”. 2 Mar 2011.
Cyclospora outbreak spreads to Texas
http://www.foxnews.com/health/2013/07/19/cyclospora-outbreak-spreads-to-texas/
Forty-eight people have been diagnosed with cyclospora infections in Texas within the past week, Medical Daily reports.
Cyclosporiasis is an intestinal illness caused by the parasite Cyclospora cayetanensis. It is believed to be contracted by consuming food or drink that has been contaminated with feces. Symptoms include diarrhea, loss of appetite and stomach cramps – and signs of illness usually appear two to 11 days after people contract the parasite.
Over 100 people have also been infected with cyclospora in Iowa and Nebraska, according to reports earlier this week. It is unknown whether the outbreaks are connected.
The Texas Department of State Health Services is currently investigating 50 new cases of cyclospora in the Dallas/Fort Worth area.
It is highly unusual for such a large quantity of newly reported cases to appear within the span of one week, and investigators are looking into a possible source of food…
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Breast Cancer Drugs in Late-Stage Development/Recently Approved
The article is 2012-2013 based and reader discretion is sought to ascertian the stage of approval
Afinitor® (everolimus)
https://newdrugapprovals.wordpress.com/2013/04/27/drug-spotlight-afinitor-everolimus-novartis/
Sponsor: Novartis
Method of Action: Mammalian target of rapamycin (mTOR) inhibitor
Indications/Phase of Trial: Hepatocellular carcinoma; human epidermal growth factor receptor 2-positive (HER2+) breast cancer first-line and second-line; lymphoma; nonfunctional carcinoid tumor (Phase III; all new indications)
Approved in July in U.S., EU for advanced hormone-receptor-positive (HR+) and human epidermal growth factor Receptor 2-negative (HER2-) metastatic breast cancer with exemestane in postmenopausal women who have already received certain other medicines for their cancer
Approved earlier for adults with pancreatic neuroendocrine tumors (PNET) that cannot be treated with surgery; adults with advanced renal cell carcinoma (RCC) when certain other medicines have not worked; adults with angiomyolipoma, seen with tuberous sclerosis complex (TSC), when surgery is not required immediately; and adults and children with TSC who have a brain tumor called subependymal giant cell astrocytoma (SEGA) that cannot be removed completely by surgery
Avastin (Bevacizumab; RG435)
Sponsor: Roche/Genentech
Method of Action: Monoclonal antibody; Vascular endothelial growth factor (VEGF) inhibitor
Indications/Phase of Trial: U.S.: Relapsed ovarian cancer, platinum-sensitive (Registration); first-line metastatic breast cancer and first-line metastatic ovarian cancer (both Phase III).
EU: Relapsed platinum-resistance ovarian cancer (Phase III)
Metastatic colorectal cancer, treatment beyond progression (Registration); adjuvant breast cancer, HER2- and HER2+; adjuvant NSCLC; first-line glioblastoma (GBM) multiforme; high-risk carcinoid (all Phase III)
Approved for metastatic colorectal cancer (mCRC) when started with the first or second intravenous 5-FU–based chemotherapy for metastatic cancer; advanced nonsquamous non-small-cell lung cancer (NSCLC) with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease; metastatic RCC (mRCC) with interferon alfa; and GBM in adult patients whose cancer has progressed after prior treatment. Effectiveness based on tumor response, as no data have shown whether Avastin improves disease-related symptoms or survival in people previously treated for GBM
Approval conditionally granted in 2008 and withdrawn November 2011 for HER2- metastatic breast cancer (mBC) with Paclitaxel
Buparlisib (BKM120)
Sponsor: Novartis
Method of Action: Pan-PI3K inhibitor
Indications/Phase of Trial: mBC (Phase III and confirmatory Phase I/II); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- locally advanced or mBC which progressed on or after aromatase inhibitor (AI) treatment (Phase III; BELLE-2 study recruiting as of November 2012); with Fulvestrant, in postmenopausal women with hormone receptor-positive HER2- AI-treated, locally-advanced or mBC who progressed on or after mTOR inhibitor-based treatment (Phase III; BELLE-3 study, recruiting as of October 2012); with Paclitaxel in patients with HER2- inoperable locally advanced or mBC, with or without PI3K pathway activation (Phase III; BELLE-4 study, recruiting as of November); metastatic castration-resistant prostate cancer (CRPC; Phase II; recruiting as of October); recurrent glioblastoma (Phase II; recruiting as of November); recurrent/metastatic head and neck squamous cell carcinoma (Phase II; recruiting as of October); endometrial cancer (Phase I/II); NSCLC (Phase I/II); prostate cancer (Phase I/II); GBM multiforme (Phase I/II); with Fulvestrant in postmenopausal women with estrogen receptor-positive metastatic breast cancer (Phase I); previously treated advanced colorectal cancer (Phase I)
Faslodex (Fulvestrant Injection)
Sponsor: AstraZeneca
Method of Action: Estrogen receptor antagonist
Indications/Phase of Trial: First line HR+ mBC (Phase III; FALCON study commenced Oct. 29)
