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News Breaks
February 1, 2013
07:49 EDTGSK, PRGOPerrigo commences launch of clobetasol emulsion propionate foam, 0.05%
Perrigo (PRGO) announced that it has launched clobetasol emulsion propionate foam, 0.05%, the generic equivalent of Olux -E Foam, 0.05%. Perrigo will commence shipment of the product immediately. As Perrigo was the first generic filer against this product, it has 180 days of generic exclusivity. The launch date was agreed upon in a 2012 litigation settlement between Perrigo and GlaxoSmithKline (GSK).
News For PRGO;GSK From The Last 14 Days
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February 8, 2016
08:10 EDTGSKOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
07:03 EDTGSKBiogen joins Centre for Therapeutic Target Validation
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06:28 EDTGSKPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. 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
February 4, 2016
07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
07:23 EDTGSKGlaxoSmithKline confirms 2015 ordinary dividend of 80p, special dividend of 20p
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07:23 EDTGSKGlaxoSmithKline sees double digits CER FY16 core EPS percentage growth
If FX rates held at January average levels estimated impact of +5% on 2016 Sterling core EPS growth.
07:21 EDTGSKGlaxoSmithKline reports Q4 EPS (7.3p) vs. 21.5p last year
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06:13 EDTPRGOPfizer insists Allergan deal won't be thwarted by U.S. politicians, FT says
Pfizer (PFE) has insisted that its $160B acquisition of Allergan (AGN) will not be stifled by political opposition, amid criticism that the deal will cost the U.S. Treasury billions of dollars in future tax revenues, the Financial Times reports. Pfizer CEO Ian Read also reiterated his intention to postpone until 2018 a decision on whether to break of the combined entity into two or three smaller companies, but has said that he would be open to offers for its generics unit, the report says. Mylan (MYL) has been connected to a potential acquisition of Pfizer's generic drugs business after it failed in its attempt to buy Perrigo (PRGO) last year, the report says. Reference Link
February 2, 2016
08:17 EDTGSKAdaptimmune, GSK expand strategic immunotherapy collaboration
Adaptimmune Therapeutics (ADAP) and GlaxoSmithKline (GSK) announced that the companies have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune's lead clinical cancer program, an affinity enhanced T-cell immunotherapy targeting NY-ESO-1, toward pivotal trials in synovial sarcoma. Adaptimmune and GSK announced a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program through clinical proof of concept and, on exercise, will assume full responsibility for the program.
07:42 EDTGSKPressure mounts on big pharma names to shrink, sharpen focus, FT says
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06:32 EDTGSKGSK, J&J back Index Ventures' $1B biotech business spinoff, Reuters says
GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ) will back a new spinoff from Index Ventures, which is spinning off its biotech portfolio into a new $1B entity, Reuters reports. The New Medicxi Ventures business will be helmed by the existing life sciences team from Index and will include all the current biotech portfolio firms, the report says. Medicxi raises $229M for a new fund in Europe with GSK and J&J each putting in 25%, Reuters reports. Reference Link
January 26, 2016
12:12 EDTPRGOEndo spike attributed to takeover speculation
The midday spike in shares of Endo International (ENDP) is being attributed to takeover speculation. Conjecture has Perrigo (PRGO) interested in a potential acquisition of Endo, trading sources tell The Fly. Shares of Endo are up $1.26 to $59.10 in midday trading. The Fly, in fulfilling its mission of explaining stock movement, often comes across the many unconfirmed rumors being passed through trading desks and social media platforms. On the occasion that rumors or speculation appear on The Fly's news feed, it should be viewed not as giving credence to the conjecture, rather as simply highlighting its impact on the stock prices of the companies involved.

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