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News Breaks
April 23, 2014
06:16 EDTAZN, RHHBY, SNY, BMY, NVS, MRK, LLY, PFE, JNJ, GSKPharmaceutical companies narrowing focus, WSJ reports
After decades of broadening their drug portfolios through acquisitions, the Wall Street Journal reports that pharmaceutical companies are reversing course to focus more narrowly on what they think they can do best. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
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July 22, 2014
05:25 EDTAZNAdams Express, MedImmune announce clinical trial partnership
Advaxis (ADXS) has entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis' lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. Both MEDI4736 and ADXS-HPV are cancer immunotherapies, a new class of treatments that use the body's own immune system to help fight cancer. Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted. Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
05:21 EDTRHHBYRoche announces Genentech Avastin granted priority review by FDA
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July 21, 2014
18:40 EDTJNJOn The Fly: After Hours Movers
UP AFTER EARNINGS: Netflix (NFLX), up marginally after reporting Q2 results... Sanmina (SANM), up 13.2% after reporting third quarter results and fourth quarter guidance above analyst estimates... Chipotle (CMG), up 10.1%... Helix (HLX), up 5.2%... Canadian National (CNI), up 1.13%... CYS Investments (CYS), up 1.7%. ALSO HIGHER: Apache (APA), up 5% after Bloomberg says JANA discloses $1B position... Johnson & Johnson (JNJ), up 1% after announcing a $5B share repurchase program... TG Therapeutics (TGTX), up 4.3% after reporting second quarter results and preliminary clinical results from TG-1101 Phase I study... DOWN AFTER EARNINGS: Rambus (RMBS), down 3.6% after reporting second quarter results... Ultra Clean (UCTT), down 4% after reporting quarterly results. ALSO LOWER: Tallgrass Energy (TEP), down 5% after filing to sell 7M common units representing limited partners.
17:03 EDTJNJJohnson & Johnson announces $5B share repurchase program
Johnson & Johnson announced that its board has approved the repurchase of up to $5B of the company's common stock. The company had approximately 2.82B shares of common stock outstanding as of June 29.
17:01 EDTJNJJohnson & Johnson announces $5B share repurchase program
07:38 EDTNVSNovartis management to meet with JPMorgan
Meetings to be held in Los Angeles/Pasadena on July 24 and in San Francisco on July 25 hosted by JPMorgan.
07:21 EDTMRKGilead could be hurt by new HCV drugs, says Wells Fargo
Noting that data on a new Merck (MRK) HCV treatment is expected in November, Wells Fargo thinks Merck's HCV drug could be combined with Gilead's (GILD) Sovaldi to shorten the duration of treatment to four weeks. Other companies could take similar actions, and Gilead's per patient revenues would be significantly reduced if this occurs, the firm warned. However, it continues to have an upbeat outlook on Gilead heading into what it sees as a strong quarter and is still upbeat on the company's long-term HCV opportunity. It keeps an Outperform rating on Gilead.
07:11 EDTNVS, RHHBY, SNY, GSKInternational Society of DNA Vaccines to hold a conference
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07:03 EDTNVSAnacor, Sandoz enter into agreement for commercialization of Kerydin in the U.S.
Anacor Pharmaceuticals (ANAC) announced that it has entered into an exclusive agreement with Sandoz, a Novartis (NVS) company, pursuant to which Sandoz will distribute and commercialize Anacorís drug KERYDIN topical solution, 5% in the United States. PharmaDerm, the branded dermatology business of Sandoz, will be responsible for the sales and marketing of KERYDIN. On July 8, Anacor announced that the U.S. FDA approved the New Drug Application for KERYDIN, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today. The agreement with Sandoz entitles Anacor to upfront payments totaling $40M and an additional milestone payment of $25M expected to be paid in January 2015. Under the agreement, Sandoz and Anacor will share equally, under a long-term profit-sharing arrangement, the gross profits accrued by Sandoz on sales of KERYDIN, except that in 2015 Anacor will start receiving profit-sharing payments after the first $50M of gross profits have been accrued by Sandoz. The long-term profit-sharing arrangement includes cumulative minimum profit-sharing payments to Anacor in 2016 totaling $45M. Anacor will also have the option to repurchase all rights in KERYDIN from Sandoz on the later of three years from launch or December 31, 2017, at a price to be determined pursuant to the agreement. Under the terms of the agreement, Anacor will supply product to Sandoz at cost through Anacorís contract manufacturers, and Sandoz will be responsible for all of its selling, marketing, distribution, general and administrative costs related to the commercialization of KERYDIN. Anacor will hold the NDA and will be responsible for any further development of KERYDIN.
06:43 EDTMRK, RHHBY, BMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 20, 2014
15:42 EDTRHHBYRoche not looking for big acquisitions, Reuters says
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July 17, 2014
17:42 EDTRHHBYCepheid says Roche patent suit will not have material adverse impact on results
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14:54 EDTJNJJohnson & Johnson weakness creates buying opportunity, says Argus
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10:56 EDTJNJJohnson & Johnson reports 18% passive stake in Minerva
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08:34 EDTNVSVanda requests award of $539M in proceedings with Novartis
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08:08 EDTPFE, BMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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07:18 EDTGSKMylan wins motion to enjoin GlaxoSmithKline from production of generic product
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06:23 EDTGSKGlaxoSmithKline admits to bribing Chinese officials in 2001, FT reports
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05:32 EDTNVSNovartis reconfirms FY14 revenue guidance up at low to mid single digit rate
The company stated, "We are reconfirming our outlook for FY14. Group net sales in 2014 are expected to grow at a low to mid-single digit rate. Group core operating income is expected to grow ahead of sales in 2014, and now refined to mid to high-single digit. This outlook recognizes the entry of generic competition for Diovan monotherapy in the U.S. on July 7, including an authorized generic from Sandoz on the same date. If June average exchange rates prevail for the remainder of the year, the currency impact for the year would be -1% on sales and -3% to -4% on core operating income."
05:29 EDTNVSNovartis reports Q2 Core EPS $1.34, consensus $1.42
Reports Q2 revenue $14.6B, consensus $14.81B. Reports continued pipeline progress with positive regulatory decisions and significant clinical trial data released in Q2.
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