Nov. 5, 2014, 7:34 AM| Comment!
Nov. 3, 2014, 1:06 PM
- The FDA accepts Boehringer Ingelheim's NDA for Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in patients at least 12 years old who remain symptomatic on at least inhaled corticosteroids.
- Spiriva is currently cleared for the maintenance treatment of bronchospasm (HandiHaler) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
- The Respimat inhaler provides a pre-measured amount of medicine in a slow moving mist that helps the patient inhale the drug. It is designed to deliver the medication in a way that does not depend on how fast air is breathed in from the inhaler.
- Asthma and COPD-related tickers: (THRX -3%)(GSK -0.3%)(AZN -0.8%)(NVS -1.3%)(REGN +0.6%)(SNY -1.5%)(TEVA +1.5%)(OTCQX:RHHBY -1.3%)
Oct. 28, 2014, 12:44 PM
- Roche's (OTCQX:RHHBY +0.5%) Ventana Medical Systems enters into an agreement with ImmunoGen (IMGN +2.2%) to develop biomarker assays and a companion immunohistochemistry diagnostic test for one or more of ImmunoGen's product candidates. The initial test in the partnership is for folate receptor alpha (FRa) that is being used in the trials of ImmunoGen's FRa-targeting antibody-drug conjugate, IMGN853. Certain cancers such as epithelial ovarian and endometrial, highly express FRa.
- Specific financial terms are not disclosed.
Oct. 20, 2014, 10:40 AM
- Laboratory Corporation of America (LH -0.2%) launches its HIV GenoSure Archive, the first laboratory test that helps clinicians optimize antiretroviral (ARV) drug regimens for virally suppressed HIV patients. The test was developed using the Next Generation Sequencing Platform (NGS).
- Previous lab testing to guide ARV drug selection required higher viral loads than many HIV patients have. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples and then analyzing the polymerase region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely used ARV drug classes.
- HIV-related tickers: (ABBV +1.2%)(GILD +1.6%)(BMY +0.1%)(PFE -0.2%)(GSK -0.3%)(ABT +0.2%)(JNJ +0.1%)(PGNX +3%)(MRK +0.1%)(OTCQX:RHHBY +0.6%)
Oct. 20, 2014, 7:51 AM
- New Link Genetics (NASDAQ:NLNK) and Roche's Genentech (OTCQX:RHHBY) enter into an exclusive worldwide license agreement for the development of New Link's IDO pathway inhibitor, NLG919.
- Under the terms of the agreement, New Link will receive an upfront payment of $150M and will be eligible to receive more than $1B in milestones plus escalating double-digit royalties on commercial sales of multiple products by Genentech. The latter will fund R&D, manufacturing and commercialization costs and will provide research funding to New Link which will continue to pursue development activities associated with NLG919 in combination with its HyperAcute vaccine platform. New Link will retain the option for co-promotion rights for NLG919 and potential next generation IDO/TDO compounds in the U.S.
- NLNK is up 30% premarket on increased volume.
Oct. 17, 2014, 8:12 AM
- Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) are set to present data from their respective immunotherapy drugs for the treatment of triple negative breast cancer (TNBC) at December's San Antonio Breast Cancer Symposium. TNBC does not respond to either of two types of hormonal therapy or drugs that target HER2 receptors, such as Roche's Herceptin.
- Both companies' products are PD-1 inhibitors. Roche is also testing its candidate, called MPDL3280A, for the treatment of melanoma and lung, bladder, kidney, bowel and blood cancers. Merck's product, Keytruda (pembrolizumab) injection, is currently cleared for the treatment of melanoma.
- Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) are also players in the space.
Oct. 17, 2014, 7:40 AM
- In a comparative study sponsored by the National Institutes of Health and run by the Diabetic Retinopathy Clinical Research Network (DRCR.net), Regeneron's (NASDAQ:REGN) Eylea (aflibercept) injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity from baseline at week 52 compared to both Genentech's (OTCQX:RHHBY) Avastin (bevacizumab) and Lucentis (ranibizumab) injection. The was the study's primary endpoint.
- The mean number of injections using the protocol-specified retreatment regimen was one fewer in the Eylea cohort compared to Avastin and Lucentis and fewer patients in the Eylea group received criteria-based macular laser treatments.
- DRCR.net is finalizing and verifying the data before submitting it for publication.
Oct. 16, 2014, 10:43 AM| 1 Comment
Oct. 16, 2014, 9:29 AM
- Roche (OTCQX:RHHBY) financial results ytd through Q3 (Millions of CHF): Group Sales: 34,757 (-0.3%); Pharmaceuticals: 26,965 (-0.8%), U.S. Pharma: 11,528 (+0.9%), Europe Pharma: 7,070 (+1.7%), Japan Pharma: 2,406 (-3.5%), International Pharma: 5,961 (-5.6%); Diagnostics: 7,792 (+1.5%).
