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.
Oct. 17, 2014, 8:34 AM
- The U.S. District Court for the District of Connecticut grants a preliminary injunction against Ethicon Endo-Surgery (NYSE:JNJ) preventing it from manufacturing, marketing and selling its Harmonic ACE +7 ultrasonic energy device. The injunction is the result of Covidien's (NYSE:COV) lawsuit that alleges the product infringes on three of its patents.
- Ethicon's Harmonic devices were found to infringe the same patents in a prior suit in the same court. Ethicon is currently appealing the court's damages award of $175M.
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 16, 2014, 7:46 AM
Oct. 15, 2014, 1:11 PM
- Janssen-Cilag International NV (JNJ +0.3%) files a Type II Variation with the European Medicines Agency seeking clearance to expand the label of Stelara (ustekinumab) to include treatment of moderate-to-severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies.
- In the EU, Stelara is currently approved for the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to or who have a contraindication to or are intolerant to other systemic therapies including ciclosporin, methotrexate or PUVA. It also is cleared for the treatment of active psoriatic arthritis, alone or in combination with methotrexate, in adults who responded inadequately to DMARD therapy.
Oct. 14, 2014, 8:37 AM
- Johnson & Johnson (NYSE:JNJ) Q3 results by selected line item:
- Consumer: Leaders: OTC Intl: +6.2%; OTC WW: +4.5%; Oral Care - U.S.: +4.2%; Oral Care Intl: +3.2%. Laggards: Women's Health - U.S.: -89.6%; Women's Health WW: -20.3%; Women's Health Intl: -4.2%; Wound Care/Other Intl: -3.2%.
- Pharmaceuticals: Leaders: Infectious Diseases WW: +90.1%; Edurant U.S.: +75.0%; Xarelto U.S.: +68.3%; Edurant Intl: +58.3%; Stelara U.S.: +52.8%; Oncology U.S.: +34.4%. Laggards: Incivo Intl: -50.0%; Other Infectious Diseases Intl: -41.5%; Risperdal Consta Intl: -16.5%; Other Neuroscience U.S.: -13.9%; Concerta/Methylphenidate U.S.: -10.5%.
- Medical Devices and Diagnostics: Leaders: Cardiovascular Care U.S.: +12.8%; Cardiovascular Care Intl: +5.2%; Orthopaedics U.S.: +3.2%; Diabetes Care: +3.0%. Laggards: Diagnostics WW: -90.4%; Diagnostics Intl: -81.4%; Vision Care U.S.: -12.5%; Vision Care WW: -5.9%; Surgical Care U.S.: -3.9%.
Oct. 14, 2014, 8:14 AM
- Johnson & Johnson (NYSE:JNJ) Q3 results: Total Revenues: $18,467M (+5.1%); Consumer: $3,589M (-0.6%); Pharmaceutical: $8,307M (+18.1%); Med Device & Diagnostics: $6,571M (-5.2%).
- Revenue by geographic segment: U.S.: $8,842M (+11.6%); Europe: $4,446M (-0.7%); Western Hemisphere ex-U.S.: $1,820M (-1.2%); Asia-Pacific/Africa: $3,359M (+0.9%); International: $9,625M (-0.3%); Worldwide: $18,467 (+5.1%).
- COGS: $5,399M (+1.0%); R&D Expense: $2,023M (-0.9%); SG&A Expense: $5,468M (+2.9%); Net Income: $4,749M (+59.3%); EPS: $1.66 (+59.6%).
- Gross Profit: $13,068M (+6.8%); COGS: 29.2% (-3.9%); Gross Margin: 70.8% (+1.7%); Operating Profit: $5,577M (+14.4%); Operating Earnings Yield: 30.2% (+8.9%); Net Earnings Yield: 25.7% (+51.6%).
- 2014 EPS guidance raised to $5.92 - 5.97 from $5.85 - 5.92.
Oct. 14, 2014, 7:48 AM| Comment!
Oct. 13, 2014, 5:30 PM
JNJ vs. ETF Alternatives
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale of a range of products in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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