Mon, Apr. 13, 6:29 PM
- Looking to grab a bigger chunk of a burgeoning healthcare analytics market by offering more industry-specific solutions, IBM is buying Phytel, a provider of cloud-based patient data aggregation/analysis software, and Explorys, provider of a massive clinical database (said to consist of 315B datapoints) and a slew of analytics apps that run on top of them. Terms are undisclosed.
- IBM declares Phytel will help it give healthcare providers "insights into patient health from data about patient behaviors and their engagement with care plans," and that Explorys will "accelerate the delivery of IBM Health Cloud and IBM Watson cognitive solutions to model and apply medical evidence and large scale analytics to data."
- Both companies are being added to a new Watson Health unit based out of Boston. The business aims to provide software/services that can surface insights from large volumes of anonymous personal health data. As part of the effort, Big Blue is launching Watson Health Cloud, a platform that allows this data to be "anonymized, shared and combined with a dynamic and constantly-growing aggregated view of clinical, research and social health data."
- IBM's partnership with Apple (NASDAQ:AAPL) has been expanded to cover Apple's HealthKit (health/fitness data) and ResearchKit (medical research) frameworks, via Watson and Health Cloud. The latter will provide a data storage/aggregation platform for iOS apps using HealthKit and ResearchKit. In addition, IBM will "build a suite of enterprise wellness apps using HealthKit."
- Also: 1) IBM is partnering with Medtronic (NYSE:MDT) to create diabetes management solutions that pair Medtronic's devices (and the data they produce) with IBM's analytics and cognitive computing tools. 2) IBM is partnering with Johnson & Johnson (NYSE:JNJ) to "create intelligent coaching systems centered on preoperative and postoperative patient care, including joint replacement and spinal surgery."
Mon, Apr. 13, 5:30 PM
Mon, Apr. 13, 9:28 AM
- Privately-held Ichor Medical Systems and Janssen Pharmaceuticals (NYSE:JNJ) enter into a product development collaboration and worldwide license agreement to develop and commercialize DNA-based vaccine products for the treatment of chronic hepatitis B infection utilizing Ichor's drug administration-boosting TriGrid electroporation technology.
- Electroporation is a molecular biology technique in which an electrical field is applied to cells in order to increase the permeability of the cell membranes thereby facilitating the introduction of drugs into the cells.
- Ichor's TriGrid Delivery System increases DNA drug delivery up to 1,000x compared to conventional injection.
- Under the terms of the agreement, Ichor will receive an upfront payment, R&D support and development and sales milestones of up to $85M in addition to royalties on commercial sales of licensed products. Janssen will assume responsibility for certain development costs and all commercial costs associated with the partnership, including manufacturing and distribution expenses for TriGrid.
Thu, Apr. 9, 10:42 AM
- A 63-subject Phase 2 study evaluating Pharmacyclics' (PCYC -0.1%) Imbruvica (ibrutinib) in patients with the blood cancer Waldenstrom's macroglobulinemia (WM) showed an overall response rate (ORR) of 91% after a median of 19.1 months of treatment and a two-year overall survival (OS) rate of 95% in a group of difficult-to-treat patients. Trial participants had received an average of two prior therapies and 40% were non-responsive to the prior treatments.
- Imbruvica, jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ +0.7%), is a Bruton's tyrosine kinase (BTK) inhibitor approved for certain lymphocytic leukemia patients, mantle cell lymphoma and WM.
- Waldenstrom's macroglobulinemia is a type of non-Hodgkin lymphoma in which cancer cells make large amounts of a certain type of antibody, immunoglobulin M, that accumulates in the blood.
Wed, Apr. 8, 10:38 AM
- A Phase 3 trial, called ANNEXA-A, evaluating Portola Pharmaceuticals' (PTLA +2.7%) andexanet alfa as an antidote to the anticoagulant Factor Xa inhibitor Eliquis (apixaban) successfully achieved all primary and secondary endpoints with high statistical significance. Andexanet alfa produced rapid reversal of the anticoagulant effect of apixaban which was sustained for the duration of the infusion in healthy volunteers. Patients on anticoagulant therapy sometimes need a reversal agent in situations that present a risk of difficult-to-control bleeding, such as surgery or trauma.
- The company plans to submit the data from ANNEXA-A and ANNEXA-R (rivaroxaban) and initial data from a Phase 4 study as part of its Biologics License Application (BLA) to the FDA under an accelerated approval pathway by the end of this year.
- Eliquis is marketed by Bristol-Myers Squibb (BMY +0.7%) and Pfizer (PFE +0.3%). Rivaroxaban is marketed under the brand name Xarelto by Janssen (JNJ -0.1%).
Mon, Apr. 6, 1:23 PM
- Berkeley, CA-based Aduro Biotech (Pending:ADRO) is set for its IPO of 5M shares of common stock at $14 - 16.
