Aug. 28, 2014, 12:11 PM
- Johnson & Johnson's (JNJ -0.3%) DePuy Synthes unit recalls certain lots of its Craniomaxillofacial Distraction System also called External Mandibular Fixator and/or Distractor and a Bone Plate. The lots are being recalled due to the risk of the device reversing direction and losing the desired distraction distance after surgery.
- Infants are at greatest risk due to the potential sudden obstruction of the trachea which could lead to respiratory arrest.
- There have been 15 reports of injury associated with use of the device.
Aug. 25, 2014, 8:23 AM
- Vivus (NASDAQ:VVUS) acquires a group of patents related to topiramate from Janssen Pharmaceuticals (NYSE:JNJ). The patents cover the use of topiramate as a monotherapy and in combination with other agents to treat a variety of medical conditions.
- Vivus agrees to pay a one-time upfront fee and royalties on Qsymia (phentermine and topiramate extended release) sales to Janssen on the basis of the assignment of patents. Janssen agrees to drop its lawsuit against Vivus.
Aug. 22, 2014, 11:21 AM
- Johnson & Johnson (JNJ -0.7%) invests $20M in the form of a convertible note in regenerative medicine company ViaCyte in exchange for a future equity stake and the rights to its type 1 diabetes combination product candidate VC-01.
- VC-01 works by loading pancreatic progenitor cells into a proprietary device that is implanted under the skin. The progenitor cells then mature into insulin-producing cells that assist the under-producing pancreas.
Aug. 21, 2014, 8:07 AM
- Ilumina (NASDAQ:ILMN) has formed collaborative partnerships with AstraZeneca (NYSE:AZN), Janssen Biotech (NYSE:JNJ) and Sanofi (NYSE:SNY) to develop a universal next-generation sequencing (NGS) system focused on oncology. The system will employ an multi-gene panel that will be used for patient selection in clinical trials of targeted cancer therapies. Illumina plans to commercialize the tests after obtaining regulatory approval.
- The emergence of panel-based assays will be a paradigm shift from today's single-analyte companion diagnostics.
- An estimated 800 oncology drugs are in development worldwide. At present, 125 cancer driver genes, 71 tumor suppressors and 54 oncogenes that drive tumor growth through 12 cellular signalling pathways have been discovered.
Jul. 30, 2014, 7:16 PM
- Johnson & Johnson (NYSE:JNJ) starts a worldwide withdrawal of its laparascopic power morcellators -- devices for removing fibroid uterine growths -- on concerns that their spinning blades risk spreading cancer elsewhere in the body.
- The company's Ethicon unit suspended sales and distribution in April; now JNJ is asking customers to return already-purchased devices.
Jul. 28, 2014, 12:34 PM
- The FDA approves a label expansion for Janssen Biotech's (JNJ -0.2%) Imbruvica (ibrutinib) to include patients with chronic lymphocytic leukemia (CLL) who carry a 17p deletion, a genetic malformation associated with poor responses to standard treatment.
- Imbruvica is currently approved to treat adults with CLL who have received at least one prior treatment and adults with mantle cell lymphoma who have received at least one prior treatment.
Jul. 25, 2014, 12:05 PM
- The EMA's Committee for Medicinal Products for Human Use (CHMP) adopt a positive opinion supporting approval of Imbruvica (ibrutinib) as a treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) or adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or as a first-line treatment in patients with the 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.
- Ibrutinib is being co-developed by Johnson & Johnson (JNJ -0.2%) unit Janssen-Cilag International NV and Pharmacyclics Switzerland GmbH. Once approved, Janssen will market it exclusively in EMEA (Europe, Middle East, Africa) and co-promote it in the U.S.
- A final decision from the European Commission usually takes ~3 months.
Jul. 22, 2014, 1:40 PM
- In a Phase 3 trial comparing a once-daily dose of Solzentry (maraviroc) (PFE +0.7%) with Prezista (darunavir) (JNJ +1.1%) and Norvir (ritonavir) (ABBV +0.2%) to emtricitabine/tenofir with darunavir plus ritonavir (DRV/r) in antiretroviral-naive patients, the maraviroc combination failed to achieve its primary endpoint of -10% non-inferiority (no worse than) at Week 48.
