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%)
Oct. 1, 2014, 8:21 AM
- Yesterday, the U.S. Government released the first comprehensive disclosure of payments made by medical companies to doctors. Over the first five months of 2013, med firms paid $3.5B to doctors to fund items such as research, consulting, royalties to hospitals to help develop products and fees for speaking engagements. The monies were disbursed in two broad categories: research funding and fees to doctors for consulting and other non-research services.
- Roche's (OTCQX:RHHBY) Genentech unit led the way in the non-research category with $135M. Most of this (90%) went to a Southern California hospital network for royalties.
- Bristol-Myers Squibb (NYSE:BMY) was #1 in the research category with $329M which, according to the company, was largely the value of experimental medicines used in studies.
- Medtronic (NYSE:MDT) paid one unidentified doctor ~$3M who was among a group of six physicians paid at least $500K by the device maker. The company's total outlay for the period was $30.1M.
- Johnson & Johnson (NYSE:JNJ) paid $68M for non-research expenses.
- The disclosures, mandated by Obamacare, cover 4.4M payments to ~550K doctors and 1,360 teaching hospitals from August to December 2013.
- The disclosures are a bit controversial. Physicians complained that the government did not give them enough time to review the data to correct mistakes.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Sep. 29, 2014, 7:38 AM
- Shares of micro cap Exelixis (NASDAQ:EXEL) are up 26% premaket on healthy volume in response to positive Phase 3 results for cobimetinib announced today by Roche. Exelixis discovered the drug internally. It entered into a global co-development agreement with Genentech (OTCQX:RHHBY) in late 2006. In November 2013, Exelixis exercised its option to co-promote cobimetinib, if approved, in the U.S. It is entitled to an equal share of U.S. profits and losses which will decrease as sales increase and will share equally in U.S. marketing and commercialization costs. It is eligible to receive royalties on ex-U.S. sales.
Sep. 29, 2014, 7:28 AM
- At the European Society of Medical Oncology (ESMO) Congress today, Roche (OTCQX:RHHBY) announced positive from a Phase 3 clinical trial evaluating the safety and efficacy of the combination of cobimetinib plus Zelboraf (vemurafenib) compared to Zelboraf alone in patients with advanced melanoma.
- The results showed that patients with previously-untreated BRAF V600 mutation-positive advanced melanoma who received the combination lived significantly longer that those who received Zelboraf alone. Median progression-free survival in the combination therapy cohort was 9.9 months compared to 6.2 months in the monotherapy cohort.
- The data is currently under European Medicines Agency review. Roche plans to submit an NDA to the FDA later this year.
Sep. 25, 2014, 7:27 AM
- Roche's (OTCQX:RHHBY) Avastin (bevacizumab) and Xeloda (capecitabine) achieve their primary endpoints in two Phase 3 clinical trials in HER2-negative metastatic breast cancer.
- In the 185-patient IMELDA study, the safety and efficacy of maintenance treatment with Avastin plus Xeloda chemotherapy was compared to Avastin alone in patients with HER2-negative metastatic breast cancer that had not progressed during first-line induction treatment with Avastin plus docetaxel chemotherapy. The trial met its primary endpoint of improving progression-free survival (PFS) with a statistically significant 62% reduction in the risk of tumor progression in the Avastin plus Xeloda cohort compared the Avastin alone group (median PFS after induction: 11.9 months vs. 4.3 months). The study also hit its secondary endpoint of an improvement in overall survival (OS) with a statistically significant 57% reduction in the risk of death in the the Avastin plus Xeloda group compared to Avastin alone (median OS after induction: 39.0 months vs. 23.7 months).
- The 494-patient TANIA study evaluated the safety and efficacy of Avastin as a second-line therapy in HER2-negative metastatic breast cancer patients treated with Avastin plus chemo as a first-line treatment. The trial met its primary endpoint of improving PFS in the second-line, significantly reducing the risk of tumor progression by 25% (median PFS: 6.3 months vs. 4.2 months).
- The safety profiles in both trials were consistent with earlier studies.
Sep. 17, 2014, 4:29 PM| Comment!
Sep. 15, 2014, 7:46 AM
- Roche (OTCQX:RHHBY) commences a Phase 3 clinical trial to evaluate the safety and efficacy of lampalizumab for the treatment of patients with geographic atrophy (GA), the advanced form of age-related macular degeneration (AMD). The primary endpoint of the 936-patient placebo-controlled study is the reduction in the rate of GA progression evaluated at week 48 from baseline.
