Oct. 21, 2014, 10:52 AM
- The FDA accepts Eli Lilly's NDA for empagliflozin plus immediate-release metformin hydrochloride for the treatment of adults with type 2 diabetes (T2D). The product is part of the Lilly/Boehringer Ingelheim Diabetes alliance portfolio.
- Empagliflozin is a sodium glucose co-transporter-2 inhibitor which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilize glucose.
- The FDA approved Jardiance (empagliflozin) as an adjunct to diet and exercise to improve glycemic control in adults with T2D in August 2014. Metformin has been in clinical use for many years.
- Diabetes-related tickers: (JNJ +0.4%)(OTCQB:ISLT)(OTCQB:BTHE +20%)(VTAE +2.5%)(NVO +0.5%)(MRK +0.9%)(NASDAQ:VKTX)(HPTX +0.4%)(ABT +1.2%)(OTCPK:TKPHF)(OTCPK:TKPYY -0.5%)(MDT +1.7%)(SNY -0.2%)(OTCQB:SNYNF -0.5%)(MNKD +2.4%)(ALR +1.4%)(TNDM +3%)
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. 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. 1, 2014, 12:28 PM
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%)
Sep. 15, 2014, 9:47 AM
- In a randomized controlled trial, Abbott's (ABT +0.1%) absorbable scaffold, Absorb, performed comparably to the company's metallic stent, Xience, in patients with coronary artery disease.
- At one year, the patient-oriented clinical endpoint of all adverse events (death, heart attacks, revascularizations) was 7.3% for Absorb and 9.1% for Xience. The device-oriented clinical endpoint of target lesion failure was 4.8% for Absorb and 3.0% for Xience. The rate of definite stent thrombosis was 0.6% for Absorb.
- Absorb is a first-of-its-kind device that functions like a stent by opening a blocked artery and restoring blood flow, but dissolves over time. It is made of polyactide, the same material as dissolving sutures. It is the world's first drug-eluting vascular scaffold to be commercially available internationally. It achieved CE Mark clearance in Europe in January 2011.
Sep. 12, 2014, 4:32 PM| 3 Comments
Sep. 11, 2014, 1:56 PM
Sep. 3, 2014, 10:24 AM
- Abbott Laboratories (ABT +0.8%) earns CE Mark clearance for its FreeStyle Libre Flash Glucose Monitoring System for people with diabetes. The system eliminates the need for routine finger pricks by reading glucose levels through a sensor that can be worn on the back of the upper arm for as long as 14 days. There is also no need for a finger prick calibration.
- The sensor takes minute-by-minute glucose measurements in the interstitial fluid via a small filament that is inserted under the skin and held in place by an adhesive pad. The patient scans the sensor with a hand-held reader to obtain the glucose result in less than one second.
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.
Aug. 18, 2014, 11:40 AM
- Abbott Laboratories (ABT +0.6%) and the Department of Defense will collaborate on developing portable blood tests to help evaluate potential concussions. The tests will be developed on Abbott's i-STAT System, a hand-held diagnostic analyzer.
- U.S. Army Medical Research and Material Command Brain Health Coordinator Col. Dallas C. Hack, M.D., says, "The quick and accurate diagnosis of a concussion is critical so that soldiers who are affected - whether in the battlefield or not - can be removed from duty to recover and to prevent further injury."
- Research suggests that certain proteins are released in the bloodstream following a brain injury. Detecting a mild traumatic brain injury such as a concussion can be difficult with imaging technology because it may not show abnormalities and the symptoms can be similar to or be mistaken for other conditions.
Jul. 16, 2014, 10:42 AM
- Abbott Laboratories (ABT +0.2%) Q2 results: Total Revenues: $5,551M (+1.9%); International Revs: $3,990M (+2.7%); U.S. Revs: $1,561M (+0.1%); Nutrition: $1,731M (+1.6%); Diagnostics: $1,189M (+4.8%); Est. Pharmaceuticals: $1,216M (-0.2%); Medical Devices: $1,373M (+1.3%).
- COGS: $2,506M (-1.5%); R&D Expense: $335M (-7.7%); SG&A Expense: $1,788M (+4.3%); Net Income: $466M (-2.1%); EPS: $0.30 (flat).
- Gross Profit: $3,045 (+5.0%); COGS: 45.1% (-3.4%); Gross Margin: 54.9% (+3.0%); Operating Profit: $922M (+11.9%); Operating Earnings Yield: 16.6% (+9.8%); Net Earnings Yield: 8.4% (-4.0%).
- 2014 EPS guidance raised to $2.19 - 2.29 from $2.16 - 2.26.
Jul. 16, 2014, 7:46 AM| Comment!
Jul. 15, 2014, 5:30 PM
Jul. 14, 2014, 7:03 AM
- Mylan (NASDAQ:MYL) acquires Abbott Labs' (NYSE:ABT) ex-U.S. specialty and branded generics business for $5.3B in an all-stock transaction. Abbott will receive 105M shares of MYL common stock representing a 21% ownership stake.
- The assets include a portfolio of more than 100 drugs that generate ~$1.9B in annual sales. The deal includes a sales force of ~2,000 representatives in more than 40 non-U.S. markets and two manufacturing facilities. The transaction will be immediately accretive to Mylan adding ~$0.25/share to diluted EPS the first year and increasing thereafter.
Jul. 11, 2014, 7:48 PM
- Reuters reports that generic drug firm Mylan (MYL -1%) is in advanced negotiations with Abbott Laboratories (ABT +0.1%) to purchase a multibillion dollar portfolio of its established off-patent Europe-based drugs. The transaction is a tax inversion deal that will enable Mylan to redomicile in Switzerland.
- Mylan has been in the hunt for foreign assets since its failed attempt to buy Swedish drugmaker Meda AB earlier this year. Its two main competitors, (TEVA +0.9%) and Actavis (ACT +0.5%) are domiciled in lower tax countries.
- Abbott will use the proceeds of the sale, rumored to be as high as $5B, to invest in higher growth opportunities.
ABT vs. ETF Alternatives
Abbott Laboratories discovers, develops, manufactures and sells health care products. Its products include branded generic pharmaceuticals manufactured internationally, marketed and sold outside the United States.
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