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Nov. 3, 2015, 10:17 AM
- Janssen's (JNJ -0.9%) European unit Janssen-Cilag International NV submits a Type II variation application to the European Medicines Agency (EMA) seeking an expanded label for IMBRUVICA (ibrutinib) to include treatment-naive chronic lymphocytic leukemia (CLL) patients.
- IMBRUVICA, co-developed by Cilag GmbH International and Pharmacyclics LLC (ABBV -1.2%), is currently cleared in the EU for the treatment of adults with relapsed/refractory mantle cell lymphoma, adults with CLL who have received at least one prior therapy, first-line treatment of adults with CLL who have the 17p deletion or TP53 mutation and are unsuitable for chemo and in adults with Waldenstrom's macroglobulinemia who have received at least one prior line of therapy or first-line in those unsuitable for chemo.
Nov. 3, 2015, 9:32 AM
- A Phase 2b clinical trial, LATTE 2, assessing long-acting injectable formulations of Viiv Healthcare's (NYSE:GSK) (NYSE:PFE) (OTC:SGIOF) (OTCPK:SGIOY) cabotegravir and Janssen's (NYSE:JNJ) EDURANT (rilpivirine) for the maintenance treatment of HIV-1 infection met its primary endpoint at 32 weeks. The results showed the two-injectable-drug regimen was comparable in maintaining viral suppression rates to a three-drug oral regimen of cabotegravir and two nucleoside transcriptase inhibitors.
- Viral suppression rate (plasma HIV-1 RNA <50 c/ml) at week 32 for the two-drug regimen dosed every eight weeks was 95% and 94% for those dosed every four weeks. This compared favorably to 91% for the three-drug regimen.
- Patients on the four-week regimen reported more adverse events (AEs) leading to withdrawal (5%; n=6) than those on the eight-week regiment (2%; n=2) and those on the oral regimen (2%; n=1). The most common AE was injection site pain (93% of injection recipients). Two patients in the eight-week cohort withdrew for injection intolerance. Two patients, one in the eight-week group and one in the oral group, experienced virologic failure.
- Cabotegravir is an investigational integrase strand transfer inhibitor and analogue of ViiV's Tivicay (dolutegravir). It is being evaluated as a once-daily oral tablet and as a long-acting intramuscular injection.
- The results will be presented at an upcoming scientific conference.
Oct. 29, 2015, 6:31 AM
- Allergan (NYSE:AGN) is up 15% premarket on light volume on the news that it is in talks with Pfizer (NYSE:PFE) about a possible merger. If the deal goes through, it would create the world's largest healthcare firm with a market value of $330B, larger than Johnson & Johnson's (NYSE:JNJ) market cap of $278B.
- A lower tax bill is one of the reasons Allergan is an attractive target for Pfizer considering the Botox maker is domiciled in tax-friendly Dublin. The U.S. government clamped down on tax inversion deals last year which scuppered the AbbVie/Shire deal so it is unclear how this might effect Pfizer's ability to change its domicile.
- Potential Pfizer takeover targets GlaxoSmithKline (NYSE:GSK) and Shire (NASDAQ:SHPG) are both down slightly in premarket trading.
- Update: Both Pfizer and Allergan confirm the commencement of "friendly" discussions regarding a potential combination.
Oct. 26, 2015, 7:29 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Janssen's (NYSE:JNJ) EDURANT (rilpivirine) for use in adolescent patients aged 12 to <18 years who are infected with the HIV-1 virus and have a viral load less than or equal to 100K HIV-1 RNA copies/ml at the start of treatment.
- EDURANT was previously approved in Europe in November 2011, in combination with other retroviral agents, for the treatment of adult patients (at least 18 years old) with HIV-1 infection with a viral load of at least 100K HIV-1 RNA copies/ml.
- About one in seven new HIV infection occur in adolescents and young adults.
- A final decision by the European Commission usually takes ~60 days.
