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News Breaks
June 11, 2014
07:54 EDTCBST, SLXP, AZN, THRXFDA Anesthetic & Analgesic Drug Products Advisory Committee holds a meeting
The Committee reviews the potential cardiovascular risk associated with products in the class of peripherally-acting opioid receptor antagonists including Cubist's Alvimopan, AstraZeneca's Movantik, Theravance's Axelopran in a meeting being held at FDA Silver Spring, Maryland offices on June 11 at 8 am. Webcast Link
News For CBST;SLXP;AZN;THRX From The Last 14 Days
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July 31, 2014
06:24 EDTAZNAstraZeneca offers 'no comment' on Pfizer, Reuters reports
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July 30, 2014
06:10 EDTAZNAstraZeneca enters respiratory disease transaction with Almirall
AstraZeneca announced that it has entered an agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875M on completion, and up to $1.22B in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments. Upon completion of the transaction, AstraZeneca will own the rights for the development and commercialization of Almirall’s existing proprietary respiratory business, including rights to revenues from Almirall’s existing partnerships, as well as its pipeline of investigational novel therapies. The franchise includes Eklira, LAS40464, LAS100977 or abediterol, and multiple pre-clinical programs. Under the agreement, Almirall Sofotec, an Almirall subsidiary focused on the development of innovative proprietary devices, will also transfer to AstraZeneca. Almirall’s pipeline of respiratory assets and its device capabilities further strengthen AstraZeneca’s respiratory portfolio, which includes Symbicort and Pulmicort, as well as the company’s investigational medicines in development. The addition of aclidinium and the combination of aclidinium with formoterol, both in proprietary Genuair device, will allow AstraZeneca to offer patients a choice between dry powder inhaler and metered dose inhaler devices across a range of molecules and combinations. AstraZeneca and Almirall anticipate that, subject to local consultation and legislation, a significant number of employees dedicated to the respiratory business, including Almirall Sofotec employees, will transfer to AstraZeneca. The transaction is subject to certain competition law clearances as well as other customary terms and conditions. The companies anticipate the transaction will complete by the end of 2014.Reference Link
July 28, 2014
05:36 EDTAZNQIAGEN, AstraZeneca announce collaboration
QIAGEN (QGEN) announced a collaboration agreement with AstraZeneca (AZN) for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with IRESSA, AstraZeneca's targeted therapy for non-small cell lung cancer, or NSCLC. The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel QIAGEN companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca's oral monotherapy anti-cancer treatment when tumor tissue is not available. QIAGEN already offers the therascreen EGFR RGQ PCR Kit as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014. The companies will collaborate to create a new companion diagnostic for IRESSA based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study presented at the "World Lung 2013" conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method.
July 26, 2014
20:12 EDTTHRXTheravance looks overvalued, Barron's says
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July 24, 2014
10:03 EDTTHRXOn The Fly: Analyst Downgrade Summary
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07:32 EDTTHRXTheravance downgraded at BofA/Merrill
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06:07 EDTTHRXTheravance downgraded to Neutral from Buy at BofA/Merrill
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July 23, 2014
10:02 EDTSLXPOn The Fly: Analyst Initiation Summary
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10:02 EDTCBSTOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: 21st Century Fox (FOXA) downgraded to Market Perform from Outperform at Cowen... Brinker (EAT) downgraded to Sector Perform from Outperform at RBC Capital... Cubist (CBST) downgraded to Market Perform from Outperform at JMP Securities... DiamondRock (DRH) downgraded to Neutral from Outperform at RW Baird... DuPont (DD) downgraded to Neutral from Overweight at JPMorgan... FirstMerit (FMER) downgraded to Neutral from Overweight at JPMorgan... Helmerich & Payne (HP) downgraded to Accumulate from Buy at Tudor Pickering... Hexcel (HXL) downgraded to Hold from Buy at Canaccord... Juniper (JNPR) downgraded to Neutral from Buy at BofA/Merrill... King Digital (KING) downgraded at BofA/Merrill... Lexmark (LXK) downgraded at Raymond James... McDonald's (MCD) downgraded at RW Baird... Mead Johnson (MJN) downgraded to Outperform from Buy at CLSA... National Oilwell (NOV) downgraded to Accumulate from Buy at Tudor Pickering... Nintendo (NTDOY) downgraded to Hold from Buy at Jefferies... Raytheon (RTN) downgraded to Market Perform from Outperform at Bernstein... Targa Resources (TRGP) downgraded to Accumulate from Buy at Global Hunter... Time Warner (TWX) downgraded to Market Perform from Outperform at Cowen... Timmins Gold (TGD) downgraded to Market Perform from Outperform at Cowen... United Technologies (UTX) downgraded to Market Perform from Outperform at Wells Fargo... Viacom (VIAB) downgraded to Market Perform from Outperform at Cowen... Xilinx (XLNX) downgraded at BMO Capital.
08:10 EDTSLXPDeutsche Bank hosts an analyst Specialty Pharma/Industry conference call
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06:05 EDTCBSTCubist downgraded to Market Perform from Outperform at JMP Securities
JMP Securities downgraded Cubist citing the Q2 miss and slowing growth.
July 22, 2014
17:13 EDTCBSTCubist sees FY14 revenue toward low end of previous range
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16:08 EDTSLXPSalix initiated with a Hold at Deutsche Bank
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16:01 EDTCBSTCubist reports Q2 EPS 23c, may not compare to consensus 2c
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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.
July 17, 2014
05:24 EDTSLXPSalix, Pharming Group announces FDA approval of Ruconest
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