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  • Yesterday, 4:17 PM
    • Bloomberg reports that, according to sources close to the matter, Johnson & Johnson's (NYSE:JNJ) bid for Actelion (OTCPK:ALIOY) is now north of $250, $4 above its initial offer of $246, which Actelion rejected.
    • According to Mirabaud analyst Nick Turner, the revised bid, a modest 1.6% above the initial price, may get the job done.
    • Previously: Actelion up 16% on higher bid from J&J (Nov. 29)
    | Yesterday, 4:17 PM | 7 Comments
  • Thu, Dec. 1, 9:17 PM
    • Johnson & Johnson (NYSE:JNJ) is ordered by a federal jury in Dallas to pay more than $1B to six plaintiffs who said they were injured by Pinnacle hip implants.
    • The jurors said the hip implants were defectively designed and that JNJ and its DuPuy Orthopaedics unit failed to warn patients about the risks.
    • JNJ, which still faces nearly 9K lawsuits over the implants, stopped selling the product in 2013 after the FDA toughened regulations on artificial hips; it plans to appeal the verdict.
    | Thu, Dec. 1, 9:17 PM | 57 Comments
  • Tue, Nov. 29, 3:28 PM
    • Barclays' Geoff Meacham has downgraded BioMarin Pharmaceutical (BMRN -1.4%), Johnson & Johnson (JNJ -0.5%), Seattle Genetics (SGEN -0.2%), United Therapeutics (UTHR -4.1%) and Vertex Pharmaceuticals (VRTX -0.9%) to Equal Weight from Overweight.
    • He trimmed BMRN's price target to $105 (21% upside) from $125 citing "moderating growth and an overall lack of catalysts in 2017."
    • J&J's price target was sliced to $125 (11% upside) from $130 due to a "less compelling risk/reward profile."
    • SGEN's fair value target was lowered to $53 (21% downside risk) from $70 due to valuation.
    • UTHR's price target was revised to $100 (21% downside risk) from $115 citing the likely impact of Uptravi on Orenitram uptake.
    • He lowered Vertex's price target to $90 (5% upside) from $100 citing the lack of upside for Kalydeco and Orkambi.
    | Tue, Nov. 29, 3:28 PM | 11 Comments
  • Tue, Nov. 29, 11:02 AM
    • The rollercoaster in the price of Actelion (OTCPK:ALIOY +15.9%) continues. Shares have rebounded sharply from an earlier sell-off in response to the news that suitor Johnson & Johnson (JNJ -0.7%) has raised its offer for the Swiss biotech.
    | Tue, Nov. 29, 11:02 AM | 1 Comment
  • Tue, Nov. 29, 6:49 AM
    • Actelion (OTCPK:ALIOY) shares are down almost 6% in Zurich on reports that it is resisting Johnson & Johnson's (NYSE:JNJ) $17B offer for an outright sale. The aim of the complicated deal structure previously reported is to enable the company to remain independent while allowing J&J's U.S. group to retain a major equity stake.
    • Lurking in the background is Sanofi (NYSE:SNY) which could jump into the mix considering its widely-known interest in acquisitions since it plans to divest its generics business. Sanofi shares are up over 1% in Paris.
    | Tue, Nov. 29, 6:49 AM | 3 Comments
  • Tue, Nov. 29, 2:50 AM
    • Actelion (OTCPK:ALIOY) is considering a complicated deal to combine with part of Johnson & Johnson (NYSE:JNJ), a move that will leave the Swiss company independent from the U.S. drugs giant, FT reports.
    • The structured transaction would create a new, larger biotech firm uniting Actelion with relevant parts of J&J's pharma business, with the latter becoming a major shareholder in the new business.
    | Tue, Nov. 29, 2:50 AM | 1 Comment
  • Mon, Nov. 28, 7:11 AM
    • Johnson & Johnson's (NYSE:JNJ) Janssen Research & Development, LLC initiates an open-label Phase 2b study assessing the combination of simeprevir, odalasvir and JNJ-4178 (AL-335) in treatment-naive and treatment-experienced patients with chronic hepatitis C virus infection genotypes 1,2,4,5 and 6 without cirrhosis.
