Dec. 12, 2014, 11:24 AM
Dec. 3, 2014, 12:06 PM
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 17, 2014, 9:16 AM
Oct. 27, 2014, 11:41 AM
- The FDA approves St. Jude Medical's (STJ -0.3%) TactiCath Quartz irrigated ablation catheter. The product gives physicians a real-time objective measure of the force that the catheter applies to a patient's heart wall during an ablation procedure. The technology is associated with a reduction in the rate of atrial fibrillation recurrence when optimal treatment measures are used.
- Related tickers: (BCR +1.2%)(MDT -0.1%)(JNJ +0.9%)(BSX +0.8%)(HNSN +2.1%)(ABT -0.6%)
Oct. 22, 2014, 12:24 PM
- In response to the changes in the tax code related to inversions, Abbott (ABT -1.1%) and Mylan (MYL -2.5%) adjust the terms of their $5.3B all-stock deal. The pricing terms related to product manufacturing and supply have been changed in favor of New Mylan and the number of shares of stock to be issued to Abbott have been increased to 110M from 105M.
- Former shareholders of Mylan will own ~78% of New Mylan and Abbott and its affiliates will own ~22%. The transaction is expected to close in Q1 2015.
Oct. 22, 2014, 11:31 AM
- The European Commission approves privately-held Switzerland-based Ferring Pharmaceuticals' Cortiment (budesonide) for the induction of remission in patients with active mild-to-moderate ulcerative colitis. Budesonide is a locally acting glucocorticosteroid.
- Ferring licensed Cortiment from Cosmo Pharmaceuticals SpA for the EU, Asia (ex-Japan), Australia, Canada, Latin America and Africa. The product is sold under the brand name Uceris in the U.S. by Salix Pharmaceuticals (SLXP -0.2%).
- UC-related tickers: (NASDAQ:VBLX) (RCPT)(OTCPK:TKPHF)(OTCPK:TKPYY +0.2%)(ATHX +2.3%)(SHPG +1.3%)(PFE +0.7%)(ABT -0.4%)(ABBV +1.2%)(CNDO +1.1%)(JNJ +1%)(SGYP -3.2%)
Oct. 22, 2014, 8:25 AM
- Abbott (NYSE:ABT) Q3 results ($M): Total Revenues: 5,104 (+5.8%), Nutrition: 1,787 (+9.3%), Diagnostics: 1,180 (+4.9%), Established Pharmaceuticals: 771 (+11.5%), Medical Devices: 1,329 (-1.0%); COGS: 2,331 (+3.4%); R&D Expense: 307 (-9.4%); SG&A Expense: 1,603 (-0.6%); Net Income: 538 (-44.3%); EPS: 0.36 (-41.0%).
- Gross Profit: 2,773 (+7.9%); COGS: 45.7% (-2.3%); Gross Margin: 54.3% (+2.0%); Operating Profit: 863 (+39.4%); Operating Earnings Yield: 16.9% (+31.8%); Net Earnings Yield: 10.5% (-47.4%).
- 2014 Guidance: EPS: $1.22 - 1.24; non-GAAP EPS: $2.25 - 2.27 from $2.19 - 2.29.
- Q4 Guidance: EPS: $0.32 - 0.34; non-GAAP EPS: $0.68 - 0.70.
Oct. 22, 2014, 7:42 AM
Oct. 21, 2014, 5:30 PM
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.
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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