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Feb. 18, 2015, 1:54 PM
- The FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meets Friday, February 20 to discuss the Premarket Approval Application (PMA) from privately-held San Clemente, CA-based VertiFlex for its Superion InterSpinous Spacer for the treatment of moderate lumbar stenosis (narrowing of the openings for the spinal cord and nerve roots).
- The device, CE marked in Europe since 2007, alleviates back pain via insertion in the lumbar area which decompresses the spine and relieves the pressure. Its value proposition is a one-piece expandable, reversible and motion preserving implant that is easily inserted via a small incision in the back under local anesthesia in the outpatient setting.
- Executive Summary, Panel Questions
- Related tickers: (NYSE:ABT) (NYSE:MDT) (NYSE:JNJ)
Feb. 17, 2015, 5:58 PM
- Boston Scientific (NYSE:BSX) +11.8% AH after settling the $7.2B lawsuit brought by Johnson & Johnson (NYSE:JNJ) for $600M, ending litigation that has nagged BSX since its 2006 acquisition of Guidant.
- JNJ had sought damages after accusing Guidant of breaching their merger agreement by going with the higher offer from BSX.
- BSX says it admits no liability in the settlement, and will record a $600M charge in its Q4 2014 financial results.
Feb. 12, 2015, 1:18 PM
- Novavax (NVAX +1.7%) commences patient enrollment in a Phase 1 clinical trial evaluating the safety, tolerability and pharmacokinetics of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M. The study, being conducted in Australia, involves 230 healthy subjects between the ages of 18 and 50. Each person will receive two intramuscular injections, one on Day 0 and one on Day 21.
- The trial will also evaluate immunogenicity as measured by serum concentrations of IgG antibodies to the Ebola Makona strain glycoprotein.
- According to CEO Stanley C. Erck, the company now has the capability to rapidly scale up manufacturing to produce millions of doses of Ebola vaccine.
- Related tickers: (GSK -1%)(JNJ -1.8%)(OTCPK:BVNRY)(MRK +0.1%)(NLNK +5.3%)
- Previously: Johnson & Johnson announces Ebola vaccine development consortia (Jan. 16)
- Previously: First Glaxo Ebola vaccine to arrive in Liberia (Jan. 23)
Feb. 12, 2015, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Feb. 11, 2015, 3:38 AM
- President Obama is expected to announce plans today to withdraw most of the U.S. troops assigned to combat the Ebola outbreak in West Africa, where they had been deployed to assist with supply logistics, construction and training.
- The return of the troops comes as the number of new infections drops in the region - from 1,000 new suspected, probable and confirmed Ebola cases a week in October to about 150 a week in recent reports.
- Ebola-related stocks: JNJ, GSK, HEB, BCRX, NLNK, NNVC, INO, TKMR -0.5% AH
Feb. 3, 2015, 1:07 PM
- The FDA grants Priority Review for the New Drug Application (NDA) for Janssen Research & Development's (JNJ +0.7%) Yondelis (trabectedin) for the treatment of patients with advanced soft tissue sarcoma (STS). Priority Review status shortens the review clock to six months from the usual ten. The FDA's decision date is, therefore, on or around August 3.
- Trabectadin is a synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. It works by preventing cancer cells from multiplying.
- Yondelis is approved in 77 countries for the treatment of advanced STS as a single agent and in 70 countries for relapsed ovarian cancer in combination with Doxil/Caelyx (doxorubicin HCl liposome injection). It has had a rough time in the U.S., however. The FDA rejected it for the treatment of ovarian cancer in 2009.
Jan. 30, 2015, 7:39 AM
- The FDA approves Janssen's (NYSE:JNJ) Prezcobix (darunavir/cobicistat) for the treatment, in combination with other antivirals, of adults patients with HIV-1 infection. Darunavir is protease inhibitor (sold as a single agent under the brand name Prezista by Janssen) and cobicistat is a CYP3A4 inhibitor (sold as a single agent under the brand name Tybost by Gilead (NASDAQ:GILD) Sciences).
Jan. 29, 2015, 12:22 PM
- The FDA approves the use of Janssen's (JNJ -0.5%) and Pharmacyclics' (PCYC +0.6%) Imbruvica (ibrutinib) for the treatment of patients with Waldenstrom's macroglobulinemia (WM), a rare blood cancer also called lymphoplasmacytic lymphoma.
- Imbruvica is an Orphan Drug for the treatment of WM so it will have a seven-year period of market exclusivity for this indication.
- It is also approved for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma.
Jan. 22, 2015, 3:45 AM
- After lawyers for both companies made final presentations on Wednesday, Johnson & Johnson's (NYSE:JNJ) multibillion-dollar trial with Boston Scientific (NYSE:BSX) over its purchase of device maker Guidant now lies in the hands of a federal judge.
- As Guidant’s successor, J&J is seeking more than $7.2B in damages and interest from Boston Scientific for violating clauses included under their agreement to combine in 2004.
