Tue, Feb. 9, 8:07 AM
- EPIRUS Biopharmaceuticals (NASDAQ:EPRS) commences its pivotal Phase 3 clinical trial, called UNIFORM, to demonstrate the bioequivalence of BOW015 to J&J's (NYSE:JNJ) Remicade (infliximab) in rheumatoid arthritis (RA). The 58-week, double-blind, one-to-one randomized, comparator-controlled study will be conducted across sites in the U.S., Europe and Latin America. The primary endpoint is the proportion of patients achieving ACR20 (20% improvement in RA symptoms) at Week 16.
- The company plans to file global marketing applications in 2017 based on 30-week data.
Mon, Feb. 8, 8:17 PM
- Genco, the logistics company bought by Fedex (FDX -1.2%) for $1.4B in 2014, is taking over operations from a Johnson & Johnson (JNJ +1.5%) distribution center.
- The changeover will begin in April. J&J Health Care Systems founded its Memphis Logistics Center in 2003 at at 770,000-square-foot location. The center distributes medical device and diagnostic equipment.
- Some 450 full-time workers are employed at the center, and the move will include employee changes; "some job actions" were taken last week, a spokeswoman says, but "a vast majority of the employees at our Memphis Distribution Center received offers of employment from Genco."
Fri, Feb. 5, 9:49 AM
- The FDA's Arthritis Advisory Committee will meet on Tuesday, February 9 to discuss and review the Biologics License Application (BLA) from Incheon, Korea-based Celltrion seeking clearance of its biosimilar to Janssen's (JNJ -2.9%) Remicade (infliximab).
- Based on a quick review of the FDA's document, it appears that Celltrion's application has the necessary data proving bioequivalence.
- Remicade is J&J's top seller, generating almost $6.6B in sales over the past four quarters.
- Draft questions
- FDA briefing doc
- Celltrion briefing doc
Tue, Feb. 2, 9:00 AM| Tue, Feb. 2, 9:00 AM
- January monthly performance was: -3.31%
- 52-week performance vs. the S&P 500 is: -2%
- $0.10 in dividends were paid in January
- Top 10 Holdings as of 12/31/2015: Exxon Mobil Corporation (XOM): 3.35%, AT&T Inc (T): 3.15%, Microsoft Corp (MSFT): 3.11%, Apple Inc (AAPL): 2.84%, Verizon Communications Inc (VZ): 2.5%, General Electric Co (GE): 2.36%, Johnson & Johnson (JNJ): 2.21%, Chevron Corp (CVX): 2.2%, Wells Fargo & Co (WFC): 2.06%, Procter & Gamble Co (PG): 1.93%
Mon, Feb. 1, 10:57 AM
- Aduro Biotech (ADRO +1%) earns $22.4M in clinical development milestone payments from Janssen Biotech (JNJ -0.9%) related to ADU-214, AQDU-7412 and other products utilizing Aduro's LADD technology platform for the treatment of certain cancers.
- LADD (live-attenuated double-deleted) Listeria monocytogenes are strains of bacteria that are engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T-cell-mediated immunity.
- The companies inked their initial agreement in May 2014 and expanded it five months later.
- Previously: Aduro Biotech on deck for IPO (April 6, 2015)
Thu, Jan. 28, 4:27 AM
- Artisan Partners, a major shareholder in Johnson & Johnson (NYSE:JNJ), is urging several activists to pressure the consumer products giant to consider major changes at the company.
- The demands include separating J&J's three divisions - consumer products, pharmaceuticals and medical devices - into standalone units, replacing board members, and reviewing standards for executive pay and financial reporting,.
Wed, Jan. 27, 9:23 AM
- Thinly traded micro cap TransEnterix (NYSEMKT:TRXC) is up 22% premarket on robust volume as investors buy in anticipating improved prospects for the firm, including the potential for a takeover by companies aiming for a piece of the surgical robot pie, like Johnson & Johnson (NYSE:JNJ).
- In yesterday's earnings call, JNJ Chief Alex Gorsky said his company will be very active in the device arena going forward.
