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February 4, 2014
08:25 EDTABBV, ABBV, AET, AET, AMGN, AMGN, ESRX, ESRX, HSP, HSP, MNTA, MNTA, PFE, PFEFTC to hold a workshop
The Biologics Workshop explores competition issues involving biologic medicines and follow-on biologics with a focus on the potential impact of state regulations affecting competition. Companies participating include AbbVie, Aetna, Amgen, Express Scripts, Hospira, Momenta Pharmaceuticals and Pfizer at the FTC Washington, D.C. offices on February 4 at 8:30 am. Webcast Link
News For ABBV;AET;AMGN;ESRX;HSP;MNTA;PFE From The Last 14 Days
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August 26, 2014
08:01 EDTPFEPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
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August 25, 2014
16:17 EDTAMGNWestern Digital CFO Leyden to retire, Olivier Leonetti to succeed
Western Digital (WDC) announced that CFO Tim Leyden is retiring. He is being succeeded by Olivier Leonetti, who has served as vice president, finance at Amgen (AMGN) from 2011. Leyden will remain with the company through January 2015 in a transition role and advisory capacity to president and chief executive officer Steve Milligan and to Leonetti for an interim period to ensure a smooth transition. The changes are effective as of September 8.
06:29 EDTPFEPfizer mulls possible AstraZeneca offer options, FT says
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August 22, 2014
14:19 EDTPFEViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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August 21, 2014
15:16 EDTABBVDEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
13:32 EDTPFEBristol-Myers, Pfizer announce approval of Eliquis for treatment of DVT, PE
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09:54 EDTPFEPotential Pfizer, AstraZeneca deal seen around year-end, Reuters says
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
08:02 EDTPFEPfizer initiates U.S. EAP for palbociclib.
Pfizer announced that the company has initiated a multi-center, open-label expanded access program in the U.S. for palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for post-menopausal women with hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer for whom letrozole is considered appropriate therapy.
07:57 EDTABBVGilead HCV risks overblown, says Bernstein
Bernstein believes that investors are concerned about upcoming competition to Gilead's (GILD) HCV drug from AbbVie's (ABBV) HCV treatment. But Bernstein says that insurers can only prevent 16% of the U.S. population from receiving Gilead's drug, and the firm does not expect the HCV market share dynamics to change in the near-term. It keeps an Outperform rating on Gilead.
07:55 EDTPFEActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTPFEPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
August 20, 2014
11:50 EDTHSPJudge rules generic Precedex FDA approval postponed, WSJ says
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08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 19, 2014
09:09 EDTHSPHospira discloses it filed lawsuit against FDA regarding Precedex
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09:08 EDTHSPHospira backs FY14 EPS $2.30-$2.50, consensus $2.43
05:11 EDTAMGNGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
11:41 EDTHSP, PFECubist rises after report sparks takeover interest speculation
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08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
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