Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Tue, Jan. 13, 7:06 AM
- Roche (OTCQX:RHHBY) enters into a development and commercialization deal with Japan's Meiji Seika Pharma and Canada's Fedora for OP0595, a beta-lactamase inhibitor in Phase 1 development. Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics (e.g., penicillins, cephalosporins, monobactams) which is of keen interest from the medical community considering the ever-increasing threat of bacterial resistance.
- Under the terms of the agreement, Roche obtains worldwide rights to OP0595 except Japan where Meiji retains rights. Meiji and Fedora will receive upfront payments and various milestones potentially up to $750M plus tiered royalties on commercial sales.
Mon, Jan. 12, 2:14 AM
- Roche (OTCQX:RHHBY) is acquiring a majority of Foundation Medicine (NASDAQ:FMI) for more than $1B, by buying a combination of outstanding and newly issued shares for a 52.4%-56.3% stake on a fully diluted basis.
- Foundation is the leader in the growing area of sequencing the genes of tumor samples, looking for mutations that can help predict which drug will be most effective for a particular patient.
Sun, Jan. 11, 10:29 PM
- Based on an assessment by the independent Data Monitoring Committee, Bristol-Myers Squibb (NYSE:BMY) stops its Phase 3 trial, CheckMate-017, evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced squamous cell non-small cell lung cancer (NSCLC). The committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) compared to docetaxel. This is the first time a PD-1 inhibitor has shown a survival advantage in lung cancer.
- Eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.
- The company will complete a full analysis of the data and work with investigators on the future presentation and publication of the results.
- PD-1-related tickers: (NASDAQ:MDVN) (NYSE:MRK) (NASDAQ:FPRX) (NASDAQ:CELG) (OTCQX:RHHBY) (NYSE:AZN)
Fri, Jan. 9, 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.
Wed, Jan. 7, 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| Comment!
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%)
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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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