Nov. 4, 2014, 6:31 AM| 1 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. 21, 2014, 9:08 AM
- Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
- Nintedanib (trade name Ofev) is a small molecule tyrosine kinase inhibitor that was recently approved by the FDA for idiopathic pulmonary fibrosis.
- CRC-related tickers: (NASDAQ:GILD) (NYSE:LLY) (NASDAQ:MGNX) (OTCPK:BAYRY) (OTCPK:BAYZF) (NASDAQ:AMGN) (OTC:MKGAF) (NYSE:BMY) (NASDAQ:ONXX) (NASDAQ:IMMU) (NASDAQ:ONCY) (NASDAQ:ARQL) (NYSE:SNY) (OTCQB:SNYNF) (NASDAQ:REGN)
Oct. 20, 2014, 8:56 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF) initiate a Phase 3 clinical trial to assess the safety and efficacy of dupilumab administered concomitantly with topical corticosteroids for the treatment of adults with moderate-to-severe atopic dermatitis (AD). The 16-week randomized, double-blind, placebo-controlled multinational study will enroll ~700 patients.
- Dupilumab is a fully-human mAb that blocks IL-4 and IL-13 signalling. It was created using Regeneron's VelocImmune technology and is being co-developed with Sanofi.
- Dermatitis-related tickers: (NYSE:VRX) (NASDAQ:ANAC) (NYSE:GSK) (NYSE:PRGO)
Oct. 17, 2014, 9:30 AM
- Amgen (NASDAQ:AMGN) files suit in the U.S. District Court of Delaware against Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Regeneron Pharmaceuticals (NASDAQ:REGN) alleging infringement on three of its patents covering monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). Amgen seeks an injunction to prevent the manufacture, use and sale of Sanofi and Regeneron's PCSK9 inhibitor alirocumab.
- Amgen recently submitted its BLA to the FDA for its PCSK9 inhibitor evolocumab.
Oct. 17, 2014, 9:20 AM
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. 15, 2014, 4:30 PM
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. 6, 2014, 5:32 PM
- The FDA approves Regeneron Pharmaceuticals' (REGN -0.7%) Eylea (aflibercept) for the treatment of macular edema following retinal vein occlusion. It was previously cleared for the treatment of neovascular age-related macular degeneration, macular edema following central retinal vein occlusion and for diabetic macular edema.
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%)
Sep. 30, 2014, 7:20 AM
- Dupilumab, a fully human mAb being co-developed by Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) (OTCQB:SNYNF), met all primary and secondary endpoints in a 60-patient Phase 2a proof-of-concept study in patients with moderate-to-severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids.
- Dupilumab-treated patients demonstrated a statistically significant improvement in the size of nasal polyps which was the primary endpoint. Statistically significant improvements were also observed in the secondary endpoints of objective measures of sinusitis by CT scan, nasal air flow and patient-reported symptoms. Patients in the test group who had asthma demonstrated significant improvements in asthma control.
- Details of the study will be presented at a future medical conference.
- The companies plan to proceed with the clinical development of the drug for this indication.
Sep. 22, 2014, 7:46 AM
- The Japanese Ministry of Health, Labour and Welfare approves the use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) injection for the treatment of choroidal neovascularization (myopic CNV).
- Eylea is already approved for sale for neovascular age-related macular degeneration (wet AMD) and macular edema secondary to central vein occlusion (CRVO).
- Eylea is marketed in Japan by Bayer Healthcare's (OTCPK:BAYRY) (OTCPK:BAYZF) Japanese subsidiary Bayer Yakuhin, Ltd.
Sep. 16, 2014, 7:33 AM
- The FDA designates Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) a Breakthough Therapy (BTD) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
- Drugs tagged as Breakthrough Therapies must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies or over placebo if no therapies are available. It was created by the FDA to expedite the development and review of drugs for serious or life-threatening conditions. BTD-labelled drugs are Fast Track'd but have the additional benefit of more-intensive agency guidance and discussion.
- Eylea is currently approved for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.
- The company expects to submit a supplemental BLA (sBLA) in the U.S. for diabetic retinopathy this year.
Sep. 4, 2014, 7:51 AM
- Bayer (OTCPK:BAYRY) (OTCPK:BAYZF) subsidiary Bayer Yakuhin, Ltd. submits a marketing authorization application to the Japanese Ministry of Health, Labour and Welfare for Eylea (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion (BRVO).
- Eylea is currently approved for use in Japan for neovascular (wet) age-related macular degeneration and macular edema secondary to central retinal vein occlusion.
- Marketing applications for Eylea for the treatment of choroidal neovascularization secondary to pathologic myopia and for the treatment of diabetic macular edema are currently under regulatory review.
- Related ticker: (REGN +0.7%)
Aug. 11, 2014, 7:12 AM
- The European Commission approves Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea (aflibercept) for the treatment of visual impairment caused by diabetic macular edema (DME). The new indication complements its current approvals for wet age-related macular degeneration (AMD) and macular edema following central retinal vein occulsion (CRVO).
- Partner Bayer (OTCPK:BAYRY) (OTCPK:BAYZF) plans to launch Eyea for DME this quarter.
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