Oct. 23, 2015, 12:18 PM
- The FDA approves J&J unit Janssen's (JNJ +0.6%) chemotherapeutic Yondelis (trabectedin) for the second-line treatment of two types of soft tissue sarcomas, liposarcoma and leiomyosarcoma, that cannot be removed by surgery or is metastatic. Approved patients are those who have previously received chemotherapy that contained anthracycline.
- Clinical trial data supporting clearance showed an average improvement in progression-free survival of 2.7 months in patients receiving Yondelis compared to those receiving dacarbazine.
- According to the National Cancer Institute, there are ~12K cases of soft tissue sarcomas diagnosed in the U.S. each year.
- The FDA declined to approve trabectedin for the treatment of ovarian cancer in 2009.
- Previously: Yondelis may finally break through in the U.S. (Feb. 3)
Oct. 22, 2015, 2:04 PM
- Johnson & Johnson (NYSE:JNJ) declares $0.75/share quarterly dividend, in line with previous.
- Forward yield 3.04%
- Payable Dec. 8; for shareholders of record Nov. 24; ex-div Nov. 20.
Oct. 19, 2015, 10:05 AM
- In a 628-subject Phase 3 clinical trial, Janssen's (JNJ -0.3%) STELARA (ustekinumab) demonstrated statistically significantly higher rates of clinical response than placebo in Crohn's disease patients who previously failed conventional therapy. The study, called UNITI-2, assessed a single intravenous infusion of STELARA (130 mg or ~6 mg/kg) or placebo at week zero in patients who previously failed treatment with steroids and/or immunomodulators and were either naive to or had been exposed to anti-TNF-alpha therapy but had not failed.
- At week 6, 52% of patients treated with STELARA 130 mg and 56% of those receiving ~6 mg/kg achieved clinical response compared to 29% for placebo (p<0.001). Clinical response was defined as a reduction from baseline in Crohn's Disease Activity Index (CDAI) score of at least 100 points.
- At week 8, the clinical response rates in the STELARA cohort were 47% and 58%, respectively, compared to 32% for placebo (p<0.001). 31% patients receiving STELARA 130 mg and 40% receiving ~6 mg/kg achieved achieved clinical remission versus 20% for placebo (p=0.009). Clinical remission was defined as CDAI score of less than 150 points.
- The company intends to file an sNDA for Crohn's disease in 2016.
- STELARA, a human interleukin-12 and -23 antagonist, is currently approved for the treatment of adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Oct. 16, 2015, 7:55 AM
- Alios BioPharma, a unit of Janssen Pharmaceutical (NYSE:JNJ), initiates a Phase 2a clinical trial assessing the combination of AL-335, odalasvir (ACH-3102) and simeprevir (OLYSIO) in treatment-naive HCV-1 patients. Approximately 60 participants in the randomized, open-label, three-arm study will receive once-daily treatment for four, six or eight weeks. The primary endpoint is safety. Secondary endpoints include pharmacokinetics, the proportion of patients achieving sustained viral response (SVR) at four weeks, six weeks and eight weeks and the effect on the viral resistance profile after treatment. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is February 2016. The estimated study completion date is August 2016.
- AL-335 is a nucleotide-based NS5B polymerase inhibitor. Odalasvir is an NS5A inhibitor and simeprevir is an NS3/4A inhibitor.
- In May Achillion Pharmaceuticals (NASDAQ:ACHN) granted Janssen an exclusive worldwide license to develop and commercialize HCV products and regimens containing one or more of Achillion's HCV assets, including odalasvir (ACH-3102), ACH-3422 and sovaprevir.
- Johnson & Johnson (JNJ) acquired Alios BioPharma in September 2014.
- Related tickers: (NASDAQ:GILD) (NYSE:MRK) (NYSE:ABBV) (NYSE:BMY)
Oct. 14, 2015, 10:28 AM
- In a partial victory for Boston Scientific (BSX +0.1%), a Delaware court reduces a $100M verdict award in to a woman in May for injuries allegedly suffered from the company's transvaginal mesh device to $10M. Judge Mary Johnston referred to the original award as "grossly disproportionate to the injuries suffered and shocks the court's conscience and sense of justice." The company wanted the entire verdict set aside and a new trial, but the judge denied the request. It intends to appeal the decision.