- TransEnterix is preparing to launch its CE-Mark'd Alf-X system in Europe and is in the process of securing 510(k) clearance in the U.S. for its Surgibot system. According to chief Todd Pope, Alf-X has many features that Intuitive Surgical's (NASDAQ:ISRG) da Vinci system lacks, such as eye-tracking software and haptic feedback which enables surgeons to regain the sense of touch and pressure feedback that they give up when using da Vinci. The single-port Surgibot system allows the surgeon to be in the sterile field which means he/she can stand beside the patient rather than behind a console. It also features a combination of reusable and disposable instruments.
Tue, Jan. 26, 9:42 AM
- Ness Ziona, Israel-based Mapi-Pharma (MAPI) is set for its IPO of 3.125M ordinary shares at $15 - 17.
- The clinical stage firm develops improved extended-release formulations of existing drugs which it refers to as product life cycle management or LCM. Its LCM products offer advantages over currently marketed versions such as improved patient compliance and reduced side effects while allowing for extended patent and regulatory exclusivity.
- Lead product candidates include a once-monthly injection formulation (glatiramer acetate depot) of Teva Pharmaceutical Industries' (TEVA -0.3%) COPAXONE (glatiramer acetate) which is dosed 3x/week; an extended-release formulation (pregabalin ER) of Pfizer's (PFE +0.1%) LYRICA (pregabalin)(dosed 2-3 times per day) and a once-monthly depot formulation of J&J's (JNJ +1.8%) RISPERDAL CONSTA (risperidone) which is administered once every two weeks.
- 2015 Financials (9 mo.)($M): Collaboration revenue: 0.6 (+999%); Operating Expenses: 4.5 (-16.6%); Net Loss: (6.3) (-120.0%); Cash Burn: (0.6) (+86.6%).
Tue, Jan. 26, 7:24 AM
- Johnson & Johnson (NYSE:JNJ) Q4 results ($M): Total Revenues: 17,811 (-2.4%); Consumer: 3,320 (-7.9%); Pharmaceutical: 8,064 (+0.8%); Medical Devices & Diagnostics: 6,427 (-3.3%).
- Revenues by region: U.S.: 9,293 (+8.0%); Europe: 4,002 (-12.2%); W. Hemisphere ex-U.S.: 1,442 (-19.1%); Asia Pacific & Africa: 3,074 (-7.1%).
- Sample of sales by product/segment: OTC: 1,045 (-2.6%); Remicade: 1,680 (+0.5%); Orthopedics: 2,423 (-0.7%); Surgery: 2,413 (-2.5%); Stelara: 742 (+36.1%).
- Net Income: 3,215 (+27.5%), EPS: 1.15 (+29.2%); Non-GAAP Net Income: 4,043 (+11.9%); Non-GAAP EPS: 1.44 (+5.1%).
- 2016 Guidance: Revenues: $70.8 - 71.5B; Non-GAAP EPS: $6.43 - 6.58.
Tue, Jan. 26, 6:46 AM
- Johnson & Johnson (NYSE:JNJ): Q4 EPS of $1.44 beats by $0.02.
- Revenue of $17.81B (-2.4% Y/Y) misses by $70M.
Mon, Jan. 25, 5:30 PM
Thu, Jan. 21, 5:31 PM
- Johnson & Johnson (NYSE:JNJ) has stopped trials of a drug it's developing that's similar to the one made by Portugal's Bial that left a person brain dead and five others hospitalized with serious disorders in France.
- The company's Janssen unit has suspended two mid-stage international trials and says it hasn't received reports of serious adverse events in its studies.
- Bial's disastrous drug trial involved some 90 people taking a drug targeted at mood and anxiety issues. All trials of that drug have been suspended, French officials said.
- The drug in question in both Bial's and Janssen's trials uses an FAAH inhibitor, targeting the body's endocannabinoid system.
- J&J was studying patients with social anxiety disorder and major depressive disorder with anxious distress; it will gather more information and re-evaluate.