- In a Phase 2 trial, the lampalizumab-treated group demonstrated a 20% reduction in GA lesion progression versus placebo. Lampalizumab-treated patients with the complement factor I biomarker demonstrated a 44% decrease in the rate of disease progression.
- No regulatory-approved therapies for GA currently exist.
Sep. 8, 2014, 7:22 AM
- The European Commission approves Roche's (OTCQX:RHHBY) RoActemra (tocilizumab) for the treatment of patients with severe, active and progressive rheumatoid arthritis (RA) who have not been treated with methotrexate. It is the first interleukin-6 (IL-6) receptor antagonist approved in Europe for early RA.
- The early RA indication is the fifth update and expansion to RoActemra's European label in three years.
Sep. 3, 2014, 11:56 AM
- The two firms sign a master clinical supply agreement whereby Roche (OTCQX:RHHBY +0.7%) will supply Gazyva (obinutuzumab) to Infiniti Pharmaceuticals (INFI +46.2%) for use in planned clinical studies to evaluate the combination of Gazyva and IPI-145 (duvelisib) as a treatment for patients with blood cancers.
- The companies also consummate a material transfer agreement whereby Infiniti will supply IPI-145 to Roche to use in its preclinical and translational research to evaluate the combination of duvelisib and Gazyva.
Sep. 2, 2014, 10:40 AM
- Roche (OTCQX:RHHBY -0.3%) debuts the molecular testing systems cobas 6800/8800 for blood and plasma donor screening in markets accepting the CE mark. The fully automated high throughput PCR analyzers can generate 96 results in less than 3.5 hours and up to 960 results in an eight-hour shift (8800) with substantial "walk-away" time and minimal operator interaction.
Aug. 28, 2014, 7:49 AM
- Pacific Biosciences of California (NASDAQ:PACB) achieves a development milestone under its agreement with Roche (OTCQX:RHHBY) triggering a $10M milestone payment. The companies signed a Development, Commercialization and License Agreement on September 23, 2013 whereby Pac Bio will develop diagnostic products for exclusive commercialization by Roche based its Single Molecule Real-Time (SMRT) technology. The agreement's initial term is 13 years. Roche may renew for 5-year periods. Pac Bio may earn up to an additional $30M in development milestones.
Aug. 25, 2014, 11:21 AM
Aug. 25, 2014, 10:18 AM
- The FDA approves Iroko Pharmaceuticals' Zorvolex (diclofenac) for the management of osteoarthritis pain. The agency cleared the NSAID for the treatment of mild-to-moderate pain in adults in October 2013.
- Related tickers: (PFE +0.1%) (MRK +0.9%) (OTCPK:BAYZF) (OTCPK:BAYRY +1.2%) (OTCQX:RHHBY +0.6%) (TEVA -0.5%) (MYL +0.8%) (PRGO -0.1%) (GSK +0.8%)
Aug. 25, 2014, 7:12 AM| Comment!
Aug. 24, 2014, 5:31 PM
- Roche (OTCQX:RHHBY, OTCPK:RHHBF) will pay $74/share for InterMune (NASDAQ:ITMN), a 38% premium to its Friday close and 63% higher than Aug. 12 when news of a potential sale emerged.
- The deal gives Roche access to pirfenidone, which targets idiopathic pulmonary fibrosis, a disease that causes tissue deep in the lungs to become thick and scarred over time. Analysts predict pirfenidone will generate $1B in global sales by 2019.
- Pirfenidone joins Roche’s stable of pulmonary treatments, including Pulmozyme for cystic fibrosis, Xolair for asthma, and in-development asthma drug lebrikizumab. Roche plans to speed pirfenidone’s U.S. start-up and help get insurance coverage for the medicine.
- Press release
Aug. 19, 2014, 12:51 PM
- Venture Capital firm Rock Health recently added eight digital health companies to its portfolio increasing its total to 55. The new additions include Welkin Health, whose Android app enables diabetics to access coaching and advice from the company's educators, Acumen which uses smartphone video for evaluating children with neurological disorders and two providers of platforms that ensure compliance with patient privacy laws.
- Another firm in the line up is Augmedix, which uses Google Glass to assist doctors in getting information to electronic record systems and to retrieve information verbally.
- Rock Health is partnering with Abbott Labs (ABT +0.2%), General Electric and Genentech (OTCQX:RHHBY +0.6%) to provide advice and resources to the portfolio companies. Other partners include Blue Shield of California and Deloitte Consulting.
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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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