- In April, it settled 2,970 mesh-related lawsuits for $119M. Many more remain outstanding, however, for the company and fellow mesh manufacturers Johnson and Johnson (JNJ -1.3%) an C.R. Bard (BCR -0.1%).
- Previously: Boston Scientific on the hook for $100M in Delaware transvaginal mesh trial (May 28)
Oct. 13, 2015, 8:06 AM
- Johnson & Johnson (NYSE:JNJ) Q3 results ($M): Total Revenues: 17,102 (-7.4%); Consumer: 3,314 (-7.7%); Pharmaceutical: 7.694 (-7.4%); Medical Devices & Diagnostics: 6,094 (-7.3%).
- Revenues by Region: U.S.: 8,791 (-0.6%); Europe: 3,802 (-14.5%); W. Hemisphere ex-U.S.: 1,463 (-19.6%); Asia Pacific & Africa: 3,046 (-9.3%).
- Net Income: 3,358 (-29.3%); EPS: 1.20 (-27.7%); Non-GAAP EPS: 1.49 (-0.7%).
- Key Product Sales: Remicade: 1,613 (-9.5%); Stelara: 613 (+12.9%); Invega Sustenna/Xeplion: 459 (+13.9%); Zytiga: 548 (-3.5%); Xarelto: 461 (+11.4%); Invokana/Invokamet: 340 (+392.8%).
- 2015 Guidance: EPS: $6.15 - 6.20 from $6.10 - 6.20.
Oct. 13, 2015, 7:32 AM
- Johnson & Johnson (NYSE:JNJ): Q3 EPS of $1.49 beats by $0.04.
- Revenue of $17.1B (-7.4% Y/Y) misses by $350M.
Oct. 13, 2015, 6:56 AM
- Johnson & Johnson's (NYSE:JNJ) board of directors approve a $10B share repurchase program. The initiative has no time limit and may be suspended or discontinued at any time. The buyback will be financed with debt. Management will discuss the program this morning during the earnings call.
Oct. 12, 2015, 5:30 PM
Oct. 12, 2015, 12:26 PM
- Johnson & Johnson (JNJ +0.8%) reports Q3 results tomorrow morning before the open. The conference call begins at 8:30 am ET. Consensus view is EPS of $1.45 (-12.7%) on revenues of $17.5B (-5.2%).
Oct. 12, 2015, 10:44 AM
- Thinly traded nano cap Celsion (CLSN +9.2%) moves up on a healthy 10x surge in volume in response to its announcement of positive preclinical results for its GEN-1 IL-12 immunotherapy. Specifically, the combination of GEN-1 IL-12 with Roche's (OTCQX:RHHBY +0.7%) Avastin (bevacizumab) and J&J's (JNJ +0.9%) Doxil (doxorubicin HCl liposome injection) showed a greater than 98% reduction in tumor burden compared to the combination of Avastin and Doxil alone in an ovarian cancer cell line called SKOV3 implanted into immunocompromised mice.
- GEN-1 is an immunotherapy consisting of an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system. It is administered via an intraperitoneal (body cavity) injection.
- The company is currently enrolling patients in a Phase 1b trial called OVATION. A Phase 1/2 combination study should commence in mid-2016.
Oct. 9, 2015, 4:11 AM
- Johnson & Johnson (NYSE:JNJ) has begun clinical trial of a preventive Ebola vaccine regimen in Sierra Leone, which will combine two vaccine components from Crucell Holland and Janssen Pharmaceutical.
- Is the Ebola outbreak finally over? For the first time since the disease was reported in March 2014, the World Health Organization reported no new cases over the past week.
- According to the WHO, this is part of a trend: The number of cases in West African countries has remained below 10 per week over the past three months, but that doesn't mean the virus cannot surface again.
- A total of 11,297 are said to have died since the start of the epidemic.
Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale of products in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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