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News Breaks
June 12, 2014
16:20 EDTAZN, NKTRNektar: U.S. AADPAC recommends no cardiovascular trial for pamora class
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the majority of US FDA Anesthetic and Analgesic Drug Products Advisory Committee members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist class of drugs, which includes MOVANTIKTM, an investigational treatment for opioid-induced constipation for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act date set by the FDA for MOVANTIK is September 16.
News For NKTR;AZN From The Last 14 Days
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November 18, 2014
14:59 EDTAZNRanbaxy sues FDA for rescinding approval of Nexium, Valcyte copies, Reuters says
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07:29 EDTAZNPfizer less likely to pursue AstraZeneca after PD-L1 deal, says JPMorgan
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07:18 EDTAZNWoodford confident in Astra, sees 50% chance of new Pfizer bid, Reuters reports
Investment manager Neil Woodford of Woodford Investment Management said he now has an even stronger belief in AstraZeneca (AZN), citing the company's strong product pipeline, and put the chances of a new takeover bid from Pfizer (PFE) at 50/50, reported Reuters, citing a statement from Woodford. Reference Link
06:39 EDTAZNAstraZeneca: 'Hard to comment' on whether Pfizer will come back, Reuters reports
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November 17, 2014
09:37 EDTAZNAstraZeneca to host investor day
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07:16 EDTAZNMilken Institute--Faster Cures to hold a conference
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07:08 EDTAZNMedImmune presents positive Phase IIb data for mavrilimumab in RA
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07:07 EDTAZNMedImmune presents new data in systemic lupus
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06:43 EDTAZNAstraZeneca, Pfizer deal seen less likely after Merck transaction, Reuters says
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November 16, 2014
13:36 EDTAZNAstraZeneca presents data from studies of lesinurad combined with allopurinol
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November 14, 2014
14:53 EDTAZNCVS 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
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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07:53 EDTNKTRLeerink to hold a tour
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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).
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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