Thu, Jan. 21, 9:56 AM
- Regulus Therapeutics (RGLS -4.2%) announces that enrollment is now complete in its Phase 2 clinical trial assessing the combination of RG-101 with multiple approved direct-acting antivirals [Gilead's HARVONI (ledipasvir/sofosbuvir), J&J's OLYSIO (simeprevir), Bristol-Myers' Daklinza (daclatasvir)] in treatment-naive patients with HCV infection, genotypes 1 or 4.
- 78 patients have been randomized to receive a single subcutaneous injection of 2mg/kg of RG-101 followed by 28 days of once-daily oral antivirals (one of the three) followed by another subcutaneous injection of 2 mg/kg of RG-101 on Day 29. Interim results should be available in mid-February. Primary endpoint results (SVR12) should be announced in late Q2.
- The company says its ultimate goal is to develop a single-visit combination therapy for HCV infection.
- Related tickers: (GILD -0.9%)(ABBV +0.7%)(MRK -0.3%)(JNJ -1.1%)(BMY -0.9%)
Tue, Jan. 19, 4:51 PM
- Privately-held Eiger BioPharmaceuticals completes enrollment in a Phase 2 clinical trial assessing three (50 mg, 75 mg, 100 mg) once-daily doses of Sarasar (lonafarnib), in combination with 100 mg of ritonavir [AbbVie's (NYSE:ABBV) NORVIR] once daily, in patients with chronic hepatitis delta (HDV) infection. The study consists of 24 patients with four placed in one of six treatment groups: three dosage arms for 12 or 24 weeks. Enrollment was completed in less than four months.
- Lonafarnib inhibits an enzyme called farnesyltransferase, which plays a key role in the modification of proteins in a process called prenylation. HDV uses this host cell process inside liver cells to complete an essential step in its life cycle. Lonafarnib blocks the cycle at the assembly stage, which may present a higher bar for the virus to develop resistance to therapy. It is designated an Orphan Drug in the U.S. and Europe and tagged for Fast Track review by the FDA.
- HDV, occurring only as a co-infection with HBV, represents one of the most pernicious forms of viral hepatitis. It causes more severe liver disease than HBV alone and is associated with more rapid liver fibrosis (scarring), liver cancer and liver failure. As many as 15M people worldwide are HDV-positive. It is particularly prevalent in Mongolia and Pakistan (as many as 60% of the HBV cases).
- Hepatitis-related tickers: (NASDAQ:GILD)(NYSE:MRK)(NYSE:JNJ)(NYSE:BMY)
Tue, Jan. 19, 8:21 AM
- With the aim of beefing up its performance, Johnson & Johnson (NYSE:JNJ) restructures its Medical Device businesses, exclusive of Vision Care and Diabetes Care. The initiative is expected to save $800M - 1B in pre-tax costs per year by 2018, including $200M this year, while accelerating its pace of innovation and strengthening its go-to-market model.
- The company will book restructuring charges of $2.0B - 2.4B, most of which will be incurred by 2017 ($600M will be recorded in Q4 2015).
- The actions will result in the elimination of 4 - 6% of the Medical Devices global workforce over the next two years.
- On a reporting basis, Medical Devices will be structured as follows:
- Diabetes (no change)
- Diagnostics (no change)
- Orthopaedics: Hips, Knees, Trauma, Spine & Other
- Surgery: Advanced, General, Specialty
- Vision Care (no change)
Thu, Jan. 7, 10:06 AM
- Johnson & Johnson's (JNJ -1.1%) Innovation unit and Sino Biopharma subsidiary Chia Tai Tianqing Pharmaceutical Group enter an exclusive license agreement to develop, manufacture and commercialize (outside of China) undisclosed immune-modulating agents to treat a range of human diseases, including curative treatment for chronic hepatitis B infection. Addition details, including financial terms, are not provided.
- Johnson & Johnson Innovation provides entrepreneurs and emerging companies with one-stop access to J&J's broad range of resources across its businesses, including access to dealmakers.
Johnson & Johnson operates as an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company, through its subsidiaries operates in three... More
Industry: Drug Manufacturers - Major
Country: United States
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