Tue, Feb. 3, 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.
Fri, Jan. 30, 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).
Thu, Jan. 29, 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.
Thu, Jan. 22, 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 $5B trial to begin Thursday (Nov. 19 2014)
Tue, Jan. 20, 8:44 AM
- Johnson & Johnson (NYSE:JNJ) notable changes in Q4 by segment ($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%).
Tue, Jan. 20, 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.
Tue, Jan. 20, 7:51 AM| 2 Comments
Mon, Jan. 19, 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)
Mon, Jan. 19, 5:30 PM
Mon, Jan. 19, 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)
Fri, Jan. 16, 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)
Thu, Jan. 15, 5:52 PM
- DepoMed (NASDAQ:DEPO) +3.7% AH after agreeing to acquire the U.S. license rights to the painkiller Nucynta from Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals for $1.05B.
- DEPO says it plans to reintroduce the drug, expand its sales force and promote Nucynta for both chronic pain and nerve damage caused by diabetes; DEPO says Nucynta has patent protection until 2022.
- DEPO, which previously projected 2014 sales of $232M-$242M, says the deal will increase its 2014 pro forma net product revenue guidance by ~2.5x.
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Wed, Jan. 14, 8:25 AM
- Ziopharm (NASDAQ:ZIOP) jumps 50% premarket on robust volume in response to its announcement of an exclusive license deal with partner Intrexon (NYSE:XON) (+12%) with The University of Texas MD Anderson Cancer Center covering technology and intellectual property related to non-viral adoptive cellular cancer immunotherapies. The technologies originate from two researchers who have pioneered the design and clinical investigation of chimeric antigen receptor (CAR) T cell therapies for the potential treatment of cancer using non-viral gene integration platforms.
- The two researchers are Laurence Cooper, M.D., Ph.D, professor of pediatrics at MD Anderson who has expertise in immunotherapies and Perry Hackett, Ph.D., professor within the College of Biological Sciences at Minnesota, who discovered and developed a system called Sleeping Beauty, a non-viral DNA plasmid-based gene transfer system.
- The deal brings the CAR-T technology together Intrexon's technology suite and Ziopharm's clinically tested RheoSwitch Therapeutic System interleukin-12 modules. Up to five CARs are expected to enter the clinic this year and off-the-shelf programming initiating in 2016.
- Under the terms of the agreement, MD Anderson will receive $100M from the companies in the form of $50M of common stock from each firm. In addition, the companies have committed $15M - 20M over each of the next three years for researching and developing the technologies.
- CAR-T therapies are the "next big thing" in cancer treatment.
- Related tickers: (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:AMGN) (NYSE:NVS) (NYSE:JNJ)
Tue, Jan. 13, 8:24 AM
- Janssen Biotech (NYSE:JNJ) enters into a license agreement with Vedanta Biosciences for the development and commercialization of VE202, a human microbiome modulator, that has demonstrated efficacy in preclinical models of autoimmune disease. Janssen will focus on the indication of inflammatory bowel disease (IBD).
- Under the terms of the agreement, Vedanta will receive an upfront payment and various milestones potentially up to $241M plus additional consideration related to commercialization. Vedanta may continue to explore other indications and licensing deals. Janssen may elect to expand its work into new areas under terms similar to the IBD indication.
Mon, Jan. 12, 9:46 AM
- Hospira (HSP) submits its Biologics License Application (BLA) to the FDA for Retacrit, a biosimilar to Amgen's (AMGN +1.3%) Epogen (epoetin alfa) and Janssen's (JNJ +0.5%) Procrit (epoetin alfa). The submission was actually made on December 16 under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009.
- Last week, an FDA advisory committee voted in favor of the approval of Sandoz's BLA for its biosimilar to Amgen's Neupogen (filgrastim).
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
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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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