- The clinical stage company develops technology platforms designed to stimulate strong immune responses against cancer. Its strategy aims to combine its technology platforms with immuno-oncology therapies based on their mechanisms of action, safety profiles and versatility.
- Its two proprietary platforms are based on Live, Attenuated, Double-Deleted ((LADD)) Listeria monocytogenes and cyclic dinucleotides (CDNs). The firm's lead LADD product candidate is Breakthrough Therapy-designated CRS-207 (in combination with the cellular vaccine GVAX) for the treatment of metastatic pancreatic cancer and unresectable (can't be removed surgically) malignant pleural mesothelioma. CRS-207 is also an Orphan Drug for both indications. A Phase 2a trial comparing the combination of CRS-207 with GVAX to GVAX alone was stopped based on the recommendation of the Data Monitoring Committee after an interim analysis showed the study met its primary efficacy endpoint of overall survival.
- The company is collaborating with Janssen Biotech (JNJ -0.2%) on two proprietary product candidates and with Novartis (NVS +0.7%) on CDN candidates, led by ADU-S100 for palpable tumors.
- 2014 Financials ($M): Operating Expenses: 32.5; Net Loss: (17.0); Cash Burn: (19.4).
Mon, Mar. 30, 8:00 AM
- The European Medicines Agency (EMA) validates (accepts for review) the Marketing Authorization Application (MAA) for SB2, Biogen's (NASDAQ:BIIB) biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). The MAA was submitted by the firm's joint venture partner, Samsung Bioepis. This is the second MAA accepted for review by the European regulator. It validated the MAA for SB4, a biosimilar to Amgen's (NASDAQ:AMGN) Enbrel (etanercept), earlier this year.
- Both SB2 and SB4 will be manufactured at Biogen's Hillerod, Denmark facility, once approved.
Fri, Mar. 27, 9:54 AM
- Johnson & Johnson (JNJ +0.5%) and Google (NASDAQ:GOOG) establish a collaboration to develop a robotic-assisted surgery program. Terms are not disclosed.
- J&J Chairman Gary Pruden says, "This collaboration with Google is another important step in our commitment to advancing surgical care."
- Robotic-assisted surgery, led by Intuitive Surgical (ISRG) with its da Vinci systems, is forecasted to grow at a double-digit rate through at least 2020, according to iData Research.
Mon, Mar. 23, 7:30 AM
- With a shortened name and new logo, Biogen (NASDAQ:BIIB) is entering a high risk-high return phase of its corporate life. CEO George Scangos, on board since 2010, is leading the firm into several difficult-to-treat areas in neurodegenerative diseases like Alzheimer's (AD), ALS and spinal muscular dystrophy. It won't take but one or two successes for the payoff to be huge.
- Shares jumped on Friday after the company announced positive Phase 1b results for its Alzheimer's candidate, BIIB037 (aducanumab). If the Phase 3, due to start later this year, is successful it could be the largest selling drug in history. As many as 75M people could be living with AD by 2030.
- Mr. Scangos says, "The future looks pretty exciting for us. If the Alzheimer's thing works, then we're not just an MS (multiple sclerosis) company. We are broadly focused on neurodegenerative diseases. Five years down the road, with some luck, we'll have an Alzheimer's drug that's getting approved. I hope we can transform the treatment of MS. By that time, we will have made substantial progress on ALS and nerve degenerative diseases, spinal muscular dystrophy in kids. All that stuff is on our plate. I am sure of two things, not all it is going to work, but some of it will."
- The company is also working on biosimilars to Amgen's (NASDAQ:AMGN) Enbrel (etanercept) and J&J's (NYSE:JNJ) Remicade (infliximab).
Fri, Mar. 20, 3:56 PM
- Following up on its December announcement about its comparative clinical trial evaluating Cosentyx (secukinumab) versus Janssen's (JNJ +0.7%) Stelara (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis, Novartis (NVS +1.8%) presented more detailed data from the study during a research session at the American Academy of Dermatology meeting in San Francisco.
- Cosentyx showed superiority to Stelara as measured by the proportion of patients achieving a PASI 90 score (subjective improvement of 90%) at Week 16 (79.0% vs. 57.6%; p<0.0001). On the basis of PASI 100 score (completely clear skin), the results also favored Cosentyx (44.3% vs. 28.4%; p<0.0001). In addition, the proportion of patients achieving PASI 75 by Week 4 was 50.0% vs. 20.6%; p<0.0001) in favor of secukinumab.
- Secukinumab is a human monoclonal antibody that inhibits interleukin-17A, a protein found in high concentrations in psoriatic skin. Both the FDA and European Commission (EC) cleared it for the indication in January.
