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Jan. 9, 2015, 8:01 AM
- The FDA approves Roche's (OTCQX:RHHBY) cobas TaqScreen MPX Test, v2.0 for the detection and identification of HIV, HCV and HBV in donations of human whole blood and blood components including source plasma. The test, which delivers increase sensitivity, is the only FDA-approved diagnostic that simultaneously detects and identifies the three viruses in one assay.
- The assay can be performed on a fully automated system which saves time and labor by eliminating the need for consecutive rounds of testing.
Jan. 7, 2015, 10:41 AM
- Arena Pharmaceuticals (ARNA +33.4%) jumps on higher volume in early trading in response to its report of a dose-dependent effect on lymphocyte count lowering for APD334 in a Phase 1b trial.
- Mean decreases in lymphocyte count in blood from baseline were as high as 69%. Counts recovered from baseline, on average, within one week of cessation of dosing. Lymphocyte lowering has been shown to correlate with clinical efficacy in Phase 2 and 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis.
- APD334 is an oral drug that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. The company plans to proceed to Phase 2 development.
- Related tickers: (OTCPK:ALIOF) (OTC:ALIOY) (NYSE:GSK) (OTCQX:RHHBY)
Dec. 29, 2014, 7:01 AM
Dec. 29, 2014, 5:47 AM
- The FDA has given emergency approval for Roche's (OTCQX:RHHBY) LightMix Ebola Zaire rRT-PCR Test, helping health care authorities fight the current outbreak of the deadly disease.
- The test can generate results in about three hours and would allow "health-care professionals to quickly detect the virus and start patient treatment as early as possible," said Roland Diggelman, chief operating officer at Roche’s diagnostics division.
Dec. 19, 2014, 8:44 AM
- ImmunoGen (NASDAQ:IMGN) plummets 40% premarket on robust volume in response to Roche's (OTCQX:RHHBY) announcement that its Phase 3 trial evaluating Kadcyla (trastuzumab emtansine) failed to significantly improve progression-free survival as a first-line therapy in breast cancer patients.
- Kadcyla was developed based on ImmunoGen's ADC technology which uses tumor-targeting antibodies to deliver an ImmonGen cell-killing agent to cancer cells.
- Previously: Roche cancer drug fails label expansion trial (Dec. 19, 2014)
Dec. 19, 2014, 7:27 AM
- Roche's (OTCQX:RHHBY) Kadcyla (trastuzumab emtansine) alone or in combination with Perjeta (pertuzumab) fails to significantly improve progression-free survival (PFS) compared to a regimen of Herceptin (trastuzumab) plus taxane chemotherapy in a Phase 3 clinical trial assessing Kadcyla as a first-line therapy in HER2-positive breast cancer. Kadcyla is currently approved as a second-line (or later) therapy after treatment with Herceptin and a taxane.
- The study met its non-inferiority endpoint by demonstrating that all three regimens helped patients live without their disease worsening (PFS) for a similar amount of time.
- Data from the trial will be discussed with health authorities and presented at a future medical meeting.
Dec. 19, 2014, 7:09 AM
- Roche (OTCQX:RHHBY) terminates the development of its anti-amyloid candidate, gantenerumab, for the treatment of prodromal (pre-dementia) Alzheimer's disease after a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee. Clearly, the DMC's analysis showed that the Phase 3 trial would be unlikely to achieve its primary efficacy endpoint.
- The company will share the data with the medical community after a full review and analysis.
Dec. 16, 2014, 9:49 AM
- Roche (OTCQX:RHHBY -0.3%) launches the cobas Liat System for molecular diagnostics testing in the on-demand environments of physician offices, pharmacies and hospital laboratories. The fully automated system utilizes the company's polymerase chain reaction (PCR) technology and can generate results in 20 minutes or less. Its two initial tests are for Influenza A/B and Strep A.
Dec. 16, 2014, 8:19 AM
Dec. 15, 2014, 7:14 AM
- Roche's (OTCQX:RHHBY) Genentech submits a New Drug Application (NDA) to the FDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advance melanoma.
- Cobimetinib selectively blocks the activity of MEK, one of a series of proteins that make up a signaling pathway that helps regulate cell division and survival. Vemurafenib binds to mutant BRAF, another protein in the pathway, to interrupt abnormal signaling that can cause tumors to grow.
- Genentech is developing cobimetinib in collaboration with Exelixis (NASDAQ:EXEL).
Dec. 10, 2014, 8:06 AM
- The Phase 3 study of Acorda Therapeutics' (NASDAQ:ACOR) CVT-301 for the treatment of OFF episodes in patients with Parkinson's disease (PD) is underway with the enrollment of the first patient. An OFF episode is a period of time during which PD symptoms such as tremor, muscle stiffness and slow movement reemerge despite taking PD medications.
- CVT-301 is a self-administered inhaled therapy that delivers a precise dose of levodopa through the lungs to return PD patients to an ON state.
- The multi-center, double-blind, randomized Phase 3 trial will enroll ~345 subjects across three treatment arms: 50 mg, 35 mg or placebo. The primary endpoint is improvement on the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.
- Acorda obtained the rights to CVT-301 via its acquisition of Civitas Therapeutics.
- Previously: Acorda to buy biopharma firm (Sept. 24, 2014)
- PD-OFF-related tickers: (OTCQX:CYNAF) (NASDAQ:NDRM) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRTA) (OTCQX:RHHBY)
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Dec. 2, 2014, 7:10 AM
- Roche (OTCQX:RHHBY) acquires privately-held San Jose, CA-based Ariosa Diagnostics for an undisclosed sum. Ariosa provides molecular diagnostic testing services, principally non-invasive prenatal testing using cell-free DNA technology.
- The company's Harmony Prenatal Test measures fetal cell-free DNA from a sample of the mother's blood. It is designed to assess the risk of Down syndrome.
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 24, 2014, 8:40 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
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