- 2014 Guidance: Group sales growth: low-to-mid-single digit; Core EPS growth: >Group sales growth; Dividend outlook: further increase.
Oct. 15, 2014, 3:59 PM
- U.S. patients saddled with idiopathic pulmonary fibrosis have reason to cheer today. The FDA approves two new drugs to treat the disease.
- The agency approves Roche's (OTCQX:RHHBY -0.5%) Esbriet (pirfenidone) ahead of its November 23, 2014 PDUFA date under its Fast Track, Breakthrough Therapy and Orphan Drug designations.
- It approves privately-held Boehringer Engelheim's Ofev (nintedanib) ahead of its January 2, 2015 PDUFA date also under the same designations.
Oct. 9, 2014, 11:31 AM
Oct. 8, 2014, 12:35 PM
- The FDA accepts and grants priority review of Roche unit Genentech's (OTCQX:RHHBY +0.1%) supplemental Biologics License Application (sBLA) of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy. The PDUFA date is February 6, 2015.
- Lucentis is currently cleared for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
- Related tickers: (REGN -0.4%)(AGN +1.1%)(ALIM +1%)(OTCPK:BAYRY +0.2%)(OTCPK:BAYZF)(PSDV -4.8%)
Oct. 7, 2014, 11:57 AM
- BC, Canada-based Xenon Pharmaceuticals (XENE) is set for its IPO of 4M shares at $10 -12.
- The clinical-stage biopharmaceutical firm discovers and develops differentiated therapeutics for orphan indications based on its Extreme Genetics platform. It focuses its discovery efforts on rare human diseases with extreme traits, including diseases caused by mutations in ion channels.
- The Extreme Genetics platform yielded the first gene therapy product approved in the EU, uniQure's (QURE +1.5%) Glybera (alipogene tiparvovec) for the treatment of adult patients with familial lipoprotein lipase deficiency.
- Its pharma partners include (TEVA -0.3%), Genentech (OTCQX:RHHBY -2.5%) and Merck (MRK -1.2%). Collaborations have generated over $140M in revenue to Xenon so far. Future milestone payments could potentially surpass $1B.
- The company's lead product is TV-45070 for the treatment of osteoarthritis of the knee. A 300-patient Phase 2b clinical trail run by Teva subsidiary Ivax International GmbH is underway.
- A second product candidate, GDC-0276, for the treatment of pain is being developed in collaboration with Genentech. A Phase 1 study commenced in September 2014.
- Osteoarthritis of the knee-related tickers: (AMPE +0.3%)(FLXN -4.6%)(ANIK -1.2%)(ZMH -0.7%)
Oct. 6, 2014, 10:44 AM
- Privately-held Sunnyvale-CA-based Icon Bioscience announces that the last patient has completed treatment in its pivotal Phase 3 clinical trial of IBI-10090. The firm expects to report top-line data this quarter.
- IBI-10090 is a controlled sustained-release formulation of dexamethasone based on the company's Verisome drug delivery platform. It is administered via a single injection into the anterior chamber of the eye immediately following cataract surgery.
- Some eye therapy-related tickers: (NASDAQ:EYEG)(ALIM)(OTCQX:RHHBY +0.5%)(ABT +1.3%)(OHRP -0.3%)(AKRX +1.1%)(OCUL +1.4%)(NVS +0.2%)(AERI +0.7%)(AGN -0.2%)(REGN)(AAVL +0.4%)
Oct. 3, 2014, 11:55 AM
- Britain's National Institute for Health and Care Excellence (NICE), the group that advises the National Health Service on the cost-benefit profiles of medicines and care services, determines that Roche's (OTCQX:RHHBY -1.1%) Gazyvaro (obinutuzumab) does not qualify for inclusion in the government-run health program despite being approved for sale by the EC. NICE Chief Andrew Dillon says, "Although obinutuzumab is a clinically effective treatment, there were too many uncertainties in the company's submission and we cannot be confident that it is an effective use of NHS resources. With limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS."
- Gazyvaro's full-regimen price is ₤26,496. It plans to work with the agency to address the situation.
- In August, NICE rejected Kadcyla (ado-trastuzumab emtansine) for the treatment of an aggressive form of breast cancer. Roche had extended a discount to the NHS off the list price of ₤90,000.
- Unsurprisingly, Roche takes a dim view of NICE referring to the agency as "not fit for purpose."
Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
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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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