- Previously: J&J, Boston Scientific $5B trial to begin Thursday (Nov. 19 2014)
Jan. 20, 2015, 8:44 AM
- Johnson & Johnson (NYSE:JNJ) notable changes in Q4 by segment ($M):
- Consumer (-3.9%): Women's Health (-11.5%); Baby Care: (-10.4%); Wound Care: (-6.2%).
- Pharmaceutical (+9.6%); Immunology (+7.3%), Simponi/Simponi Aria: 346 (+36.2%), Stelara: 545 (+30.7%), Remicade: 1,672 (-2.3%).
- Infectious Diseases (+13.9%); Olysio/Sovriad: 321 (+999%), Edurant: 90 (+23.3%), Prezista: 448 (-2.8%), Other: 212 (-24.6%), Incivo: 5 (-95.3%).
- Neuroscience: 1,651 (unch); Invega Sustenna/Xeplion: 418 (+19.4%), Invega: 161 (+4.5%), Other: 609 (-7.3%), Risperda Consta: 294 (-8.4%).
- Oncology: 1,212 (+8.9%); Other: 199 (+111.7%), Zytiga: 595 (+20.2%), Velcade: 418 (-20.2%).
- Other: 1,482 (+28.1%), Xarelto: 428 (+57.9%), Other: 752 (+29.9%), Procrit/Eprex: 302 (-1.6%).
- Med Devices & Diag: 6,649 (-9.0%); Specialty Surgery/Other: 904 (+32.4%), Cardiovascular Care: 558 (+4.5%), Orthopedics: 2,441 (-0.6%), Surgical Care: 1,572 (-4.1%), Diabetes Care: 514 (-8.7%), Vision Care: 646 (-10.2%), Diagnostics: 14 (-97.0%).
Jan. 20, 2015, 8:21 AM
- Johnson & Johnson (NYSE:JNJ) Q4 results ($M): Total Revenues: 18,254 (-0.6%), Consumer: 3,606 (-3.9%), Pharmaceutical: 7,999 (+9.6%), Medical Devices & Diagnostics: 6,649 (-9.0%).
- Revenue by region: U.S.: 8,604 (+7.4%), Europe: 4,560 (-8.2%), W. Hemisphere ex. U.S.: 1,782 (-5.8%), Asia Pacific & Africa: 3,308 (-5.0%).
- COGS: 5,853 (-1.7%); R&D Expense: 2,635 (+9.3%); SG&A Expense: 5,822 (-1.6%); Net Income: 2,521 (-28.4%); EPS: 0.89 (-27.6%); Gross Profit: 12,401 (unch); COGS: 32.1% (-1.2%); Gross Margin: 67.9% (+0.6%); Operating Income: 3,944 (-3.1%); Operating Income Yield: 21.6% (-2.6%); Net Earnings Yield: 13.8% (-28.0%).
- 2015 non-GAAP EPS guidance: $6.12 - 6.27.
Jan. 20, 2015, 7:51 AM
- Johnson & Johnson (NYSE:JNJ): Q4 EPS of $1.27 beats by $0.01.
- Revenue of $18.25B (-0.6% Y/Y) misses by $310M.
- Shares -0.04% PM.
Jan. 19, 2015, 5:53 PM
- The FDA grants Priority Review status to Janssen Research & Development's (NYSE:JNJ) New Drug Application (NDA) for a three-month formulation of paliperidone palmitate for the treatment of adult patients with schizophrenia.
- Priority Review provides for a shorter review clock (six months) compared to the normal time frame of 10 months.
- Previously: J&J submits NDA for three-month antipsychotic (Nov. 20, 2014)
Jan. 19, 2015, 5:30 PM
Jan. 19, 2015, 5:11 PM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Cosentyx (secukinumab) as a first-line systemic treatment for adult patients with moderate-to-severe psoriasis. It is the first interleukin-17A inhibitor cleared in Europe.
- Cosentyx is also cleared for sale in Australia and Japan. FDA approval is imminent considering the unanimous positive vote by the Dermatologic and Ophthalmic Drugs Advisory Committee in October.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Jan. 16, 2015, 8:54 AM
- A consortia of global research institutions and non-government organizations has been formed to work with Janssen Pharmaceuticals (NYSE:JNJ) to accelerate the development of its Ebola vaccine. The Innovative Medicines Initiative intends to grant more than €100M to fund the development work. The project is delineated into three areas or topics:
- Topic 1: Vaccine development, Phases 1, 2 and 3. Consortia members: Janssen, London School of Hygiene and Tropical Medicine, Oxford University, Insititut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz.
- Topic 2: Manufacturing capability: Janssen, Bavarian Nordic A/S, Vibalogics.
- Topic 3: Deployment and compliance of vaccination regimens: Janssen, London School of Hygiene and Tropical Medicine, Grameen Foundation, World Vision of Ireland.
- A recently-started Phase 1 trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics. Janssen, in partnership with Bavarian Nordic A/S (OTCPK:BVNRY), has produced more than 400K regimens of the prime-boost vaccine for use in large-scale trials that could begin as early as April.
- Ebola vaccine-related tickers: (NASDAQ:NLNK) (NYSE:MRK) (NYSE:GSK)
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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