- The proportion of study subjects who were virologically suppressed (HIV-1 RNA < 50 copies/ml) was 77.3% for the maraviroc cohort and 86.8% for the DRV/r group.
- The study results were presented by ViiV Healthcare at the 20th International AIDS Congress in Melbourne, Australia earlier today. ViiV is a specialist company focused on HIV that was established in late 2009 by Glaxo (GSK -0.1%) and Pfizer.
- ViiV Healthcare CSO and CMO Dr. John Pottage says, "Athough this investigational two-drug regimen was inferior to the three-drug regimen in this study, maraviroc remains a valuable antiretroviral therapy when used in combination with other antiretrovirals and dosed twice daily in adults with confirmed CCR5-tropic HIV."
Jul. 21, 2014, 5:26 PM
- The BOD of J & J (JNJ -0.5%) authorizes the repurchase of up to $5B of the company's common stock. Shares will be bought at management's discretion on the open market or via privately negotiated transactions. There is no time limit for the program.
- Reacquired shares will be used for general corporate purposes.
Jul. 21, 2014, 11:31 AM
Jul. 17, 2014, 11:02 AM
- An analysis by Express Scripts (ESRX +0.1%) shows the enormous potential costs confronting state Medicaid programs of paying for Gilead's (GILD +1.1%) HCV treatment Sovaldi. The $84,000 full regimen tab will put substantial budgetary pressure on many states like CA ($6.8B), TX ($5.4B) and FL (3.8B) if every HCV sufferer is treated.
- Express Scripts estimates that more than 750K Medicaid patients have chronic HCV infections (total cost to treat with Sovaldi + ribavirin or Olysio (JNJ -0.5%) = ~$55B).
- Despite Gilead's assertions that Sovaldi actually saves money by curing HCV and avoiding the costs of liver failure, Congress has launched an investigation into its pricing rationale. The company's previously announced plan to sell Sovaldi to Egypt for $900 potentially complicates its position.
Jul. 15, 2014, 8:04 AM
- Johnson & Johnson (NYSE:JNJ) Q2 results: Revenues: Consumer: $3,744M (+2.4%), Pharmaceutical: $8,509M (+21.1%), Med Devices & Diagnostics: $7,242M (+0.7%); Global Business: $19,495M (+9.1%).
- COGS: $6,039M (+10.0%); R&D Expense: $2,005M (+3.0%); SG&A Expense: $5,481M (+2.0%); Net Income: $4,326M (+12.9%); EPS: $1.51 (+13.5%).
- Gross Profit: $13,456M (+8.6%); COGS%: 31.0% (+0.9%); Gross Margin%: 69.0% (-0.4%); Operating Profit: $5,970 (+17.8%); Operating Earnings Yield: 30.6% (+8.1%); Net Earnings Yield: 22.2% (+3.5%).
- EPS guidance raised to $5.85 - 5.92 from $5.80 - 5.90.
- Press release
Jul. 15, 2014, 7:46 AM| 3 Comments
Jul. 14, 2014, 5:30 PM
Jul. 14, 2014, 1:19 PM
- Johnson & Johnson's (JNJ +0.2%) Janssen Pharmaceuticals submits an sNDA for an expanded indication for Invega Sustenna (paliperidone palmitate). The label change, if approved, would include data showing significantly delayed time to relapse in patients treated with Invega Sustenna compared to selected oral antipsychotic therapies in the treatment of schizophrenia.
- In a 444-patient clinical trial, whose time to treatment failure was the primary endpoint, Invega Sustenna patients' delay of relapse was 190 days longer compared to other oral antipsychotics. The results were statistically significant.
- The FDA first approved the product in July 2009 as a treatment for schizophrenia.
Jul. 11, 2014, 1:47 PM
- Dr. Andrew Brill had to recuse himself from the FDA's Obstetrics and Gynecology Devices Ad Comm meeting this week due to his relationship with Johnson & Johnson's (JNJ -0.6%) Ethicon unit. It paid Dr. Brill ~$213,000 last year in consulting fees.
- The Committee is meeting this week to discuss the future use of power morcellators used in hysterectomies. Some experts believe the devices assist the spread of cancer by disseminating undetected cancer cells as it divides and removes tissue. Ethicon markets such a device under the trade name Gynecare Morcellex.
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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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