Approved for HR+ mBC in women who have experienced menopause and whose breast cancer has worsened after they were treated with antiestrogen medications
Herceptin (Trastuzumab; RG597)
Sponsor: Roche, in partnership with Halozyme
Method of Action: Humanized monoclonal antibody designed to target and block the function of HER2+
Indications/Phase of Trial: EU: Early HER2+ breast cancer, subcutaneous formulation (Registration)
Approved for early-stage HER2+ breast cancer that has spread into the lymph nodes, and HER2+ breast cancer that has not spread into the lymph nodes and is estrogen receptor/progesterone receptor-negative (ER-/PR-) or have one high-risk feature. High-risk is defined as estrogen receptor/progesterone receptor-positive (ER+/PR+) with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3. Can be used with Adriamycin® (doxorubicin), Cytoxan® (cyclophosphamide), and either Taxol® (paclitaxel) or Taxotere® (docetaxel); or with Taxotere and Paraplatin® (carboplatin); or alone after treatment with multiple other therapies, including an anthracycline (Adriamycin)-based chemotherapy
Also approved alone for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease; and with paclitaxel for first-line treatment of HER2+ mBC
Iniparib (Tivolza; BSI-201; SAR240550)
Sponsor: Sanofi, through acquisition of original developer BiPar Sciences
Method of Action: Poly (ADP-ribose) polymerase 1 (PARP1) inhibitor
Indications/Phase of Trial: Stage IV squamous NSCLC (Phase III; NME); solid tumors such as sarcoma and breast, uterine, lung, and ovarian cancers (Phase I/II)
Phase III trial in breast cancer failed January 2011 by failing to improve survival and progression-free survival (PFS) in breast cancer patients
Nexavar® (Sorafenib)
https://newdrugapprovals.wordpress.com/2013/07/16/nexavar-sorafenib/
Sponsor: Onyx Pharmaceuticals
Method of Action: Dual-action inhibitor that targets RAF/MEK/ERK pathway in tumor cells and tyrosine kinases
Indications/Phase of Trial: Liver cancer adjuvant (Phase III; STORM study); kidney cancer adjuvant (Phase III; SORCE/ASSURE study); thyroid cancer monotherapy (Phase III; DECISION study); breast cancer with capecitabine (Phase III; RESILIENCE study)
Approved for hepatocellular carcinoma (HCC) and RCC
Perjeta (Pertuzumab; RG1273)
Sponsor: Roche/Genentech
Method of Action: HER2/neu receptor antagonist
Indications/Phase of Trial: EU: With Herceptin and docetaxel chemotherapy for previously-untreated HER2+ mBC or locally recurrent, inoperable breast cancer in patients who have not received previous treatment or whose disease has returned after treatment in the early-stage setting (Registration)
U.S.: Approved June 2012 for HER2+ mBC with Herceptin (trastuzumab) and docetaxel, in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Switzerland: Approved August 2012 for HER2+ breast cancer with Herceptin (trastuzumab) and docetaxel in patients with advanced or locally recurring breast cancer that has not previously been treated with chemotherapy
Ridaforolimus (MK-8669; AP23573; formerly Deforolimus)
Sponsor: Merck, under exclusive worldwide license agreement with Ariad Pharmaceuticals
Method of Action: Oral inhibitor of mammalian target of rapamycin inhibitor (mTOR)
Indications/Phase of Trial: Maintenance therapy for metastatic soft-tissue sarcoma and bone sarcomas after at least four chemotherapy cycles (under review after receiving Complete Response letter from FDA in June; NME); breast cancer with exemestane, compared to breast cancer with dalotuzumab and exemestane (Phase II; recruiting as of November); advanced head and neck cancer, NSCLC and colon cancer, with cetuximab (Phase II); pediatric patients with advanced solid tumors (Phase I; recruiting as of September); with dalotuzumab in pediatric patients with advanced solid tumors (Phase I; recruiting as of August); advanced RCC, with vorinostat (Phase I; recruiting as of October 2012); breast cancer, with dalotuzumab (Phase I: recruiting as of September); endometrial and ovarian cancers, with paclitaxel and carboplatin (Phase I; recruiting as of September 2012); advanced cancer, with MK-2206 and MK-0752 (Phase I: recruiting as of September 2012); advanced cancer, with dalotuzumab, MK-2206 and MK-0752 (Phase I: recruiting as of August 2012)
Tivozanib (ASP4130; AV-951)
Sponsor: Aveo Oncology and Astellas
Method of Action: Tyrosine kinase inhibitor; inhibits VEGF receptor 1, 2, and 3
Indications/Phase of Trial: U.S.: Advanced RCC (Registration; NDA filed September 2012); tivozanib biomarkers in solid tumors (Phase II; BATON study); stage IV metastatic colorectal cancer (mCRC), with mFOLFOX6, and compared with bevacizumab and mFOLFOX6 (Phase II; recruiting as of November); additional data as first-line therapy for advanced RCC, followed by sunitinib (Phase II; TAURUS study, enrollment initiated in October 2012); advanced solid tumors, with capecitabine (Xeloda®; Phase I; recruiting as of October)
EU: Advanced RCC (Phase III)
Trastuzumab-DM1 (T-DM1; Trastuzumab emtansine; RG3502)
Sponsor: Roche, with linker technology developed by ImmunoGen