- Previously: Novartis' Cosentyx beats Stelara in Phase 3 trial (Dec. 12, 2014)
Thu, Mar. 19, 10:59 AM
- Janssen Pharmaceuticals (JNJ +0.2%) acquires the anti-thrombin antibody, ichorcumab, by buying XO1 Limited, a privately-held asset-centric virtual biopharmaceutical company founded by venture capital firm Index Ventures. Financial terms of the transaction are not disclosed.
- The antibody was initially developed by England's Cambridge University and Cambridge University Hospitals with the support of its commercialization arm, Cambridge Enterprise who, in turn, licensed it to X01 Limited.
- X01 Limited was established via a fund launched in 2012 by Index Ventures, in which Johnson & Johnson Innovation is an investor.
- Ichorcumab is a recombinant human antibody that mimics the activity of a human antibody that appears to produce an anticoagulated state without predisposition to bleeding.
Tue, Mar. 17, 7:58 AM
- Galapagos NV (OTC:GLPGF) (OTCPK:GLPYY) and Janssen Pharmaceutica NV (NYSE:JNJ) mutually agree to terminate their inflammation alliance and option agreements, a partnership that began in 2007. Galapagos regains the rights to GLPG1690, a selective autotaxin inhibitor currently in Phase 2 development for the treatment of ideopathic (cause unknown) pulmonary fibrosis.
- In December, the companies ended their collaboration in ulcerative colitis, with Galapagos regaining full rights to the GPR84 program, including GLPG1205 and GLPG2196. The original deal had a potential value of $1B+ for Galapagos.
Mon, Mar. 16, 8:50 PM
- A pre-planned interim analysis of the Phase 3 HELIOS study evaluating Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) showed the trial met is primary efficacy endpoint of a statistically significant improvement in progression-free survival (PFS). An Independent Data Monitoring Committee has recommended that the study be unblinded and patients receiving placebo plus BR be offered the option to receive Imbruvica.
- Bendamustine is a nitrogen mustard used to treat CLL. Rituximab (Biogen Idec's Rituxan) is a CD20-directed monoclonal antibody. CD20 is a protein found on the surface of B cells.
- HELIOS is the second randomized study to demonstrate that treatment with Imbruvica significantly improved PFS in CLL or SLL. The Phase 3 RESONATE trial showed similar results for Imbruvica as monotherapy compared to ofatumumab (Glaxo's Arzerra).
- Imbruvica is being co-developed and commercialized by Janssen Biotech (NYSE:JNJ) and Pharmacyclics (NASDAQ:PCYC).
- AbbVie (NYSE:ABBV) is undoubtedly appreciative of the encouraging results.
Wed, Mar. 11, 9:27 AM
- Johnson & Johnson's (NYSE:JNJ) McNeil consumer products business agrees to pay $25M to settle a U.S. government probe into a Pennsylvania-based facility that recalled Tylenol and other OTC medicines several years ago due to quality lapses. Under the terms of the settlement agreement, McNeil pleads guilty to a misdemeanor violation and accepts responsibility for the inadequate filing of required documents during the manufacturing process. It will pay a $20M criminal fine and forfeit $5M.
- The Fort Washington, PA plant was shut down in 2010 and has yet to reopen. Problems included excessive concentrations of active ingredients and musty-smelling products. The recalls included Zyrtec and Benadryl, in addition to Tylenol.
- McNeil's remaining U.S. facilities continue to operate, although under a 2011 permanent injunction.
Tue, Mar. 10, 3:51 PM
- Traders spread their love beyond the rumored acquisition target-stoked up move of Acadia Pharmaceuticals (ACAD +17.7%) to Geron (GERN +12.3%). Shares are up on a whopping 24M shares. Speculators are betting that Geron will be taken out, possibly by Johnson & Johnson (JNJ -0.8%), after the latter was outbid by AbbVie (ABBV +0.9%) for Pharmacyclics (PCYC).
- Previously: Geron gets boost from AbbVie-Pharmacyclics deal (March 5)
- Previously: Acadia Pharma now +17.7% as it cancels out of another conference (March 10)
Tue, Mar. 10, 1:23 PM
- Copenhagen, Denmark-based Genmab A/S plans to start a Phase 1 study of a subcutaneous formulation of its monoclonal antibody, daratumumab, that utilizes Halozyme Therapeutics' (HALO +0.9%) Enhanze technology.
- Daratumumab, being developed under a collaboration between Genmab and Janssen Biotech (JNJ -0.6%), binds to CD38 which is highly expressed on the surface of multiple myeloma cells.
- Cancer immunotherapeutics are typically slowly infused intravenously into patients in order to minimize their side effects while delivering therapeutic doses of medicine. Halozyme's Enhanze, based on its recombinant human hyaluronidase enzyme (rHuPH20), has demonstrated that it can remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). This has the potential to significantly simplify and shorten the process of drug administration.
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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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