    • Subjects will receive the triple combination for either six or eight weeks. The primary endpoint is the percentage of patients who achieve clinical cure (SVR12) at the end of treatment. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is August 2017. The estimated study completion date is October 2017.
    • An ongoing Phase 2b study is evaluating the triple combo regimen in HCV patients with or without compensated cirrhosis.
    • Simeprevir (Olysio) is an NS3/4 protease inhibitor. Odalasvir is an NS5A inhibitor. JNJ-4178 (AL-335) is a novel uridine nucleotide analog polymerase inhibitor.
    • Related tickers: (NASDAQ:GILD)(NYSE:ABBV)
    | Mon, Nov. 28, 7:11 AM | 12 Comments
  • Fri, Nov. 25, 12:11 PM
    | Fri, Nov. 25, 12:11 PM | 22 Comments
  • Fri, Nov. 25, 1:52 AM
    • Johnson & Johnson (NYSE:JNJ) has approached Actelion (OTCPK:ALIOY) about a potential takeover in a bid to boost its pharma business, Bloomberg reports.
    • Europe's largest biotech firm has two pulmonary arterial hyper tension drugs which J&J would love to get its hands on, but deliberations are still at an early stage.
    • Shares in Actelion are up around 13% so far this year, valuing the company at around $17B.
    | Fri, Nov. 25, 1:52 AM | 5 Comments
  • Mon, Nov. 21, 8:00 PM
    • The FDA approves the use of Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab), in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least one prior line of therapy.
    • The previous label was restricted to MM patients who had received at least three prior lines of therapy.
    | Mon, Nov. 21, 8:00 PM | 3 Comments
  • Fri, Nov. 18, 12:54 PM
    • ViiV Healthcare, the HIV-focused company majority owned by GlaxoSmithKline (GSK -0.7%) and Pfizer (PFE -0.4%), initiates two Phase 3 studies assessing an injectable regimen of cabotegravir and rilpivirine for the treatment of HIV-1 infection. The studies, FLAIR and ATLAS, will evaluate the safety and efficacy of the two-drug combo, administered once per month, in both treatment-naive and treatment-experienced patients.
    • According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is July/August 2018 for both studies. The estimated completion date for both is April/May 2022.
    • Cabotegravir, developed by ViiV, in an integrase strand transfer inhibitor. It is also being evaluated in a tablet formulation.
    • Rilpivirine [marketed as EDURANT by Janssen (JNJ -1.2%)] is a non-nucleoside reverse transcriptase inhibitor.
    | Fri, Nov. 18, 12:54 PM | 1 Comment
  • Thu, Nov. 17, 8:53 AM
    • Johnson & Johnson's (NYSE:JNJ) Janssen Biotech submits its Biologics License Application (BLA) to the FDA seeking approval of guselkumab for the treatment of adults with moderate-to-severe plaque psoriasis.
    • Guselkumab is a human monoclonal antibody that binds to interleukin 23 (IL-23), a pro-inflammatory cytokine. J&J expects it to be a blockbuster and one of its major growth drivers.
    | Thu, Nov. 17, 8:53 AM
  • Tue, Nov. 15, 9:55 AM
    • Results from a Phase 2 clinical trial assessing Janssen's (NYSE:JNJ) anti-interleukin 23 (IL-23) monoclonal antibody guselkumab in patients with psoriatic arthritis (PA) showed a significant treatment benefit compared to placebo. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
    • The study met its primary endpoint of a statistically valid proportion of patients treated with guselkumab achieving ACR20 (20% improvement in PA symptoms) at week 24 versus placebo (58% vs. 18.4%; p<0.001). All secondary endpoints were also met.
    • At week 16, the proportion of subjects achieving ACR20 also favored guselkumab (60% vs. 16.3%; p<0.001), as did those achieving ACR50 (34% vs. 10.2%; p=0.002) and PASI 75 (78.6% vs. 12.5%; p<0.001).