Method of Action: Antibody-drug conjugate, consisting of the antibody trastuzumab and the chemotherapy DM1 attached via a stable linker
Indications/Phase of Trial: U.S.: HER2+, unresectable locally-advanced or mBC who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy (Registration; Priority review approved Nov. 7; action date Feb. 26, 2013)
EU: Marketing Authorization Application for HER2+ mBC accepted for review by European Medicines Agency
Tyverb/Tykerb (lapatinib)
Sponsor: GlaxoSmithKline
Method of Action: Human epidermal growth factor receptor-2 (Her2) and epidermal growth factor receptor (EGFR) dual kinase inhibitor
Indications/Phase of Trial: mBC with trastuzumab (Registration); breast cancer, adjuvant therapy (Phase III); Gastric cancer (Phase III); head & neck squamous cell carcinoma, resectable disease (Phase III)
Xgeva (denosumab)
Sponsor: Amgen, with commercialization by GlaxoSmithKline in countries where Amgen has no presence
Method of Action: Fully human monoclonal antibody that specifically targets a ligand known as RANKL that binds to a receptor known as RANK
Indications/Phase of Trial: Delay or prevention of bone metastases in breast cancer (Phase III); delay or prevention of bone metastases in prostate cancer (Phase III)
Approved for prevention of fractures in men with advanced prostate cancer
Rejected in April for supplemental Biologics License Application to treat men with CRPC at high risk of developing bone metastases
Yondelis® (trabectedin)
Sponsor: Johnson & Johnson; developed in collaboration with PharmaMar
Method of Action: Binds to minor groove of DNA, interfering with the cell division and gene transcription processes, as well as DNA’s repair machinery
Indications/Phase of Trial: U.S.: Locally advanced or metastatic soft tissue sarcoma excluding leiomyosarcoma and liposarcoma who have relapsed or are refractory to standard-of-care treatment (Phase III; recruiting as of November); soft tissue sarcoma, excluding liposarcoma and leiomyosarcoma (L-type sarcoma), in previously-treated patients who cannot be expected to benefit from currently available therapeutic options (Phase III; recruiting as of November); locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated with at least an anthracycline and ifosfamide-containing regimen, or an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen, compared with dacarbazine group (Phase III; recruiting as of November); breast cancer and pediatric tumors (Phase II); Advanced malignancies and liver dysfunction (Phase I; recruiting as of November)
EU: Approved for advanced or metastatic soft tissue sarcoma, and for relapsed platinum-sensitive ovarian cancer, with DOXIL®/Caelyx®
Xtandi® Capsules (Enzalutamide; formerly MDV3100)
Sponsor: Medivation in collaboration with Astellas
Method of Action: Androgen receptor inhibitor
Indications/Phase of Trial: Prechemotherapy CRPC in patients who have failed luteinizing hormone-releasing hormone (LHRH) analog treatment only, as well as patients who have failed both LHRH analog and anti-androgen treatment. (Phase III; PREVAIL study); prostate cancer neoadjuvant therapy (Phase II); prechemo metastatic prostate cancer in Europe (Phase II; TERRAIN); prechemo metastatic and nonmetastatic prostate cancer patients in U.S. (Phase II; STRIVE); prostate cancer Hormone-naïve (Phase II; ASPIRE); prostate cancer with docetaxel (Phase I); breast cancer (Phase I)
EU: Marketing Authorization Application submitted June 2012 to European Medicines Agency, for patients with metastatic CRPC who have received docetaxel-based chemotherapy
Japan: Metastatic CRPC who have received docetaxel-based chemotherapy (Phase II)
Approved Aug. 31 for patients with metastatic CRPC who have previously received docetaxel. As a post-marketing requirement, Medivation and Astellas agreed to conduct an open-label safety study of Xtandi (160 mg/day) in patients at high risk for seizure, with data to be submitted to FDA in 2019
FDA gives tentative approval to Perrigo s ANDA for generic version of Prandin Tablets
repaglinide
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received tentative approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for repaglinide tablets, the generic equivalent to Prandin® Tablets (repaglinide tablets).
Prandin® tablets (repaglinide tablets), are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus and have annual sales of approximately $250 million, as measured by Symphony Health Solutions.
Repaglinide is an antidiabetic drug in the class of medications known as meglitinides, and was invented in 1983. It is sold byNovo Nordisk under the name of Prandin in the U.S., GlucoNorm in Canada, Surepost in Japan, Repaglinide in Egypt by EIPICO, and NovoNorm elsewhere. In Japan it is produced by Dainippon Sumitomo Pharma.
Repaglinide lowers blood glucose by stimulating the release of insulin from the pancreas. It achieves this by closing ATP-dependent potassium channels in the membrane of the beta cells. This depolarizes the beta cells, opening the cells’ calcium channels, and the resulting calcium influx induces insulin secretion.
New Drug Approvals 