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News Breaks
August 21, 2014
05:42 EDTAZN, JNJ, ILMN, SNYIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
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November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJ, SNY, AZNCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies 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). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTAZNAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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07:40 EDTSNYSanofi investor meeting timing tough in light of CEO ouster, Reuters says
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07:16 EDTAZNBIT Congress to hold a conference
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07:03 EDTAZNAstraZeneca initiates development program for Brilinta reversal agent
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05:34 EDTAZNAstraZeneca, Isis Pharmaceuticals to co-develop oligonucleotide delivery methods
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November 12, 2014
11:17 EDTAZNLeerink major pharma & biotech analysts hold analyst/industry conference call
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08:13 EDTSNYBoston Biotech to hold a conference
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07:35 EDTAZNAdvaxis submits IND application for ADXS-HPV Phase 1/2 study, MEDI4736
Advaxis (ADXS) announced that the company has submitted an Investigational New Drug application, or IND, to the FDA to conduct a Phase 1/2 study of ADXS-HPV alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. This follows the press release issued in July announcing the clinical trial collaboration between Advaxis and MedImmune, the global biologics research and development arm of AstraZeneca (AZN).
07:22 EDTILMNAssociation of Molecular Pathology is holding annual meeting
2014 Annual Meeting of AMP is being held in National Harbor, Maryland on November 12-15.
November 11, 2014
16:05 EDTAZNAmgen, AstraZeneca say Phase 3 brodalumab study met endpoints
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15:43 EDTAZNLeerink major pharma & biotech analysts hold analyst/industry conference call
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10:14 EDTSNYRegeneron data reinforce blockbuster potential of dupilumab, says Piper Jaffray
Piper Jaffray believes the Phase IIb results for dupilumab in patients with moderate to severe asthma reported by Regeneron (REGN) and partner Sanofi (SNY) reinforce the broad potential of the drug in a range of allergic diseases. The firm reiterates its $416 price target and Overweight rating on shares of Regeneron.
05:26 EDTSNYRegeneron, Sanofi announce dupilumab Phase 2b study met primary endpoint
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November 10, 2014
15:54 EDTSNYAmerican Society of Nephrology to hold a conference
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07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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