Nov. 9, 2014, 5:37 PM
- At The Liver Meeting in Boston this week, Bristol-Myers Squibb (NYSE:BMY) presented data from its ALLY Phase 3 clinical trial investigating a 12-week ribavirin-free regimen of daclatasvir in combination with Sovaldi (sofosbuvir) in HCV genotype 3 patients, a population that has emerged as one of the most difficult to treat. The SVR12 in treatment-naive patients was 90% and 86% in treatment-experienced patients. SVR12, sustained viral response 12 weeks after the completion of therapy, is considered cured.
- The results compare favorably with SVR12 in 89% of patients with HCV-1,2 and 3 in an open-label randomized study of a 24-week regimen of the two drugs.
- HCV-related tickers: (NYSE:MRK) (NASDAQ:GILD) (NYSE:ABBV) (NASDAQ:ENTA) (NYSE:JNJ) (NASDAQ:CNAT) (NASDAQ:LGND) (NASDAQ:RGLS)
Nov. 9, 2014, 5:06 PM
- At this week's Annual Meeting for the Study of Liver Diseases in Boston, Achillion Pharmaceuticals (NASDAQ:ACHN) gave poster presentations on two of its HCV product candidates.
- In a Phase 2 pilot study evaluating eight-week treatment of its NS5A inhibitor, ACH-3102, in combination with Sovaldi (sofosbuvir) in treatment-naive HCV genotype 1 patients, the interferon-free, ribavirin-free regimen demonstrated 100% SVR12 in 12 patients. SVR12 or sustained viral response 12 weeks after the completion of therapy, is considered cured. Sovaldi's SVR12 (in combination with peg-interferon alfa and ribavirin) is 90% for HCV-1. Harvoni's (sofosbuvir + ledipasvir) is 94 - 99%.
- The company presented three posters on preclinical results for its uridine analog prodrug, ACH-3422. The data showed improved potency against HCV-3 compared to sofosbuvir. The combination of ACH-3422 with ACH-3102 or sovaprevir (Achillion's Phase 2 NS3/4A inhibitor) displayed additive synergistic activity in vitro. Also, ACH-3422, in combination with other direct-acting antiviral agents, demonstrated the ability to block the appearance of resistant colonies in vitro.
- According to recent research, the global prevalence of HCV genotypes is: type 1: 46%; type 2: 13%; type 3: 22% and type 4: 13%.
- HCV-related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY) (NASDAQ:RGLS) (NASDAQ:ENTA) (NYSE:MRK) (NASDAQ:LGND) (NASDAQ:CNAT)
Nov. 7, 2014, 9:52 AM
Nov. 6, 2014, 7:08 AM
- The FDA approves the combination of Janssen Pharmaceuticals' (NYSE:JNJ) Olysio (simeprivir) and Gilead Sciences' Sovaldi (sofosbuvir) for the treatment of adults with genotype 1 HCV infection. It is the second all-oral treatment option cleared for sale in the U.S. The recommended treatment duration is 12 weeks for patients without cirrhosis and 24 weeks for patients with cirrhosis.
- Previously: Janssen applies for Olysio label expansion
Nov. 4, 2014, 9:28 AM
- AstraZeneca (NYSE:AZN) establishes a clinical trial collaboration with Pharmacyclics (NASDAQ:PCYC) and Janssen Research & Development LLC (NYSE:JNJ) to evaluate the safety and efficacy of AZN's anti-PDL1 immune checkpoint inhibitor, MEDI4736, in combination with Imbruvica (ibrutinib) for the treatment of hematologic cancers including diffuse large B-cell lymphoma and follicular lymphoma.
- MEDI4736 blocks the signals that enable tumors to avoid detection by the immune system thus countering the tumor's immune-evading tactics.
- The Phase 1 clinical trial to establish a dose regimen will be conducted by Pharmacyclics. Financial terms of the collaboration are undisclosed.
- Other MEDI4736 collaborations are ongoing.
- Previously: Incyte and MedImmune collaborate on cancer immunotherapies
- Previously: Ventana and MedImmune collaborate
- Previously: Advaxis and MedImmune team up in cancer immunotherapy
Nov. 1, 2014, 8:25 AM
- Phil Davidson likes to choose solid but "boring" stocks with healthy balance sheets and strong market positions in stable industries for his American Century Equity Income Fund, which is mostly focused on wealth preservation; when volatility spiked earlier in October, his portfolio fell 2.7% vs. the market’s 4.3% decline.
- His five favorite stocks he sees as pleasantly boring in a volatile market include Johnson & Johnson (NYSE:JNJ) for its global dominance across all three of its businesses - pharmaceutical, consumer and medical devices.
- PepsiCo (NYSE:PEP) is under activist pressure to split its beverage and snack units, an added bonus to a stock that's worth owning either way; Davidson thinks fears over the decline in the U.S. carbonated soft drink market are overblown.
- At Air Products (NYSE:APD), new CEO Seifi Ghasemi is a perfect fit to squeeze more out of a company that already has good assets in a stable industry, Davidson says.
- UPS has been under pressure to keep up with growing business to consumer shipments, and has spent money to increase capacity; the spending has weighed on earnings this year, but Davidson thinks it's bound to pay off.
- Commerce Bancshares (NASDAQ:CBSH) has been a victim of the low interest rate environment, but Davidson likes its conservative business model.
Oct. 30, 2014, 12:21 PM
- Johnson & Johnson (JNJ +0.2%) may pay more than $250M to resolve lawsuits over its ASR hip implants that were excluded from a $2.5B settlement of similar claims last year over the device’s failure, Bloomberg reports.
- JNJ reportedly is is weighing whether to settle more than 1,000 lawsuits over removals of recalled ASR hip implants that occurred after Aug. 2013, extending the same settlement terms that covered patients who had their ASR implants removed earlier than last summer.
- If JNJ resolves the additional suits, it will have settled ~75% of its total U.S. caseload.
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. 23, 2014, 4:37 PM
- The jury in a Texas court unanimously clears Johnson & Johnson's (JNJ +1.4%) DePuy Orthropedics of charges it manufactured a dangerous and defective metal-on-metal hip implant, the Pinnacle. Many eyes were on the trial because of the controversy with the technology related to potential side effects such as metallosis that is caused by the supposed debris from the metal-on-metal movement.
- If the company had lost the trial, its potential liability exposure would grow exponentially.
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, 4:46 AM
- Johnson & Johnson (NYSE:JNJ) will begin testing an Ebola vaccine in humans in January, and plans to have 250K doses of the experimental vaccine ready for use in clinical trials in May.
- The drug will combine a shot from the company's Janssen unit with one developed by Bavarian Nordic (OTCPK:BVNRY).
- J&J will invest about $200M to study and expand production of the vaccine, and aims to produce 1M doses next year.
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. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 20, 2014, 4:37 PM
- Janssen Research & Development (JNJ +0.5%) strategic partner Pharmacyclics (PCYC +2.3%) submits an sNDA to the FDA for Imbruvica (ibrutinib) for the treatment of Waldenstrom's macroglobulinemia (WM), a rare type of B-cell lymphoma with no treatment options in the U.S. If approved, it will be the fourth indication for the product.
- The FDA granted Breakthrough Therapy Designation to Imbruvica for WM in February 2013.
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. 17, 2014, 9:18 AM
- The European Commission approves Pharmacyclics (NASDAQ:PCYC) and Janssen's (NYSE:JNJ) Imbruvica (ibrutinib) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma or adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or in first-line CLL patients in the presence of 17p deletion or TP53 mutation who are unsuitable for chemotherapy.
- The FDA approved Imbuvica in July.
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Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale ofproducts in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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