Tue, Mar. 3, 7:25 AM
- Privately-held Boehringer Ingelheim files applications for marketing approval in the U.S., Europe and Canada for idarucizumab, a rapid reversal agent for its anticoagulant, dabigatran, the active ingredient in Pradaxa, a prescription blood thinner.
- The FDA designated idarucizumab a Breakthrough Therapy in June of last year. The company will pursue accelerated reviews with all three regulators.
- Blood thinner-related tickers: (NYSE:JNJ) (OTCPK:BAYRY) (NYSE:PFE) (NYSE:BMY)
Mon, Mar. 2, 8:55 AM
- As rumored, Johnson & Johnson (NYSE:JNJ) sells its underperforming Cordis unit to Cardinal Health (NYSE:CAH), which picks up the interventional vascular technology business for $1.99B. The transaction is expected to close by end of the year.
- Both stocks are unchanged premarket.
- Previously: J & J rumored to have found a buyer for Cordis unit (Feb. 23)
Thu, Feb. 26, 6:15 PM
- UnitedHealth (NYSE:UNH) has tightened its controls on hysterectomy coverage -- requiring doctors to get pre-approval from the insurer before performing most types of the procedure.
- Only outpatient vaginal hysterectomies (a small minority) won't require approval -- but the overall insurance trend is for more pre-authorizations for care, and hysterectomies are one of the most common surgeries for American women.
- It's also another hit to the laparoscopic power morcellator -- which uses spinning blades to break up tissue through small incisions. The FDA started warning against using the devices last year, and many hospitals have banned them, as they can spread a dangerous uterine cancer.
- Johnson & Johnson (NYSE:JNJ) started removing its morcellators from the market last summer.
Wed, Feb. 25, 4:47 PM
- The FDA's Arthritis Advisory Committee postpones its March 17 meeting due to pending information requests with sponsor Celltrion. This is a setback for the South Korean biopharmaceutical firm since it was expecting a positive vote on its biosimilar to Janssen Biotech's (NYSE:JNJ) Remicade (infliximab). The pan-European launch is just getting underway.
- Previously: Remicade biosimilars launched in Europe (Feb. 25)
Wed, Feb. 25, 1:43 PM
Wed, Feb. 25, 7:36 AM
- The long-anticipated major debut of biosimilars is underway in Europe. South Korean biopharmaceutical firm Celltrion's biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab) will be launched in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden under the brand name Inflectra by commercial partner Hospira (NYSE:HSP) (NYSE:PFE) and in Germany, Italy, Britain, the Netherlands, Belgium and Luxembourg under the brand name Remsima by privately-held Indian drug firm Mundipharma.
- Biosimilars to Remicade have been available in certain smaller markets in Europe for several months, but this is the first move into major markets so the results will closely watched from the global biotech industry.
- Remicade generated almost $6.9B in sales for J&J the past four quarters, including ~$2.3B in Europe.
- Remsima was approved by the European Medicines Agency in 2013. The FDA's Arthritis Advisory Committee will meet on March 17 to discuss Celltrion's biologics license application (BLA) for clearance in the U.S.
Mon, Feb. 23, 4:18 PM
- It appears that Johnson & Johnson (NYSE:JNJ) may have found a buyer for its underperforming Cordis business, something it's been seeking since August. Cardinal Health (NYSE:CAH) is rumored to be the front-runner for the medical device company.
- Cordis is the second largest unit within J&J, but it was the worst performing last year with a 3.5% decline in sales despite being the pioneer of drug-coated stents and the former market leader. The company was unable to maintain its leadership due to formidable competition and downward price pressure from insurers and hospitals.
- The company expects Cordis to fetch $1.5B - 2.0B.
Mon, Feb. 23, 11:04 AM
- The FDA's Orthopedic and Rehabilitation Devices Advisory Panel votes 5 -1 (2 abstain) that VertiFlex's Superion Interspinous Spacer System is safe and 4 -2 (2 abstain) that the risk-benefit profile is adequate.
- The FDA does not have to abide by the vote in its final decision, but it usually follows the committee's recommendation.
- Related tickers: (ABT -0.2%)(MDT +0.3%)(JNJ +0.2%)
- Previously: Ad Comm review approaches for Vertiflex spinal implant (Feb. 18)
Fri, Feb. 20, 5:56 PM
- Bloomberg reports Johnson & Johnson (NYSE:JNJ) is exploring the sale of its Cordis medical device unit to Cardinal Health (NYSE:CAH) for as much as $2B.
- The WSJ reported last August J&J is seeking a buyer for Cordis, whose products include stents, guidewires, and catheters, and that it could get $1.5B-$2B for the business.
- CAH +1.5% AH to $88.34.
Fri, Feb. 20, 7:15 AM
- The World Health Organization (WHO) approves the use of a 15-minute point-of-care test developed by Corgenix Medical (OTCQB:CONX) to detect the presence of the Ebola virus. The company developed the assay with funding assistance of the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.
- Procurement and roll-out in Africa will begin in a few weeks pending the completion of administrative procedures with the U.S. FDA.
- Ebola-related tickers: (NYSE:MRK) (NASDAQ:NLNK) (NYSEMKT:IBIO) (NASDAQ:NVAX) (NYSE:GSK) (NYSE:JNJ) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:BCRX) (NASDAQ:SRPT) (NASDAQ:CMRX) (NASDAQ:ABIO) (OTCQB:AEMD) (OTCPK:BVNRY) (NASDAQ:INO) (OTCQX:RHHBY)
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Wed, Feb. 18, 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)
Tue, Feb. 17, 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.
Thu, Feb. 12, 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)
Thu, Feb. 12, 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%)
Wed, Feb. 11, 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
JNJ vs. ETF Alternatives
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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