Mon, Jan. 19, 5:26 PM
- As expected, the European Commission approves Boehringer Ingelheim's OFEV (nintedanib) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in November backing approval.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug (Nov. 21, 2014)
- IPF-related tickers: (NYSE:BMY) (OTCQX:RHHBY) (NASDAQ:FGEN) (NYSE:AZN) (OTCPK:ALPMF) (OTCPK:ALPMY)
Fri, Jan. 16, 6:14 AM
- Looking to gain access to an experimental drug to treat spinal muscular atrophy, Roche (OTCQX:RHHBY) has agreed to buy privately-held Trophos.
- The acquisition is the latest in a spate of deals by Roche, following its purchase of a $1B stake in Foundation Medicine and licensing agreement with Genome pioneer J. Craig Venter.
- Under the terms of the agreement with Trophos, the French firm's shareholders will receive an upfront payment of €120M ($140M), plus further payments based on predetermined milestones worth up to €350M.
- OTCQX:RHHBY -2.2% premarket
Thu, Jan. 15, 8:40 AM
- "Words fail me," says Swatch (OTCPK:SWGAY) CEO Nick Hayek. "Today's SNB action is a tsunami; for the export industry and for tourism, and finally for the entire country." Swatch is lower by 15.75% in European action.
- Previously: Swiss shares crater after SNB abandons cap on euro (Jan. 15)
- A sampling of others: Cement maker Holcim (OTCPK:HCMLY) is down 11.2%, Novartis (NYSE:NVS) is down 9%, Roche (OTCQX:RHHBY) is down 7.9%, Credit Suisse (NYSE:CS) is down 11.7%, and UBS (NYSE:OUBS) is down 10.8%.
- The good news for ADR players is that's all action in Switzerland. Thanks to the franc's now 13.5% gain, the ADRs trading in the U.S. are likely all to be higher.
Thu, Jan. 15, 7:50 AM
- Roche's (OTCQX:RHHBY) Genentech unit signs a multi-year deal with genome pioneer J. Craig Venter's Human Longevity start-up to sequence and analyze tens of thousands of human genomes. The data will be used to identify new drug targets and biomarkers.
- Human Longevity's goal is to sequence 1M genomes by 2020. The transaction will enable it to have access to both genomic and clinical information from patients enrolled in clinical trials. The DNA will be stripped of personal identifying details but will be linked to clinical information.
- Financial terms are undisclosed.
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.
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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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