    • Patients receiving guselkumab experienced greater improvements in enthesitis (inflammation at the sites where tendons & ligaments attach to bone) and dactylitis (inflammation of the fingers or toes).
    • The incidence of adverse events (AEs) was 36.0% for guselkumab and 32.7% for placebo. The most common AEs were infections.
    • The company announced positive results in a Phase 3 trial in plaque psoriasis last month.
    • Previously: Janssen's psoriasis candidate guselkumab tops Humira in late-stage study (Oct. 3)
    | Tue, Nov. 15, 9:55 AM | 2 Comments
  • Sun, Nov. 13, 8:33 PM
    • Results from three Phase 2 clinical trials assessing Merck's (NYSE:MRK) MK-3682B (MK-3682/grazoprevir/ruzasvir) for the treatment of chronic hepatitis C virus (HCV) infection showed virologic cure (SVR12) rates as high as 100%. The data were presented at The Liver Meeting 2016 in Boston, MA.
    • In patients with HCV genotypes 1a, 1b, 2 and 3 treated with MK-3682B with and without ribavirin (RBV) for eight weeks, the cure rates were 93% (n=39/42); 98% (n=45/46); 86% (n-54/63) and 95% (n=98/103), respectively.
    • The same categories of patients treated with MK-3682B with/without RBV for 12 weeks showed cure rates of 98% (n=47/48); 100% (n=40/40); 97% (n=60/62) and 97% (n=155/159), respectively.
    • In HCV genotypes 2 and 3 treated with MK-3682B with/without RBV for 16 weeks, the cure rates were 100% (n=26/26) and 96% (n=72/75), respectively.
    • In the HCV-3 cohorts, 28%, 36% and 81% of the 8-week, 12-week and 16-week groups, respectively, were previously treated with peginterferon/RBV.
    • The most common adverse events (AEs) in patients receiving at least one dose of MK-3682B with/without RBV were headache (22%), fatigue (19%) and nausea (13%). There were two serious treatment-related AEs, both attributed to RBV only. There were nine discontinuations due to AEs, four from RBV only. One patient died due to AEs unrelated to the study drug.
    • MK-3682B is a fixed-dose combination of an NS5B polymerase inhibitor (MK-3682), an NS3/4A protease inhibitor (grazoprevir) and an NS5A inhibitor (ruzasvir).
    • Clinical development of MK-3682B is ongoing.
    • Related tickers: (NASDAQ:GILD)(NYSE:ABBV)(NYSE:JNJ)
    | Sun, Nov. 13, 8:33 PM | 50 Comments
  • Sat, Nov. 12, 5:00 PM
    • Johnson & Johnson (NYSE:JNJ) says experimental sirukumab treatment for rheumatoid arthritis showed mixed results against AbbVie (NYSE:ABBV) top-selling Humira in a large trial.
    • By one measure, patients with moderate to severe disease who took sirukumab showed significantly greater improvement in the Phase III study than those taking Humira. But another comparison showed no significant benefit of one drug over the other.
    • Results of the study were reported today at the annual meeting of the American College of Rheumatology in Washington.
    • Humira, and other older medicines such as Amgen (NASDAQ:AMGN) Enbrel and J&J's Remicade, works by blocking a protein called tumor necrosis factor ("TNF") that is involved in inflammation. Sirukumab is a member of an emerging new class of treatments that work instead by blocking IL-6, another protein involved in the inflammation process.
    • Source
    | Sat, Nov. 12, 5:00 PM | 4 Comments
  • Fri, Nov. 11, 1:10 PM
    • As expected, the European Commission approves the use of Janssen's (JNJ -0.9%) STELARA (ustekinumab) for the treatment of adults with moderately to severely active Crohn's disease who fail to respond adequately to conventional therapy or a tumor necrosis factor alpha antagonist or are contraindicated for such therapies.
    • The European Medicines Agency's Committee for Medical Products for Human Use (CHMP) adopted a positive opinion backing approval in September.
    • The FDA approved the indication in late September.
    • STELARA's previously approved uses in the EU are plaque psoriasis and psoriatic arthritis.
    | Fri, Nov. 11, 1:10 PM